At the end of last month, three amicus curiae briefs were filed following the petition for a writ of certiorari in the Amgen, Inc. v. Sanofi, Inc. case. We previously discussed the petition for a writ of certiorari in detail here.

The first amicus brief was submitted by the Association of University of Technology Managers (AUTM), Biogen, Bristol-Myers Squibb, Corning, Merck Sharp & Dohme, and St. Jude Children’s Research Hospital, collectively. Amici began the brief by noting that they “also are competitors, and have been directly adverse to one another in litigation over their innovations and patent rights. Yet despite their diverse interests and disagreements on many issues, amici have joined a common brief in support of the petition for certiorari in this case to urge that the Court review and reverse the Federal Circuit’s decision below.” Amici argue that the Federal Circuit’s decision “threatens to disrupt the patent bargain,” because it replaces the former statutory enablement standard – that the disclosure be sufficient to enable any person skilled in the art to make and use the invention – with a new “special, atextual” rule for genus claims.

According to amici, this new rule allows for invalidation of the patent if practicing the “full scope of the claimed embodiments” requires “substantial time and effort.” Amici argue that if this law is not reversed, innovators will be compelled to divert time and resources away from additional discoveries. Instead, the innovators will need to spend their resources on testing additional examples of their invention and “adding information already known to skilled artisans to their patent applications.” Finally, amici note they practice in “fast-paced fields of research,” where fast-paced patent filings are needed to protect innovator’s rights. If innovators with limited resources, such as universities and non-profits, must spend more time and money generating additional examples, those innovators might choose to forego their patent rights altogether in order to focus on new discoveries.

Finally, Amici argue that the Federal Circuit’s decision that enablement is a question of law is an error. They note that the same court has ruled that written description, which is in the same sentence in 35 U.S.C. § 112(a), is a question of fact to be decided by a jury.[1] They argue that the Federal Circuit’s habit of “routinely set[ting] aside jury verdicts confirming the validity of patents against enablement challenges – as it did twice in this case – lead[s] innovators to doubt whether they will have reliable patent protection for their inventions even after prevailing at trial.”

GlaxoSmithKline, PLC (“GSK”) submitted the second amicus brief. Although GSK does not consider the issue of whether enablement is a question of fact to be decided by a jury, it makes multiple arguments why the Federal Circuit’s decision should be reversed. First, it argues that the Federal Circuit has created a new rule for genus claims that could devastate the chemistry and biotechnology fields. If the law is not reversed, GSK argues, innovators will be forced to draft narrower claims to avoid invalidation of their patents, even though “known techniques could permit competitors to circumvent the literal scope of a narrow claim by making insubstantial changes to a chemical compound or a biological molecule.” GSK argues that a genus claim is generally commensurate with the innovator’s discovery, and that “[a]llowing for a wide breadth of protection based on a genus is, as a practical matter, the only means to ensure that an inventor in these arts actually receives a commercially meaningful period of exclusivity contemplated by our patent system.” If these innovators cannot receive the full patent protection that they deserve, GSK argues, then the innovators may choose trade secret protection over patent protection and disclosure.

Additionally, GSK argues the Federal Circuit’s standard for genus claims is undesirable for innovators because “it would ‘force an inventor seeking adequate patent protection to carry out a prohibitive number of actual experiments’ and ‘discourage inventors from filing patent applications in an unpredictable area.’”[2] GSK notes that the Patent Act does not limit the number of species that a claim can have, “nor does the Patent Act require different, elevated tests for enablement for certain types of claims.”

Finally, GSK lists reasons why the “full scope” enablement test “erects a formulaic, inflexible requirement that tends toward a predetermined outcome: invalidating genus claims.” It argues the rule gives additional power to judges to set aside expert testimony and “real-world facts showing that artisans were able to exploit the invention following its teachings.” GSK notes that this test is similar to other rigid, atextual tests that the Supreme Court has previously rejected.[3]

The final amicus brief was submitted from intellectual property professors throughout the United States. Like GSK, these amici did not address whether enablement is a question of fact to be decided by a jury. Amici state, “The Federal Circuit has changed the law dramatically in recent years, to the point where it is no longer possible to have a valid genus claim in the chemical and biotechnology industries.” They note that the previous standard of providing enough information to allow one of ordinary skill in the art to make and use the invention is no longer enough for genus claims, and that the Federal Circuit is now rejecting the genus claims as invalid if “the genus contains thousands or millions of possible chemicals, unless the patent itself identifies exactly which of those myriad species will work.” This leaves one of two options for innovators: (1) spend extra time and resources identifying all the possible species, or (2) draw narrow claims that will be avoided by “minor modification.”

Amici emphasize that what constitutes “undue experimentation” should be decided on a case-by-case basis by examining the facts in the case. Additional experimentation is not automatically “undue experimentation,” but “is a common part of the PHOSITA’s work.” They state, “as long as the specification provides some working examples, that disclosure can give PHOSITAs sufficient guidance to enable the full scope of the genus claims.”

The petition for a writ of certiorari and the three amicus curiae briefs were distributed last week for Conference taking place on January 21. The Court asked Sanofi for a response by February 10, 2022, but Respondents have asked for a 30-day extension of time to file this response. We will continue to watch this case and post updates on any advancements.

[1] PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1243 (Fed. Cir. 2002).

[2] In re Angstadt, 537 F.2d 498, 502-03 (C.C.P.A. 1976).

[3] KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007); see also Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U.S. 545, 553 (2014); Halo Elecs., Inc. v. Pulse Elecs., Inc., 579 U.S. 93, 104 (2016).