Patent Litigation

Disrupting the Balance: The Conflict Between Hatch-Waxman and Inter Partes Review

Disrupting the Balance: The Conflict Between Hatch-Waxman and Inter Partes Review

Since the enactment of the America Invents Act, inter partes review has been a new pathway for challenging patents. This administrative proceeding at the Patent Trial and Appeal Board has had a pro-challenger bias. IPR proceedings apply a lower standard of proof than federal district courts, use the anti-patentee claim construction standard of broadest reasonable construction, and lack the Article III standing requirement of district court litigation. This Article explains how these differences create great uncertainty in pharmaceutical patents, and what could be done to restore the balance that was created in the Hatch-Waxman Act.

Pharmaceutical patents have their own alternative litigation pathways with the Hatch-Waxman Act, passed by Congress over three decades ago, and the recent Biologics Price Competition and Innovation Act. Both balance between stimulating innovation from brand companies who hold patents and facilitating market entry from generic companies who challenge the patents. Hatch-Waxman and BPCIA litigation occur in the federal district courts, which have significantly lower patent invalidation rates than IPR proceedings. The Article argues that this uncertainty in patent rights will harm pharmaceutical innovation by decreasing incentives. Pharmaceutical companies will not spend the billions of dollars needed to research, develop, and bring a drug to market if patent validity in IPR proceedings is uncertain. In the end, the author proposes several reforms for Congress to enact that can reduce the disparities between IPR proceedings and Hatch-Waxman litigation so the balance between patent holders and patent challengers is restored.

Interview: Trial by Jury of Patent Cases Symposium

Interview: Trial by Jury of Patent Cases Symposium

In this interview, Anne Hassett, the Executive Director of NYU School of Law’s Engelberg Center on Innovation Law & Policy, discusses her experience conceiving and bringing to fruition the Trial by Jury of Patent Cases Symposium. The conference was co-hosted by NYU School of Law’s Engelberg Center and the Civil Jury Project on September 30, 2016. Distinguished federal jurists, academics, and practitioners discussed whether the 7th Amendment guarantees a right to a jury trial in patent cases and analyzed, in presentations and roundtable discussions, current issues and trends in how patent jury trials are conducted. Given her rich and varied background in the patent law sphere, Anne Hassett also discusses her own views on the matters brought up in the symposium, including the observations and experiences that shape her perspective on patent jury trials.