Public Patent Powers

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many of these powers, but they have been reluctant to use others. Notably, agencies have refused to grant compulsory licenses on patents covering federally funded drugs, despite multiple requests to do so.

The descriptive account of public patent powers has several implications for patent regulation. Public patent powers show different actions that the executive branch could take without the need for any legislative action when patents create policy concerns, as is currently happening with high drug prices. Themes in public patent powers and their use also reveal consistent policy judgments present throughout the history of patent regulation in the United States. These themes create a framework for identifying contexts where executive control over patents may be appropriate and politically feasible. The descriptive account further suggests that the Supreme Court’s decision in Oil States v. Greene’s Energy may have broader implications than previously recognized. Moving forward, this Article contends that the executive branch should create an interagency framework to guide how agencies use public patent powers and that courts should consider themes in public patent powers when deciding whether to grant injunctions in patent cases.

Introduction

The federal government helped fund the development of Xtandi, a life-saving prostate cancer drug. Researchers at the University of California Los Angeles discovered the drug, supported by millions of dollars of grants from the National Institutes of Health (NIH) and the Department of Defense (DOD).1See UCLA Spore in Prostate Cancer, NIH, https://reporter.nih.gov/search/BlYg9TxMZ0iKZATG_9un5A/project-details/6659026 [perma.cc/UL84-CXD8] (providing over .2 million of funding in FY2003 and reporting total project funding of over .9 million); Charlie D. Chen, Role of Nuclear Receptor Cofactors in Hormone Refractory Prostate Cancer (2005); Role of Nuclear Receptor Cofactors in Hormone Refractory Prostate Cancer, Def. Tech. Info. Ctr., https://dtic.dimensions.ai/details/grant/grant.7142872?search_mode=content&search_text=W81XWH-04-1-%0A0129&search_type=kws&search_field=full_search [perma.cc/NTP3-MTT8] (awarding 0,192).
Now, U.S. taxpayers and patients pay exorbitant prices for the drug. Medicare spent over $7.8 billion on Xtandi prescriptions over a five-year period.2See Medicare Part D Spending by Drug, Ctrs. for Medicare & Medicaid Servs., https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug [perma.cc/2ZN3-6NQ6] (reporting spending from 2018 to 2022). Xtandi was among the drugs selected for Medicare Price Negotiation in 2025. Any negotiated prices from that process will become effective in 2027. Press Release, Ctrs. for Medicare & Medicaid Servs., HHS Announces 15 Additional Drugs Selected for Medicare Drug Price Negotiations in Continued Effort to Lower Prescription Drug Costs for Seniors (Jan. 17, 2025), https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower [perma.cc/3WDD-98WC].
In 2022, the average wholesale price was $130 per capsule in the United States—more than six times the price in Japan.3Xtandi: 2021–2022 Request to US Department of Health and Human Services to Use the US Government’s Rights in Patents, Knowledge Ecology Int’l, https://www.keionline.org/xtandi2021#prices-US [perma.cc/HWS8-5FB9] (reporting that the price in Japan was .64 per capsule in 2021).

The high U.S. price is largely due to patents. Since 2012, Astellas Pharma and Pfizer have marketed Xtandi in the United States without generic competition. The Food & Drug Administration (FDA) has approved generic versions of the drug, but patents are preventing those generics from reaching the market.4Xtandi, Drugs@FDA: FDA-Approved Drugs, U.S. Food & Drug Admin., https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203415 [perma.cc/D846-VMHU]; see also Letter from FDA to Actavis Lab’ys re: ANDA 209614 Approval (May 14, 2021); Letter from FDA to Sandoz re: ANDA 216068 Tentative Approval (Aug. 2, 2022); Christopher Yasiejko, Astellas, Aurobindo to Drop Patent Fight over Xtandi Cancer Drug, Bloomberg L. News (Sept. 4, 2019, 1:20 PM), https://www.bloomberglaw.com/bloomberglawnews/pharma-and-life-sciences/X3IF5NS0000000?bna_news_filter=pharma-and-life-sciences#jcite [perma.cc/W3VV-CVDJ]; Complaint, Astellas v. Zydus, No. 1:16-cv-1120 (D. Del. Dec. 2, 2016); Dismissal Order, Astellas v. Zydus, No. 1:16-cv-1120 (D. Del. June 18, 2018).
Recently, legislators and scholars have asked the NIH and DOD to step in and authorize generic manufacturers to start producing Xtandi despite the patents.5See, e.g., Letter from Sen. Elizabeth Warren et al. to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (Jan. 10, 2023); Letter from Sen. Elizabeth Warren, Rep. Lloyd Doggett & Sen. Angus S. King, Jr., to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (Feb. 17, 2022); Letter from Ameet Sarpatwari, Assistant Professor of Med., Brigham and Women’s Hosp., Harvard Med. Sch., et al. to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (Feb. 2, 2022).
The Bayh-Dole Act, which provides default rules for patents on federally funded inventions, gives the government power to grant compulsory licenses on the patents covering Xtandi.6U.S. Patent No. 8,183,274, col. 1 ll. 20–24; U.S. Patent No. 7,709,517, col. 1 ll. 14–18; U.S. Patent No. 9,126,941, col. 1 ll. 18–23; see also Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, 88 Fed. Reg. 85593 (Dec. 8, 2023).
Advocates argue that granting compulsory licenses on the Xtandi patents would allow generics to enter the market, which in turn would lower the drug price.7See supra note 5 and accompanying text.
But so far, agencies have refused to grant compulsory licenses.8See Ed Silverman, NIH Rejects Bid to Cut a Cancer Drug’s Price by Sidestepping Patents, Stat (Mar. 22, 2023), https://www.statnews.com/pharmalot/2023/03/22/nih-cancer-patents-bayh-dole-xtandi [perma.cc/6GVR-AWNW]; Carolyn Y. Johnson, Taxpayers Helped Fund This 9,000 Cancer Drug. Should the Government Help Cut the Price? Wash. Post (Jan. 14, 2016, 12:02 PM), https://www.washingtonpost.com/news/wonk/wp/2016/01/14/taxpayers-helped-fund-this-129000-cancer-drug-should-the-government-help-cut-the-price [perma.cc/29AW-W72U]; Michael Hiltzik, Column, The Government Could Force a Price Cut for This Prostate Cancer Drug by As Much As 80%. Why Hasn’t It Acted?, L.A. Times (Feb. 10, 2022, 6:00 AM), https://www.latimes.com/business/story/2022-02-10/xtandi-pricing-prostate-cancer-drug [perma.cc/F8H8-DGCP].

Most recently, in December 2023, the Biden Administration published proposed guidance stating that even though the government has not granted compulsory licenses to address the high price of Xtandi, it could if it wants to.9The guidance addresses a statutory interpretation debate about whether the Bayh-Dole Act allows agencies to order compulsory licenses based on unreasonable prices. See Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights, 88 Fed. Reg. at 85598–99. This debate is described in more detail in Part IV.
This proposed guidance drew harsh criticism from some, such as the Wall Street Journal Editorial Board, who described the proposal as an attempt to “steal” patents.10Editorial, Biden Ambushes Pharma Patents, Wall St. J. (Dec. 10, 2023, 5:30 PM), https://www.wsj.com/articles/biden-ambushes-pharma-patents-30a71b62 [perma.cc/Y47V-UBSU].
As this “patent heist” rhetoric shows, a heated debate persists over whether the government should order compulsory licenses on patents covering prescription drugs. In recent years, numerous members of Congress and other commentators have urged the government to order compulsory licenses to expand access to life-saving medicines.11See, e.g., Letter from Sen. Elizabeth Warren, Sen. Angus S. King, Jr. & Rep. Lloyd Dogget to Gina Raimondo, Sec’y, Dep’t of Com. & Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (June 9, 2023); Letter from Sen. Bernard Sanders to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (June 7, 2023); Letter from Sen. Elizabeth Warren to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs (Apr. 22, 2022); Letter from Amy Kapczynski, Professor of L., Yale L. Sch., et al., to Sen. Elizabeth Warren (Apr. 20, 2022); Brittany Day, Note, A Modest Proposal: Leveraging Private Enforcement Mechanisms and the Bayh-Dole Act to Reduce Drug Prices in the U.S. Healthcare Industry, 17 Duke J. Const. L. & Pub. Pol’y 51, 52 (2021); Editorial, How the Government Can Lower Drug Prices, N.Y. Times (June 20, 2018), https://www.nytimes.com/2018/06/20/opinion/prescription-drug-costs-naloxone-opioids.html [perma.cc/DSQ2-NQJK]; Alfred B. Engelberg & Aaron S. Kesselheim, Use the Bayh-Dole Act to Lower Drug Prices for Government Healthcare Programs, 22 Nature Med. 576 (2016).
Others, however, strongly oppose such licenses.12See Megan Van Etten, Setting the Record Straight on the Bayh-Dole Act and March-in, PhRMA (May 10, 2023), https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Fact-Sheets/A-C/bayh-dole-multipage-V5.pdf [perma.cc/47NW-9PQB]; Joseph P. Allen, President Biden: Don’t Misuse Bayh-Dole March-in Rights, STAT (Sept. 17, 2021), https://www.statnews.com/2021/09/17/president-biden-dont-misuse-bayh-dole-march-in-rights [perma.cc/6QMV-UT33]; Fred Reinhart, Exercising Bayh-Dole March-in Rights Would Handicap Covid-19 Innovation, STAT (May 4, 2020), https://www.statnews.com/2020/05/04/bayh-dole-march-in-rights-handicap-covid-19-innovation [perma.cc/VE3P-9T33].

Amidst the debates about whether the government should intervene when patent holders charge unreasonably high prices for drugs, less attention has been given to the larger ecosystem of patent powers that Congress has given agencies. The law that authorizes agencies to order compulsory licenses on federally funded inventions is just one of many laws that expressly authorize agencies to make decisions about how patents are used in commerce. Other similar laws have received attention in isolation. For example, scholars and legislators have pointed to Section 1498—a law that insulates government contractors from injunctions for patent infringement—as another potential tool to address high drug prices.13Letter from Sen. Elizabeth Warren et al. to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (June 23, 2022); Hannah Brennan, Amy Kapczynski, Christine H. Monahan & Zain Rizvi, A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health, 18 Yale J.L. & Tech. 275, 349–53 (2016); Amy Kapczynski & Aaron S. Kesselheim, ‘Government Patent Use’: A Legal Approach to Reducing Drug Spending, 35 Health Affs. 791, 792 (2016).
Scholars have also observed that the International Trade Commission (ITC) has statutory discretion to allow imports of products that infringe patents to address concerns about anticompetitive conduct.14Colleen V. Chien & Mark A. Lemley, Patent Holdup, the ITC, and the Public Interest, 98 Cornell L. Rev. 1, 5 (2012).
But the broader institutional design choice by Congress to give agencies express power to control patents has gone relatively unnoticed.

This Article examines that institutional design choice by providing the first comprehensive survey of the U.S. Code to compile laws that expressly give agencies power to make decisions about patents. This empirical survey provides new insights about how Congress has struck the balance between public and private control when designing the patent system, as well as new insights about the full scope of express powers that agencies currently have.

Across 68 statutes, I locate 113 conditions that explicitly allow the executive branch to control patents.15Appendix A.
These powers, which I refer to as “public patent powers,” generally allow agencies to make choices about who can access patented technology and how patent holders can exercise their rights to exclude.16See infra Part II.
I then create a taxonomy of four distinct types of public patent powers: powers for the government (1) to obtain patent licenses, (2) to obtain patents, (3) to grant third parties patent licenses, and (4) to directly regulate how patents are used.17See infra Part II.
Although agencies have used many of their powers in a variety of contexts,18See infra Part II.
they have been reluctant to grant compulsory licenses on patents covering federally funded inventions. The NIH, for example, has consistently refused to grant compulsory licenses on federally funded drugs under the Bayh-Dole Act, despite multiple requests to do so—both in the case of Xtandi and in other cases.19See infra Section II.D.3.

Based on these findings, this Article makes a descriptive claim that Congress has expressly created numerous structures for agencies to make decisions about how patents are used in commerce. At least 68 different laws explicitly allow executive actors to make some form of decision about patents, including decisions about whether the government and third parties can use patented inventions. This descriptive claim contributes to the ongoing debate about the nature of patent rights by showing that the patent system includes more explicit structures for regulatory oversight than previously recognized. The landscape of laws provides a roadmap of existing executive powers, and the observations about their use in practice provide guidance about practical barriers that may arise for different types of powers. It also reveals several themes in public patent powers: Congress has granted these express powers in contexts where inventions were developed with federal funds, where technology is useful for government programs, where public health and safety needs are at stake, and where patents are coupled with market power.20See infra Section III.B.
These themes create a framework for identifying situations where limits on private control of patents might be both appropriate and politically feasible. Furthermore, the plethora of public patent powers shows that the Supreme Court’s 2018 decision in Oil States v. Greene’s Energy may have broader implications than previously appreciated.21See infra Part III.

The descriptive account of public patent powers raises normative questions about whether agencies should use these powers more often. Several reasons could be behind the failure to order compulsory licenses on federally funded inventions, some of which are more worrying than others.22See infra Section IV.A.
The same is true for agencies’ sporadic use of other powers, such as the power to place conditions in funding agreements. It is difficult to normatively assess how agencies have been using their powers because there is no coherent theory supporting when the various powers should be used. To address this problem, the executive branch should create an interagency framework that provides guidance about when agencies should use their powers. Interagency guidance would be helpful because although public patent powers allow a range of agencies across a range of regulatory contexts to make decisions about patents, questions about whether to use the powers involve similar economic policy and public welfare questions across contexts. The Biden Administration took a first step toward this model in December 2023 when it released a draft interagency framework regarding when agencies should use their powers to order compulsory licenses on federally funded inventions.23Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights, 88 Fed. Reg. 85593 (Dec. 8, 2023).
This Article contends that the federal government should not stop there. It should provide interagency guidance about when the full scope of public patent powers should be used, including the powers of the government to produce patented products, to authorize government contractors to use patents, to place conditions in funding agreements, and to grant exclusive licenses on agency-owned patents.24See infra Section IV.B.

Outside of the executive branch, courts also should consider lessons from public patent powers. The themes in public patent powers reveal consistent policy judgments about contexts where regulatory oversight of patent decisions is appropriate.25See infra Section III.B.
In these contexts, Congress has recognized that the government should have the power to limit private control over decisions about how patents are used. How much control private patent holders should have over their patents is the same issue that courts consider when deciding whether to grant injunctions in patent cases.26See infra Section I.B.
Therefore, themes in public patent powers provide guidance about where limits on private control—through the denial or tailoring of injunctions—might be appropriate.

This Article proceeds in four parts. Part I describes the patent right to exclude and surveys the ongoing debate over how broadly private patent holders should control decisions about how patents are used. Part II defines the concept of “public patent powers” and explains how these powers operate in the administrative state. Part III discusses implications of the descriptive claim about public patent powers for patent regulation. Part IV addresses normative considerations about the use of public patent powers and provides suggestions for how agencies and courts could use insights from the descriptive account of public patent powers moving forward.

I. The Patent Right to Exclude

The Constitution authorizes Congress to create a patent system.27 U.S. Const. art. I, § 8.
Throughout the history of the United States, Congress has authorized the executive branch to grant patents.28See Greg Reilly, Power over the Patent Right, 95 Tul. L. Rev. 211, 249–62 (2021).
Under the current law, patents entitle patent holders “to exclude others from making, using . . . or selling” the claimed inventions.2935 U.S.C. § 154(a)(1).
The right to exclude, however, is not unlimited. This Part describes limits on the right to exclude and ongoing debates about the appropriate level of control to grant to private patent holders. It then describes recent calls for agencies, rather than courts, to play a more active role in tailoring patent rights.

A. Limits on the Right to Exclude

A patent creates an entitlement to “exclude others from making, using, offering for sale, or selling the invention.”30Id.
After obtaining a patent, a patent holder has broad discretion over how to use their right to exclude. Typically, the patent holder can decide whether to grant licenses to others to use the patented invention and on what terms.31See, e.g., In re Indep. Serv. Orgs. Antitrust Litig., 203 F.3d 1322, 1325–37 (Fed. Cir. 2000).
But the patent right to exclude is not absolute. For example, antitrust law places some constraints on patent licensing activities.32See, e.g., FTC v. Actavis, Inc., 570 U.S. 136 (2013); DOJ & FTC, Antitrust Guidelines for the Licensing of Intellectual Property (2017); Michael A. Carrier, Cabining Intellectual Property Through a Property Paradigm, 54 Duke L.J. 1, 108–09 & n.524 (2004) (“[B]oth the Department of Justice and the Federal Trade Commission have ordered compulsory licensing as a condition of antitrust consent decrees and merger approvals.”).
Patents also last only for a limited time, typically around 20 years.3335 U.S.C. §§ 154(a)(2)–(b).
Moreover, patent holders cannot exclude others if a court or the U.S. Patent & Trademark Office (Patent Office) concludes that the patent does not meet the patentability requirements.34See 35 U.S.C. §§ 282(b), 318(b), 328(b). Patent holders also cannot use a patent to stop certain experimental uses, see Madey v. Duke Univ., 307 F.3d 1351 (Fed. Cir. 2002), or to stop others who used an invention before the patent application was filed from continuing to do so, 35 U.S.C. § 273. See also id. §§ 252, 287(c), 318(c), 328(c).

The right to exclude is also limited by the remedies available when third parties infringe patents.35Carrier, supra note 32, at 110–18 (describing equitable defenses in patent cases).
Generally, when the law creates an entitlement, the law must also decide what rules will apply to protect the entitlement.36Guido Calabresi & A. Douglas Melamed, Property Rules, Liability Rules, and Inalienability: One View of the Cathedral, 85 Harv. L. Rev. 1089, 1105–06 (1972).
These protections typically involve a mix of what scholars have referred to as “property rules” and “liability rules.”37Id. at 1092.
Under a property rule, the person who holds the entitlement cannot be forced to relinquish the entitlement involuntarily38See id.
: If a patent holder does not want to voluntarily license its patent to someone, the patent holder could obtain an injunction to stop the other entity from infringing the patent.39See Sarah Rajec, Third-Party Interests and the Property Law Misfit in Patent Law, 41 Cardozo L. Rev. 1859, 1883–84 (2020).
Under a liability rule, a third party can encroach on an entitlement if the party is willing to pay an objectively determined amount40Calabresi & Melamed, supra note 36, at 1092.
: A liability rule is in place when the remedy for patent infringement is damages rather than an injunction. Under a liability rule for patents, a third party can simply make payments to infringe a patent, regardless of the patent holder’s desires.41See Rajec, supra note 39, at 1884.
Patent law provides for a mix of property rules and liability rules to protect patent entitlements. Sometimes injunctions are awarded as remedies for patent infringement, and sometimes damages are4235 U.S.C. §§ 283–84.
—courts play the primary role in determining whether injunctions are appropriate in different circumstances.4335 U.S.C. § 283.

B. The Role of Injunctions in Patent Law

In general, when a court denies an injunction, it limits a patent holder’s right to exclude. By denying injunctions, courts allow third parties to access technology in exchange for a fee. Because of this tradeoff, debates about the availability of injunctive relief have become debates about how broadly patent holders should control patent rights to exclude.

For much of American history, patent law doctrine created strong property rules for patent infringement remedies. Courts routinely awarded injunctions as remedies for patent infringement.44 James Bessen & Michael J. Meurer, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk 264 n.8 (2008).
In 2006, however, the Supreme Court announced a new test for courts to decide whether injunctions are appropriate for patent infringement.45eBay Inc. v. MercExchange, LLC, 547 U.S. 388, 390 (2006).
In eBay Inc. v. MercExchange, LLC, the Court held that the equitable four-factor test that courts generally apply to decide whether to grant injunctions also applies to patent cases.46Id. at 390.
The eBay test provides that courts may award injunctions if (1) the plaintiff has shown an irreparable injury, (2) damages are inadequate to compensate for the injury, (3) the equitable balance of the hardships between the parties supports an injunction, and (4) the public interest would not be disserved by an injunction.47Id. at 391.

