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

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

Conducted on Thursday, September 5, 2019

Recorded event now available

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Program Materials

This CLE webinar 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.


Eight of the top 10 best 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. At a time when global litigation is the norm, it is vital to understand and coordinate strategies around the world.

In the U.S., there is an abundance of decisions on written description, but only a handful of Federal Circuit cases address the obviousness of inventions related to biologics. Further, 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 can be particularly challenging to establish an inventive step for new antibody products. 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
  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 counsel overcome the inconsistency in the EPO's treatment of 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

Luo, Simon
Simon Tianle Luo

Wu Feng & Zhang

Mr. Luo focuses his area of practice on biotech and biopharmaceuticals. He has more than 12 years’ experience in...  |  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

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