Antibody Patenting: Meeting Written Description and Obviousness Requirements, U.S. and European Perspectives

An encore presentation featuring live Q&A

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

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Tuesday, August 9, 2022

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

Early Registration Discount Deadline, Friday, July 15, 2022

or call 1-800-926-7926

This CLE course will guide 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 best to 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.

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.

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 also encounter similar problems in Europe, with the EPO taking a strict view on what makes a new antibody inventive and sufficiently disclosed. In 2021, the EPO updated the influential Guidelines for Examination in the European Patent Office, definitively setting out important aspects of its approach to examining claims directed to antibodies. These guidelines were further revised in March 2022, reflecting the dynamic developments in this field of technology and the necessary evolution of strategies to obtain adequate patent protection.

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. Guidance 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?

This is an encore presentation with live Q&A.

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.

Attorney
Finnegan Henderson Farabow Garrett & Dunner

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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