Even after eBay, the availability of injunctions for patent infringement remains a contentious topic.48See, e.g., STRONGER Patents Act of 2019, S. 2082, 116th Cong. § 106 (2019) (proposing to make it easier to get an injunction for patent infringement by creating a presumption of irreparable harm and inadequate damages); Adam Mossoff, The Injunction Function: How and Why Courts Secure Property Rights in Patents, 96 Notre Dame L. Rev. 1581, 1581 (2021); Dirk Auer, Geoffrey A. Manne, Julian Morris & Kristian Stout, The Deterioration of Appropriate Remedies in Patent Disputes, 21 Federalist Soc’y Rev. 158 (2020); Ted Sichelman, Purging Patent Law of “Private Law” Remedies, 92 Tex. L. Rev. 517 (2014).
The tradeoff between a property rule (injunctions) and a liability rule (damages) involves a balance of competing policy interests. This tradeoff seeks to balance the goal of providing incentives for investment in research with the goal of providing public access to innovative technologies.49Sarah R. Wasserman Rajec, Tailoring Remedies to Spur Innovation, 61 Am. U. L. Rev. 733, 735 (2012).
In general, scholars have argued that strong property rights encourage investment in research and development because they provide stable expectations about investments and allow investors to capture more of the value of their inventions.50 Bessen & Meurer, supra note 44, at 34–35.
Proponents of injunctions have also argued that injunctions are particularly appropriate in patent law because patents are difficult to value, which systematically risks undervaluing patent damages.51John M. Golden, “Patent Trolls” and Patent Remedies, 85 Tex. L. Rev. 2111 (2007); Auer et al., supra note 48, at 162–65; see also Calabresi & Melamed, supra note 36, at 1118–21.

At the same time, others have embraced the eBay test, and most acknowledge that liability rules are appropriate in some circumstances.52See, e.g., Mark A. Lemley, Taking the Regulatory Nature of IP Seriously, 92 Tex. L. Rev. See Also 107, 109–11 (2014); Golden, supra note 51, at 2148–49 (expressing skepticism about categorical rules to deny injunctions, but noting courts could still deny injunctions based on undue hardship or the public interest).
In the eBay decision itself, Justice Kennedy observed in a concurring opinion that limits on injunctive relief can be appropriate to address concerns about anticompetitive conduct by patent holders. Specifically, Justice Kennedy discussed concerns that firms that do not “practice” inventions could use the threat of injunctions “as a bargaining tool to charge exorbitant fees” on patent licenses.53eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 396 (2006) (Kennedy, J., concurring).
Non-practicing firms are those that acquire and assert patents but do not make, use, sell, or license their patented inventions.54 FTC, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy Ch.3, at 38 (2003).

In Justice Kennedy’s view, when a firm that does not practice an invention uses the threat of an injunction solely to gain “undue leverage in negotiations,” an injunction “may not serve the public interest.”55eBay Inc., 547 U.S. at 396–97 (Kennedy, J., concurring).
Courts, having adopted this test, now deny injunctions more often when patent holders do not practice inventions.56Rajec, supra note 39, at 1889.
Scholars have suggested that limits on injunctions are in the public interest in other situations, such as in public health crises like the COVID-19 pandemic.57See, e.g., Sapna Kumar, Compulsory Licensing of Patents During Pandemics, 54 Conn. L. Rev. 57 (2022) (proposing legislative reform to increase availability of compulsory licenses in response to drug shortages); see also Sichelman, supra note 48, at 525; BJ Ard, More Property Rules than Property? The Right to Exclude in Patent and Copyright, 68 Emory L.J. 685, 730–35 (2019) (proposing suggestions to incorporate more liability rules in IP remedies); Mark A. Lemley & Carl Shapiro, Patent Holdup and Royalty Stacking, 85 Tex. L. Rev. 1991, 2035–39 (2007) (proposing courts deny injunctions in narrow situations to address concerns about patent holdup).
Moreover, some have observed that liability rules are not necessarily inconsistent with the goal of incentivizing research and development.58Arti Rai et al., Panel, Whether and How the U.S. Government Should Exercise Its Compulsory Licensing Authority Under 28 U.S.C. § 1498 and the Bayh-Dole Act, 11 N.Y.U. J. Intell. Prop. & Ent. L. 38, 51–52 (2021).
If compensation awards are high, they can provide strong incentives to innovate.59See Daniel J. Hemel & Lisa Larrimore Ouellette, Valuing Medical Innovation, 75 Stan. L. Rev. 517 (2023).
Based on these considerations, scholars have argued that a more context-specific utilitarian view of when injunctions are appropriate—rather than a strong property rules framework—better supports the goals of the patent system.60See, e.g., Rajec, supra note 49, at 773–83 (arguing for a greater role for the public interest prong of the eBay test).

C. Regulatory Oversight of Patents

Recently, discourse about the availability of injunctions for patent infringement has shifted from debates about what courts should do to debates about what agencies should do. In response to high drug prices, scholars and policymakers have urged federal agencies to take more control over patents on costly drugs.61See supra note 11 and accompanying text.
Many have also suggested that agencies should step in and remove the threat of injunctions for generic manufacturers who infringe pharmaceutical patents.62See id.
These proposals are controversial, and agencies have been reluctant to use their powers to authorize generic production of pharmaceuticals.63Letter from Lawrence A. Tabak, Acting Dir., NIH, to Robert Sachs and Clare Love (Mar. 21, 2023) [hereinafter Xtandi Determination II] (denying march-in license request); Letter from Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs., to Robert J. Sachs, Clare M. Love & Eric Sawyer (Feb. 5, 2024) (affirming NIH decision); see supra note 12 and accompanying text.

Drug pricing proposals focus primarily on two laws that give agencies powers to remove the threat of injunctions for patent infringement: Section 1498 and the Bayh-Dole Act.64See 28 U.S.C. § 1498; 35 U.S.C. § 203.
Proposals to use Section 1498 and the Bayh-Dole Act are notable because they rely on existing laws that allow executive actors to make judgments about the breadth of control patent holders have over their rights to exclude. When advocating for agency use of these powers, commentators urge agencies to balance the same policy goals that courts typically balance when deciding whether to grant injunctions in patent cases. Both Section 1498 and the Bayh-Dole Act authorize agencies to decide whether injunctions will be available for third parties who infringe patents under certain conditions.65See id.
If an agency decides to insulate a third party from an injunction, the agency is making the decision to protect the patent by a liability rule rather than a property rule. In making these decisions, agencies can balance the policy goals of incentivizing investment and promoting public access to technology.

The fact that Congress has given agencies powers to make these patent policy decisions has not received much academic attention. As discussed above, it is well known that both courts and Congress have powers to tailor rights to exclude.66See supra Sections I.A–B, which discuss how scholars regularly acknowledge that Congress tailors the right to exclude when it passes patent laws, such as the laws that set the conditions for receiving patents and patent terms. Courts further tailor those rights when they interpret patentability standards and determine remedies.
Less attention has been given, however, to contexts where agencies have powers to tailor patent rights to exclude.67See infra notes 70–72, for discussion of literature on agency powers.

Indeed, some scholars have assumed that little regulatory oversight exists after patents are issued. For example, Professor Greg Reilly describes the patent examination system as including “[n]o significant government role in regulating, enforcing, or reconsidering patent rights.”68Reilly, supra note 28, at 222.
Moreover, he argues that throughout the twentieth century, there was “virtually no government control, regulation, or involvement with issued patents.”69Id. at 260–61; see also Herbert Hovenkamp, The Emergence of Classical American Patent Law, 58 Ariz. L. Rev. 263, 292–93 (2016) (describing “considerable insulation from subsequent regulatory control” in patent examination system).
At the same time, however, others discuss individual laws that allow for executive actors outside the Patent Office to regulate rights to exclude—for example, proposals to use Section 1498 and the Bayh-Dole Act.70See supra notes 11, 13 and accompanying text.
Scholars have also discussed the role of the ITC in making decisions about whether to allow imports that infringe U.S. patents.71Chien & Lemley, supra note 14, at 39–43; see also Sapna Kumar, The Other Patent Agency: Congressional Regulation of the ITC, 61 Fla. L. Rev. 529 (2009).
Moreover, others have discussed the role that agencies play in influencing patent policy, including standards for patentability and patent litigation.72See, e.g., Tejas N. Narechania, Patent Conflicts, 103 Geo. L.J. 1483, 1492–94 (2015); Jacob S. Sherkow, Administrating Patent Litigation, 90 Wash. L. Rev. 205 (2015); Arti K. Rai, Patent Validity Across the Executive Branch: Ex Ante Foundations for Policy Development, 61 Duke L.J. 1237 (2012); John F. Duffy, The Federal Circuit in the Shadow of the Solicitor General, 78 Geo. Wash. L. Rev. 518 (2010).

Amidst this literature, little is known about how often and in what contexts Congress has expressly authorized agencies to control patents. To understand what powers agencies have under existing laws and to evaluate whether the current landscape of public patent powers strikes the right balance, this Article conducts a survey of the U.S. Code to provide empirical information about contexts where Congress has expressly authorized agencies to make decisions about patents.

II. Public Patent Powers in the Administrative State

This Article defines “public patent powers” as laws that expressly give the executive branch a lever of control over patent rights to exclude. These laws allow agencies to control patents in two primary ways. First, they allow agencies to make decisions about when patents will be protected by liability rules. Agencies can make decisions that require patent holders to license or sell patents in exchange for compensation. Second, they allow agencies to directly regulate how rights to exclude are exercised. Agencies can either take control of patent title or place limits on patent use. This Part describes my methodology for locating public patent powers, then provides a detailed description of how public patent power laws operate in the administrative state.

A. Identifying Public Patent Powers

I conducted an empirical, comprehensive search of the U.S. Code and identified 113 express powers across 68 statutes that expressly create public patent powers.73These laws are listed in Appendix A. To identify public patent powers, I searched for the term “patent” in the U.S. Code on Westlaw and then reviewed each statute to determine whether it included a public patent power as defined in this Article. This methodology is subject to a few potential limitations. The search is current as of October 28, 2022. It only includes laws that were on the books at that time, not later passed laws or laws that were previously enacted and were repealed. I also did not search for the phrase “intellectual property,” so it is possible other laws give agencies powers over patents using that phrase. Furthermore, the search is limited to codified laws. Nonetheless, this methodology provides a comprehensive analysis of codified laws that expressly grant executive powers to control patents. To the extent more exist, it only further supports the descriptive claim that Congress has created numerous structures for agencies to oversee how patents are used.
I sorted these powers into four different categories: powers to obtain patent licenses, to obtain title to patents, to grant licenses to third parties, and to regulate how patent holders can use their rights to exclude. Table 1 summarizes the frequency of each type of power.

Table 1: Frequency of Public Patent Powers

Type of Public Patent Power

Number of Express Statutory Grants

Government License

40

Government Title

40

Third-Party Licenses

26

Direct Regulation

7

Total

113

Together, these laws show that Congress has created numerous structures that allow executive actors to make decisions about how patents are used in commerce. Public patent powers allow the government to regulate access to patented inventions, either by accessing technologies itself or by deciding the terms upon which third parties can access technologies. In doing so, these laws allow executive actors, rather than courts or private parties, to make decisions about how broadly patent holders can use their right to exclude.

Outside of these express public patent powers, it is worth noting that many other laws may allow agencies to influence patent holder conduct, including decisions about whether to grant third parties access to patented inventions. For example, the recently enacted Medicare price negotiation program allows Medicare to negotiate the prices of drug products that do not face competition in the market.74See Inflation Reduction Act of 2022, Pub. L. No. 117-169, § 11001, 136 Stat. 1818, 1833 (2022).
This law may lead patent holders to license their patents more readily to avoid price negotiation.75See Arti K. Rai, Rachel E. Sachs & W. Nicholson Price II, Cryptic Patent Reform Through the Inflation Reduction Act, 37 Harv. J.L. & Tech. 57, 72–82 (2023).
Similarly, antitrust laws can influence patent settlement and licensing agreements.76See Carrier, supra note 32. Moreover, the Defense Production Act allows the government to order domestic manufacturing, which in turn could order companies to infringe patents. See 50 U.S.C. §§ 4501, 4511.
These other laws that do not expressly mention patents provide even more structures for agencies to regulate patent holder conduct. This Article, however, focuses on explicit grants of powers over the right to exclude to study the institutional design choices that expressly authorize public control over patent decisions.

Furthermore, this Article focuses on laws that allow agencies to control patents after they issue, regardless of whether the patents are valid or invalid. The Patent Office has powers to revoke patents that issued in error.7735 U.S.C. §§ 311–19, 321–29.
This Article studies other types of powers that allow agencies to regulate patents, even when patents meet the patentability standards. Additionally, because the Patent Office plays little role in regulating how patents are used after they issue, this Article focuses on agencies outside the Patent Office. The following Sections describe the different types of public patent powers.

B. Government Patent Licenses

One type of public patent power allows the government to obtain a license to make or use patented technology.78This Article uses the phrase “patent license” more broadly than the term is used in commercial transactions. In commercial transactions, patent licenses typically refer to voluntary agreements to pay to use patented inventions. This Article defines “patent licenses” to include situations where the government can decide to use patented technology in exchange for compensation, regardless of whether the patent holder consents.
These laws allow the government, rather than private patent holders, to make decisions about whether the government can use patented inventions.79Patent infringement includes making, using, or selling technology. 35 U.S.C. § 271. Throughout this Article, I will refer to “making, using, or selling” the invention as “using” the invention.
The laws provide three main ways that the government can obtain patent licenses: (1) it can use patented technology without a license and then pay later if patent infringement is shown, (2) it can prospectively obtain patent licenses, or (3) it can reserve licenses when it funds research. Table 2 summarizes those laws.

Table 2: Government Patent Licenses

 

Liability Rule

Public Control

Unlicensed Patent Use

If court finds gov’t infringed patent, remedy is limited to reasonable compensation.

 

 

Gov’t can decide whether to use
patented technology.

Prospective Patent Licenses

Gov’t pays patent holder for patent license before use.

Reserved Licenses on Federally Funded Inventions

Gov’t obtains license as condition of providing funding for research.

1. Unlicensed Patent Use

Several statutes relate to unlicensed use of patented technology by the government.80E.g., 16 U.S.C. § 831r; 19 U.S.C. § 1337(l); 22 U.S.C. § 2356(a); 28 U.S.C. § 1498.
Generally, patent holders cannot obtain injunctions to stop the government from using patented technology.81Brennan et al., supra note 13, at 299, 343.
When the government uses patented technology without permission, however, the patent holder can seek reasonable compensatory damages.82See 28 U.S.C. § 1498; Crozier v. Fried. Krupp Aktiengesellschaft., 224 U.S. 290, 293 (1912).
These laws, therefore, functionally create patent licenses for government use of inventions.83See Crozier, 224 U.S. at 305 (“[Section 1498], looking at the substance of things, provides for the appropriation of a license to use the inventions . . . .”).

Section 1498, codified at 28 U.S.C. § 1498, provides the default legal framework when the government uses patented technology without a license.84Several other laws create similar structures when imports “by or for” the United States infringe a U.S. patent, 19 U.S.C. § 1337(l), when U.S. patents are infringed in connection with government activities to furnish assistance to foreign countries, 22 U.S.C. § 2356(a), and when the Tennessee Valley Authority infringes patents, 16 U.S.C. § 831r.
The law states that if the government does so, the patent holder can seek “reasonable and entire compensation.”8528 U.S.C. § 1498(a). Congress passed Section 1498 in 1910 to address concerns about the lack of a remedy when the federal government infringed patents. Before the law, courts held that sovereign immunity barred tort claims against the government for patent infringement. Lionel Marks Lavenue, Patent Infringement Against the United States and Government Contractors Under 28 U.S.C. § 1498 in the United States Court of Federal Claims, 2 J. Intell. Prop. L. 389, 408–13 (1995). The Act of 1910 thus sought to “provide additional protection for owners of patents . . . .” See Act of June 25, 1910, ch. 423, 36 Stat. 851 (codified at 28 U.S.C. § 1498(a)).
Executive agencies have regularly used technology without a license, and patent holders have regularly used Section 1498 to seek compensation from a range of agencies.86See Brennan et al., supra note 13, at 302 (noting judgments paid by the National Institutes of Health, National Gallery of Art, National Park Service, and General Services Administration under Section 1498); Lavenue, supra note 85, at 492–96 (describing 279 reported cases under Section 1498 from 1910 to 1995).
Examples include use of combat ships by the U.S. Navy,87FastShip, LLC v. United States, 892 F.3d 1298, 1300 (Fed. Cir. 2018).
use of ammunition rounds by the U.S. Army,88Liberty Ammunition, Inc. v. United States, 835 F.3d 1388, 1391 (Fed. Cir. 2016).
use of materials processing methods by the Oak Ridge National Laboratory,89Hitkansut LLC v. United States, 130 Fed. Cl. 353, 360–67 (2017), aff’d, 721 F. App’x 992 (Fed. Cir. 2018).
and use of an automated process for processing mail by the U.S. Post Office.90Return Mail, Inc. v. United States, 159 Fed. Cl. 187 (2022), aff’d, No. 1:11-cv-00130-CFL, 2024 WL 562455 (Fed. Cir. Feb. 13, 2024), petition for cert. docketed, No. 24-0047 (July 16, 2024).
Some Section 1498 suits have resulted in compensation awards,91See, e.g., FastShip, 892 F.3d at 1310; Hitkansut, 130 Fed. Cl. at 391–95.
though courts have denied damages when they conclude that the government did not infringe the asserted patents.92E.g., Liberty Ammunition, 835 F.3d at 1406; Return Mail, 159 Fed. Cl. at 201.

2. Prospective Patent Licenses

Twenty-two statutes expressly authorize agencies to acquire patent licenses in a range of situations.937 U.S.C. § 171(1) (USDA program for developing crude rubber); 7 U.S.C. § 178g (critical agricultural materials program at USDA); 7 U.S.C. § 178h (critical agricultural materials program at Commerce Department); 10 U.S.C. § 3793 (patents useful to the Department of Defense); 16 U.S.C. § 832a (Bonneville project); 16 U.S.C. § 833a (Fort Peck project); 16 U.S.C. § 1447b (Regional Marine Research Boards); 20 U.S.C. § 3477 (Department of Education facilities); 20 U.S.C. § 3480 (Department of Education activities); 30 U.S.C. § 666 (coal mining research program at Department of Energy); 31 U.S.C. § 5111 (coin production for Treasury Department); 36 U.S.C. § 2114 (American Battle Monuments Commission); 42 U.S.C. § 242b (National Center for Health Statistics); 42 U.S.C. § 299c-5 (Agency for Healthcare Quality and Research); 42 U.S.C. § 2201 (Nuclear Regulatory Commission); 42 U.S.C. § 5817 (Energy Research & Development Administration); 42 U.S.C. § 7257 (Department of Energy research laboratories and testing sites); 42 U.S.C. § 7261 (Department of Energy activities); 42 U.S.C. § 7404 (EPA air pollution control research program); 49 U.S.C. § 106 (FAA activities); 49 U.S.C. § 114 (TSA activities); 51 U.S.C. § 20113 (NASA activities). In addition, one statute allowed the Atomic Energy Commission to obtain licenses to use atomic energy patents filed before 1979. Atomic Energy Act of 1954 § 153, 42 U.S.C. § 2183.
These laws also allow the government to acquire patent licenses either with or without the consent of the patent holder.9420 U.S.C. § 3477 (allowing acquisition by “purchase, lease, condemnation, or otherwise”); see also 49 U.S.C. §§ 106, 114; 51 U.S.C. § 20113; 16 U.S.C. § 833a (allowing acquisition by “purchase, lease, donation, or by the exercise of the right of eminent domain”).
In contrast to Section 1498, these statutes contemplate prospective licenses before agencies use inventions.95Several of these provisions also authorize agencies to acquire licenses retroactively by acquiring releases from past infringement. 10 U.S.C. § 3793 (military departments); 20 U.S.C. § 3480 (Department of Education); 42 U.S.C. § 5817 (Energy Research & Development Administration); 42 U.S.C. § 7261 (Department of Energy). Although agencies could potentially acquire patent licenses under their ancillary authority even without express mandates, see Narechania, supra note 72, at 1518–23, express authorizations make clear that agencies can spend money on patent licenses.
Prospective licensing provisions appear in two primary contexts. First, some are in general grants of authority for agencies to carry out programs. For example, one statute authorizes patent licenses for acquisitions of supplies or processes “useful” to any military department.9610 U.S.C. § 3793.
Some statutes authorize acquisition of patents licenses “useful” to the Department of Education9720 U.S.C. § 3480.
or the Department of Energy (DOE).9842 U.S.C. § 7261.
Others allow acquisition of patent licenses deemed “necessary” by the FAA Administrator,9949 U.S.C. § 106(n).
by the TSA Administrator,10049 U.S.C. § 114.
or by NASA.10151 U.S.C. § 20113.
Second, some licensing provisions appear in laws that create specific government research programs. For example, statutes authorize the DOE to acquire patent licenses useful for a coal mining research program10230 U.S.C. § 666.
and the EPA to do the same for an air pollution research program.10342 U.S.C. § 7404.

