Last month, the U.S. Supreme Court heard oral argument in the closely watched patent case, Amgen v. Sanofi. This long-running dispute involves the enablement requirement of 35 U.S.C. §112. Sufficient enablement has been the subject of much debate—particularly for healthcare patents—and the Court's decision may significantly impact enablement's role in promoting future innovation. Those responsible for managing intellectual property at companies of all sizes are keeping a close eye on this case.
Enablement is part of the patent bargain: inventors are granted a monopoly to exclude others from practicing their invention in exchange for public disclosure. Inherent in this bargain is the statutory language adopted by Congress requiring that the inventor's disclosure be sufficiently detailed to allow one to "make and use" the invention. When interpreting the statute, however, the U.S. Court of Appeals for the Federal Circuit has sometimes required the "full scope" of the patent claims be taught so they can be practiced "without undue experimentation." This is the heart of the dispute. The Supreme Court has previously struck down Federal Circuit tests if it determined they created obligations beyond the statutory limits.
In Amgen, The Court was presented with two questions regarding enablement: (1) does it require that the specification "enable those skilled in the art to reach the full scope of the claimed embodiments" without undue experimentation or (2) does it require only that the specification teach those skilled in the art to "make and use" the claimed invention. Undue experimentation and claim breadth seemed to be the cornerstone of the hearing, with questions related to implications for the healthcare industry, specifically antibody patents.
In this case, the disputed claims cover a class of antibodies defined by their function, i.e., their ability to bind certain epitopes on the PCSK9 protein. The issue is whether Amgen's patent, which disclosed examples of antibodies that bind PCKS9 and methods for making such antibodies, covers claims to all antibodies with that function, even if not expressly disclosed. This issue arises primarily in pharmaceutical patents, but the questions presented are not limited to a specific technology or to functional claims.
Regarding legal precedent, the Court asked Amgen whether it agreed that applying the Wands factors was the accepted standard and whether they are useful. Amgen responded that the Wands factors have outgrown their utility and have become an abstract checklist, replacing the statutory standard. It argued that the enablement inquiry is whether a skilled artisan can reliably get to the invention using the patent and tools already available. The Court asked whether it was appropriate to evaluate the amount of effort necessary for obtaining embodiments outside the scope of disclosed examples. Amgen responded that it was correct to look at the effort to obtain an "embodiment" but not all embodiments.
Both Amgen and Sanofi were asked numerous questions related to the technology and undue experimentation. Chief Justice Roberts inquired about the reasonableness standard within the context of an invention with many embodiments. Amgen argued that reasonableness should be judged by what is most important to a skilled artisan, whether the invention would involve painstaking experimentation, and if that somehow impedes the skilled artisan from practicing the invention's full scope. The Court wanted to understand Sanofi's position on experimentation in an unpredictable field, such as the one at issue here. The Court was concerned that Sanofi's position would be one where the standard was that of no experimentation, but Sanofi clarified that the test is whether the amount of experimentation is undue.
Finally, the Justices addressed broader effects of the Federal Circuit's traditional approach. The Court asked Amgen if it stood by the suggestion that the Federal Circuit test inhibited research into antibody-based pharmaceuticals. Amgen said that the Federal Circuit had been doing so for some time and that this case was an example of how untenable the test had become. The government also participated at oral argument and, the Court asked whether it should simply dismiss the case as improvidently granted, despite granting certiorari against the Solicitor General's recommendation. During the government's argument, the Court commented it would be up to Congress to modify the law and the government agreed.
Based on the oral argument, it is hard to predict where the Justices currently stand. The Court could issue a decision that may impact enablement far beyond the specific functional genus claims issue here. Not only could the decision impact many issued patents and pending cases, it could also dramatically alter patent prosecution strategies and best practices, especially in the life sciences. However, the Court could leave the status quo by either affirming the Federal Circuit or simply dismissing the case, even at this late stage.
Stay tuned for this Summer's Supreme Court's decision to see where the fate of the enablement doctrine lies.
Originally printed in Haaretz Biomed Magazine on May 16, 2023.
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