Yesterday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Medytox, Inc. v. Galderma S.A. affirming a final written decision by the Patent Trial and Appeal Board (PTAB) invalidating Medytox’s patent claims covering methods for treating patients with botulinum toxin and denying a revised motion to amend patent claims. On appeal, the Federal Circuit rebuffed several challenges, including an Administrative Procedures Act (APA) challenge to the PTAB’s motion to amend pilot program, holding that the PTAB’s change in claim construction was not arbitrary or capricious, nor did it prevent Medytox from litigating construction issues.
The Supreme Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s longstanding requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions with such clarity and specificity as to enable one skilled in the art to make and use the claimed invention. Moreover, the Court has consistently held that a patent fails to satisfy the enablement requirement if a person having ordinary skill must engage in undue experimentation to practice the claimed invention. The Federal Circuit has gone a step further, requiring that patents enable the full scope of a claimed invention. Amgen is a ratification of this aspect of the Federal Circuit’s enablement jurisprudence.
Earlier today, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. So, we simply learned today that the extraordinary disclosure and detail provided by Amgen was not enough.
Yesterday’s oral argument in Amgen v. Sanofi was long-awaited and closely watched by many in the patent community. The Justices seemed skeptical that the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision was a significant departure from existing law, and they repeatedly questioned whether this particular case can be resolved on the facts and by employing current legal tests. During oral argument, Sanofi’s counsel, Paul Clement, admitted that the Court’s affirmance of the CAFC decision could result in the inability to functionally claim a genus in this particular area of antibody science, but said that’s ok because “functional genus claims are terrible. I think they retard the science.”
The U.S. Supreme Court heard three separate arguments today in Amgen v. Sanofi, a case that even Sanofi’s counsel agreed could effectively wipe out patents involving genus claims if the Court sides with Sanofi, or—as counsel for Sanofi and the Solicitor General’s Office suggested the Court could do—if it were to dismiss the case as improvidently granted.