Agencies regularly obtain patent licenses for a variety of uses.104See, e.g., FAR 27.202, 31.205-37, 52.227-6, 52.227-9 (2023) (setting out regulations for patent royalties paid under government contracts).
For example, agencies spend significant funds on information technology products, such as software licenses, which often involve patents.105 U.S. Gov’t Accountability Off., GAO-14-413, Federal Software Licenses: Better Management Needed to Achieve Significant Savings Government-Wide 1 (2014); see also U.S. Gov’t Accountability Off., GAO-22-104752, Defense Acquisitions: DOD Should Take Additional Actions to Improve How It Approaches Intellectual Property 1 (2021) (“The Department of Defense (DOD) acquires and licenses intellectual property (IP)—including technical data, computer software, and user manuals . . . to operate and maintain its cutting-edge weapon systems . . . .”).
When the government negotiates patent licenses, its public patent powers affect bargaining dynamics.106See Kapczynski & Kesselheim, supra note 13, at 795.
The government has threatened to use its powers to use or buy patents in order to obtain more favorable licensing terms on a couple notable occasions—like negotiations over purchases of aircraft technology during World War I and anthrax treatments after the September 11 terrorist attacks.107Christopher J. Morten & Charles Duan, Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crises, 23 Yale J.L. & Tech. 1, 16–18, 26–31 (2020) (citing Act of Mar. 4, 1917, ch. 180, 39 Stat. 1168, 1169 (1917) (appropriating funds to acquire patents “by purchase, condemnation, donation, or otherwise”)); Kapczynski & Kesselheim, supra note 13, at 794; Brennan et al., supra note 13, at 303 (observing that Bayer “cut its prices by half” after threat of invoking Section 1498).

3. Federally Funded Inventions

When the federal government funds research, laws generally reserve a license for the government to use any resulting inventions.108Eight statutory provisions reserve licenses for the government to practice inventions developed with government resources. 15 U.S.C. § 3710a (cooperative research agreements); 15 U.S.C. § 3710d (federal employee patents); 22 U.S.C. § 2179 (patents resulting from financial assistance payments for prototype desalting plans); 33 U.S.C. § 2314a (federal employee inventions); 35 U.S.C. §§ 202(c)(4), 210(c) (Bayh-Dole Act); 42 U.S.C. § 7403(g)(6)(iv)(II) (inventions developed with grants from Direct Air Capture Technology Advisory Board); 51 U.S.C. § 20135 (inventions made under contracts with NASA). Three other statutes expressly provide that inventions developed under grants are subject to the Bayh-Dole Act policies. 52 U.S.C. § 21041 (research to improve voting equipment and technology); 15 U.S.C. § 5308 (National Metal Casting Research Institutes); 15 U.S.C. § 2218 (research on fire prevention and control). I coded these three statutes as including the same conditions as the Bayh-Dole Act: reservation of government licenses, options for the government to obtain title, and march-in rights for third parties.
These laws typically do not require compensation for patent use. Instead, they reserve “paid-up” licenses that are “nonexclusive, nontransferable, [and] irrevocable.”10935 U.S.C. § 202(c)(4).
The most prominent example in this group is the Bayh-Dole Act, which sets the default rules about patents on inventions developed with federal funding.110Bayh-Dole Act, Pub. L. No. 96-517, § 6(a), 94 Stat. 3015, 3019–28 (1980) (codified as amended at 35 U.S.C. §§ 200–11).
The Bayh-Dole Act reserves a royalty-free license for the government to practice all federally funded inventions when third parties obtain patents on those inventions.11135 U.S.C. §§ 202(c)(4), 210(c). The Stevenson-Wydler Act also reserves a license if the government employees obtain patent rights. 15 U.S.C. 3710d(a).
Government researchers regularly use these licenses.112 U.S. Gov’t Accountability Off., GAO-03-536, Technology Transfer: Agencies’ Rights to Federally Sponsored Biomedical Inventions 5 (2003) (“[F]ederal research officials say that this is a common occurrence in the research arena, making the license to use federally funded inventions a valuable asset to the government.”).
Moreover, the government has successfully invoked its licenses under the Bayh-Dole Act as an affirmative defense in Section 1498 suits against the government.113See, e.g., Pilley v. United States, 74 Fed. Cl. 489, 502 (2006).

C. Government Patent Title

A second category of laws allows the government to obtain title to patents. When the government holds title to a patent, it has total control over the right to exclude. The government can choose whether to license the patent and on what terms. It can choose to make the patented invention freely available to the public or, alternatively, it can decide to exclude others from using the invention.114There are unresolved legal questions about the significance of government ownership of patents. Some have suggested that there is no constitutional basis for the government to own patents. Under this view, patents are contracts between the government and patent holders. When the government obtains title to a patent, a merger occurs, and the patent right to exclude ceases to exist. See Caleb A. Holland, Note, “PrEP”aring for a Challenge to Government-Owned Patents, 70 Cath. U. L. Rev. 493, 504–05 (2021); Frank J. Wille, Government Ownership of Patents, 12 Fordham L. Rev. 105, 111 (1943); Thomas Ewing, Government Owned Patents, 10 J. Pat. Off. Soc’y 149, 149–53 (1928). As a descriptive matter, laws have authorized agencies to exclusively license patents for decades, and agencies regularly do so. See infra notes 159–162.
The government also has discretion over whether to sue parties for patent infringement and whether to sell the patent.115See 35 U.S.C. § 207(a).

Laws provide for situations where the government can both obtain patents in the first instance and obtain patents from third parties. Under certain circumstances, laws authorize the government to obtain a patent in the first instance when an invention was developed with federal funding.116See infra Section II.C.3.
Other laws authorize the government to obtain existing patents during routine government operations and during times of war.117See infra Sections II.C.1–2.
Table 3 summarizes those laws.

Table 3: Government Patent Title

 

Liability Rule

Public Control

Patent Buyouts

Gov’t pays private party for patent title.

 

 

Gov’t has total control over right to exclude.

War Powers

Gov’t pays private party after war, as Congress
directs.

Federally Funded Inventions

N/A—gov’t obtains patent in the first instance.

1. Patent Buyouts

Several laws allow agencies to buy existing patents, i.e., for “patent buyouts.”118Michael Kremer, Patent Buyouts: A Mechanism for Encouraging Innovation, 113 Q.J. Econ. 1137, 1138 (1998).
All twenty-two laws that expressly authorize agencies to acquire prospective patent licenses also expressly authorize agencies to acquire patents themselves.119See supra note 93 and accompanying text.
For example, 10 U.S.C. § 3793 appropriates funds for the Department of Defense to acquire both useful “patents” and “[l]icenses . . . under patents.” Like statutes that allow the government to obtain patent licenses, these statutes contemplate that agencies could acquire patents with or without the consent of the patent holder.120See supra note 94 and accompanying text.

In the nineteenth and early twentieth centuries, Congress authorized funds for agencies to purchase patents on several occasions for military operations.121See Act of Aug. 8, 1846, ch. 169, 9 Stat. 82, 82 (appropriating ,000 for the Secretary of Navy to purchase “assignment” of patent on “manger-stopper” in war ships); Act of July 4, 1836, ch. 360, 5 Stat. 126, 126 (appropriating ,000 to purchase “Bell’s[] right, interest, and title, in and to two certain patents” on cannon technology); Act of Mar. 2, 1812, ch. 34, 2 Stat. 691, 691 (appropriating ,000 to “purchase of Winslow Lewis, his patent right to the plan of lighting lighthouses . . . if the same shall be proved to be a discovery made by him” and to contract with him to maintain lighthouses); Marcus B. Finnegan & Richard W. Pogue, Federal Employee Invention Rights—Time to Legislate, 55 Mich. L. Rev. 903, 939 n.119 (1957) (describing laws that made funds available to buy patents, including annual appropriations for military departments until 1953).
After World War II, Congress created a specific patent buyout scheme when it decided to nationalize the atomic energy industry.122Lavenue, supra note 85, at 434.
In order to maintain a government monopoly over the industry, the government purchased atomic energy patents.123See N.V. Philips’ Gloeilampenfabrieken v. Atomic Energy Comm’n, 316 F.2d 401, 404–05 (D.C. Cir. 1963); Dean C. Dunlavey, Government Regulation of Atomic Industry, 105 U. Pa. L. Rev. 295, 334 (1957).
To do this, the Atomic Energy Act of 1946 revoked all patents that were useful solely for the production of fissionable material and prohibited future patents.124Atomic Energy Act of 1946, Pub. L. No. 79-585, § 11(a)(1)–(2), 60 Stat. 755, 768 (codified as amended at 42 U.S.C. § 2181).
Congress provided compensation for revoked patents, which made the statute operate as a patent buyout. Since then, however, the government does not appear to have purchased patents.125See Morten & Duan, supra note 107, at 42 & n.179 (“[T]rue patent buyouts seem rare, or perhaps altogether extinct.”); Daniel J. Hemel & Lisa Larrimore Ouellette, Innovation Policy Pluralism, 128 Yale L.J. 544, 594 (2019).

2. War Powers

The Trading with the Enemy Act of 1917 authorizes the President to seize patents and patent applications during wartimes.12650 U.S.C. § 4307; see also Miller v. United States, 78 U.S. (11 Wall.) 268, 308 (1870) (describing confiscation of enemy property as proper exercise of war powers).
In response to hostile conduct by German property owners during World War I,127Rudolf M. Littauer, Confiscation of the Property of Technical Enemies, 52 Yale L.J. 739, 749 (1943) (describing disclosures by German owners of property in the United States to German government during WWI).
Congress authorized the President to appoint an official (a “property custodian”) to take custody of property in the United States belonging to enemies or enemy allies.12850 U.S.C. § 4306; see also Standard Oil Co. v. Markham, 57 F. Supp. 332 (S.D.N.Y. 1944).
The law expressly allows the President to order enemy-owned “patents” and “applications therefor” to be transferred to the property custodian.12950 U.S.C. § 4307(c).
As subsequently amended, the law allows the custodian to then act as the owner of these patents.130Littauer, supra note 127, at 750–51. Sales can only be made to U.S. citizens through a public auction or to the U.S. government. Id. at 751–52.
While the custodian holds any patents, it has discretion over how to use those patents, including whether to grant licenses or to sell them.13150 U.S.C. § 4312 (allowing property custodian to exercise rights “as though he were the absolute owner” of seized property).
During this time, the custodian can grant licenses for the government to use any patented invention for free.132Id. § 4324 (authorizing property custodian to return any patent royalties paid by the United States to the government); id. § 4329(d) (barring claims against the United States for use of property held by the property custodian during WWII).
At the end of the war, patents can be returned as Congress directs.13350 U.S.C. § 4312; see Littauer, supra note 127, at 741.

Presidents have authorized such property custodians twice: during World War I and World War II.134Exec. Order No. 2729-A (Oct. 22, 1917); Exec. Order No. 9095, 7 Fed. Reg. 1971 (Mar. 13, 1942).
In both wars, the property custodian acquired tens of thousands of patents and patent applications.135Ewing, supra note 114, at 149; Littauer, supra note 127, at 739. During WWII, the custodian confiscated patents held by residents of enemy-occupied countries in addition to enemy countries. This policy sparked backlash from some who considered it a violation of international law. Id. at 741–42, 765–67.
During World War I, the government acquired patent applications made by German citizens and assigned some of those to the Secretary of War and the Secretary of Navy.136Ewing, supra note 114, at 149.
The custodian sold 6,000 chemical patents at a nominal price to the U.S. government.137Littauer, supra note 127, at 752.
Notably, it auctioned off Bayer’s patent on aspirin to an American company.138Thomas V. DiBacco, Aspirin’s Long Record Began with Germany, World War I, Wash. Post (Jan. 11, 1993, 7:00 PM), https://www.washingtonpost.com/archive/lifestyle/wellness/1993/01/12/aspirins-long-record-began-with-germany-world-war-i/248b0a5e-6950-488b-ae6e-9be78c45d9c8 [perma.cc/9WXN-86GK].
During World War II, the property custodian seized at least 40,000 patents and patent applications, and then offered nonexclusive, royalty-free licenses under those patents to the American public.139Wille, supra note 114, at 105; see also Standard Oil Co. v. Markham, 57 F. Supp. 332, 335–36 (S.D.N.Y. 1944) (describing licensing policy for butyl patents).
After both wars, Congress created procedures for claims for the return of property not sold and for proceeds on property sold.14050 U.S.C. §§ 4309, 4329; Littauer, supra note 127, at 752–54 (describing procedures for return of property after WWI); see also Honda v. Clark, 386 U.S. 484 (1967).
No president has authorized a property custodian since.

3. Federally Funded Inventions

Several laws allow the government to obtain patents covering inventions developed with federal resources. The most significant laws in this category are the Bayh-Dole Act and the Stevenson-Wydler Act. Passed in 1980, these laws create the default rules for patents covering inventions developed by both government employees and third parties that receive federal funding.14115 U.S.C. §§ 3701–24; 35 U.S.C. §§ 200–10. Moreover, the Stevenson-Wydler Act made technology transfer a policy for agencies to pursue. See Rebecca S. Eisenberg, Public Research and Private Development: Patents and Technology Transfer in Government-Sponsored Research, 82 Va. L. Rev. 1663, 1665 (1996).
Generally, agencies can obtain patents on inventions developed by government employees.14235 U.S.C. § 207(a)(1) (authorizing agencies to “apply for, obtain, and maintain patents”); Exec. Order No. 10096, 15 Fed. Reg. 389 (Jan. 23, 1950), as amended by Exec. Order No. 10695, 22 Fed. Reg. 365 (Jan. 17, 1957), Exec. Order 10930, 26 Fed. Reg. 2583 (Mar. 28, 1961) (creating uniform policy for government to obtain title to inventions developed by government employees within scope of employment).

When agencies fund research by third parties, the law is more complicated. The Bayh-Dole Act requires that when agencies provide funding to small businesses or nonprofits (namely, universities), agencies must give the grantee the option to obtain title to any patents on the resulting inventions.14335 U.S.C. § 202(a). Before the Bayh-Dole Act, the government generally made federally funded inventions freely available to the public. Eisenberg, supra, note 141, at 1663; U.S. Gov’t Accountability Off., GAO-03-536, supra note 112, at 3. The Bayh-Dole Act allowed greater exclusive rights over federally funded inventions to address concerns that free public access to inventions thwarted incentives for private companies to make investments needed to commercialize the results of federally funded research. Eisenberg, supra note 141, at 1664; Bradley Graham, Patent Bill Seeks Shift to Bolster Innovation, Wash. Post (Apr. 7, 1979), https://www.washingtonpost.com/archive/business/1979/04/08/patent-bill-seeks-shift-to-bolster-innovation [perma.cc/592K-BCL6].
Yet the government may still retain title to federally funded inventions developed by small businesses and nonprofits in multiple circumstances, such as where grantees are foreign, where exceptional circumstances warrant “restriction or elimination” of patent rights, and where grantees do not timely disclose the invention.14435 U.S.C. §§ 202(a), (c)(1); 37 C.F.R. § 401.14(d). Three statutes expressly provide that the Bayh-Dole policies apply. 15 U.S.C. § 5308; 15 U.S.C. § 2218; 52 U.S.C. § 21041. Because the Bayh-Dole Act only applies to a “contract, grant, or cooperative agreement,” some agencies can avoid the Bayh-Dole requirements in limited circumstances when they enter into agreements under their “other transaction authority.” See, e.g., 10 U.S.C. § 4021; see also U.S. Gov’t Accountability Off., GAO-22-105357, Other Transaction Agreements: DOD Can Improve Planning for Consortia Awards 4–6 (2022).

Outside the limits of the Bayh-Dole Act, agencies generally have discretion to decide how to allocate patent rights when they fund third-party research. For example, in funding agreements with large companies, the law gives agencies discretion to decide whether to retain patent rights. The executive branch has consistently exercised that discretion to broadly give grantees the option to obtain patents. In the 1980s, President Reagan issued an executive order that expanded the Bayh-Dole Act to all recipients of federal research grants, regardless of size.145Memorandum on Government Patent Policy, 1 Pub. Papers 248 (Feb. 18, 1983); Exec. Order No. 12591, 52 Fed. Reg. 13414 (Apr. 22, 1987). After President Reagan announced this policy, Congress amended the Bayh-Dole Act to allow march-in rights on all federally funded inventions, including inventions developed by large businesses. It did not amend the Act to give large companies an option to obtain patent title on federally funded inventions. See Trademark Clarification Act, Pub. L. No. 98-620, 98 Stat. 3335, 3367–68.
Subsequent presidents left this policy in place, and, in 2018, the National Institutes of Standards and Technology (NIST) passed a regulation that codified this longstanding policy.146Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 72 Fed. Reg. 15954 (proposed Apr. 13, 2018) (to be codified at 37 C.F.R. pts. 401, 404).
As a result, agencies today typically give large companies the option to obtain patents on federally funded research.147The practical effects of this policy choice have received little attention. NIST’s proposed rule to codify this policy received only 17 comments. Id. at 15955. I am not aware of any systematic study about how often large companies obtain patent rights through federal funding agreements. I am similarly not aware of any study on how agencies have implemented laws that require the government to retain title, though it appears agencies often waive their rights. See, e.g., 10 C.F.R. § 783.1 (waiving DOE patent rights to a class of inventions); David S. Bloch, Alternatives to March-in Rights, 18 Vand. J. Ent. & Tech. L. 247, 251 (2016) (citing regulation to suggest that NASA and DOE “almost always use these waiver rules to grant contractors rights in subject inventions”). How agencies allocate patent rights in funding agreements with large companies would be a good topic for a GAO study.

Yet that regulation does not apply to all funding agreements with large companies because ten laws restrict agency discretion further. These laws require patent title to vest with the government, unless the government waives its rights.148See 7 U.S.C. § 171(7) (USDA patents on methods of processing guayule shrubs and rubber); 7 U.S.C. § 4606(k) (patents on inventions developed through use of funds collected by the Honey Board); 16 U.S.C. § 831d (TVA); 15 U.S.C. § 2511; 15 U.S.C. § 5104(b); 42 U.S.C. § 2182; 42 U.S.C. § 5906(b)(3); 42 U.S.C. § 5908; 42 U.S.C. § 6981; 51 U.S.C. § 20135(b). One statute directed that when a public corporation was privatized, the government would obtain title on patents. The corporation could then obtain an exclusive license or buy the patents. 42 U.S.C. § 2297h-12.
Before the Bayh-Dole Act created a uniform patent policy for federally funded inventions, several laws created program-specific patent rules. Although some of those laws have since been repealed, others still remain on the books.149See Eisenberg, supra note 141, at 1663 n.2.
Because the Bayh-Dole Act expressly left those laws in place for funding agreements with entities other than small businesses and nonprofits,15035 U.S.C. § 210. One statute was passed after the Bayh-Dole Act, but the Bayh-Dole Act states it takes precedence over future legislation. Id.; 7 U.S.C. § 4606(k) (inventions funded by Honey Board).
these laws still apply to inventions developed by large companies.151Before the Bayh-Dole Act, the government did not typically issue exclusive licenses or collect royalties on patents. Eisenberg, supra note 141, at 1676, 1698; Finnegan & Pogue, supra note 121, at 940–41. Government ownership under these laws, therefore, would have effectively made the invention freely available to the public. Today, however, the government can likely require royalties and grant exclusive licenses on these patents. 35 U.S.C. § 207(a)(2); see supra note 114 and accompanying text.

These laws require government title on inventions made under contracts with agencies in a range of research areas, including nuclear energy research15242 U.S.C. §§ 2182, 5908.
and space research.15351 U.S.C. § 20135(b) (contracts with NASA).
Again, commercialization and public interest are concerns. The law that vests patent rights on nuclear energy research with the DOE, for example, provides that the Secretary may waive the government’s patent rights to promote commercialization.15442 U.S.C. § 5908(c); 10 C.F.R. § 784.3(a) (2023); see also 10 C.F.R. §§ 784.4–5, 784.11 (2023) (listing criteria for considering waivers).
Furthermore, one law—covering inventions developed by contracts with the Tennessee Valley Authority (TVA)—is unaffected by the Bayh-Dole Act, and thus, requires all patents on TVA-funded inventions to vest with the government.155Tennessee Valley Authority Act of 1933, 16 U.S.C. § 831d; 35 U.S.C. § 201(b).
Table 4 summarizes when the government can obtain patents on federally funded inventions.

Table 4: Government Title on Federally Funded Inventions

Funding Agreements

Government Title

Government employees

Gov’t can obtain patent.

Small businesses and nonprofits

Gov’t must give contractor option to obtain title on patents, unless:

(1) contractor is foreign,

(2) exceptional circumstances exist, or

(3) contractor does not timely disclose invention.

Other entities

Gov’t can obtain title, but has exercised discretion to let contractors obtain title. Nonetheless, 14 laws require title to vest in gov’t, unless the gov’t waives rights for public interest or commercialization.

