On Friday, February 10, 2023, the latest round of amicus briefs in Amgen Inc. v. Sanofi poured in. The case, set to be argued on March 27 before the U.S. Supreme Court, asks the Court to wrestle with the enablement requirement of Section 112 of the Patent Act. Specifically, the Court has been asked to address the propriety of the Federal Circuit’s heightened enablement requirement for genus claims, which may also be referred to as functional claims. The Federal Circuit has held that the specification for such claims must enable those skilled in the art to reach the full scope of the claimed embodiments without undue experimentation.
Petitioners Amgen Inc., et al. have argued that the Federal Circuit’s reach-the-full-scope test for enablement has no basis in Section 112’s text, runs counter to centuries of precedent, and is bad policy that harms innovation. Respondents Sanofi, et al. have responded that the Federal Circuit’s test comports with Supreme Court precedent requiring sufficient disclosure to enable a skilled artisan to make the entire invention claimed. Sanofi further argues that the Federal Circuit’s test satisfies the basic requirement of the “patent bargain” that a patentee claim no more than is enabled by the patent. Amici from both industry and academia have weighed in on either side of the debate.
Those writing in support of Amgen include the Chemistry and Law Division of the American Chemical Society, the National Association of Patent Practitioners, GSK (formerly GlaxoSmithKline), AbbVie, and a group of “diversified researchers and innovators,” which includes Bristol Myers Squibb, Corning Inc., Merck Sharp & Dohme, and 3M among others. In broad strokes, amici in support of Amgen argue that genus claiming is necessary to protect innovations, especially in the pharmaceutical and biotechnology fields, from easy design-arounds that practice the heart of the invention but avoid infringement by making minor, inconsequential changes. These amici worry that the Federal Circuit’s heightened enablement test imposes an unnecessarily high burden on fields where research and development are already expensive and risky endeavors.
On the other side, Sanofi is supported by such amici as Nobel Prize-winner Sir Gregory Paul Winter, Eli Lilly and Company, Pfizer, Johnson & Johnson, AztraZeneca Pharmaceuticals, Bayer, Fresenius Kabi USA, and the United States Patent and Trademark Office. The USPTO argues that Amgen’s concerns about design-arounds are misplaced, since an inventor can claim an innovative process with many applications through a process patent and may deal with insignificant alterations through the doctrine of equivalents. The USPTO further argues that allowing a patentee to patent an entire genus of products that share a function while not requiring the patentee to enable the full scope of the claim will foreclose others from inventing potentially better products that achieve the same goal, a sentiment echoed by many amici. Pfizer, for example, argues that allowing a patentee to claim a genus that it has not fully enabled runs the risk of allowing a patentee to block competitors and “preempt the future before it has arrived.” Brief of Amicus Curiae Pfizer Inc. in Support of Respondents, at 10 (quoting Ariad Pharms., Inc. v. Eli Lilly Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010)).
It remains to be seen how the Court will rule on this contentious and important issue, but those in the pharmaceutical and biotechnology spaces would be well advised to keep a close eye on this case. If the Court reverses the Federal Circuit, it could signal a significant shift in the enablement requirement for broadly drafted genus claims.