On May 18, 2023, the U.S. Supreme Court issued a unanimous opinion in the case of Amgen Inc. v. Sanofi and Aventisub LLC (Docket No. 21-757), holding that two U.S. patents owned by Amgen failed to satisfy the enablement requirement of 35 U.S.C. §112(a). The Court’s ruling upheld the opinion of the Federal Circuit.
U.S. Patent Nos. 8,829,165 and 8,859,741 – considered genus patents – purportedly covered antibodies used to treat high cholesterol. In 2014, Amgen filed a Complaint alleging that Sanofi’s promotion and sale of Praluent® infringed these two patents, among several others.
As previously reported, the issue before the Court was the scope of the enablement standard which states:
- The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.1
By ruling in favor of Sanofi, the Court found that the specifications of Amgen’s patents sufficiently enabled 26 exemplary antibodies the patents identified by amino acid sequences but failed to enable other antibodies because “the claims before us sweep much broader than those 26 antibodies. And we agree with the lower courts that Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.”2
In its opinion, the Court expressly rejected Amgen’s “roadmap” or “conservation substitution” positions, stating:
- These two approaches amount to little more than two research assignments. The first merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies—calling on scientists to create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors. The second isn’t much different. It requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too—an uncertain prospect given the state of the art.3
The Court concluded that:
- Section 112 of the Patent Act reflects Congress’s judgment that if an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the statutory enablement requirement according to its terms. . . . Today’s case may involve a new technology, but the legal principle is the same.4
Legal professionals and biotech developers have hailed the Supreme Court’s opinion as a win for U.S. innovation. Sanofi described the decision as:
- [A]n unequivocal win for America’s innovation economy, its scientists, and researchers. Most importantly, it is a win for patients who rely on the lifesaving discoveries made through years of research and investment by the biopharma community. The justices rejected an attempt to radically change the longstanding legal standard for patent validity under the enablement doctrine – a move that would have blocked progress for entire classes of molecules, deterred innovative competition, and led to potential increases of drug prices.5
Dr. Irena Royzman, head of Kramer Levin’s Life Sciences practice agreed with Sanofi, stating:
- The decision encourages competition and invention. Indeed, there is tremendous value to discovering new treatments that bind to the same, known target as they can be more effective or have fewer side effects. Instead of being impeded by non-enabled claims that lay claim to a therapeutic target, innovators big and small can invest in research and development and discover other and better therapeutics within the scope of non-enabled patent claims.”6
Paul Michel, Retired Chief Judge for the Federal Circuit, also weighed in, stating:
- As I consider the underlying logic of the Supreme Court’s opinion, I can only conclude that it will lead lower courts to enforce the following rule: For a claim to a large genus to pass muster under sec. 112, the specification must explicate which members of the genus meet any functional limitations and which do not—and why. Put differently, if the artisan must engage in ‘trial-and-error’ screening of candidates, no matter how routine, that automatically fails enablement. That is, the specification must inform the artisan in such detail, she can make all the candidates that do function without ever having to make any that do not.7
1 https://www.law.cornell.edu/uscode/text/35/112
2 Opinion of the Court, Amgen Inc., ET AL., Petitioners v. Sanofi ET AL, p. 15
3 Opinion of the Court, Amgen Inc., ET AL., Petitioners v. Sanofi ET AL, p. 16 – 17.
4 Opinion of the Court, Amgen Inc., ET AL., Petitioners v. Sanofi ET AL, p. 19.
6 https://www.law360.com/ip/articles/1679242?utm_source=rss&utm_medium=rss&utm_campaign=section
7 https://ipwatchdog.com/2023/05/22/reactions-amgen-hard-work-ahead-biotech-innovators-
attorneys/id=161140/.
Acknowledgments
We would like to thank Robert McSorley and Frank Vido for providing insight and expertise that greatly assisted this research.