October 13, 2017
Authored and Edited by Christopher B. McKinley; Jeffrey M. Jacobstein; Jennifer H. Roscetti
In Amgen Inc. v. Sanofi, DED-1-14-cv-01317 (Mar. 16, 2016), patents directed to anti-PCSK9 antibodies were challenged as invalid for lacking written description support and not being enabling because the claims recited a large genus of antibodies for which no examples were provided. However, a jury found that the specification’s description of numerous experiments with various antibodies provided sufficient written description support and was enabling. Further discussion of the decision can be found on Finnegan’s Prosecution First Blog.
Following the jury’s decision, the district court denied the defendants’ motion for a new trial and renewed motion for judgment as a matter of law on written description and enablement. Amgen Inc. v. Sanofi, 227 F. Supp. 3d 333 (D. Del. 2017). The defendants appealed and in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), the CAFC reversed and remanded for a new trial. The CAFC held post-priority-date evidence could be used to show the lack of sufficient representative examples or a structure-function correlation adequate to satisfy the written description requirement as well as to show undue experimentation for enablement purposes. The CAFC also held the district court erred in instructing the jury on written description because “disclosing an antigen does not satisfy the written description requirement for a claim to an antibody.” Further discussion of the decision can be found on Finnegan’s Federal Circuit IP Blog.
Written description (35 USC § 112), Enablement (35 USC § 112), Food and Drug Administration (FDA), United States Court of Appeals for the Federal Circuit (CAFC)
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