Inducement to Infringe in Hatch-Waxman Litigation

Lessons from Commil USA v. Cisco Systems and Bayer Schering v. Lupin for Pharma Patents

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


Conducted on Wednesday, August 21, 2013

Recorded event now available

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Program Materials

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

When a drug is given to a patient such that it falls within the scope of a claimed method, direct infringment of a method patent results. In the context of potential infringement by a generic drug maker prior to marketing the drug, how a drug will be used is typically determined by review of the proposed labeling in the ANDA.

Under Hatch-Waxman, submitting an ANDA seeking approval of a generic drug for a use claimed in a patent listed in the Orange Book is an act of infringement. Consequently, the ANDA-filing generic maker must file a Paragraph IV certification with respect to the relevant listed patent.

The Federal Circuit affirmed infringement in AstraZeneca v. Apotex even though the patents covered a use that the ANDA applicant tried to carve out of the label. The court found the label induced infringement of the patent claim because the proposed generic label copied instructions from the dosing and administration section that would cause patients to perform the patented method.

On June 25, 2013, the Federal Circuit ruled in Commil USA v. Cisco Systems Inc. that good faith belief in the patent's invalidity may negate 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 the Commil, AstraZeneca and Bayer Schering cases as a springboard to discuss strategy and tactics regarding claim language as well as label language. The panel will offer guidance on coordinating patent, regulatory and clinical personnel; maintaining consistency between claims and likely or actual claim language; and coordination throughout patent prosecution and label negotiation with the FDA.

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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. AZ v. Apotex, 669 F.3d 1370 (Fed. Cir. February 2012)
    1. District court
    2. Federal Circuit
  3. Bayer Schering v. Lupin, __F.3d__ (Fed. Cir. April 2012)
    1. District court
    2. Federal Circuit
    3. Status of motion for rehearing
  4. Strategies and tactics
    1. Coordinate patent, regulatory and clinical personnel early
    2. Maintain consistency between claims and likely or actual label language
    3. Maintain the coordination referenced above throughout the U.S. patent prosecution and label negotiation with FDA

Benefits

The panel will review these and other key questions:

  • What can be learned from the AstraZeneca v. Apotex, Bayer Schering v. Lupin, and Commil USA v. Cisco Systems Inc. decisions?
  • What are the best approaches to maintain consistency between claims and likely or actual label language?
  • What steps can be taken to maintain the coordination of patent, regulatory and clinical personnel throughout the patent prosecution and label negotiation with the FDA?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.

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

David P. Frazier, Ph.D.
David P. Frazier, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

He focuses his practice primarily on patent litigation, strategic pre-litigation client counseling, due diligence...  |  Read More

Robert F. Shaffer
Robert F. Shaffer

Partner
Finnegan Henderson Farabow Garrett & Dunner

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

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