Patent Term Adjustments and Extensions: Leveraging Recent Decisions and USPTO Rule Changes

Description

After the Federal Circuit's decision in Novartis v. Kappos (2014) holding that filing a request for continued examination (RCE) stops the accumulation of B-delay, the USPTO implemented PTA rule changes in 2015: "Changes to Patent Term Adjustment in View of the Federal Circuit Decision in Novartis v. Lee." In July 2022, the USPTO proposed to revise the rules of practice about patent term adjustment regarding information disclosure statements.

Since then, the Federal Circuit decided Gilead Sciences Inc. v. Lee (2015), Mohsenzadeh v. Lee (2015), Daiichi Sankyo Co. Ltd. v. Lee (2015), Pfizer v. Lee (Fed. Cir. 2016), and Actelion Pharm Ltd. v. Matal (Fed. Cir. 2018). In Gilead, the Federal Circuit upheld the USPTO's PTA calculation that subtracted days between Gilead filing a response to a restriction requirement and a supplemental IDS. In Mohsenzadeh, Pfizer, and Actelion, the Federal Circuit addressed A-delay, holding that a patent is only entitled to PTA for a delay in the prosecution of the application form which the patent directly issued not the application from which it derived priority. In Daiichi, the Federal Circuit again decided in favor of the USPTO regarding the "interim procedure" instituted post-Wyeth.

We have district court decisions, such as Supernus Pharms. Inc. and United Therapeutics v. Lee, (E.D. Va. 2016), appeal pending, challenging the USPTO's application of its rules and Gilead in its PTA calculations. The impact of prosecution actions on eventual PTA remains an essential aspect of practitioners' considerations as the case law evolves.

Patent term extensions under 35 U.S.C. 156 were designed to create new incentives for the research and development of specific products subject to pre-market government approval by a regulatory agency. The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting pre-market government approval from a regulatory agency.

These extensions can be significant for some products, primarily pharmaceutical products. There is little room for error in these applications, as a denied application can mean the loss of millions to billions of dollars. Familiarity with the statute, governing rules, and legal precedent is thus crucial.

Listen as our authoritative panel of patent attorneys, in combination having well over 100 years of practical U.S. patent law experience, examines the recent developments for PTAs and their potential impact, methods for calculating PTA, and what can be done to preserve rights, and offers best practices for maximizing PTA. Also included in the discussion will be patent term extension considerations.