Faculty Notes
Elvin R. Latty Professor of Law Arti Rai is the lead investigator on a one-year grant from the Laura and John Arnold Foundation to examine whether the administrative system for patent review established by the America Invents Act of 2011 is impacting patent terms for small-molecule drugs and large-molecule biologics and thereby affecting the availability of less expensive generic or biosimilar equivalents. The study is the first rigorous empirical investigation of the role that the administrative review system, known as the Patent Trial and Appeal Board (PTAB), is playing relative to federal district courts, previously the sole venue for patent challenges. It focuses on how the introduction of the PTAB has impacted effective patent terms for small-molecule drugs — those generally administered as pills — and large molecule biologics, which are generally delivered as infusions and injections. In order to evaluate impact, the study is examining both patents on the key compounds as well as secondary patents that cover such ancillary features as formulations and are sometimes considered to be of lower quality than compound patents. Rai, the faculty co-director of the Duke Center for Innovation Policy and an internationally recognized expert in innovation policy and intellectual property, administrative, and health law, is the former administrator of policy and external affairs at the U.S. Patent and Trademark Office (USPTO). She is undertaking the study with three colleagues. Bills pending before both the U.S. House of Representatives and the Senate would require challengers to choose between contesting small molecule and biologic patents in federal court or at the PTAB. But in their grant application, Rai and her colleagues point to key research that shows the industry “often manages to extend monopoly protection over patents of even dubious validity simply because it’s so hard to challenge them in federal court.” They contend that the PTAB, with administrative judges who are technical experts, facilitates “faster and cheaper challenges” and, possibly, greater accuracy. The current
study, Rai said, will provide essential empirical context for the current policy debate. They are building novel and highly detailed datasets to facilitate three main areas of inquiry: the factors that drive case selection in the district courts and at the PTAB, to discern the incremental role the PTAB is playing over and above district court litigation for different classes of patents; the effect of the PTAB on the timing and prevalence of generic and biosimilar entry; and what the data suggest about settlements in PTAB challenges and how they may be influencing generic and biosimilar availability. On Nov. 19, Rai testified before the U.S. House Committee on the Judiciary’s Subcommittee on Courts, Intellectual Property, and the Internet in a hearing titled “The Patent Trial and Appeal Board and the Appointments Clause: Implications of Recent Court Decisions.” The hearing considered implications of an Oct. 31 ruling of the U.S. Court of Appeals for the Federal Circuit in Arthrex, Inc., v. Smith & Nephew, Inc., Arthrocare Corp., in which the court held the appointment of the administrative patent judges (APJs) to the PTAB by the U.S. Secretary of Commerce to be in violation of the Constitution’s Appointments Clause. The court severed the portion of the Patent Act that restricts removal of APJs from office, thereby making them “inferior officers” that can be appointed by “heads of departments” like cabinet secretaries, as opposed to “principal officers” that must be nominated by the president and confirmed by the U.S. Senate. After exploring different implications of the Federal Circuit’s ruling, Rai testified that the “cleanest path forward” would involve “surgical” congressional intervention that gives the USPTO director a unilateral right of review over APJ decisions including, potentially, a right that applies retroactively. “This approach would cure any perceived constitutional infirmity without subjecting APJs to political pressure that isn’t transparent,” she wrote in her prepared testimony submitted in advance of the hearing. “In order to accommodate the director’s workload, the right of review should be discretionary.” d
Duke Law Magazine • Summer 2020
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