In REGENXBIO v. Sarepta Therapeutics, the Federal Circuit reversed a district court and held that recombinant host cells are patent eligible — setting new precedent for gene therapy, CAR-T, and mRNA I
In Seagen v. Daiichi Sankyo, the Federal Circuit reversed a damages verdict and held broad antibody‑drug conjugate claims invalid for inadequate written description & enablement under §112(a).
In Duke University v. Sandoz Inc., the Federal Circuit reversed a $39M jury verdict, holding the patent claim invalid for failing to meet §112’s written description requirement for a claimed chemical
In FMC v. Sharda, the Federal Circuit vacated a TRO, finding that the term “composition” should not include a stability requirement omitted from the final patent.
