Antibody Patenting After Amgen v. Sanofi: U.S. and European Perspectives

Meeting Written Description and Obviousness Requirements

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


Wednesday, November 20, 2019

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

Early Registration Discount Deadline, Friday, October 25, 2019

or call 1-800-926-7926

This CLE webinar will provide guidance to patent counsel on the patentability requirements in the USPTO and EPO for claiming a broad genus of antibodies, recent case law that could impact those claims, and how to best protect antibody inventions in light of the recent developments.

Description

Patent applicants frequently employ functional claims to provide broad protection for antibody inventions. However, in Amgen v. Sanofi, the Federal Circuit called into question the USPTO's practice of granting claims that define antibodies by their ability to bind to a newly characterized antigen.

Whether this test satisfies the written description requirement under 35 U.S.C. 112 was the subject of a petition for certiorari to the Supreme Court on the Federal Circuit's Amgen decision. However, the Court denied certiorari, leaving that question unresolved.

Under prevailing law, to meet the written description requirement, an application must disclose the claimed invention in such detail that a person of ordinary skill would understand the inventors possessed the full scope of the claimed invention at the time of filing. After Amgen v. Sanofi, it may be more difficult to obtain some antibody claims, particularly if it will no longer suffice to characterize the antigen bound by the claimed antibody.

Alternatively, a patent specification must provide a sufficient number of representative examples or a structure-function relationship across the full scope of the claimed genus. What those concepts entail, and how to satisfy them for antibody-based technologies, is the subject of current debate.

Antibody claims are also encountering similar problems in Europe, with the EPO taking a strict view on what makes a new antibody inventive. The EPO has also imposed strict limits on how broadly a claim can be justified based on the data in the patent specification.

Biotech companies, universities, and others are scrambling to determine how to protect their antibody patents on both sides of the Atlantic.

Listen as our authoritative panel of patent attorneys examines the patentability requirements in the USPTO and EPO for claiming a broad genus of antibodies, recent case law that could impact those claims, and how to protect antibody inventions amid recent developments. Our panel will discuss best practices on what and how much data to include in a patent application to support claims of differing scope, the extent to which post-filing data can be relied on to support the claims, and how examiners are being instructed to examine antibody inventions.

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Outline

  1. Written description requirements
  2. Obviousness requirements
  3. Case law developments
  4. How to best protect antibodies
  5. What data and how much data is needed
  6. How broadly should claims be drafted
  7. What guidance do examiners receive regarding antibody patentability

Benefits

The panel will review these and other relevant issues:

  • How broadly can the applicant claim? How much support does a filing need to have?
  • What are the differences between U.S. requirements and EPO requirements?
  • What is a sufficient description of a genus? Can functional language be included?
  • When can post-filing data be used?

Faculty

Jacobstein, Jeffrey
Jeffrey M. Jacobstein

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Jacobstein focuses on strategic client counseling, including due diligence, patent prosecution, and post-grant...  |  Read More

Murphy, Amanda
Amanda K. Murphy, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

Randall, Victoria
Dr. Victoria Randall, Ph.D.

Associate
Finnegan

Dr. Randall has extensive experience in a broad range of life sciences subject matter. Her areas of interest include...  |  Read More

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