Antibody Patenting: Meeting Written Description and Obviousness Requirements, U.S. and European Perspectives
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Wednesday, December 4, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide patent counsel on the patentability requirements relevant to examination before the USPTO and EPO when claiming antibodies, recent case law that could impact those claims, and how best to protect antibody inventions in light of the recent developments.
Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.
Mr. Jacobstein focuses on strategic client counseling, including due diligence, patent prosecution, and post-grant proceedings, with an emphasis on biotechnology and the life sciences. His experience includes prosecuting and appealing applications within the USPTO, as well as post-grant proceedings and larger portfolio management, licensing, and opinion work. He has conducted numerous evaluations for diligence, clearance, and freedom-to-operate assessments, and has extensive experience providing patentability, validity, enforceability, and infringement opinions.
Dr. Randall has extensive experience in a broad range of life sciences subject matter. Her areas of interest include antibody technologies, antisense therapeutics, blood products, vaccines, gene manipulation, and stem cell culture methods. She enjoys all aspects of prosecution, including drafting, filing, examination, and grant procedures. She has experience with oppositions and appeals, representing both patentee and opponent at Oral Proceedings before the European Patent Office (EPO). She has managed large, complex portfolios protecting high-value pharmaceuticals. She also has experience prosecuting supplementary protection certificates and has been involved in litigation proceedings before the UK High Court.
Patent applicants frequently employ functional language in claims to provide broad protection for antibody inventions. Under prevailing U.S. law, however, to satisfy the written description and enablement requirements, an application must disclose the claimed invention in such detail that a person of ordinary skill would understand the inventors possessed the full scope of the claimed invention at the time of filing, and be able to make and use that full scope without undue experimentation. What those concepts entail and how to satisfy them for antibody-based technologies is the subject of current debate. After the Supreme Court’s decision in Amgen v. Sanofi, however, it may be more difficult to obtain some antibody claims, particularly if it will no longer suffice to characterize the claimed antibody by its various functions.
Claiming antibodies in Europe can also be challenging, with the EPO taking a strict view on what makes a new antibody inventive. In 2021, the EPO updated the influential Guidelines for Examination in the European Patent Office, definitively setting out important aspects of its approach to examining claims directed to antibodies. These guidelines have been further revised since, and there have been several recent decisions from the EPO Boards of Appeal reflecting the dynamic developments in this field of technology and the necessary evolution of strategies to obtain adequate patent protection.
Biotech companies, universities, and others are scrambling to determine how to protect their antibody patents on both sides of the Atlantic.
Listen as our authoritative panel of patent attorneys examines the patentability requirements when prosecuting before the USPTO and EPO, recent case law that could impact those claims, and how to protect antibody inventions amid recent developments. Our panel will discuss best practices on what and how much data to include in a patent application to support claims of differing scope, the extent to which post-filing data can be relied on to support the claims, and how examiners are being instructed to examine antibody inventions.
- Written description and enablement requirements
- Novelty and Non-Obviousness requirements
- Case law developments
- How to best protect antibodies
- What data and how much data is needed
- How broadly should claims be drafted
- Guidance examiners receive regarding antibody patentability
The panel will review these and other relevant issues:
- How broadly can the applicant claim? How much support does a filing need to have?
- What are the differences between U.S. requirements and EPO requirements?
- What is a sufficient description of a genus? Can functional language be included?
- When can post-filing data be used?
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