Under this complex framework, the government has given patents to many private companies.156Scholars have suggested that agencies do not often exercise their discretion to retain title under the conditions that the Bayh-Dole Act allows them to enter in agreements with nonprofits and small businesses. Lisa Larrimore Ouellette & Rebecca Weires, University Patenting: Is Private Law Serving Public Values?, 2019 Mich. St. L. Rev. 1329, 1335–37; Arti K. Rai & Rebecca S. Eisenberg, Bayh-Dole Reform and the Progress of Biomedicine, L. & Contemp. Probs., Winter/Spring 2003, at 289, 294 & n.28 (“Perhaps not surprisingly, NIH declarations of exceptional circumstances have been extremely rare.”). Agencies have exercised their authority to obtain title at least occasionally though. See Campbell Plastics Eng’g & Mfg. v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004); L-3 Commc’ns Corp. v. Jaxon Eng’g & Maint., Inc., 125 F. Supp. 3d 1155 (D. Colo. 2015).
But it has also amassed a relatively large patent portfolio on a range of technologies. In FY2020, eleven agencies collectively obtained 2,577 patents and filed 2,623 patent applications.157 NIST, Federal Laboratories Technology Transfer Fiscal Year 2020 142 (2022) (reporting patent metrics for USDA, DOC, DOD, DOE, HHS, DHS, DOI, DOT, VA, EPA, and NASA).
Four agencies—DOD, DOE, HHS, and NASA—received over 100 patents each.158DOD obtained 655 patents, DOE obtained 929 patents, HHS obtained 738 patents, and NASA obtained 142 patents. Id.

When the government obtains patents, there are some limits on how agencies can use those patents. Generally, agencies can grant exclusive licenses, but only if necessary to promote commercialization of an invention.159See 35 U.S.C. § 209.
When agencies grant exclusive licenses, the Bayh-Dole Act includes several further limits. Exclusive licenses must provide for inventions to be manufactured “substantially in the United States,” and agencies must give preferences to small businesses.160Id. §§ 209(b)–(c). The domestic manufacture requirement can be waived or modified if not commercially feasible. 37 C.F.R. § 404.5(a)(2).
The government has regularly granted exclusive licenses on its patents.161 NIST, supra note 157.
Five agencies—USDA, DOD, DOE, HHS, and the VA—reported more than 100 income-bearing exclusive licenses each in FY2019, and eleven agencies collectively reported 1,069 income-bearing exclusive licenses.162Id. at 143–44.

Occasionally, agencies have used their discretion to place additional terms in patent licenses beyond what the Bayh-Dole Act requires.163W. Nicholson Price II, Grants, 34 Berkeley Tech. L.J. 1, 33 (2019) (describing agency discretion to include conditions in grants, such as to send progress reports to agencies).
In the biomedical context, the NIH placed a reasonable pricing clause in some license agreements for a short period. In 1987, a pharmaceutical company launched an HIV drug developed with NIH assistance at a price of $10,000 per year.164 Senate Health, Educ., Lab., and Pensions Comm., 118th Cong., Public Investment, Private Greed 9 (2023) [hereinafter Senate HELP Report].
In response to public protests, the company lowered its price, and the NIH began a policy of including a reasonable pricing clause in certain agreements.165Id.
From 1989 to 1995, the NIH included a reasonable pricing clause in exclusive patent licenses on government patents that resulted from cooperative research and development agreements with private industry.166The clause stated that HHS could require the licensee to confidentially submit documentation to show a reasonable relationship between the price of the product, the public investment, and public health and safety needs. U.S. Gov’t Accountability Off., GAO-21-52, Biomedical Research: NIH Should Publicly Report More Information About the Licensing of Its Intellectual Property 11 & n.26, 32 n.70 (2020); NIH, Reports of the NIH Panels on Cooperative Research and Development Agreements 15 (1994) [hereinafter NIH Report].
The agency stopped the policy in response to industry arguments that the clause was deterring collaborations.167Press Release, NIH News, Rescinding Reasonable Pricing Clause (Apr. 11, 1995), https://www.techtransfer.nih.gov/sites/default/files/documents/pdfs/NIH-Notice-Rescinding-Reasonable-Pricing-Clause.pdf [perma.cc/8ATA-6VXA]; see also NIH Report, supra note 166, at 16–18.
When it did so, industry panelists stated that the clause created uncertainty about how the government might intervene in a pricing decision under the clause.168 NIH Report, supra note 166, at 28. Some have questioned whether the reasonable pricing clause deterred industry collaborations in practice, noting that the average number of collaborative research agreements per year when the NIH included reasonable pricing provisions was similar to prior years. See Ameet Sarpatwari, Alison K. LaPidus & Aaron S. Kesselheim, Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed with Government Support, 172 Annals of Internal Med. 348 (2020). Furthermore, the NIH inconsistently included the reasonable pricing clause in agreements, which casts doubt on arguments about its effects on industry collaborations. Id. After receiving public comments, the NIH released an access planning policy on January 10, 2025. NIH, NIH Intramural Research Program Access Planning Policy, NOT-OD-25-062 (Jan. 10, 2025), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-062.html [https://perma.cc/GBA7-DFTL].
More recently, in May 2024, the NIH proposed to develop a policy to consider patient access plans when it licenses NIH-owned inventions.169National Institutes of Health (NIH) Office of Science Policy (OSP): Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning, 89 Fed. Reg. 45003 (May 22, 2024).

On rare occasions, the government has brought affirmative patent infringement suits based on government-owned patents.170The government has, for example, filed infringement suits under the Hatch-Waxman Act when companies have sought approval for generic versions of drugs covered by government-owned patents. See, e.g., U.S. Gov’t Accountability Off., GAO-21-52, supra note 166, at 53–54. The government has also occasionally induced parties to enter patent licenses without litigation by conducting infringement investigations. Id. at 52.
Recently, the government sued Gilead for infringement of CDC-owned patents on a preventive HIV treatment.171United States v. Gilead Scis., Inc., No. 1:19-cv-2103-MN, 2024 WL 1251282 (D. Del. Mar. 22, 2024), appeal docketed, (Jul. 12, 2024).
In that case, the NIH funded clinical trials that demonstrated positive results in patients.172 U.S. Gov’t Accountability Off., GAO-21-52, supra note 166, at 54.
Using publicly available data from those trials, Gilead obtained FDA approval for an antiviral drug used to prevent HIV, Truvada. In response to concerns about high prices on Truvada, commentators advocated that the government enforce its patents to recoup public investment in the drug.173See Christopher Morten et al., Should the U.S. Government Actively Assert Its Own Patents?, 11 N.Y.U. J. Intell. Prop. & Ent. L. 19, 20 (2021) (panel discussion).
After licensing negotiations failed, DOJ sued in November 2019.174 U.S. Gov’t Accountability Off., GAO-21-52, supra note 166, at 54.
A jury returned a verdict that found the patents invalid, which a district court judge recently upheld.175Gilead, 2024 WL 1251282. The U.S. government voluntarily dismissed its appeal of this lawsuit after entering into a settlement with Gilead. Press Release, Gilead, Gilead Statement on Successful Resolution with U.S. Department of Justice and the Department of Health and Human Services on Patents (Jan. 15, 2025), https://www.gilead.com/company/company-statements/2025/gilead-statement-on-successful-resolution-with-us-department-of-justice-and-the-department-of-health-and-human-services-on-patents [https://perma.cc/88HW-QURK].

D. Third-Party Licenses

A third category of laws allows the government to grant patent licenses to third parties, with or without the consent of patent holders. The laws in this category allow the government to authorize third parties to use patented technology without the threat of an injunction in exchange for compensation. These laws allow third-party licenses in a variety of contexts, including for government contractors,17628 U.S.C. § 1498(a).
for federally funded inventions,17735 U.S.C. § 203(a)(1).
for patents necessary to comply with clean air regulations,17842 U.S.C. § 7608.
for patents crucial to the atomic energy industry,179Atomic Energy Act of 1954 § 153, 42 U.S.C. § 2183.
and during times of war.18050 U.S.C. § 4310.
Several others require patents on federally funded inventions to be dedicated to the public.181See infra Section II.D.4.
Table 5 summarizes these contexts.

Table 5: Third Party Licenses

 

Liability Rule

Public Control

Government
Contractors

Gov’t pays private party under Section 1498 framework or in research funding agreement.

 

 

 

Gov’t decides whether third party can use patented technology.

War Powers

Third party pays
compensation.

Compulsory
Licenses

Third party pays patent holder.

Public Dedication

Gov’t funds research, and
patent holder must make
invention freely available to the public.

1. Government Contractors

As discussed above, Section 1498 and the Bayh-Dole Act allow the government to obtain licenses to use patented inventions. Both laws also authorize the government to obtain patent licenses for government contractors. If the government authorizes its contractor to use a federally funded invention, the government contractor’s actions are covered by the paid-up reserved license under the Bayh-Dole Act.18235 U.S.C. § 202(c)(4) (reserving license for invention practiced “for or on behalf of the United States”). Five other laws also reserve licenses on federally funded inventions that can be used by contractors. 15 U.S.C. § 5308; 15 U.S.C. § 2218; 33 U.S.C. § 2314a(b); 42 U.S.C. § 7403(g)(6)(iv)(II); 52 U.S.C. § 21041(c). Another statute reserves a license for government contractors to practice inventions that government employees obtain patents on. 15 U.S.C. § 3710d(a).
Agencies have used this power to authorize government contractors to use federally funded inventions in the defense industry.183 U.S. Gov’t Accountability Off., GAO-03-536, supra note 112, at 5–7.
These reserved licenses can also be a defense in patent suits against government contractors. Recently, the United States successfully invoked a reserved license as a defense in a patent suit when a government contractor used a method of preparing mouse models to study Alzheimer’s Disease.184Univ. of S. Fla., Bd. of Trs. v. United States, 162 Fed. Cl. 59, 67 (2022), aff’d, 92 F.4th 1072 (Fed. Cir. 2024).

If the government authorizes a government contractor to use any other patented invention, the Section 1498 framework applies.18528 U.S.C. § 1498(a) (covering use of patented invention “by or for the United States”); see also 19 U.S.C. § 1337(l) (applying Section 1498 framework to imports “by or for” the United States).
If the government authorizes a contractor to use any invention for the government’s benefit, the exclusive remedy for the patent holder is to seek reasonable compensation.186Advanced Software Design Corp. v. Fed. Rsrv. Bank of St. Louis, 583 F.3d 1371, 1375 (Fed. Cir. 2009). Congress amended § 1498 to include government contractors in 1918 after a Supreme Court decision interpreted the law to apply only to government employees, not contractors. Morten & Duan, supra note 107, at 19–20. During World War I, concerns arose that potential patent infringement liability may impede the government’s ability to secure good and services from contractors. Id. The contractor provision of Section 1498 aims to facilitate government procurement of goods and services by reducing the threat of patent infringement suits against government contractors. Id.
If patent infringement is shown, the government, rather than the contractor, typically pays.187Richmond Screw Anchor Co. v. United States, 275 U.S. 331, 344 (1928) (“[Section 1498] is more than a waiver of immunity and effects an assumption of liability by the Government.”); Lavenue, supra note 85, at 421–22. Although the government can require contractors to indemnify the government for infringement costs under certain conditions, the result is often that the government is liable for any damages. Id. at 415, 440–52.
The government has used Section 1498 to broadly protect government contractors from patent infringement liability.188See, e.g., TVI Energy Corp. v. Blane, 806 F.2d 1057 (Fed. Cir. 1986); W.L. Gore & Assocs., Inc. v. Garlock, Inc., 842 F.2d 1275, 1283 (Fed. Cir. 1988) (noting that Section 1498 authorizes party to participate in government contract bid, even if the party is currently enjoined from such activities based on patent infringement); Sevenson Env’t Servs., Inc. v. Shaw Env’t, Inc., 477 F.3d 1361, 1363 (Fed. Cir. 2007) (holding that suit against hazardous waste remediation contractor was “barred by government contractor immunity”); Brennan et al., supra note 13, at 302 n.135 (describing Section 1498 use in contracts for manufacture of batteries, electronic passport readers, and military thermal targets).
Part 27 of the Federal Acquisition Regulation authorizes agencies to include an authorization and consent clause in government contracts.18948 C.F.R. § 27.102(b).
This clause authorizes contractors to use “any invention described in and covered by a United States patent” in performing contracts and therefore makes Section 1498 the exclusive remedy for any resulting patent infringement.190FAR § 52.227-1.
The federal government has regularly included authorization and consent clauses in government contracts.191Lavenue, supra note 85, at 439–40 (“This clause appears in almost all government contracts, except for small purchases, that encompass complete performance and delivery within the United States.”).
Furthermore, beginning in 1958, the government enacted a policy of not considering potential patent infringement when considering bids for government contracts, which expanded the use of Section 1498 for government contractors.192Id. at 473–76. This policy was hotly debated in the 1990s. Despite proposals to change it by statute, the Federal Acquisition Streamlining Act of 1994 made no changes to Section 1498. Id. at 476–92.
Around this same time, in the 1960s, the DOD purchased patented drugs from unlicensed sources to obtain lower prices.193Brennan et al., supra note 13, at 304–06; see also Ellen F.M. ’t Hoen, The Global Politics of Pharmaceutical Monopoly Power 43 (2009) (describing price decrease as a result).
These purchases sparked Section 1498 litigation that mostly ended in settlements.194Brennan et al., supra note 13, at 306 (noting that congressional testimony suggests that the parties typically agreed to a “reasonable and apparently modest royalty”).

Beyond proactively including Section 1498 authorization in contracts, the government has intervened in lawsuits where third parties are accused of patent infringement. In suits involving technology to detect fraudulent U.S. Treasury checks195Advanced Software Design Corp. v. Fed. Rsrv. Bank of St. Louis, 583 F.3d 1371 (Fed. Cir. 2009).
and to scan electronic passports, 196Iris Corp. v. Japan Airlines Corp., 769 F.3d 1359 (Fed. Cir. 2014).
the government argued that Section 1498 provided the exclusive remedy because the defendants used the technologies to benefit the government. In both cases, the Federal Circuit agreed with the government and held that the patent holder must seek relief exclusively for reasonable compensation under Section 1498.197Advanced Software, 583 F.3d at 1377–78; Iris Corp., 769 F.3d at 1362–63; see also Arlton v. Aerovironment, Inc., No. 2:20-cv-07438-AB-GJS, 2021 WL 1589302, at *8–10 (C.D. Cal. Apr. 22, 2021) (agreeing with government that it provided “authorization and consent” when NASA lab entered contracts for defendant to produce unmanned aerial vehicles).
More recently, the government asserted that Section 1498 applies to shield Moderna from liability for any patent infringement that occurred when Moderna produced COVID-19 vaccines pursuant to government contracts.198Arbutus Biopharma Corp. v. Moderna, Inc., No. 22-252, 2023 WL 2455979, at *1 (D. Del. Mar. 10, 2023).
The case is currently pending before the District of Delaware.199Arbutus, 2023 WL 2455979. The parties in that case dispute whether Moderna’s production of vaccines was for the government’s benefit if the vaccines were intended to be distributed to private parties. Id. at *2.

2. War Powers

The government can also impose third-party licenses on patents during times of war. One law allows the President to grant licenses to U.S. citizens on enemy-owned patents during wartime.200The President sets the terms of the license, including price. 50 U.S.C. § 4310(c).
A license shall only be granted if the President determines it will serve the “public welfare” and the applicant has a good faith intention to manufacture the patented invention.201Id. The licenses can be nonexclusive or exclusive, and can require production of supplies for the military. Id.
When the President grants licenses, royalties collected are held in a trust for patent holders.202Id. § 4310(d).
After the war ends, patent holders can bring patent infringement suits against licensees.203Id. § 4310(f).
Moreover, after World War I, Congress created compulsory patent licenses when it returned patents that had been confiscated during the war by specifying that the patents “shall be returned subject to the license.”204Settlement of War Claims Act of 1928, Pub. L. No. 70-122, § 13, 45 Stat. 254, 271–72. That law as amended remains on the books today. 50 U.S.C. § 4309(j); see also Petra Moser & Alessandra Voena, Compulsory Licensing: Evidence from the Trading with the Enemy Act, 102 Am. Econ. Rev. 396, 396 (2012) (describing compulsory licensing and suggesting that compulsory licenses increased domestic innovation).

3. Compulsory Licenses

Several laws allow agencies to order compulsory licenses on patents during normal government operations. These laws allow agencies to award licenses on patents to private parties, under which the private parties pay the licensing fees. Compulsory licensing laws appear in three contexts: federally funded inventions, inventions critical to the atomic energy industry, and inventions necessary to comply with clean air regulations.

Bayh-Dole March-in Rights

In addition to allowing government contractors to use the government’s reserved license, the Bayh-Dole Act gives agencies “[m]arch-in rights” to grant third-party licenses on patents covering federally funded inventions.20535 U.S.C. §§ 203(a), 210(c). In addition to the Bayh-Dole Act, one other law reserves march-in rights for federally funded inventions made under collaborative research agreements. 15 U.S.C. § 3710a(b). This provision specifies that march-in rights should only be used in “exceptional circumstances” if needed to meet health and safety needs, public use needs, or domestic manufacture requirements. Id.
March-in rights are broader than reserved licenses on federally funded inventions because they do not require the third party’s infringing acts to be taken “for or on behalf of” the government.20635 U.S.C. §§ 202(c)(4), 203.
Under the march-in rights law, agencies can require patent holders to grant license to third parties “upon terms that are reasonable under the circumstances” when patent holders have refused to grant a license.20735 U.S.C. § 203(a).
Agencies can grant march-in licenses when necessary to: (1) make the invention available to the public on reasonable terms, (2) alleviate health or safety needs, (3) meet public use requirements of federal regulations, or (4) comply with domestic manufacturing requirements.208Id. § 203(a). Notably, the law permits march-in rights for all contractors with patent rights on federally funded inventions, not just small businesses and nonprofits. Id. § 210(c).

So far, agencies have not used their march-in rights under the Bayh-Dole Act either on their own initiative or in response to a petition requesting a march-in license.209 John R. Thomas, Cong. Rsch. Serv., R44597, March-in Rights Under the Bayh-Dole Act 8–10 (2016) [hereinafter CRS R44597].
Most march-in requests have been filed with the NIH, requesting licenses on patents covering five different federally funded biomedical technologies.210Bloch, supra note 147, at 254–58; Timeline Regard Bayh-Dole March-in Right Requests, Knowledge Ecology Int’l, https://www.keionline.org/march-in-rights-timeline [perma.cc/6T58-NSCX].
Two petitions were based on product shortages, and the others were based on complaints of excessively high drug prices.211Ryan Whalen, Note, The Bayh-Dole Act & Public Rights in Federally Funded Inventions: Will the Agencies Ever Go Marching In?, 109 Nw. U. L. Rev. 1083, 1106 (2015); CRS R44597, supra note 209, at 9–10; see also Letter from Clare M. Love & Robert Sachs to Xavier Becerra, Sec’y, Dep’t of Health & Hum. Servs. (Nov. 18, 2021).
The NIH denied all petitions with similar reasoning. In response to petitions based on product shortages, the NIH concluded that compulsory licenses would not alleviate the shortages.212Determination in the Case of Petition of CellPro, Inc. (NIH Aug. 1, 1997) [hereinafter CellPro Determination] (noting that injunction order allowed infringing party to continue selling device until another FDA approved device was marketed); Determination in the Case of Fabrazyme Manufactured by Genzyme Corporation (NIH Dec. 1, 2010) (opining that petitioner would need to go through lengthy regulatory approval process selling patented drug product).
For petitions based on high drug prices, the NIH has concluded that march-in licenses are not warranted when the drug is available on the market.213In the Case of Norvir Manufactured by Abbott Laboratories, Inc. (NIH July 29, 2004) [hereinafter Norvir Determination I] (rejecting march-in petition where HIV/AIDS drug was “widely available”); In the Case of Xalatan Manufactured by Pfizer, Inc. (NIH Sept. 17, 2004) [hereinafter Xalatan Determination] (noting that drug is “widely available” for glaucoma patients); Determination in the Case of Norvir Manufactured by AbbVie (NIH Nov. 1, 2013) [hereinafter Norvir Determination II]; Letter from Francis S. Collins, Dir., NIH, to Andrew S. Goldman (June 20, 2016) [hereinafter Xtandi Determination I] (rejecting petition because drug is “broadly available as a prescription drug” without evidence of impending “short supply”); Xtandi Determination II, supra note 63, at 2 (noting that Xtandi is “widely available”). The NIST proposed a rule that would exclude high prices as a reason for exercising march-in rights, but it did not finalize that rule. Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 88 Fed. Reg. 17730, 17730–31 (Mar. 24, 2023) (to be codified at 37 C.F.R. pts. 401, 404); see Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 86 Fed. Reg. 35, 41 (proposed Jan. 4, 2021) (to be codified at 37 C.F.R. pts. 401, 404). In December, the Department of Commerce released proposed guidance taking the position that high prices can be a reason for march-in. See infra Section IV.B.

b. Atomic Energy Industry

Other laws allow the government to grant third parties licenses on patents that are important to the atomic energy industry. As discussed above, Congress created a patent buyout system for atomic energy patents in 1946.214See supra notes 122–124 and accompanying text.
Eight years later, through the Atomic Energy Act of 1954, Congress allowed private companies to participate in the atomic energy industry again, subject to extensive regulation.215Dunlavey, supra note 123, at 297, 300–01.
As part of opening the atomic industry to the private sector, Congress modified the 1946 Act’s total prohibition on patents related to atomic energy. The 1954 Act continued to prohibit patents on inventions used in atomic weapons, but it allowed the possibility of patents on other types of inventions related to nuclear energy.216Note, Security Inventions: Compensation Under Patent and Atomic Energy Acts, 31 Ind. L.J. 90, 100 (1955).
At the same time that Congress expanded availability of patents on atomic energy inventions, it reserved powers for the executive branch to grant licenses on those patents. The compulsory licensing provisions aimed to prevent a monopoly from forming over patents that were essential to the atomic energy industry.217See 83 Cong. Rec. 11483, 11484 (1954) (statement of Rep. Holifield) (noting concerns that patents could allow companies with know-how advantages to “exclude all of American industry unless they paid through the nose in the form of royalties”); 83 Cong. Rec. 10834, 10858 (1954) (statement of Sen. Gore) (describing concerns that a group of companies “have almost a monopoly upon the know-how of atomic energy,” which coupled with patents could “block the use by the people of this great natural resource”).

