Alert

Inducement to Infringe in Hatch-Waxman Litigation: Strategies for Patent Drafting, Prosecution, and Litigation

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


Thursday, May 28, 2020

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, May 8, 2020

or call 1-800-926-7926

This CLE webinar will provide patent counsel with guidance on claim and label language; to proactively coordinate patent, regulatory, and clinical personnel; and to maintain consistency between claims and likely or actual label language throughout patent prosecution and label negotiation with the FDA.

Description

Direct infringement of a method patent occurs when a drug is provided to a patient such that it falls within the scope of a patented method. In the context of potential infringement by a generic drug maker before marketing the drug, how a drug will be used is typically determined by a review of the proposed labeling in the ANDA.

Under Hatch-Waxman, submitting an ANDA seeking approval for a generic drug in a use claimed in an Orange Book patent listing is infringement. Consequently, the ANDA-filing generic maker must file a Paragraph IV certification for the relevant listed patent attesting that the patent is either invalid or not infringed.

The Federal Circuit ruled in Commil USA v. Cisco Systems Inc. that good faith belief in the patent's invalidity may negate the requisite intent for induced infringement. This decision will have a significant impact on induced infringement in the ANDA litigation context.

Listen as our authoritative panel of patent counsel uses recent cases as a springboard to discuss strategy and tactics regarding claim language as well as label language. The panel will offer guidance on proactively coordinating patent, regulatory and clinical personnel, maintaining consistency between the label and likely or actual claim language, and coordination throughout patent prosecution and label negotiation with the FDA. Further discussion will address litigation issues unique to Hatch-Waxman induced infringement.

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Outline

  1. Traditional infringement analysis focus is on claim language, but inducement to infringe analysis in the Hatch-Waxman context additionally focuses on the label language
  2. Recent court treatment
  3. Strategies and tactics
    1. Maintain the coordination referenced above throughout the U.S. patent prosecution and label negotiation with FDA
    2. Maintain consistency between claims and likely or actual label language
    3. Coordinate patent, regulatory, and clinical personnel early

Benefits

The panel will review these and other notable questions:

  • What are the lessons from recent decisions?
  • What are the best approaches to maintain consistency between claims and likely or actual label language?
  • What are the steps to maintain the coordination of patent, regulatory, and clinical personnel throughout the patent prosecution and label negotiation with the FDA?

Faculty

Bosch, Michele
Michele C. Bosch

Partner
Finnegan Henderson Farabow Garrett & Dunner

Ms. Bosch leads the firm’s Chemical and Metallurgical practice group. Her practice includes many areas of...  |  Read More

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

Rudolph, Barbara
Barbara R. Rudolph, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and...  |  Read More

Shaffer, Robert
Robert F. Shaffer

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Shaffer focuses on Hatch-Waxman Paragraph IV disputes, where he has represented branded pharmaceutical companies in...  |  Read More

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