Groombridge, Wu, Baughman & Stone LLP won a major victory on behalf of Genentech in patent litigation brought by Baxalta, Inc. and Baxalta GmbH (now subsidiaries of Takeda Pharmaceuticals) concerning Genentech’s breakthrough Hemophilia A treatment, HEMLIBRA® (emicizumab-kxwh), which has transformed the lives of thousands of patients. The U.S. District Court for the District of Delaware had granted Genentech’s motion for summary judgment, holding that Baxalta’s patent is invalid for lack of enablement.
The Federal Circuit affirmed the district court’s grant of summary judgment. In its first major enablement case following the Supreme Court’s decision in Amgen Inc v. Sanofi, 598 U.S. 594 (2023), the Federal Circuit clarified that it does not “interpret Amgen to have disturbed” the Federal Circuit’s prior enablement case law, and reiterated that a patent “”must enable the full scope of the invention as defined by its claims,’ allowing for ‘a reasonable amount of experimentation.'” Baxalta’s patent, the Federal Circuit affirmed, claimed millions of potential antibodies while disclosing only eleven examples, directing “skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the eleven antibodies they elected to disclose.” Under Amgen and the Federal Circuit’s prior case law, the court held, Baxalta’s patent failed the enablement requirement.
Partner Eric Stone argued the Federal Circuit appeal and the summary judgment motion in the district court. The team also included partners Nicholas Groombridge and Josephine Young, counsel Naz Wehrli, and associate Ariella Barel.
View the decision: https://cafc.uscourts.gov/opinions-orders/22-1461.OPINION.9-20-2023_2193254.pdf