The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies that perform a specified function. In the May 18, 2023, opinion authored by Justice Gorsuch, the High Court affirmed the Federal Circuit’s holding invalidating two Amgen patents that claimed antibodies that inhibit the PCSK9 protein because the patents did not fully enable the potentially millions of antibodies that could perform the functions described in the patents.

Relying on a trio of decisions from the 19^th and early 20^th Centuries, Justice Gorsuch stated the basic principle of enablement to be:

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable.

The opinion acknowledged that “a specification may call for a reasonable amount of experimentation to make and use a patented invention” and noted that “[w]hat is reasonable in any case will depend on the nature of the invention and the underlying art.”

Ultimately, because Amgen’s patents sought “to monopolize an entire class of things defined by their function”—a genus of PCSK9 antibodies, which could number in the millions—the High Court held that the patents’ description of how to make only 26 examples was not enough to fully enable the claims. This was because “the more a party claims, the broader the monopoly it demands, the more it must enable.” According to the High Court, a person of skill in the art who tries to make every antibody claimed by the Amgen patents would have to engage in an undue amount of experimentation, as the patent offers “little more than advice to engage in ‘trial and error.’” The patents were, therefore, not enabled.

Patent Preparation & Prosecution & Freedom-to-Operate (FTO) Perspectives

The Amgen decision is likely to affect how patent practitioners prepare, prosecute, and strategically develop patent portfolios, particularly in the life sciences and chemical arts.

First, this decision will likely push patent practitioners and their clients into (a) claiming less broadly or (b) conducting and disclosing in their patent applications more experimental examples, to more adequately enable broad patent claims. The argument over whether one can enable claims covering millions of variants by disclosing a few dozen examples now seems to be settled.

Second, this decision will likely have a significant impact on companies, particularly early-stage companies, that historically have tried to secure a broad monopoly to a particular compound to incentivize external investment. Patent practitioners will need to fine tune their playbook to ensure that clients are obtaining meaningful patent protection through securing patents that can stand up to a validity challenge based on a lack of enablement.

Third, the Amgen decision may affect how life science and chemical companies approach their routine FTO/patent landscape risk assessments, through which they seek to determine whether third-party patents could potentially impact their ability to produce a compound or carry out a claimed process. Often, such efforts have focused on identifying broad patents that seem to cover “the entire genus,” as was the case with Amgen’s claimed PCSK9 antibodies. The Amgen decision suggests that such broad patents may be susceptible to an invalidity challenge for lack of enablement. Expect more nuanced analyses of third-party patents that place greater emphasis on the validity of third-party patents under Amgen.

Patent Litigation Perspective

Future litigants and lower courts alike will toil for some time in the shadows of the typically (for the Supreme Court) cursory Amgen decision, which provides a general pronouncement of the U.S. Supreme Court’s view of the law and leaves it for lower courts to discern how to apply that general pronouncement to real world disputes. Expect at least two upshots in the context of patent litigation, especially in the field of life sciences.

First, there will likely be an uptick in dispositive motion practice. In Amgen, the issue of enablement was decided by the court as a matter of law, based on a finding by the lower court that no reasonable jury could find the claims enabled. With the Amgen affirmance of that move, expect accused infringers to try to keep the issue from reaching a jury in the first place, for example through motions for summary judgment.

Second, expect a potpourri of creative arguments including (a) the applicability of the Amgen decision beyond the particular facts and procedural posture of the case; (b) whether the patentability requirement known as “written description” is as stringent as the post-Amgen enablement requirement; (c) to what extent a given set of facts “bear[s] more than a passing resemblance” to the 19^th and 20^th Century cases cited in the Amgen decision; and (d) whether the patent being challenged “discloses some general quality running through the [claimed genus] that gives it a peculiar fitness for the particular purpose.”  Also, accused infringers in non-life science cases will undoubtedly seek to raise the enablement arguments decided in Amgen, and it will be interesting to see to what extent lower courts are willing to accept such arguments.

Conclusion

While much ink will be spilled trying to predict the long-term implications of the unanimous Amgen decision, one certainty is that this case will have a long-lasting impact on how thoughtful legal practitioners prepare new patent applications, carry out necessary FTO clearance work, and structure their invalidity arguments before U.S. courts.