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test’ for written description of antibodies leaves no doubt that current guidance pertaining to antibody claims is outdated, and that additional written description examination guidance will be released soon.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 Kevin E. Noonan, PhD, to lead this critically important program:
During this one-hour distance learning program, 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
- Enablement v. written description
- 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
Meet Your Session Leader:
Kevin E. Noonan, PhD
Partner
McDonnell Boehnen Hulbert & Berghoff LLP
Dr. Noonan serves as Chair of the firm’s Biotechnology & Pharmaceuticals Practice Group. An experienced biotechnology patent lawyer, Dr. Noonan brings more than 20 years of extensive work as a molecular biologist studying high-technology problems in serving the unique needs of his clients. His practice involves all aspects of patent prosecution, interferences, and litigation.
He represents pharmaceutical companies both large and small on a myriad of issues, as well as several universities in both patenting and licensing to outside investors. He has also filed amicus briefs in landmark patent and other cases to district courts, the Federal Circuit and the U.S. Supreme Court involving patenting issues relevant to biotechnology. Dr. Noonan is a frequent speaker, commentator and author on a variety of intellectual property law topics. He is a founding author of the Patent Docs weblog, a site focusing on biotechnology and pharmaceutical patent law.
