Antibody Patenting and Licensing Challenges in Light of Amgen v. Sanofi

Tech Transfer Central Webinar – August 23, 2018

Over the past decade, multiple patents on therapeutic antibodies have been invalidated in the courts, often for lack of written description — and it won’t be getting any easier after the Amgen v. Sanofi Fed Circuit decision. The case indicated that even for a new class of antibodies, the written description requirement can be met only through the disclosure of a “sufficient” number of representative antibodies — including highly specific amino acid sequences. Disclosure of target antigens without the antibody disclosure will cut it no longer. Because what is a “sufficient” number is unclear, universities that don’t have the resources to characterize a large number of antibodies before applying for a patent face a significant challenge. Adding to the challenge is the retroactive application of the ruling, leaving billions in antibody patents at risk.

The USPTO’s recently issued memorandum regarding the withdrawal of the ‘newly characterized antigen test’ for written description of antibodies leaves no doubt that current guidance pertaining to antibody claims is outdated, and that additional written description examination guidance will be released soon.

Research universities invest millions of dollars in discovering and developing antibodies, and they — and their potential licensees — are faced with uncertainty and heightened risk in the wake of these developments.

That’s why Technology Transfer Tactics’ Distance Learning Division has tapped biotech patent expert and MBHB partner Kevin E. Noonan, Ph.D., to lead this critically important webinar.

During this one-hour distance learning event, Dr. Noonan will discuss the current state of the law regarding written description and claim scope and the effects of these changes on the outlook for patenting and licensing antibodies.

  • Technology background
  • Legal development

    • Enablement v. written description

      • Noelle v Ledermann
      • Centocor v. Abbott
      • AbbVie v. Janssen

    • Yeda v. Abbott

  • Amgen v. Sanofi: the Federal Circuit clarifies written description for antibodies

    • Ariad v. Eli Lilly

  • Implications on antibody patent scope
  • Effects on licensing
  • Alternative antibody embodiments
  • Retroactivity
  • Strategy going forward

    • Review and revision of pending patents
    • Claim construction 
    • How faculty researchers can help
    • Use of third-parties for characterization


CLP and CLE Credits Available

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