32 Pages Posted: 14 Sep 2016
Date Written: September 1, 2016
For patents in most industries, Inter Partes Review (IPR) offers a new, efficient alternative pathway to challenge patents of dubious quality. However, for pharmaceutical patents, IPR is a means to avoid the litigation pathway created under Hatch-Waxman over thirty years ago. This Article explains that critical differences between district court litigation in Hatch-Waxman proceedings and IPR jeopardize the delicate balance Hatch-Waxman sought to achieve between patent holders and patent challengers. As IPR has grown in popularity, it has become evident that these proceedings favor patent challengers; compared to district court challenges, patents are twice as likely to be found invalid in IPR challenges.
In recent decisions, courts have recognized the anti-patentee bias of IPR, yet punted to Congress the job of changing the provisions. It is critical that Congress reduce the disparities between IPR proceedings and Hatch-Waxman litigation. The high patent invalidation rate in IPR proceedings creates significant uncertainty in intellectual property rights. Uncertain patent rights will, in turn, disrupt the nature of competition in the pharmaceutical industry, drug innovation, and consumers’ access to life-improving drugs.
Keywords: Hatch-Waxman, pharmaceutical industry, Inter Partes Review, innovation, patents
Suggested Citation: Suggested Citation
Shepherd, Joanna, Disrupting the Balance: The Conflict between Hatch-Waxman and Inter Partes Review (September 1, 2016). NYU Journal of Intellectual Property & Entertainment Law, Forthcoming; Emory Legal Studies Research Paper No. 16-419. Available at SSRN: https://ssrn.com/abstract=2838236