One provision allows the Atomic Energy Commission to declare any patent to be “affected with the public interest” if licensing the invention is of “primary importance” in atomic energy production.218Atomic Energy Act of 1954 § 153, 42 U.S.C. § 2183. The powers of the Atomic Energy Commission have since transferred to the Energy Research and Development Administration and the U.S. Nuclear Regulatory Commission. Atomic Energy Commission, U.S. Nuclear Regul. Comm’n, https://www.nrc.gov/reading-rm/basic-ref/glossary/atomic-energy-commission.html [perma.cc/LKK6-7ALB] (last updated Mar. 9, 2021).
When a patent is declared as affected with the public interest, the Commission is licensed to use the invention, and third parties can apply for a “nonexclusive patent license.”21942 U.S.C. § 2183.
The Act also includes a provision that allows courts to order compulsory licensing for the Commission’s licensees if patent holders intentionally violate antitrust laws, which would allow the Commission to decide who could access the patented technology.220Id. § 2188.
It appears that agencies have not ordered third-party licenses on atomic energy patents.221Congressional testimony from a Deputy General Counsel at the DOE suggests that the march-in procedures might have been used twice, but the record is not clear. See Toward Greater Public-Private Collaboration in Research and Development: How the Treatment of Intellectual Property Rights Is Minimizing Innovation in the Federal Government; Hearing Before the Subcomm. on Tech. and Procurement Pol’y, 107th Cong. 99 (2001) (statements of Deidre Lee, Director, Def. Procurement, Dep’t of Def. and Eric J. Fygi, Deputy General Counsel, Dep’t of Energy). The Atomic Energy Act procedures have likely expired because they only apply to patents filed before September 1, 1979. 42 U.S.C. § 2183(h).

c. Clean Air Regulations

One law allows the government to grant licenses on patents covering technology that is necessary to comply with clean air regulations. In the 1970 amendments to the Clean Air Act, Congress included a provision that aims to guarantee that regulated entities have adequate access to technology needed to meet statutory obligations.222Jessica Bernardini, Comment, Leveraging Mandatory Licensing Under the Clean Air Act—A Novel Framework to Domestic Reduction of Greenhouse Gases, 51 Env’t L. 301, 305 (2021); see also S. Rep. 91-1196, at 42–43 (1970) (“The purpose [of mandatory licensing] is to guarantee to all producers in a given field an adequate supply of technology with which to meet the statutory obligations . . . .”); 91 Cong. Rec. 32900, 32902 (1970).
It provides that where a patent is necessary to comply with a clean air regulation, district courts may order the patent holder to license it on “reasonable terms and conditions.”223Specifically, it applies to requirements for motor vehicle standards, hazardous air pollutant standards, and standards of performance for new stationary sources. See 42 U.S.C. § 7608. The provision requires that “no reasonable alternative methods” be available to comply with the regulations. Id.
The district court can only issue this order if, upon a request from the EPA Administrator, the Attorney General makes a certification that the conditions for compulsory licensing are met.224Id. The EPA issued regulations in 1994 that create procedures that allow parties to petition for a mandatory license. 40 C.F.R. § 95.2 (2024).
EPA and DOJ have not requested compulsory licenses under this law.225See Narechania, supra note 72, at 1501–02 (“But the EPA seems to have never even considered invoking this authority, even in cases where it seems obvious to do so.”); Bernardini, supra note 222, at 316–17.

4. Public Dedication

Nine laws allow agencies to require patents to be dedicated to the public when the inventions were developed with federal funding, subject to the limits of the Bayh-Dole Act.22615 U.S.C. § 2054(d) (Consumer Product Safety Commission grants); 22 U.S.C. § 2572 (Department of State grants for arms control research); 30 U.S.C. § 666 (DOE grants for coal mining research); 30 U.S.C. § 937 (HHS grants for Black Lung disease research); 30 U.S.C. § 951 (research grants to improve coal mine working conditions); 30 U.S.C. § 1226 (Department of Interior grants for mining research); 30 U.S.C. § 1328 (Department of Interior grants for coal mining research); 42 U.S.C. § 10308 (Department of Interior grants for water resources research); 49 U.S.C. § 30182 (motor vehicle safety research).
Like laws that vest title to the government on federally funded inventions, these laws do not apply to funding agreements with small businesses and nonprofits.227See supra Section II.C.3.
But they do apply to other agreements, such as those with large companies.22835 U.S.C. § 210.
Public dedication laws cover funding agreements in a range of research programs including arms control22922 U.S.C. § 2572.
and coal mining research.23030 U.S.C. § 1328.
When patents are dedicated to the public, they enter the public domain, and the information contained in them can be used freely.231Littauer, supra note 127, at 739–40 (describing effects of public dedication).
The laws place some limits on public-availability requirements. Typically, the federal contribution must be more than minimal,232See, e.g., 15 U.S.C. § 2054(d); 49 U.S.C. § 30182.
and agencies can waive the public availability requirement if necessary for the public interest23322 U.S.C. § 2572; 30 U.S.C. § 937; 30 U.S.C. § 951; 30 U.S.C. § 1226; 30 U.S.C. § 1328.
or national security.23430 U.S.C. § 666; 42 U.S.C. § 10308.
Therefore, in deciding whether to waive this requirement, agencies can decide whether to require patent holders to make patents freely available to third parties. In other words, they can decide whether to require patent holders to license their inventions for free.235I am not aware of any systematic study about how agencies have used their discretion under public dedication laws.

E. Direct Regulations

A fourth category of public patent power laws allows executive officials to make decisions about how patent holders (or patent applicants) can exercise their rights to exclude with respect to third parties. These laws do not create liability rules for patent infringement but, instead, allow agencies to make some form of decision that limits how patent holders can exercise their rights to exclude. Table 6 summarizes these laws.

Table 6: Direct Regulations

 

Public Control

ITC Exclusion Orders

Gov’t can decide not to enter an exclusion order
for imports that infringe U.S. patents for public interest and policy reasons.

Secrecy Orders

Gov’t can decide whether patent issuance should be
delayed for national security reasons.

Federally Funded
Inventions

Gov’t can place limits on licensing activities
of patent holders or place conditions in funding agreements.

1. ITC Exclusion Orders

One law allows the International Trade Commission (ITC) to limit exclusion orders, even when imports infringe U.S. patents.23619 U.S.C. § 1337.
In 1930, Congress created procedures for patent holders to file complaints before the ITC based on allegations that imports of certain articles infringe U.S. patents.237Id. §§ 1337(a)(1)(B), (b). The ITC can also conduct investigations on its own initiative.
If the ITC concludes that the imports would infringe a valid and enforceable patent and that a domestic industry exists for the patented articles, the ITC can then enjoin importation by issuing an exclusion order.238The ITC can also issue a cease and desist order. I refer to both collectively as “exclusion order[s].” 19 U.S.C. §§ 1337(a)(2), (d), (f).
But the law does not mandate that the ITC enter an exclusion order. It gives the ITC discretion to deny or tailor injunctive relief, even when it finds patent infringement, based on consideration of an injunction’s potential effects on (1) public health and welfare, (2) competitive conditions in the United States, (3) domestic production of competitive articles, and (4) U.S. consumers.23919 U.S.C. §§ 1337(d), (f).
Moreover, if the ITC enters an exclusion order, the U.S. Trade Representative can disapprove the order for “policy reasons.”240The law gives this power to the President, which has been delegated to the U.S. Trade Representative. See Assignment of Certain Functions Under Section 337 of the Tariff Act of 1930, 70 Fed. Reg. 43251 (July 21, 2005); 19 U.S.C. § 1337(j).

Although the ITC may deny injunctive relief, this denial does not create a de facto liability rule—patent holders can still seek injunctions in district court, notwithstanding an ITC order.241ITC determinations do not necessarily have preclusive effect in subsequent district court litigation. See Tex. Instruments, Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558 (Fed. Cir. 1996). In practice, however, scholars have observed that the ITC is more likely to grant injunctions than district courts. Chien & Lemley, supra note 14, at 16.
Nonetheless, decisions about whether to limit exclusion orders allow the ITC to decide whether patent holders can use their patents to obtain a particular type of remedy: an administrative order that bars imports. Under this law, executive actors can choose to allow third parties to import goods based on public interest and economic policy reasons, even where those actors conclude importation will infringe a patent.24219 U.S.C. §§ 1337(d), (f).

The ITC has denied exclusion orders based on public interest factors before, but only rarely.243See Chien & Lemley, supra note 14, at 19 (“[I]n the vast majority of section 337 cases, the ITC finds that excluding goods does not threaten the public interest.”).
It has done so three times; in each situation, the ITC concluded that alternative goods were unavailable and an injunction would disserve public health and welfare needs.244Id. at 21–23.
These cases involved technology including car parts needed to meet fuel standards,245Certain Automatic Crankpin Grinders, Inv. No. 337-TA-60, USITC Pub. 1022, at 1, 20 (Dec. 1979) (“[T]here are overriding public interest considerations in not ordering a remedy which will hamper the supply of energy efficient automobiles.”).
equipment needed for nuclear physics research,246Certain Inclined-Field Acceleration Tubes and Components Thereof, Inv. No. 337-TA-67, USITC Pub. 1119, at 25–31 (Dec. 1980) (“The competing interest here is the continued availability of tubes essential to research programs affecting the public health and welfare.”).
and hospital beds for burn victims.247Certain Fluidized Supporting Apparatus and Components Thereof, Inv. No. 337-TA-182/188, USITC Pub. 1667, at 1–2, 25 (Oct. 1984) (“[P]ublic health considerations override SSI’s interests as an exclusive patent licensee . . . .”).
Similarly, the U.S. Trade Representative has denied exclusion orders for policy reasons (also rarely).248See Chien & Lemley, supra note 14, at 37 n.197.
Most recently, in 2013, the U.S. Trade Representative disapproved an exclusion order that would have enjoined Apple from importing iPhone and iPad devices that infringed a Samsung patent. Significantly, the Samsung patent at issue was essential to an industry standard, which raised special policy concerns.249Letter from Ambassador Michael B.G. Froman to Hon. Irving A. Williamson, Re: Disapproval of the U.S. International Trade Commission’s Determination in the Matter of Certain Electronic Devices, Inv. No. 337-TA-794 (Aug. 3, 2013); Certain Elec. Devices, Including Wireless Commc’n Devices, Portable Music & Data Processing Devices & Tablet Computs., Inv. No. 337-TA-794, Comm’n Op.2824 (July 5, 2013) (Terminated); see also DOJ & PTO, Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments 6 (2013). Subsequent administrations changed this guidance. PTO, DOJ & NIST, Withdrawal of 2019 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments 1 (2019).

Beyond denying exclusion orders, the ITC has also applied the public interest factors to tailor exclusion orders. The two primary ways that the ITC has tailored exclusion orders are: (1) providing exceptions that allow certain imports to continue and (2) delaying implementation of exclusion orders.250See Chien & Lemley, supra note 14, at 32–36.
For example, in 2020, the ITC delayed implementation of an exclusion order for slurries used in semiconductor production to allow parties time to switch to non-infringing alternatives.251Certain Chem. Mech. Planarization Slurries and Components Thereof, Inv. No. 337-TA-1204, at 42–53 (Jan. 2022) (Terminated).

2. Secrecy Orders

Secrecy orders provide another example of how the government can limit patent rights. In the interest of national security, defense agencies can direct the Patent Office to keep patent applications secret and therefore withhold them from publication.25235 U.S.C. § 181.
If the Patent Office thinks public disclosure of a patent application might harm national security, the Patent Office must send the application to the relevant defense agency.253Id.
Those agency officials then notify the Patent Office if the application should be kept under a secrecy order.254Id.
Another statute creates a similar framework for patent applications filed during wartime.25550 U.S.C. § 4310(i).
By imposing a secrecy order, defense agencies can delay the issuance of the patent because the Patent Office cannot grant a patent unless its application is published.25635 U.S.C. § 181. Secrecy orders last for renewable one-year periods or for the duration of war if issued during war. Id.

Agencies appear to regularly issue secrecy orders. At the end of FY2022, the Federation of American Scientists reported that 6,057 secrecy orders were in effect, based on data it obtained from the Patent Office.257Fed. of Am. Scientists, Invention Secrecy Activity, Project on Gov’t Secrecy, https://sgp.fas.org/othergov/invention/stats.html [perma.cc/489R-H5BB].
Agencies issued 87 new secrecy orders in FY2022, most of which came from the U.S. Navy, while others came from the Army, the Air Force, and the Department of Energy.258Id. Secrecy orders allow agencies to influence how inventors can exclude others from using their inventions because they can withhold the patent, even if an application discloses a patentable invention. Moreover, if the patent application ultimately issues into a patent after the secrecy order is lifted, the secrecy order limits recovery for damages during the period of the secrecy order to compensation for government uses of the invention. See 35 U.S.C. §§ 154(d), 183, 284; 50 U.S.C. § 4310(i). I coded the provisions that provide compensation for government use as allowing agencies to obtain patent licenses.

3. Federally Funded Inventions

When agencies allow private parties to obtain patents on federally funded inventions, they can place conditions in funding agreements to regulate how patent holders will exercise their rights to exclude. Several laws place restrictions on how patent holders can license patents covering federally funded inventions. These laws do not create liability rules: The patent holders still can decide whether to license the patents at all. But the laws do provide a level of government control over how patent holders can use their patents.

The Bayh-Dole Act places several conditions on how patent holders can use patents on federally funded inventions. For example, the law requires that if grantees license patents exclusively, the licensed products must be manufactured “substantially in the United States” if “commercially feasible.”25935 U.S.C. § 204. Agencies can further restrict patent rights as needed in exceptional circumstances to promote policy goals of the Bayh-Dole Act. Id. § 202(a).
For nonprofit organizations—which are typically universities—the law requires agency approval before the nonprofit can assign its patents,26035 U.S.C. § 202(c)(7).
and nonprofits must give preference to small businesses in their licensing policies.261Id.
Furthermore, nonprofits must give some royalties to inventors and use the remaining royalties for science and educational purposes.262Id.
In certain circumstances, if a nonprofit receives a significant amount of royalties, it must make payments to the U.S. Treasury.263Id.

Beyond the Bayh-Dole Act, two other laws place conditions on licensing of federally funded inventions. In research programs about solid-state lighting technologies and energy storage technologies, laws require patent holders to give industrial participants in federal programs the first options to negotiate licenses.26442 U.S.C. § 16192(h); 42 U.S.C. § 17231(h)(7). Both laws also note that the Secretary may include terms necessary to promote “accelerated commercialization of inventions” under the programs. 42 U.S.C. § 16192(h); 42 U.S.C. § 17231(h)(7).

Outside of these statutory requirements, agencies can voluntarily place other conditions in funding agreements.265See Price, supra note 163, at 33. The Bayh-Dole Act places some limits on what sorts of conditions agencies can require. See 35 U.S.C. § 202(f).
For example, in September 2023, HHS included a reasonable pricing clause in a funding agreement with Regeneron on the next generation of research on antibodies to prevent COVID-19.266Press Release, U.S. Dep’t of Health & Hum. Servs., HHS Announces Details of Partnership with Regeneron to Develop Life-saving Monoclonal Antibodies (Sept. 8, 2023), https://www.hhs.gov/about/news/2023/09/08/hhs-announces-details-partnership-regeneron-develop-life-saving-monoclonal-antibodies.html [perma.cc/NE7B-4WSG]. This agreement was with BARDA, another sub-agency within HHS that funds life sciences research.
The clause states that if Regeneron commercializes a new product based on the federally funded research, the list price in the United States will be equal to or less than the price in comparable countries.267Id.

III. Implications

Public patent powers reveal that as a matter of institutional design, Congress has given agencies outside the Patent Office numerous express powers to regulate how patents are used. The descriptive account of public patent powers has several implications for patent regulation. Because public patent powers appear in existing laws, they create a roadmap of actions the executive branch could take without the need for any legislative action when patents create policy concerns. Moreover, common themes in public patent powers reveal a statutory scheme that contemplates, and even embraces, executive regulatory involvement. These themes provide a framework for identifying situations where regulatory oversight of patent decisions may be appropriate and politically feasible. Furthermore, the descriptive account of public patent powers uncovers a patent system that includes more express structures for regulatory oversight than previously recognized. This in turn means that the Supreme Court’s decision in Oil States v. Greene’s Energy268Oil States Energy Servs. v. Greene’s Energy Grp., 138 S. Ct. 1365 (2018).
may have broader implications than previously appreciated. This Part analyzes these implications.

A. Roadmap for Executive Actions

The landscape of public patent powers and their use provides lessons about what powers exist, where their use might be politically feasible, and where practical barriers may arise. Because public patent powers are expressly included in existing law, agencies can use these powers without any further legislative action. Table 7 summarizes these powers and how the government has used them.

Table 7: Public Patent Powers in Practice

Public
Patent Powers

Forms of Public Control

Use in Practice

Unlicensed
Patent Use

Gov’t actors and gov’t contractors can use patented technology without threat of injunction; patent holder can seek reasonable compensation.

Gov’t actors and gov’t contractors have used patented technology without licenses in a range of contexts.

Prospective Patent Licenses

Gov’t can pay to use patented technology; government actors and gov’t contractors can use federally funded inventions without payment.

Gov’t actors and gov’t contractors have used patented technology with licenses in a range of contexts.

Patent Buyouts

Gov’t can pay to obtain title to patent.

Gov’t has purchased patents in the defense context, but has not done so in decades.

Government Title on Federally Funded Inventions

Gov’t can obtain title on employee inventions, and on contractor inventions under certain circumstances. When agencies own patents, they can place conditions on patent licenses.

Agencies have voluntarily given large companies options to obtain patents on federally funded inventions. Agencies have granted exclusive licenses and placed conditions on licenses.

R&D Funding Agreements

Laws place several limits on patent licensing activities; agencies can place further conditions on licensing and use of patented technology. Some require public dedication.

Agencies regularly fund third party R&D and have placed conditions in research agreements.

Compulsory Licensing

Gov’t can order compulsory licenses on patents covering federally funded inventions, atomic energy technology, and technology necessary to comply with clean air regulations.

Agencies appear not to have ordered compulsory licenses.

ITC Exclusion Orders

ITC can deny or tailor remedy based on public interest factors, and U.S. Trade Representative can disapprove exclusion orders for policy reasons.

ITC and U.S. Trade Representative have occasionally denied or tailored injunctive relief based on public interest factors.

War Powers

Gov’t can seize patents and require licenses during war.

Gov’t seized patents during WWI and WWII.

Secrecy Orders

Gov’t can withhold patent for national security reasons, subject to payment for gov’t use.

Defense agencies have imposed numerous secrecy orders on patent applications.

When confronted with patent policy concerns in regulated industries, agencies can look to public patent powers as potential regulatory tools. Whether to use public patent powers will be a context-specific inquiry, and different powers might be more useful in different contexts. Section 1498, for example, might be more useful to address urgent public health and safety needs because it allows the government and government contractors to act quickly without threats of injunctions, then determine whether patent infringement occurred and whether damages are owed later.269See Morten & Duan, supra note 107, at 50–51.
Prospective licenses, on the other hand, could save litigation costs down the line, and conditions in funding agreements may allow for more ex ante regulation.

