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

Recording of a 90-minute premium CLE video webinar with Q&A


Conducted on Thursday, May 28, 2020

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Program Materials

This CLE webinar will provide patent counsel with suggestions 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 Supreme Court ruled in Global-Tech Appl. Inc. v. SEB S.A., 563 U.S. 754 (2011) that induced infringement requires that the accused infringer knew of the patent and that the accused infringer intended its actions to cause direct infringement. In the pharma litigation context, knowledge of the patent is easily shown by the patents listed in the Orange Book and the generic manufacturer’s paragraph IV certification. Knowledge that the accused infringer intended its actions to cause direct infringement may be established by the instructions and information in a drug label.

Several other Federal Circuit cases address label language in an induced infringement analysis, including Sanofi v. Watson (Fed. Cir. 2017), Eli Lilly v. Teva Parenteral Medicines (Fed. Cir. 2017), and Vanda v. West-Ward Pharms (Fed. Cir. 2018), all of which will be discussed in detail for the guidance of pursuing induced infringement claims in Hatch-Waxman litigation.

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

Feldstein, Mark
Mark J. Feldstein, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Hasford, Justin
Justin J. Hasford

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Hasford has experience in all areas of intellectual property law. His practice focuses on complex patent litigation...  |  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

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

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

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