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Antibody Patenting: U.S. and Asian Perspectives

Meeting Patentability Requirements in the USPTO, JPO, and CNIPA

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

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Conducted on Thursday, September 10, 2020

Recorded event now available

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This CLE course will guide patent counsel on the patentability requirements at the USPTO, JPO, and CNIPA 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.

Unlike the decision in Amgen, 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 JPO requires that the specification describe actual data relating to a claimed use. 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.

To obtain a granted claim on a new antibody to a known antigen, all jurisdictions generally require defining and claiming the antibody structurally. Japanese (JPO) and Chinese examiners (CNIPA) typically require the inclusion of the sequences of the antibody's six complementarity determining regions when claiming an antibody. 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 an unexpected technical effect or was produced using non-conventional techniques.

Listen as our authoritative panel of patent attorneys provides guidance on protecting design rights in the global marketplace. The panel will discuss the key differences between the patent laws in the U.S. and other countries that must be understood when developing a strong global IP strategy. The panel will offer best practices for U.S. companies on developing a global strategy.

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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 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 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 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
Dr. 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

Miao Cheng, Daniel
Daniel Miao Cheng

Director, 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

Yamamoto, Osamu
Osamu Yamamoto

Partner, Patent Division, Chief of Chemical Section
Yuasa and Hara

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

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