Writing for Bloomberg Law, Kathy Williams, Ph.D., Analyzes the Supreme Court’s Decision in Amgen v. SanofiPrint PDF
Kathy Williams, Ph.D., a partner in Nutter’s Intellectual Property Department and chair of the firm’s Life Sciences group, authored an article on the U.S. Supreme Court upholding a Federal Circuit 2021 decision that invalidated Amgen’s patent on its cholesterol inhibitor Repatha on the basis of lack of enablement in Bloomberg Law. In the piece, “High Court Whiffed in Adopting ‘Rigid’ Test for Patent Enablement,” Kathy pointed out that the Supreme Court missed an opportunity to address the law on patent enablement and only “half-heartedly” engaged with the legal precedent in this area, which until recently had been flexible and fact-dependent.
“By affirming the Federal Circuit’s approach, the high court failed to recognize that there exists abundant legal precedent on enablement applying a flexible, fact-dependent approach. The court essentially bought into the Federal Circuit’s erroneous interpretation of enablement that focuses on knowing which species of a claimed genus will work, thus requiring that a patentee demonstrate that virtually all species of a genus are operative,” Kathy stated. Furthermore, she noted, “This approach is troublesome because if the goal of enablement as articulated by statutory law is knowing ‘how to make and use an invention,’ then one need not know in advance which species (or how many) species will work.”