An Administrative Meter Maid: Using Inter Partes Review and Post-Grant Review to Curb Exclusivity Parking via the “Failure to Market” Provision of the Hatch-Waxman Act

Brian T. Apel*

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created several statutory forfeiture provisions that proved only marginally effective at curbing the practice of exclusivity parking. More recently, Congress created new quasi-judicial administrative proceedings that effectively replace certain kinds of district court patent litigation. This Note describes the complex statutory scheme that gave rise to exclusivity parking, explains why previous and current attempts to curtail exclusivity parking were and remain ineffective, and suggests amending the “failure to market” provision to include these new administrative proceedings as a way to help curb exclusivity parking.

* J.D. Candidate, May 2016, University of Michigan Law School; B.A. Chemistry, 2008, Northwestern University. I would like to thank Christopher J. Sorenson and Jonathan R.K. Stroud for providing the practitioner’s perspective; Professors Rebecca S. Eisenberg and Daniel A. Crane for their invaluable assistance and guidance; Daniel Osher and the entire Michigan Law Review staff for their tireless efforts from start to finish; and my wife, Jenna, for her unconditional love and support.

Download as PDF