Document Type
Article
Publication Date
2016
Abstract
In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section II, which discusses a series of twenty-eight discrete interpretive issues, arranged in five categories: which rules apply, earning exclusivity, forfeiture of exclusivity, commencing the exclusivity term, and enjoyment (use) of the exclusivity term. It devotes considerable attention to developments since 2009 (our last article): new issues that have arisen relating to 180–day exclusivity generally, such as premature notice of paragraph IV certification, as well as the body of law emerging around the forfeiture provisions enacted in 2003. Section III briefly discusses three policy issue arising out of the 180–day exclusivity scheme: the impact of the scheme on subsequent generic applicants, the relationship between the scheme and patent settlements, and authorized generics — noting key judicial, legislative, and academic commentary on each. The Article concludes with a discussion of recent and pending legislative proposals that indirectly or directly address 180–day exclusivity and notes the exclusivity for interchangeable biologics that was modeled, in part, on the generic drug precedent. Section I of this article provides the necessary background regarding the statutory language as well as a high-level description of the steps FDA has taken to implement the scheme. It defers discussion of the details of FDA's implementing regulations to section II. Section II discusses the discrete interpretive issues, arranged in five categories: which rules apply, earning exclusivity, forfeiture of exclusivity, commencing the exclusivity term, and enjoyment (use) of the exclusivity term. This section presents each issue as a question and then offers a short answer and a more full discussion. In some cases, the issue is sufficiently discrete and the discussion sufficiently brief that the article dispenses with a "short answer" altogether. Because FDA has announced that it will release guidance on 180-day exclusivity sometime in 2016, section II flags open issues as well as apparent agency policies that could be confirmed in guidance. We conclude in section III with a brief discussion of lingering and renewed criticisms of the scheme, in the courts, academic literature, and Congress. We note a variety of proposals, both in Congress and in the secondary literature, to change the scheme yet again.
Recommended Citation
Erika Lietzan; Julia Post, The Law of 180-Day Exclusivity, 71 Food & Drug L.J. 327, 400 (2016)