Antibody Patenting: U.S. and Asian Perspectives

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


Thursday, April 18, 2019

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

or call 1-800-926-7926

This CLE webinar will guide patent counsel on the patentability requirements at the USPTO, JPO and CNIPA/CPO when claiming antibodies, recent case law that could impact those claims, and how to protect antibody inventions in light of the latest developments.

Description

Patent applicants frequently employ functional claims to provide broad protection for antibody inventions. However, the Amgen v. Sanofi decision from 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. As the Supreme Court declined to grant certiorari on the appeal from the Federal Circuit’s decision, the district court must now determine whether an antibody may be defined by reference to the portion of the antigen to which it binds. The fate of many antibody patents may hinge on a final resolution of that case.

Unlike the decision in Amgen v. Sanofi, Japan and China will grant a patent for an antibody without producing an actual antibody, provided the antigen is structurally described and has some function.

To meet the support requirements, the Japan Patent Office (JPO) requires that the specification describe actual data relating to a claimed composition. Japanese law does not permit post-filing data showing such activity to overcome a rejection, if the specification does not include any data on activity. Chinese support and disclosure requirements are similar. Chinese examiners (NIPA/CPO) typically require inclusion of the sequences of the antibody's six complementarity determining regions when claiming an antibody.

To obtain a granted claim on a new antibody to a known antigen, all jurisdictions generally require defining and claiming the antibody structurally. Furthermore, outside the U.S., structural non-obviousness per se may be insufficient to claim an antibody even if defined by sequence, and it may be necessary to demonstrate that the antibody produces unexpected technical effect or was produced using non-conventional techniques.

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

Listen as our authoritative panel of patent attorneys examines the patentability requirements in the USPTO, JPO and NIPA/CPO 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. 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 for antibody claims
  2. Obviousness requirements for antibody claims
  3. Case law developments
  4. How examiners are being instructed to assess antibody claims
  5. How to best protect antibodies globally and how broadly claims should be drafted
  6. How to provide disclosure and data in a patent application to support different claim strategies

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, JPO requirements and CNIPA/CPO requirements?
  • What is a sufficient description of a genus? Can functional language be included?
  • When can post-filing data be used?
  • What is needed to demonstrate the nonobviousness of antibody claims in the different jurisdictions?

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

Yamamoto, Osamu
Osamu Yamamoto

Partner
Yuasa and Hara

Mr. Yamamoto is an experienced patent attorney. He has 10 years of experience in biotechnology and pharmaceutical...  |  Read More

Miao Cheng, Daniel
Daniel Miao Cheng

President, Founding Partner
Cheng & Peng

Mr. Miao Cheng is an experienced Chinese patent attorney and has been practicing Chinese law for 16 years. His practice...  |  Read More

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