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

A live 90-minute premium CLE video webinar with interactive Q&A

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Tuesday, November 15, 2022

1:00pm-2:30pm EST, 10:00am-11:30am PST

Early Registration Discount Deadline, Friday, October 21, 2022

or call 1-800-926-7926

This CLE course will guide IP counsel in calculating patent term adjustments, understanding the interplay with patent term extensions, examining recent court treatment, and offering approaches for preserving rights and maximizing patent term adjustments and extensions.

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.

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Outline

  1. Recent case law developments
  2. Calculating PTA
    1. 14-4-4-4
    2. Wyeth 3 yr. pendency
    3. RCE and terminal disclaimer impact
  3. Patent term extensions
    1. Eligibility
    2. Calculation
    3. Restrictions on PTE
  4. Best practices
    1. Preservation of rights
    2. Maximizing PTA vs. PTE

Benefits

The panel will review these and other highly relevant issues:

  • What are the lessons from the recent Federal Circuit decisions regarding the patent term calculation?
  • How will the recent changes for the USPTO alter the landscape for PTA and PTE practice?
  • What best practices should patent applicants take to preserve rights and maximize PTA and PTE?

Faculty

Irving, Thomas
Thomas L. Irving

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

MacAlpine, Jill
Jill K. MacAlpine, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling,...  |  Read More

Van Horn, Charles
Charles E. Van Horn

Senior Counsel
Finnegan Henderson Farabow Garrett & Dunner

Mr. Van Horn has a strong working knowledge of the specialized areas of patent reexamination, patent term extension,...  |  Read More

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