By viewing various public patent power laws together, rather than in isolation, agencies can evaluate which of the existing options would be best suited to address policy concerns. Agencies can also consider which powers might be most feasible to implement in practice. Federally funded drugs, like Xtandi, provide an example of how agencies might consider the full scope of public patent powers. Although agencies have been reluctant to order march-in licenses on federally funded drugs, the government has a host of other tools it could use to address high drug prices. For example, HHS recently included a reasonable pricing clause in a research funding agreement in response to a proposal from Senator Sanders.270 Senate HELP Report, supra note 164, at 10; U.S. Dep’t of Health & Hum. Servs., supra note 266. Pfizer also accepted a most favored nation clause in government purchase agreements for Paxlovid. Sydney Lupkin, Feds’ Contract with Pfizer for Paxlovid Has Some Surprises, NPR (Feb. 1, 2022, 5:22 PM), https://www.npr.org/sections/health-shots/2022/02/01/1075876794/feds-contract-with-pfizer-for-paxlovid-has-some-surprises [perma.cc/3LAZ-9JWX].
It could include a similar clause in future patent licenses and funding agreements. Some scholars have proposed that the government add more requirements for patent holders to pay royalties to the government, which could then be used to subsidize further research or treatment costs for patients.271David A. Hyman & Charles Silver, Are We ‘Paying Twice’ for Pharmaceuticals?, Regulation, Winter 2020–2021, at 14, 18.
The NIH could try other strategies too—for example, when it makes patent licensing decisions, it could consider patient affordability.272See U.S. Gov’t Accountability Off., GAO-21-52, supra note 166, at 33–35 (finding that the NIH does not consider affordability of drugs when it makes licensing decisions). But see supra note 169 (describing NIH access plan policy).
The government might also consider whether it should directly purchase or produce patented drugs to reduce prices.273See Brennan et al., supra note 13, at 346–48; Dana Brown & Christopher Morten, Four Steps to Transform the Pharmaceutical Industry and Survive the Pandemic, In These Times (Sept. 10, 2020), https://inthesetimes.com/article/pharmaceutical-industry-pandemic-covid-vaccine [perma.cc/BC78-CAN8].
Other commenters have proposed that government authorization of government contractors to produce medicine under Section 1498, or to even buy patents.274See, e.g., Daniel Hemel & Lisa Larrimore Ouellette, Opinion, Pharmaceutical Profits and Public Health Are Not Incompatible, N.Y. Times (Apr. 8, 2020), https://www.nytimes.com/2020/04/08/opinion/coronavirus-drug-company-profits.html [perma.cc/3CVX-387B]; Expanding Access to Semaglutide Through 28 U.S.C. § 1498, Pub. Citizen (Aug. 5, 2024), https://www.citizen.org/article/expanding-access-to-semaglutide-through-section-1498/ [perma.cc/D99H-2358].
That other public patent powers have been used more often than compulsory licenses historically suggests that these other tools might be more feasible to implement in practice.

B. Framework for Regulatory Oversight

Several themes emerge in contexts where Congress has created and agencies have used public patent powers. In general, public patent powers appear in four contexts: (1) where inventions were developed with federal funding, (2) when technology is useful for government programs, (3) when public health and safety needs are at stake, and (4) when patents are coupled with market power. This Section analyzes these four contexts and explains how they are consistent with policy judgments made throughout the history of patent regulation in the United States. The common themes provide a deeper understanding of policy judgments that Congress has made when designing the patent system. Together, the four themes in public patent powers create a framework for identifying situations where heightened regulatory oversight of patent decisions may be warranted and politically feasible. This framework could provide guidance for both agencies—to identify situations where existing powers could be used—and legislators—to identify contexts where additional express powers may be useful.

1. Federally Funded Research

Congress has given agencies numerous levers of control over patents that cover federally funded inventions. Agencies typically retain total control over inventions developed by government employees.275See supra Section II.C.3.
Agencies can also sometimes retain title on other federally funded inventions, subject to limits in the Bayh-Dole Act.276See supra Section II.C.3.
Moreover, when private parties obtain patents on federally funded inventions, the Bayh-Dole Act reserves a license for the government and its contractors to use those inventions, and it allows agencies to grant march-in licenses under certain conditions.27735 U.S.C. §§ 202, 203.
Congress has also placed additional conditions on how patent holders can use exclusive patent rights on federally funded inventions, like the requirement to give preference to small businesses and domestic manufacturers in exclusive licensing decisions.278See supra Section II.E.3.
Agencies have further used their discretion in funding agreements and patent licenses to control how patents are used, such as their inclusion of reasonable pricing clauses in agreements.279See supra Sections II.D.3, E.3.

Regulatory control over federally funded research reflects a judgment that patents should be subject to limited private control when public funding supported the development of the invention. This judgment is consistent with contractual and equitable principles developed in common law doctrine: It long recognized that employers can require employees to assign patent rights to the employer as part of employment contracts.280Wille, supra note 114, at 106. Such agreements can also be implied when an employee is hired to develop an invention. Solomons v. United States, 137 U.S. 342, 346 (1890); Standard Parts Co. v. Peck, 264 U.S. 52, 59–60 (1924); see Oren Bracha, Owning Ideas: The Intellectual Origins of American Intellectual Property, 1790–1909, at 243–52 (2016).
Common law has also provided for a “shop-right,” which gives a party who contributed to the development of a patented invention a license to use the invention based on equitable principles.281See United States v. Dubilier Condenser Corp., 289 U.S. 178, 188–89 (1933); Bracha, supra note 280, at 241–42.
Moreover, courts have held that Congress has broad discretion to place conditions on the receipt of federal funds under its spending power.282See, e.g., South Dakota v. Dole, 483 U.S. 203, 206–07 (1987). The outer bounds of the power to place conditions on federal spending are not clear and are currently being litigated in challenges to the Medicare price negotiation program. See Hannah-Alise Rogers, Cong. Rsch. Serv., R47682, Constitutional Challenges to the Medicare Drug Price Negotiation Program 14–17 (2023). Courts thus far, however, have continued to recognize broad discretion to place conditions on Medicare spending decisions. See AstraZeneca Pharms. v. Becerra, 719 F. Supp. 3d 377, 395–96 (D. Del. Mar. 1, 2024); Boehringer Ingelheim Pharms., Inc. v. HHS, 2024 WL 3292657, at *8–10 (D. Conn. July 3, 2024).

Furthermore, courts and commentators have long observed that fundamental fairness is at stake when public funding contributes to the development of an invention. When exclusive rights cover federally funded inventions, the exclusive rights can create a so-called “double tax,” which requires the public to pay once through taxes to support the research, then again through higher prices when the invention is sold.283Eisenberg, supra note 141, at 1666; Daniel J. Hemel & Lisa Larrimore Ouellette, Beyond the Patents–Prizes Debate, 92 Tex. L. Rev. 303, 312, 371–72 (2013).
Courts and scholars have noted that such a double tax raises fairness concerns.284E.g., Eisenberg, supra note 141, at 1668, 1673 (“When inventions are made with public funds, equitable arguments for rewarding research performers with patent rights have lesser force than when private firms have put their own capital at risk to make the inventions . . . .”); Finnegan & Pogue, supra note 121, at 943 (“[I]t would be unfair to permit enforcement of resulting patent rights to the personal profit of the employee and at the expense of the public [when] the invention was originally paid for, as established by the traditional judicial standards, by the public.”); Houghton v. United States, 23 F.2d 386, 391 (1928) (describing it as “unthinkable” that a private party should be able to charge monopoly rents on a publicly funded invention); see also 83 Cong. Rec. 10746–47 (1954) (Statement of Sen. Lehman) (describing opposition “to unjustified public subsidy of private enterprise” in debates over the Atomic Energy Act of 1954); Electric Vehicles and Other Alternatives to the Internal Combustion Engine: Joint Hearings on S. 451 and S. 453 Before the S. Comm. on Com. and the S. Subcomm. on Air and Water Pollution of the Comm. on Pub. Works, 90th Cong. 80 (1967) (statement of Sec’y Boyd) (“If public funds are involved, then the public should get the benefit.”).
Several limits in the Bayh-Dole Act aim to address fairness concerns, such as march-in rights, if inventions are not made available to the public on reasonable terms, and the limits on the government’s ability to grant exclusive licenses unless necessary for commercialization.285See supra Sections II.C.3, D.3.
Furthermore, federal funding provides an additional incentive to invent beyond the ordinary incentive patent protection provides. This additional innovation incentive may lessen the justification for strong patent rights as necessary tools to encourage investment in research and development.286Eisenberg, supra note 141, at 1666–67.

Federally funded research is an area where the patent system has consistently included limits on private control. Industries where the federal government funds significant amounts of research—such as the health, space, energy, and defense industries287See Historical Trends in Federal R&D, Am. Ass’n for the Advancement of Sci., https://www.aaas.org/programs/r-d-budget-and-policy/historical-trends-federal-rd [perma.cc/7GNZ-4J7A].
—are, thus, appropriate targets for regulatory oversight.

2. Government Programs

Congress has also included public patent powers in multiple laws when patents cover technology useful for government programs. As a default rule, government actors and government contractors can use any patented technology without the threat of injunctions.288See 28 U.S.C. § 1498.
Similarly, reserved licenses under the Bayh-Dole Act allow the government and its contractors to freely use patented technology developed with federal funding.28935 U.S.C. §§ 202(c)(4), 210(c). The Bayh-Dole Act states that one policy goal is to ensure the government obtains sufficient rights to “meet the needs of the Government.” Id. § 200.
Many other program-specific laws authorize agencies to purchase patents and patent licenses useful to their operations.290See supra Sections II.B.2, C.1.
Under this system, the government has regularly used patented technology and broadly authorized government contractors to do so as well.291See supra Sections II.B, D.1.
It has used these powers in connection with a host of government programs, including military operations and biomedical research programs.292See supra Sections II.B, C.

These laws reflect a policy judgment that private parties should not be able to use patents to unduly interfere with public uses of patented technology. Collectively, the laws create liability rules by barring injunctions against the government and government contractors. Liability rules, in turn, prevent the possibility that a patent holder could hold out on licensing negotiations, to stop government programs, or could threaten to, in order to obtain unreasonably high compensation.293Morten & Duan, supra note 107, at 53–54.
Preventing holdout on public uses of patents is consistent with eminent domain doctrine, which prevents private property owners from stopping public uses of private property.294Calabresi & Melamed, supra note 36, at 1106–08 (describing how liability rules can prevent holdout problems); Carrier, supra note 32, at 30, 71 (“Eminent domain precludes individual landowners from holding out and preventing the government from utilizing land that it needs to effectuate certain public policies.”).
Public patent powers are not necessarily exercises of eminent domain power—it remains unsettled whether patents are protected by the Takings Clause.295See Oil States Energy Servs. v. Greene’s Energy Grp., 584 U.S. 325, 344 (2018). Whether patents are protected by the Takings Clause is outside the scope of this Article. However, see infra Section III.C, for discussion on Oil States and administrative regulation of property.
But the policy judgment behind barring injunctions for public uses of patented technology is analogous to the policy behind eminent domain. Moreover, limits on remedies against the government are consistent with historical practice, where sovereign immunity has traditionally insulated the government from injunctions and tort liability for patent infringement.296See supra note 85 and accompanying text.

Government programs are another area where the patent system has consistently included limits on private control. Federal programs, ranging from military operations to research programs,297E.g., Am. Ass’n for the Advancement of Sci., supra note 287.
are thus also targets for agencies and Congress to consider regulatory oversight.

3. Public Health and Safety Needs

Congress has also consistently empowered agencies to oversee patents when public health and safety needs are at stake. For example, the Bayh-Dole Act allows march-in licenses to alleviate public health and safety needs, and it permits agencies to retain title to patents whenever warranted by public health and safety needs.29835 U.S.C. § 203(a)(2).
Similarly, the law directs the ITC to consider public health and welfare when deciding whether to limit exclusion orders on imported goods.29919 U.S.C. § 1337(d).
Compulsory licensing provisions for environmental regulations and the atomic energy industry also relate to public health and safety. Furthermore, secrecy orders and war powers allow executive officials to act quickly in response to national security concerns.300See supra Sections II.C.2, D.2, E.2.
The law also allows agencies to limit the public availability of federally funded inventions if needed for national security.301See supra Section II.D.4.

Agencies have often used their public patent powers in response to health and safety concerns as well. In the national security context, agencies have used licenses and bought patents on defense weapons systems,302See supra Sections II.B.1, C.1, D.1; U.S. Gov’t Accountability Off., GAO-03-536, supra note 112, at 5.
seized patents during World War I and World War II,303See supra Section II.C.2.
and imposed secrecy orders on numerous patent applications.304See supra Section II.E.2.
In the biomedical context, agencies have used patent licenses to conduct research,305See supra Section II.D.1.
imposed conditions on NIH funding and license agreements,306See supra Sections II.C.3, E.3.
purchased drugs for federal health programs,307See supra Section II.D.1.
and limited exclusion orders.308See supra Section II.E.1.
Moreover, public health concerns about a federally funded HIV drug recently motivated the government to take the rare action of initiating a patent infringement suit in an effort to recoup its investment.309See supra Section II.C.3.
The government has also threatened to use public patent powers in licensing negotiations in both the defense and biomedical contexts, such as when it obtained patent licenses on aircraft technology in World War I and anthrax treatments after September 11.310See supra Section II.B.2.

This history reflects a consistent policy judgment that patent holders should not be able to use patents to thwart public health or safety. Patent law doctrine has long incorporated this policy judgment based on equitable principles in remedies. Even before eBay, injunctions for patent infringement were occasionally denied or limited based on public health and safety concerns,311See Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538, 1547–48 (Fed. Cir. 1995) (discussing examples where courts denied injunctions for patent infringement on public interest grounds); Carrier, supra note 32, at 108 n.521 (citing examples).
such as the need for access to medical diagnostic tests and the need for a sewage drainage facility to continue operating.312Hybritech Inc. v. Abbott Lab’ys, No. CV 86-7461/AK(PX), 1987 WL 123997, at *1–2 (C.D. Cal. July 14, 1987) (limiting injunction to ensure continuous supply of monoclonal test kits to cancer and hepatitis patients); City of Milwaukee v. Activated Sludge, Inc., 69 F.2d 577, 593 (7th Cir. 1934) (noting injunction would “close the sewage plant,” which would “endanger[] the health and lives” of the community).
The patent system has consistently included limits on private control when public health and safety needs are at stake. Issues involving public health and safety needs, such as health care and safety regulations, are additional targets for regulatory oversight.313See Am. Ass’n for the Advancement of Sci., supra note 287.

4. Patents Coupled with Market Power

Congress has also included several structures for regulatory oversight where patents are coupled with market power. In competitive markets, a patent allows the patent holder to charge heightened prices, but competition still exerts some control over the ultimate price the patent holder can charge. When patent holders have market power, however, they have more power over the prices they charge for patented products. For example, a producer of a patented type of tennis ball could exclude competitors from making the exact same type of tennis ball, but they would still face competition from producers of other types of tennis balls. If the producer set the price of the patented tennis balls too high, tennis players could purchase other unpatented tennis balls instead. If a patent holder has market power, however, the patent holder has more control over the price. And if the U.S. Tennis Association (USTA) required a particular type of patented tennis balls in matches, for example, tennis players could not so easily switch to other products. This could create a situation where the patent holder has monopoly power over at least one segment of the market, since the patent allows it to exclude competitors from making the USTA-required tennis balls.

When patents cover technology that is required to comply with an industry standard, patent holders have significant market power.314Carl Shapiro & Mark A. Lemley, The Role of Antitrust in Preventing Patent Holdup, 168 U. Pa. L. Rev. 2019, 2019–21 (2020) (noting that the owner of a valid essential patent who could obtain injunctions to block competitors would “wield enormous monopoly power”); Charles Duan, Mandatory Infringement, 75 Fla. L. Rev. 219, 223–24 (2023) (describing “strong, durable market power” where regulation requires the use of IP).
Several public patent powers target technology required to comply with an industry standard, including government regulations. For example, the compulsory licensing provision of the Clean Air Act applies to technologies required to comply with regulatory standards.31542 U.S.C. § 7608. The Committee Report also acknowledged concerns about market concentration, noting that the compulsory licensing provision “in no way is designed to give large manufacturers production rights to the inventions[,] trade secrets or discoveries of others.” S. Rep. No. 91-1196, at 42 (1970); see also 116 Cong. Rec. 42386 (1970) (statement of Sen. Muskie) (describing compulsory licensing “to prevent the stringent standards of the Act from contributing to monopolist concentrations in any industries”).
The Bayh-Dole Act also allows march-in licenses when patented inventions are required to comply with government regulations.316See Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights, 88 Fed. Reg. 85593, 85599 (Dec. 8, 2023) (describing public use prong of march-in statute).
Furthermore, agencies have considered whether patented technology is required to comply with an industry standard when implementing public patent powers. The U.S. Trade Representative pointed to the fact that technology was required to comply with an industry standard when it disapproved an exclusion order for Apple products that infringed Samsung patents.317See supra note 249 and accompanying text.

Other public patent powers also have taken market power into account. For example, the preference for small businesses and nonprofits in the Bayh-Dole Act was justified in part by arguments that those entities typically did not have market power and would promote competition in the economy.318Eisenberg, supra note 141, at 1695–96.
Similarly, concerns about a monopoly over atomic energy motivated the compulsory licensing law for patents critical to that industry.319See supra note 217 and accompanying text. The compulsory licensing provision was influenced by a message from President Eisenhower to Congress, which stated: “[C]onsiderations of fairness require some mechanism to assure that the limited number of companies, which as government contractors now have access to the program, cannot build a patent monopoly which would exclude others desiring to enter the field.” President Dwight D. Eisenhower, Special Message to the Congress Recommending Amendments to the Atomic Energy Act (Feb. 17, 1954); 100 Cong. Rec. 10732–33 (daily ed. July 16, 1954) (statement of Sen. Thye) (expressing concern that small businesses and rural electric cooperatives “are not frozen out by anyone who has monopolistic designs on this development”).
Furthermore, the law allows the ITC to consider “competitive conditions” when deciding whether to limit exclusion orders, which could include concerns about market power.32019 U.S.C. §§ 1337(d), (f).

Regulation over how patent holders with market power exercise their rights to exclude is often done through antitrust law, which has long placed at least some limits on patent licensing activities for patent holders with market power.321See, e.g., FTC v. Actavis, Inc., 570 U.S. 136 (2013); DOJ & FTC, Antitrust Issues in the Tying and Bundling of Intellectual Property Rights, in Antitrust Enforcement and Intellectual Property Rights: Promoting Innovation and Competition (2007).
Market power also historically could be considered as part of the public interest prong in the equitable test for injunctions.322See, e.g., Hodge v. Hudson River R.R., 12 F. Cas. 276, 278–79 (C.C.S.D.N.Y. 1868) (placing conditions on injunction where railroad was a “common carrier[]”).
Furthermore, in the context of standard essential patents that are required to comply with industry standards, private parties have often voluntarily agreed that limits on injunctions are appropriate.323“Standard essential patents” refer to core patents in certain industries that rely on standards to facilitate interoperability across devices. For example, Wi-Fi allows different types of phones to wirelessly connect to the internet. Mark A. Lemley & Timothy Simcoe, How Essential Are Standard-Essential Patents?, 104 Cornell L. Rev. 607, 609–10 (2019).
Most standard-setting organizations require their members to agree to license standard-essential patents on fair, reasonable, and non-discriminatory terms.324Id. at 610.

Contexts where patent holders have market power represent another area where the patent system has consistently included limits on private control. Agencies and Congress thus might consider situations where patent holders have market power—such as when patented technology is required to comply with a government regulation—as potential areas for regulatory oversight.

C. The Regulatory-Property Debate

In addition to creating a framework for regulatory oversight, the descriptive account of public patent powers contributes to the ongoing descriptive debate about the nature of patent rights. Although the patent system has existed for centuries, a surprisingly active debate exists about whether the patent system is better conceived of as a regulatory program or a private property system.325Mark A. Lemley, Property, Intellectual Property, and Free Riding, 83 Tex. L. Rev. 1031 (2005); Rajec, supra note 39, at 1861–62; Reilly, supra note 28, at 274–75; Jonathan S. Masur, Institutional Design and the Nature of Patents, 104 Iowa L. Rev. 2535, 2536–39 (2019); Adam Mossoff, Statutes, Common Law Rights, and the Mistaken Classification of Patents as Public Rights, 104 Iowa L. Rev. 2591, 2591–94 (2019).
The debate involves multiple dimensions—a descriptive debate about what rights patents confer, a doctrinal debate about the protections that attach to patents, and a policy debate about how patent rights should be structured.326Reilly, supra note 28, at 274–75; Masur, supra note 325, at 2536–39.

