One of Congress' central goals in enacting the Hatch-Waxman Act was to expedite and encourage earlier market entry for generic pharmaceutical products. The Act provides that a generic firm may challenge a drug patent during its term by filing paperwork with the FDA that alleges either that its generic product does not infringe the relevant patent, or that the patent is invalid. If the patentee disagrees with the allegation of the generic firm, it may file suit and have a court determine infringement and validity. If the generic firm prevails in court on either count, it may enter the market with its generic drug immediately, despite the patent protection that would have otherwise prevented its market entry. In order to encourage generic firms to pursue such challenges to pioneer patents earlier during the patent terms, Congress included a generic exclusivity provision in the Act, which rewards the first generic firm to challenge a pioneer patent with 180 days of generic market exclusivity, during which time no other generic version of that drug may enter the market. As the provision is currently interpreted, market exclusivity is provided to the generic firm that is first-in-time to file a challenge against the patent, regardless of whether that firm subsequently prevails in establishing patent invalidity or non-infringement. This Note examines the dispute that arose out of the generic exclusivity provision, critiques the current state of generic exclusivity law in light of recent congressional amendments, and proposes that Congress further amend the Act to require forfeiture of generic exclusivity when the first generic firm to file a challenge against the pioneer patent is not also the first to complete a successful challenge to that pioneer patent.
Ashlee B. Mehl,
The Hatch-Waxman Act and Market Exclusivity for Generic Manufacturers: An Entitlement or an Incentive?,
Chi.-Kent L. Rev.
Available at: https://scholarship.kentlaw.iit.edu/cklawreview/vol81/iss2/13