As scrutiny of inventive step and sufficiency intensifies in Europe under evolving EPO and UPC practice, originators face growing pressure to substantiate broad antibody claims with a credible technical contribution and sufficient data at the point of filing. This pressure is further reinforced post-Amgen v. Sanofi (2023) in the U.S., where the enablement doctrine has tightened the boundaries for broad antibody claims.
This session will examine the core IP challenges in the antibody and biologics space, placing recent high profile European and U.S. case law in the context of practical strategies you can deploy to secure broad and robust protection for biological molecules.
Are broad functional antibody claims in the U.S. still defensible post-Amgen v. Sanofi (2023)?
- What impact has the landmark UPC Court of Appeal decision in Amgen v. Sanofi & Regeneron (Nov 2025) had on antibody claims in Europe?
- How is inventive step for antibodies being assessed currently by major patent offices, including USPTO, EPO, JPO and CNIPA?
- Is the presumption of obviousness of antibody inventions at the EPO justified? - How does the notion of “routine methods” impact antibody patentability?
- How much data do you need in a patent application to demonstrate inventiveness?
- Is there a middle ground between broad, functionally defined claims and narrowly-defined sequence claims?
- How can you curate an antibody development and IP strategy that is adaptable to a changing prior art and reference antibody landscape?
