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

Meeting Written Description and Obviousness Requirements

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


Conducted on Wednesday, November 7, 2018

Recorded event now available

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Program Materials

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, the recent Amgen v. Sanofi decision from the Federal Circuit has 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, along with the more fundamental question of whether a test for written description separate from enablement even exists under U.S. law, are currently the subject of a petition for certiorari to the Supreme Court from the Federal Circuit’s decision in Amgen v. Sanofi. The fate of many antibody patents rests on a final resolution of that case.

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 merely 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 therefore now scrambling to determine how best 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 best protect antibody inventions in light of the latest developments. Our panel will consider best practices on what and how much data should be included 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 examiners are being instructed regarding antibody patentability

Benefits

The panel will review these and other relevant issues:

  • How broadly can the applicant claim? How much support is needed on a filing?
  • 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

Ford, Hazel
Dr. Hazel Ford

European Patent Attorney
Mathys & Squire

Dr. Ford is a European and UK patent attorney with extensive experience drafting patent applications and prosecuting...  |  Read More

Jacobstein, Jeffrey
Jeffrey M. Jacobstein

Atty
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

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