Obviousness of Biologics Inventions: Strategies for Biologics Claims in the U.S., Europe, and China

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

Conducted on Tuesday, March 9, 2021

Recorded event now available

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Course Materials

This CLE course will guide patent counsel on overcoming the challenges of obviousness in biologics patent claims in the U.S., Europe, and China. The panel will examine the similarities and differences between claim types that have the best chance of success. The group will also discuss recent case law and critical issues that arise.


Several of the top-selling drugs last year were biologics. Unsurprisingly, patents relating to new biologics products are often challenged in patent offices and courts around the world, as well as the PTAB. When global litigation is the norm, it is vital to understand and coordinate strategies around the world.

There is an abundance of decisions on the written description in the U.S., but only a handful of Federal Circuit cases address the obviousness of inventions related to biologics. With the advent of IPR, over 200 petitions have been filed at the PTAB alleging biologic claims are not patentable under Section 103.

In Europe, it is particularly challenging to establish an inventive step for new antibody products, with strict tests for when a new product is considered inventive, and what scope of patent claim might be obtained. Also, China has seen rapid growth as a destination for biologics patents.

Listen as our authoritative panel of patent attorneys provides an in-depth analysis of biologic IPR petitions. The panel will review the similarities and differences between biologic claim types that have the best chance of success in the U.S., China, and Europe and the obviousness issues that may arise. The panel will also review current EPO and China practice, discuss recent case law , and outline key issues that arise. The panel will offer guidance addressing obviousness issues in biologics inventions.



  1. The U.S.
    1. PTAB treatment
    2. Court treatment
    3. Strategies for overcoming obviousness challenges
  2. Europe
    1. EPO treatment
    2. Court treatment
    3. Strategies for overcoming obviousness challenges
    4. Relationship between non-obviousness arguments and claim scope
  3. China
    1. Agency treatment
    2. Court treatment
    3. Strategies for overcoming obviousness challenges


The panel will review these and other key issues:

  • What evidence should counsel provide to support its assertion of nonobviousness in biologics patents?
  • How can patent counsel guide applicants during patent application drafting to reduce the likelihood of rejection?


Diner, Bryan
Bryan C. Diner

Finnegan Henderson Farabow Garrett & Dunner

Mr. Diner practices all aspects of intellectual property law, including strategic patent portfolio management,...  |  Read More

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

Mouta-Bellum, Carla
Carla Mouta-Bellum, Ph.D.

Arrigo Lee Guttman & Mouta-Bellum

Dr. Mouta-Bellum focuses on drafting and prosecuting patent applications in the fields of biotechnology and...  |  Read More

Feng, Amy
Amy Feng

Wu Feng & Zhang

Ms. Feng focuses her practice on biotech and pharma patent, chemical engineering, material, and chemistry. She handles...  |  Read More

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