This Article contributes to the descriptive aspect of that debate by providing new information about the statutory rights that patents confer. The compilation of laws that expressly allow agencies to make decisions about patents shows that patent holder discretion over how to use patents is not as unfettered as some have previously assumed. Professor Greg Reilly, for example, has argued that even though Congress has broad power to decide how to structure patent rights, it descriptively has structured patent entitlements similarly to private property rights because patents have traditionally been subject to “virtually no government control, regulation, or involvement” after they issue.327Reilly, supra note 28, at 260–61; id. at 222 (describing “[n]o significant government role in regulating, enforcing, or reconsidering patent rights” as similar to private property).
Public patent powers cast doubt on that premise because they reveal a long tradition of numerous levers of government control over patents after they issue. Under these laws, regulatory agencies can make decisions about how patents are used in many different ways. These laws allow agencies, rather than courts or Congress, to balance goals of incentivizing research and providing public access to innovative technology.328To be sure, the existence of public patent powers does not definitively resolve whether patents are private property. Most public patent powers are consistent with permissible regulations of private property. The government can take private property for public uses in exchange for compensation under the Takings Clause, and it has broad power to regulate how private property is used. See Carrier, supra note 32, at 52–80; Bessen & Meurer, supra note 44, at 31 (“Neither tangible nor patent property rights offer absolute rights of exclusion and under some circumstances these rights are curtailed.”). It is not clear whether Congress provided compensation in exchange for patent licenses and buyouts because it is required under the Takings Clause or instead as a policy choice to encourage investment in innovation. But regardless of whether patents are private property, public patent powers show descriptively that Congress has designed the patent system to contain multiple structures for continuing regulatory oversight.

The descriptive claim about public patent powers also shows that the Supreme Court’s 2018 decision in Oil States v. Greene’s Energy329Oil States Energy Servs. v. Greene’s Energy Grp., 584 U.S. 325 (2018).
may have broader implications than previously recognized. In that case, patent holders used private property arguments to challenge the use of the administrative procedures to revoke patents, arguing that patents were forms of private property that must be adjudicated in Article III courts.330Id.
The Supreme Court rejected this argument on the ground that patents “convey only a specific form of property right—a public franchise.”331Id. at 338.
Because patents are public franchises, the Court reasoned that they confer “only the rights” that statutes prescribe.332Id.
Therefore, provisions included in the statutory entitlements—like post-grant review procedures—limit the entitlement from the outset. Such limits therefore do not implicate constitutional protections.333The unconstitutional conditions doctrine may place some limits on what types of conditions Congress can conclude on patent grants, but the Supreme Court has not yet decided whether that doctrine applies to patents. Id. at 342 n.4.

Most of the discussion about Oil States has focused on its implications for constitutional challenges to agency adjudications.334See, e.g., Caleb Nelson, Vested Rights, “Franchises,” and the Separation of Powers, 169 U. Pa. L. Rev. 1429 (2021); James E. Pfander & Andrew G. Borrasso, Public Rights and Article III: Judicial Oversight of Agency Action, 82 Ohio St. L.J. 493 (2021). Some have considered how the public franchise framing may influence Takings Clause claims, but they have not considered implications of Oil States for existing statutory conditions on patents. See Robin Feldman, Patents as Property for the Takings, 12 N.Y.U. J. Intell. Prop. & Ent. L. 198, 245–51 (2023); Raj Bhargava et al., The Constitutionality of Medicare Drug-Price Negotiation Under the Takings Clause, 51 J.L. Med. & Ethics 961, 965–66 (2023); Jordan T. Owens, Note, Patents as Property: Oil States and Its Implications on the Takings Clause, 41 Cardozo L. Rev. 1601, 1605–08 (2020); Jesse Wynn, Note, Patents, Public Franchises, and Constitutional Property Interests, 71 Case W. Rsrv. L. Rev. 887, 892–93 (2020).
But public patent powers reveal that Oil States might have broader consequences for the patent system. Because public patent powers are expressly included in statutes, they are limits on patent entitlements themselves, just like the availability of post-grant review procedures. This means agencies will not violate any patent protections afforded to patent holders if they choose to exercise these powers; the patent grants included the possibility that agencies could use these powers.

Since the Court has classified patents as public franchises, the statutory nature of patent powers also undercuts constitutional challenges that might be raised against the use of public patent powers. For example, a patent holder might bring a Takings Clause or Due Process Clause challenge to grants of compulsory licenses. But under the public franchise framework, the statutory conditions that allow agencies to grant compulsory licenses limit patent entitlements from the outset.335See Oil States, 584 U.S. at 338, 344.
Because of the lack of attention to systematic public patent powers, this potential implication of Oil States has flown under the radar.

Public patent powers and Oil States might also influence litigation about laws that indirectly affect how patent holders can use their patents. For example, in pending litigation about the Medicare price negotiation program, drug manufacturers have argued the program is a taking of their patent rights because it limits how much they can charge Medicare for patented drugs.336See, e.g., Complaint at 2, ¶¶ 2–3, Merck & Co. v. Becerra, No. 1:23-cv-01615 (D.D.C. June 6, 2023); Complaint at 3, ¶ 4, Janssen Pharms., Inc. v. Becerra, No. 3:23-cv-3818 (D.N.J. July 18, 2023). Although drug companies raised this argument in their complaints, they have focused on arguments about takings of their physical property in the briefing. See O’Neill Institute, Inflation Reduction Act, Health Care Litigation Tracker, https://litigationtracker.law.georgetown.edu/issues/inflation-reduction-act/ [perma.cc/L56G-EQ3G]; see, e.g., Combined Opposition to Defendants’ Motion for Summary Judgment and Reply in Support of Plaintiffs’ Motion for Summary Judgment, Merck & Co., No. 1:23-cv-01615 (D.D.C. Oct. 19, 2023).
In making this argument, Merck suggested that because it has patents on its drugs, the government cannot make its own versions of those drugs.337Complaint at 16, ¶ 59, Merck & Co., No. 1:23-cv-01615 (D.D.C. June 6, 2023) (“Pharmaceutical drugs are doubly protected because they are also patented . . . . That is why Medicare cannot just manufacture its own versions of Merck’s drugs for beneficiaries; it must procure them from Merck.”).
Public patent powers, however, show that the patent right to exclude is not so broad. The government can infringe any patent without the threat of an injunction, and it can authorize its contractors to do the same.338See supra Sections II.B.1, D.1.
And, under Oil States, this does not raise constitutional issues because it is part of the patent entitlement from the outset.339See Oil States, 584 U.S. at 338.
Viewed in this light, the choice to simply limit how much the government is willing to pay, rather than produce it owns drugs, seems far less extreme. Therefore, the descriptive claim about existing public patent powers has wide-ranging implications for the power of agencies to make decisions about patents.

IV. The Future of Public Patent Powers

The descriptive claim about public patent powers and their use raises normative questions about whether agencies should be using their public patent powers more often. This Part discusses normative considerations that surround questions about whether agencies should more actively use their powers, like the power to grant compulsory licenses on federally funded inventions. It first discusses potential reasons why agencies have not used certain powers, then provides suggestions for how agencies and courts might use insights from public patent powers moving forward. Specifically, this Part proposes that the executive branch create an interagency framework to give more concrete guidance about when different powers should be used and that courts should consider themes in public patent powers when deciding whether to grant injunctions in patent cases.

A. Assessing Agency Inaction

Agencies have used some of their public patent powers regularly, such as the powers to obtain patents on government-employee research, to use patented inventions, and to authorize government contractors to use patented inventions.340See supra Sections II.B.1, C.3, D.1.
Other powers, like the war powers, have been used only occasionally.341See supra Section II.C.2.
But notably, agencies have not granted Bayh-Dole march-in licenses, either on their own initiative or in response to march-in petitions.342See supra Section II.D.3.
Whether that lack of use is good or bad as a policy matter is difficult to assess; there could be multiple reasons why agencies have been reluctant to order compulsory licenses, which may have different normative implications. This Section discusses several potential explanations for why agencies have not ordered compulsory licenses, particularly for federally funded drugs.

One potential reason for agency hesitation is that agencies may not have adequate information about contexts where compulsory licenses are warranted. Currently, the executive branch provides little comprehensive public information about what inventions are subject to march-in rights, which makes it difficult for members of the public to identify instances where march-in petitions are warranted.343See Whalen, supra note 211, at 1112 (proposing a centralized database of Bayh-Dole subject inventions).
Lack of expertise might also hinder an agency’s ability to assess whether compulsory licenses are appropriate. The Bayh-Dole Act allows funding agencies to make decisions about march-in licenses.34435 U.S.C. § 203(a).
Although funding agencies have expertise about the technology at issue, they may lack expertise about economic policy questions surrounding whether inventions are available to the public on reasonable terms and whether third-party licenses would address these concerns. Similarly, funding agencies may not have expertise in innovation-policy questions about the role that patents serve to incentivize investment in research and development.345In rejecting march-in petitions, the NIH expressed deference on these points to other actors, including Congress and the FTC. See, e.g., CellPro Determination, supra note 212, at 7 (“The patent system, with its resultant predictability for investment and commercial development, is the means chosen by Congress for ensuring the development and dissemination of new and useful technologies.”); Norvir Determination I, supra note 213, at 6 (“The NIH also maintains that the FTC is the appropriate agency to address the question of whether Abbott has engaged in anti-competitive behavior.”).

A second reason behind agency inaction might be agency bias. In the research context, agencies often collaborate with the same entities on a repeated basis to develop new technologies, which gives agencies an incentive to maintain good relationships with their collaborators.346See Price, supra note 163, at 34; Whelan, supra note 211, at 1110; Rai et al., supra note 58, at 40 (observing that march-in licenses are “very unpopular with the important constituencies of NIH”).
This is particularly true because collaborations can be financially lucrative for an agency if collaborators agree to license agency-owned patents or otherwise make payments to the agency. Since the Bayh-Dole Act leaves decisions about whether to order march-in licenses to the funding agencies, it may create bias that favors their collaborators.34735 U.S.C. § 203(a).
Furthermore, funding agencies may have a systematic bias to favor strong patent rights. Funding agencies often own patents themselves, and federal employees are often inventors on patents.348See Whalen, supra note 211, at 1109 (noting that NIH Director who rejected march-in petition for Fabrazyme is listed as an inventor on 19 patents to which Bayh-Dole may apply).
Agencies and individual employees, therefore, could receive higher royalty payments if patents are more valuable.349See 35 U.S.C. §§ 202(c)(7), 209.
Regulatory capture, which refers to the ability of well-resourced regulated entities to influence agencies, might also contribute to agency inaction.350See Rachel E. Barkow, Insulating Agencies: Avoiding Capture Through Institutional Design, 89 Tex. L. Rev. 15, 21–23 & n.23 (2010); Steven P. Croley, Theories of Regulation: Incorporating the Administrative Process, 98 Colum. L. Rev. 1, 5 (1998); Developments in the Law—Conflicts of Interest in the Legal Profession, 94 Harv. L. Rev. 1244, 1428–33 (1981).

A third reason for inaction may simply be that agencies do not think compulsory licenses are particularly useful. Procedural requirements, such as judicial review, delay the time between when an agency can order a license and when it will actually go into effect.351See 35 U.S.C. § 203(b); 37 C.F.R. § 401.6; see also Xtandi Determination II, supra note 63, at 2 (citing “lengthy administrative process” as a reason that march-in proceedings would not effectively lower drug prices). These procedures exist against the backdrop of the TRIPS Agreement, which is an international agreement that requires judicial review of compulsory patent licenses. Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 31, Apr. 15, 1994, Marrakesh Agreement Establishing the Word Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 313 [hereinafter TRIPS Agreement]. It also typically requires that efforts must be made to obtain a license on reasonable terms from the patent holder before a compulsory license is ordered, just as the Bayh-Dole Act does, 35 U.S.C. § 203(a), although the TRIPS Agreement allows exceptions to this requirement in response to national emergencies, concerns of extreme urgency, and public noncommercial use. TRIPS Agreement, art. 31(b), 1869 U.N.T.S. at 313.
These delays are in tension with the time-sensitive goal of authorizing patent use to alleviate pressing public health needs.352Rai & Eisenberg, supra note 156, at 311; see also id. at 293–94, 310 (noting the Bayh-Dole Act also requires cumbersome procedures when agencies elect to retain title). Procedural requirements also impose costs on agencies. See Nicholas Bagley, The Puzzling Presumption of Reviewability, 127 Harv. L. Rev. 1285, 1321 (2014).
Moreover, because patents themselves only last for limited periods of time, the delay in time before a march-in license goes into effect decreases the time advantage gained by the license (in comparison to just waiting for the patent to expire). The NIH mentioned upcoming patent expirations when it denied the most recent petition requesting a march-in license on Xtandi.353Xtandi Determination II, supra note 63, at 2 (“In addition, given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”).

Furthermore, in the biomedical context, lengthy FDA approval procedures for manufacturers to sell products in interstate commerce can further delay when generics are able to enter the market in practice, notwithstanding an authorization to use patents.354See The Generic Drug Approval Process, U.S. Food & Drug Admin., https://www.fda.gov/drugs/cder-conversations/generic-drug-approval-process [perma.cc/3ML3-J8ZD].
Moreover, sometimes federal funding only contributed to a fraction of the total patents covering a drug product355Rai et al., supra note 58, at 46; see also Lisa Larrimore Ouellette & Bhaven N. Sampat, The Feasibility of Using Bayh-Dole March-in Rights to Lower Drug Prices: An Update 1 (Nat’l Bureau of Econ. Rsch., Working Paper No. 32217, 2024) (finding that only 2.5% of drugs have only public-sector patents listed in the Orange Book). Trade secrecy can also create barriers for generics to produce medicines without the brand’s consent, particularly for biologics. Rai et al., supra note 58, at 47.
—if the NIH grants a march-in license, and a generic manufacturer has not received FDA approval (or has for only a subset of patents on a drug), the license might not lead to production of generic medicines in practice.356In the case of Xtandi though, federal funding contributed to all patents covering the drug and generic manufacturers had received FDA approval. Memorandum in Support of the Petition to HHS to Exercise the March-in or Paid Up Royalty Right in Patents on the Prostate Drug Xtandi, Knowledge Ecology Int’l, (Jan. 25, 2022), https://www.keionline.org/wp-content/uploads/KEI-Memo-HHS-Xtandi-Bayh-Dole-March-in-Paid-up-Royalty-25Jan2022.pdf [perma.cc/C9W8-HTHM].

Finally, agencies may have concluded that compulsory licenses are not needed as a policy matter. For federally funded drugs, it could be that march-in rights have not been necessary to address the concerns that the Bayh-Dole Act sought to protect against.357Another reason for inaction could be that agencies are not sure whether they have power to grant march-in licenses based on high prices alone. Scholars have debated whether the high prices satisfy the statutory criteria for march-in licenses, which allow march-in either when an invention is not available on “reasonable terms” or when needed to address “public health” needs. See Nat’l Acads. of Scis., Eng’g & Med., The Role of NIH in Drug Development Innovation and its Impact on Patient Access 40–42 (2020). This does not explain the failure to order march-in licenses for other reasons though, such as in response to drug shortages.
When petitions have been submitted about high drug prices, the products have been on the market, just at high prices. High prices create access barriers for the public, but they also create incentives for costly innovation. Whether a patent holder has crossed the line by charging an unreasonable price or creating a public health problem involves tricky policy judgments about both innovation policy and economic policy.

Overall, it is difficult to assess whether the failure to order compulsory licenses has been good or bad as a policy matter because there is not a well-developed framework for understanding when agencies should order them. Some of these potential explanations for inaction could be concerning—for example, if compulsory licenses are needed but agencies are not ordering them due to lack of information or bias. But other potential explanations—such as licenses would not be useful or are not needed—would be less concerning. The next Section considers steps the executive branch could take to provide a better framework for determining when public patent powers should be used and for combatting potentially concerning reasons behind agency inaction.

B. Guidance for Agencies

Normative considerations about whether agencies should use public patent powers involve questions about economic policy and public welfare. Currently, no overarching framework exists for assessing when agencies should use these powers. A clearer framework is thus needed to help agencies understand how to use their powers. It would also provide clear expectations for patent holders and investors about when agencies are likely to use their powers. Furthermore, it could help the public evaluate agency inaction. The executive branch should provide such guidance by creating an interagency framework for the use of each type of public patent power.

The Biden Administration recently took a first step toward creating an interagency framework. In December 2023, the Department of Commerce proposed a draft framework for agencies considering whether to grant march-in licenses on federally funded inventions under the Bayh-Dole Act.358Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights, 88 Fed. Reg. 85593, 85593 (Dec. 8, 2023). The Department accepted comments until February 6, 2024.
The proposed guidance described concrete examples of situations where agencies might consider granting march-in licenses, such as when one company stops development on a federally funded drug product or when there is a shortage of reflective coating for traffic signs.359Id. at 85601–04.
It also articulated factors for agencies to weigh when making march-in decisions: whether alternative products are available, whether a march-in license would lead to increased public access to technology, and whether a march-in license would negatively impact research collaborations with federal agencies.360Id. at 85600–01.
Additional considerations included other policy goals of the Bayh-Dole Act, like the promotion of domestic manufacturing and the participation of small businesses in research and development.361Id. at 85602–05.
Furthermore, the guidance encouraged agencies to consider seeking input from other agencies, such as the Patent Office, to understand the implications of a potential march-in license.362Id. at 85601.

Beyond the articulated factors, the proposed guidance aimed to address uncertainty about agency power to order march-in licenses. There has long been debate about whether the Bayh-Dole Act allows agencies to order march-in licenses based solely on high prices of patented products.363See, e.g., Peter S. Arno & Michael H. Davis, Why Don’t We Enforce Existing Drug Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research, 75 Tul. L. Rev. 631, 649–53, 684 (2001); Birch Bayh & Bob Dole, Opinion, Our Law Helps Patients Get New Drugs Sooner, Wash. Post (April 11, 2002, 8:00 PM), https://www.washingtonpost.com/archive/opinions/2002/04/11/our-law-helps-patients-get-new-drugs-sooner/d814d22a-6e63-4f06-8da3-d9698552fa24 [perma.cc/XX7Z-MKZT].
The proposed guidance took the position that agencies could order march-in licenses in response to high prices under two different prongs.364Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights, 88 Fed. Reg. at 85598–99.
First, agencies may consider high prices when evaluating whether the invention is available to the public on reasonable terms and, second, when determining whether there is a public health need.365Id.; 35 U.S.C. § 203. The first Trump Administration proposed a rule that took the opposite position. Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 86 Fed. Reg. 35, 37 (Jan. 4, 2021) (proposing to “include a provision that march-in rights shall not be exercised by an agency exclusively on the basis of business decisions of a contractor regarding the pricing of commercial goods and services arising from the practical application of the invention”). This rule was not finalized. Dep’t of Commerce, Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 88 Fed. Reg. 17730, 17730–31 (Mar. 24, 2023) (“NIST has not adopted in this final rule a provision in the proposed rule regarding exercising march-in rights on the sole basis of product pricing.”).

Overall, the proposed guidance was a positive step. Although march-in licenses could be granted across a range of regulatory contexts, interagency guidance makes sense because normative questions about whether agencies should grant march-in licenses involve similar economic policy and public welfare questions. Because these considerations are similar across regulatory contexts, an interagency framework provides clearer guidance for agencies and allows them to compare factual scenarios. An interagency framework also promotes consistency across the executive branch, which in turn promotes clear expectations for investors in research and development.366Cf. NIH Report, supra note 166, at 28, 33 (detailing industry representatives’ concerns about the uncertainty of government intervention).
Furthermore, interagency guidance promotes transparency by creating a centralized framework for the public to monitor and understand. Indeed, the proposed guidance document received significant public attention when it was announced in December 2023.367E.g., Editorial, Wall St. J., supra note 10; Riley Griffin, Biden Administration Says It Can Seize Patents of Costly Drugs, Bloomberg L. (Dec. 7, 2023, 9:00 AM), https://www.bloomberg.com/news/articles/2023-12-07/biden-administration-says-it-can-seize-patents-of-costly-drugs [perma.cc/3LRG-4HAU]; Adam Cancryn, Targeting Costly Meds, Biden Admin Asserts Authority to Seize Drug Patents, Politico (Dec. 6, 2023, 3:43 PM), https://www.politico.com/news/2023/12/06/biden-admin-authority-seize-certain-drug-patents-00130452 [perma.cc/FH96-DGLN].

