Discretionary Denials at Patent Court Thwart Generic Drugmakers

The Patent Trial and Appeal Board has increasingly been using its discretion to deny patent challenge requests in recent years, frustrating generic drugmakers’ efforts to bring low-cost medications to the market.

The board, part of the U.S. Patent and Trademark Office, has broad authority to toss out patent challenges before the cases have been heard—which is known as denying institution. It occurs during inter partes review, a trial proceeding before the board to review patentability of one or more claims in a patent.

In 2019, 19% of the PTAB’s denials were due to discretionary factors, up from 4% in 2016, ...