This decision overturned a $107.5 million infringement award. The CAFC held that Wyeth’s method of treatment claims were invalid for lack of enablement because the patent did not disclose to the skilled person how to identify a therapeutically effective daily...
Background The case concerned Bristol-Myers Squibb’s (BMS) European patent No. 3288980, which was directed to the treatment of PD-L1-positive melanoma by administering nivolumab as a monotherapy. The patent had previously been revoked by the Opposition Division for...
As a reminder, this case addresses how the Hatch-Waxman act “carve-out” provisions (which has led to the emergence of “skinny labels”) interacts with US law on induced patent infringement. This case is the first time the US Supreme Court has had the opportunity to...
On 16–17 June 2026, the Court heard Otsuka’s appeal in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd. The appeal challenges the Full Federal Court’s finding that formulation patents are not eligible for patent term extensions (PTEs). The decision, expected in...
Background REGENXBIO and the Trustees of the University of Pennsylvania sued Sarepta for infringing multiple claims of U.S. Patent No. 10,526,617, which is directed to cultured host cells containing a recombinant nucleic acid molecule encoding an AAV capsid sequence...
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