Moreover, interagency guidance can address some of the potentially concerning reasons for agency inaction on march-in licenses. For example, if lack of expertise is a reason that agencies have been reluctant to grant march-in licenses, interagency coordination may allow agencies to gather information from other agencies with expertise on the relevant economic policy questions.368Jody Freeman & Jim Rossi, Agency Coordination in Shared Regulatory Space, 125 Harv. L. Rev. 1131, 1184–86 (2012).
The proposed guidance encouraged such collaboration. Agencies outside funding agencies, such as the Federal Trade Commission, have greater expertise about economic-policy questions, including whether a price is justified and whether terms of offered patent licenses are unreasonable. Furthermore, if agency bias has influenced the failure to grant march-in licenses, interagency coordination might help reduce that bias by bringing broader perspectives to the table.369Id. at 1185–87 (“At a minimum, interagency consultation . . . provide[s] opportunities for the agencies to hold each other to account for such behavior.”).

Future presidential administrations should finalize the march-in guidance—and they should not stop there.370It may be unlikely that the current Trump Administration would finalize the guidance in its current form, since the first Trump Administration proposed a rule that took a different stance on whether march-in licenses can be granted in response to high prices. Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 86 Fed. Reg. at 37. Even if the Trump Administration disagrees, however, interagency guidance about contexts where march-in licenses would be appropriate would still be useful. Future administrations should also take steps to finalize interagency guidance about march-in licenses to the extent the Trump Administration does not and to the extent they disagree with any statutory interpretations proposed by the Trump Administration.
The Biden Administration’s proposed guidance addressed just one of the government’s public patent powers: march-in licenses under the Bayh-Dole Act. But this Article has shown that agencies have an array of other public patent powers. Interagency guidance about when agencies should use their other powers would be useful too. Future guidance should address when agencies should consider invoking Section 1498 to produce patented goods themselves or to contract for production. For example, the proposed march-in guidance mentions one hypothetical scenario—a shortage of COVID-19 masks—in which the government should consider purchasing or manufacturing masks itself.371Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights, 88 Fed. Reg. 85593, 85603–04 (Dec. 8, 2023).
It would be helpful to have more concrete guidance on situations where agencies should consider this option, perhaps due to production costs, existing regulatory programs, and agency budgets.

Future guidance should also give concrete examples about when agencies should grant exclusive licenses on agency-owned patents and when public dedication might be appropriate. It should also provide examples of the types of conditions agencies might consider placing in funding agreements and patent licenses, such as reasonable pricing clauses. Guidance about when agencies should consider buying patents and bringing patent infringement suits would be helpful as well. Because each of these questions involve a mix of policy considerations about economics, innovation, and public welfare, input from economists would be particularly useful to help guide agencies through those considerations across their various regulatory contexts.

Under the interagency framework, agencies should also create their own guidance and procedures for considering use of public patent powers. The march-in statute provides the basic procedures that agencies must follow before granting a license, but agencies can supplement these procedures with more transparent guidance. For example, agencies could consider publishing more reports about patents on inventions developed with their funding.372Funding recipients currently must report patents on federally funded inventions to agencies through iEdison. See iEdison, Nat’l Inst. of Standards & Tech., https://www.nist.gov/iedison [perma.cc/WS52-BTU3].
Agencies should also consider more intra-agency coordination to identify situations where march-in licenses may be appropriate. For example, the NIH could collaborate with other subagencies within HHS—the Center for Medicare and Medicaid Services (CMS) and FDA—to gain more information about how much the government is paying for drugs through Medicare and about which generic drugs are likely to soon receive FDA approval.373See Rachel E. Sachs, Administering Health Innovation, 39 Cardozo L. Rev. 1991, 1997–2014 (2018) (describing differing expertise of CMS, FDA, and NIH).
CMS might also be able to provide information about how widely certain drugs are prescribed and how many therapeutic alternatives are available.374See id. at 2015, 2031 (observing that CMS “possesses enormous amounts of information about the health needs of the American people”).
Beyond the march-in context, agencies should also consider creating more public guidance about when they might use other powers. In general, more publicly available guidance about the use of public patent powers would provide more transparency, public accountability, and consistency moving forward.

C. Guidance for Courts

Public patent powers can provide guidance for government officials outside the executive branch as well. Common themes in public patent powers show that Congress has made consistent policy judgments about where limits on private control over patented inventions may be in the public interest.375See supra Section III.B.
These are the same policy judgments that courts make when they decide whether to grant injunctions in patent cases.376See supra Section I.B.
The statutory examples that specify where agencies may create a liability rule for patents highlight contexts where it may also be appropriate for courts to create liability rules. Courts should consider using these public patent power insights when they apply the eBay test to determine whether injunctive relief is appropriate in patent cases.

The four contexts where public patent powers typically arise provide factors that courts might consider under the public interest prong of eBay: (1) whether inventions are developed with federal funding, (2) whether technology is useful for government programs, (3) whether public health and safety needs are at stake, and (4) whether patents are coupled with market power. Where these factors are present, they may weigh toward denying or tailoring injunctive relief.

Courts already apply some of these factors when they consider whether to grant injunctions for patent infringement. Section 1498 makes injunctions unavailable for infringement by the government and authorized contractors.377Advanced Software Design Corp. v. Fed. Rsrv. Bank of St. Louis, 583 F.3d 1371, 1375 (Fed. Cir. 2009).
Further, public health and safety needs have long been recognized as public interest factors that can weigh against injunctive relief,378See Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538, 1547–48 (Fed. Cir. 1995).
and market power has been considered one too.379See, e.g., Hodge v. Hudson River R.R., 12 F. Cas. 276, 278–79 (C.C.S.D.N.Y. 1868) (placing conditions on injunction where railroad was a “common carrier[]”). Courts already consider whether patent holders have used market power in anticompetitive ways in antitrust suits. See, e.g., Ill. Tool Works Inc. v. Indep. Ink, Inc., 547 U.S. 28, 46 (2006) (finding that tying arrangements involving patented products must prove market power). But considering market power as part of the public interest analysis in patent infringement suits might allow courts to deter anticompetitive conduct earlier.
In these contexts, examples of express congressional grants of regulatory powers provide beneficial guidance for courts.

Moreover, the public patent powers framework provides another factor that courts might consider: whether inventions were developed with federal funding. By considering whether federal funding contributed to an invention as part of the eBay analysis, courts could consider equitable issues in contexts where the government funded research. This could even allow courts to deny injunctions in situations where patents cover federally funded drugs.380When patents cover small molecule drugs, the Hatch-Waxman Act requires injunctions as the remedy for patent infringement, so courts cannot exercise discretion to deny injunctions. See 21 U.S.C. § 355(j)(5)(B)(iii); 35 U.S.C. § 271(e)(4). But for biologics, the law does not categorically require injunctions. 42 U.S.C. § 262(k); see Christopher Yasiejko, Biogen Fails to Block Novartis Biosimilar of MS Drug During Suit, Bloomberg L. (June 22, 2023, 2:19 PM), https://news.bloomberglaw.com/ip-law/biogen-fails-to-block-novartis-biosimilar-of-ms-drug-during-suit [perma.cc/7CWA-FVTJ]. Courts thus could take this factor into account if a biosimilar is attempting to come on the market for a biologic was developed with federal assistance.

More generally, courts could consider the four factors in contexts outside the pharmaceutical industry. For example, when the FCC proposed to require cell phones to automatically share their locations with 911 operators, patent holders sought injunctions against cell phone operators for using their location sharing technology.381Narechania, supra note 72, at 1498–99.
The patent disputes contributed to delays in implementing the FCC rule.382See id. at 1499–500 (describing FCC inaction in response to a petition for compulsory licensing).
In that case, the technology was useful for a government program, the patent holders had market power (since their technology was required by a government regulation), and public health and safety were at stake—these facts could have weighed against granting injunctive relief. Denial of an injunction in that situation might have served the public interest by aiding implementation of an FCC rule.383The parties in the case ultimately settled, three years after the suit was filed. Stipulation of Dismissal with Prejudice as to Defendant Motorola and [Proposed] Order, Zoltar Satellite Alarm Sys., Inc. v. Motorola, Inc., No. CV-06-00044 (N.D. Cal. Sept. 22, 2008).

Considering these factors to deny or tailor injunctions may help align the overall patent system with the overarching values Congress instilled in the patent system when it created public patent powers. Courts are well suited to consider equitable concerns in context-specific cases, as they already make these sorts of determinations when they decide whether to grant injunctions. Moreover, court decisions are often a major tool for influencing policy in patent law.384Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 Va. L. Rev. 1575, 1638, 1641–58 (2003).
If courts deny or tailor injunctive relief in certain contexts, they can influence patent holder conduct and patent licensing negotiations ex ante. For example, it is now well known that courts are more likely to deny injunctions when patent holders do not practice inventions, which in turn addresses the policy concerns about nonpracticing entities being able to extract unfairly high royalties by threatening to seek injunctions.385Chien & Lemley, supra note 14, at 10; eBay Inc. v. MercExchange, LLC, 547 U.S. 388, 396 (2006) (Kennedy, J., concurring) (describing concerns about “the threat of an injunction” being employed “simply for undue leverage in negotiations”); Rajec, supra note 39, at 1885–86.

Nonetheless, courts are not a substitute for agencies when it comes to public patent powers. Court proceedings are lengthy, and sometimes swift action is needed. Many public patent powers allow agencies to quickly and flexibly respond to urgent public health and safety needs. Agencies can also regulate patent holder conduct ex ante, which is particularly important for preserving public access to technologies.386See supra Section IV.B.
In these contexts, potential infringers likely could not achieve the same quick determinations about patent remedies through courts as they could through executive actions.387Other powers like the Bayh-Dole march-in rights, however, require lengthy procedures (including judicial review), so potential infringers may be able to obtain judgments about injunctive relief on a similar timeline through courts in those contexts. See supra Section IV.A. Courts could also consider the public patent power framework under the public interest prong of the test for preliminary injunctions. See Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009).
Additionally, having some level of regulatory oversight to monitor patent use is good for the patent system. Agencies have expertise about their respective regulated industries and how patents operate in those industries. Regulatory oversight also infuses more public accountability into the patent system, which is a public regulatory program. Therefore, judicial consideration of the public patent power framework should be a supplement, not a replacement, to executive branch judgments about public patent powers.

Conclusion

The Patent Office is not the only agency involved in patent regulation. Congress has designed a system where myriad agencies have statutory powers to regulate how the public can access patented technology even after the Patent Office issues a patent. Agencies have powers to decide whether to license their own patents and whether to license the patents of others. Agencies also have discretion to obtain patents, both on products of their own research and from others. In certain circumstances, agencies can decide the terms upon which third parties can access privately held patents. Congress has regularly granted these powers to agencies across the modern administrative state. The phenomenon of public patent powers thus illustrates a long tradition of statutory limits on how private patent holders can exercise their rights to exclude, particularly when dealing with the government. It also shows a long tradition of allowing executive actors to make policy choices about how patents should be used in commerce.

Public patent powers give agencies many powers to control patents covering inventions developed with federal funding, patents on technologies useful for government programs, patents relevant to public health and safety needs, and patents coupled with market power. But agencies have historically not exercised the full scope of these powers. Notably, agencies have been reluctant to order compulsory patent licenses on federally funded inventions. The descriptive account of public patent powers and their use provides guidance for agencies, policymakers, and scholars in future reform proposals. Moving forward, agencies and policymakers should consider the full scope of the executive branch’s powers over patents, and the relative strengths and weaknesses of different powers, when patents create policy concerns.

A helpful step toward this goal would be for the executive branch to create an interagency framework to guide the use of public patent powers. Courts also should consider public patent powers when deciding whether to grant injunctions in patent cases as a way to align the patent system with congressional design. Ultimately, the patent system is a regulatory program created by the government. If patents create public welfare problems, the government need not stand idly by. The government has many tools to regulate public access to patented technology.

Appendix A: Statutes Expressly Granting Public Patent Powers

Statute

Agency

Patent Categories

Public Powers

   

Gov’t

License

Gov’t

Title

3rd Party License

Direct Reg.

7 U.S.C. § 171(1)

USDA

Patents relating to growing guayule or extracting rubber therefrom

1

1

  

7 U.S.C. § 171(7)

USDA

Improvements on methods of processing guayule shrubs and rubber

 

1

  

7 U.S.C. § 178g

USDA

Patents necessary for critical agricultural materials program

1

1

  

7 U.S.C. § 178h

Commerce

Patents necessary for critical agricultural materials program

1

1

  

7 U.S.C. § 4606

USDA

Inventions developed with Honey Board funds

 

1

  

10 U.S.C. § 3793

Defense

Any supplies or processes useful for military departments

1

1

  

15 U.S.C. § 2054(d)

CPSC

Information where federal contribution for R&D is more than minimal

  

1

 

15 U.S.C. § 2218

FEMA

Research on fire prevention and control made under government contract

1

1

1

 

15 U.S.C. § 2511

Energy

Research related to electric and hybrid vehicles made under government contract

 

1

  

15 U.S.C. § 3710a

All

Inventions made by government employee under cooperative research agreement

1

 

1

 

15 U.S.C. § 3710d

All

Government employee inventions

1

 

1

 

15 U.S.C. § 5104

Energy

Inventions developed under Steel Initiative Management Plan or Steel Initiative Research Plan

 

1

  

15 U.S.C. § 5308

Energy

Inventions developed by National Metal Casting Research Institutes

1

1

1

 

16 U.S.C. § 831d

TVA

Government employee inventions related to plants and production of fertilizer and power

 

1

  

16 U.S.C. § 831r

TVA

Processes to produce fertilizer ingredients or hydroelectric power used by TVA

1

   

16 U.S.C. § 832a

Energy

Technology necessary to carry out the Bonneville project

1

1

  

16 U.S.C. § 833a

Interior

Technology necessary to carry out the Fort Peck project

1

1

  

16 U.S.C. § 1447b

Marine Research Boards

Technology needed by Regional Marine Research Boards

1

1

  

19 U.S.C. § 1337

ITC & President

Importation of product that infringes a U.S. patent

1

 

1

1

20 U.S.C. § 3477

Education

Technology necessary for Department of Education facilities

1

1

  

20 U.S.C. § 3480

Education

Technology useful to the Department of Education

1

1

  

22 U.S.C. § 2179

President

Technology related to large-scale desalting plants that receive federal funding

1

   

22 U.S.C. § 2356(a)

All

Inventions used while furnishing foreign assistance

1

   

22 U.S.C. § 2572

State

Federally funded research in the fields of arms control, nonproliferation, and disarmament

  

1

 

28 U.S.C. § 1498

All

Patented technologies used or manufactured by or for the United States

1

 

1

 

30 U.S.C. § 666

Energy

Research related to improved methods of mining and using coal

1

1

1

 

30 U.S.C. § 937

HHS

Inventions developed under research grants for methods to test and treat lung disease in coal miners (i.e., Black Lung)

  

1

 

30 U.S.C. § 951

Interior, HHS

Federally funded inventions to improve working conditions in coal mines

  

1

 

30 U.S.C. § 1226

Interior

Federally funded inventions about mining and mineral resources

  

1

 

30 U.S.C. § 1328

Interior

Federally funded inventions relating to coal mining technologies

  

1

 

31 U.S.C. § 5111

Treasury

Technology necessary to produce coins

1

1

  

33 U.S.C. § 2314a

Army Corps of Engrs

Employee invention made in technical assistance program

1

 

1

 

35 U.S.C. § 183

All

Inventions under secrecy orders

1

  

1

35 U.S.C. § 202

All

Federally funded research

(small businesses and nonprofits)

1

1

1

1

35 U.S.C. § 203

All

Federally funded research

(small businesses and nonprofits)

  

1

 

35 U.S.C. § 204

All

Federally funded research

(small businesses and nonprofits)

   

1

35 U.S.C. § 207

All

Federally funded research

(no restrictions)

 

1

  

35 U.S.C. § 210(c)

All

Federally funded research

(entities other than small businesses and nonprofits)

1

 

1

 

36 U.S.C. § 2114

ABMC

Technology useful for the American Battle Monuments Commission

1

1

  

42 U.S.C. § 242b

HHS

(CDC)

Technology necessary to operations of the National Center for Health Statistics

1

1

  

42 U.S.C. § 299c-5

HHS

Patents necessary for operations of the Agency for Healthcare Quality & Research

1

1

  

42 U.S.C. § 2181

Energy

Inventions solely useful for or used in utilization of special nuclear material or atomic energy in an atomic weapon

 

1

  

42 U.S.C. § 2182

Energy

Inventions useful for the special nuclear material or atomic energy

 

1

  

42 U.S.C. § 2183

Energy

Patents useful for special nuclear material or atomic energy that were filed before 1979

1

 

1

 

42 U.S.C. § 2188

NRC

Patents on special nuclear material or atomic energy inventions

  

1

 

42 U.S.C. § 2201

NRC

Inventions needed by the Nuclear Regulatory Commission

1

1

  

42 U.S.C. § 2297h-12

Energy

Patents relating to atomic laser isotope separation technology (AVLIS)

 

1

  

42 U.S.C. § 5817

Energy

Patents useful to the Energy Research & Development Administration

1

1

  

42 U.S.C. § 5906

Energy

Inventions developed by joint federal-industry corporations that research nonnuclear energy

 

1

  

42 U.S.C. § 5908

Energy

Inventions are made under a contract with the DOE

 

1

  

42 U.S.C. § 6981

EPA

Inventions made under contract with EPA relating to solid waste

 

1

  

42 U.S.C. § 7257

Energy

Patents necessary for Department of Energy research

1

1

  

42 U.S.C. § 7261

Energy

Patents useful to the Department of Energy

1

1

  

42 U.S.C. § 7403

EPA

Inventions that received a federal award for developing carbon capture technology

1

 

1

 

42 U.S.C. § 7404

EPA

Research on air pollution control

1

1

  

42 U.S.C. § 7608

EPA &

DOJ

Patents necessary to comply with Clean Air Act requirements in Sections 7411 (new stationary sources), 7412 (hazardous air pollutants), or 7521 (new motor vehicles) where there are no reasonable alternatives

  

1

 

42 U.S.C. § 10308

Interior

Research related to water resources

  

1

 

42 U.S.C. § 16192

Energy

Federally funded solid-state lighting technologies

   

1

42 U.S.C. § 17231

Energy

Federally funded energy storage technologies

   

1

49 U.S.C. § 106

DOT

Technology useful to the Federal Aviation Administration

1

1

  

49 U.S.C. § 114

DOT

Technology useful to the Transportation Security Administration

1

1

  

49 U.S.C. § 30182

DOT

Research on motor vehicle safety

  

1

 

50 U.S.C. § 4307

President

Any patent controlled by an enemy or enemy ally during wartime

 

1

  

50 U.S.C. § 4309

President

Patents seized during war that were not sold or disposed of

  

1

 

50 U.S.C. § 4310

President

Patents controlled by an enemy or enemy ally during wartime; inventions would harm public safety if published during war

1

 

1

1

51 U.S.C. § 20113

NASA

Technology necessary for NASA operations

1

1

  

51 U.S.C. § 20135

NASA

Inventions made under NASA contracts

1

1

  

52 U.S.C. § 21041

Election Assistance Comm’n

Research to improve voting technology

1

1

1

 

*Associate Professor of Law, University of Colorado Law School. For helpful comments and conversations, thanks to Tom Baker, Yochai Benkler, Doni Bloomfield, Cary Coglianese, Jorge Contreras, Angus Corbett, Charles Duan, John Duffy, Kim Ferzan, Andy Grewal, John Golden, Paul Gugliuzza, Allison Hoffman, Sophia Lee, Mark Lemley, Michael Knoll, Giovanna Massarotto, Mike Meurer, Chris Morten, Tejas Narechania, Lars Noah, Lisa Larrimore Ouellette, Sean Ossei-Owusu, Arti Rai, Sarah Rajec, Jason Rantanen, Greg Reilly, Jason Reinecke, Gabe Scheffler, Ganesh Sitaraman, Peter Strauss, Talha Syed, Andrea Tosato, Saurabh Vishnubhakat, Polk Wagner, Chris Walker, Melissa Wasserman, Shelley Welton, Tess Wilkinson-Ryan, Christopher Yoo, Peter Yu; the participants at the Law & Political Economy Emerging Scholars Workshop, the Texas Law IP Roundtable, the Penn Law Summer Ad Hoc Workshop, the 2023 IP Scholars Conference, the Drexel Law Faculty Workshop, the Yale Junior Scholars Law and Industrial Policy Workshop, the 2024 AALS New Voices in Administrative Law Workshop; and everyone who engaged with this paper on the job market. Thanks also to the Michigan Law Review editors, including Ethan Greenberg and Scott Bays. Erin Higgins provided excellent assistance with researching the legislative history of statutes.