The Patent Trial and Appeal Board - A Second Constitutional Challenge

Abstract

The Patent Trial and Appeal Board, which resides within the United States Patent and Trademark Office, is authorized to cancel patents that it concludes were issued inappropriately. The Board was conceived by Congress and defined in a provision of the 2011 America Invents Act; it was meant to provide an alternative to litigation in Article III courts to challenge the validity of patents. Reviews of patent validity by the Board are an important part of the pathway by which generic drugs and biosimilars may efficiently reach the market. Since 2018, the Patent Trial and Appeal Board, and one of the key procedures it utilizes to assess the validity of patents, referred to as inter partes review, have been the subject of two separate constitutional challenges before the Supreme Court. This article analyzes the legal bases for the two constitutional challenges (with particular emphasis on the second challenge) and discusses the reasons why the Patent Trial and Appeal Board survived both. The article also assesses the importance of the Board and inter partes review to the generic drug and biosimilar industries and concludes with a discussion of the implications of the constitutional challenges for prescription drug patent law.