By Tom Irving and Michelle E. O’Brien
In a much-anticipated decision, today the Supreme Court affirmed invalidity of two Amgen patents in Amgen Inc., et al. v. Sanofi, et al. (Case No. 21-757), with Justice Gorsuch writing for a unanimous Court. The case is of particular interest because it pits one brand pharma company, Amgen, against other brand pharma companies, Sanofi and Regeneron.
Amgen developed a PCSK9-inhibiting drug that it marketed under the name Repatha, and Sanofi produced one it labeled Praluent. Each drug employs a distinct antibody with its own unique amino acid sequence, both of which are specifically covered by patents not at issue in the proceeding.
In response to Amgen’s allegation that its Praluent product infringed certain claims of U.S. Patent Nos. 8,829,165 (claims 19 and 29) and 8,859,741 (claim 7), Sanofi argued that the claims were invalid under §112 of the Patent Act. The provision relevant to the decision requires a patent applicant to describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the [invention].” 35 U.S.C. §112(a). Sanofi contended that Amgen’s patents failed to meet this standard because they sought to claim for Amgen’s exclusive use potentially millions more antibodies than the patents taught those skilled in the art how to make. Despite a jury having found the claims sufficiently enabled for a second time after the Federal Circuit remanded the case in a first appeal, the district court granted Sanofi’s motion for a judgment as a matter of law (JMOL), reversing the jury’s finding on the issue of enablement. Amgen appealed and the Federal Circuit affirmed the district court. When Amgen’s request for panel rehearing or rehearing en banc was denied, Amgen petitioned for certiorari, arguing that the Federal Circuit’s decision was not consistent with the language of the statute.
Claim 19 of US ‘165, which depends from claim 1, is representative for consideration of the issue before the Court:
- An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
- The isolated monoclonal antibody of claim 1 wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3.
Thus, as the Court saw it, the two patents claimed a monopoly over all antibodies that (1) bind to specific amino acids on the naturally-occurring protein PCSK9, and (2) block PCSK9 from impairing the body’s mechanism for removing LDL cholesterol from the blood stream. Although Amgen argued that techniques for making and testing antibodies was routine, the Court was not convinced, observing that “scientists estimate that there may be as many unique antibodies as there are stars in the galaxy.” The Court also pointed out that scientists understand that changing even one amino acid in the sequence can alter an antibody’s structure and function, explaining that “scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody’s structure and function.” In the context of Amgen’s claims which require binding and blocking, the Court, highlighting aspects of antibody science that remain unpredictable, noted that just because an antibody can bind to an antigen does not mean that it can also block.
To support its affirmance, the Court focused on “the patent bargain” that in exchange for a right to exclude others for a limited time, the patent statutes have imposed an enablement requirement on the patent specification to ensure “the public may have the full benefit [of the invention or discovery], after the expiration of the patent term.” The Court cited precedent that if the patent disclosure is “so obscure, loose, and imperfect, that this cannot be done, it is defrauding the public of all the consideration, upon which the monopoly is granted.”
To decide whether Amgen satisfied the enablement requirement for these two patents, the court focused on its prior precedent such as Wood v. Underhill, 5 How. 1 (1846); O’Reilly v. Morse, 15 How. 62 (1854); The Incandescent Lamp Patent, 159 U. S. 465 (1895); Minerals Separation, Ltd. v. Hyde, 242 U. S. 261 (1916); and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928), noting that while the technologies in these older cases may seem a world away from the antibody treatments of today, the decisions are no less instructive for it.
Examining Morse, Incandescent, and Holland in great detail, the Court reasoned that the more one claims, the more one must enable. From these cases, the Court concluded that for broad claims that far exceed what is specifically disclosed, as in the Amgen patents, one skilled in the art must find qualities in common that would allow reasonable extrapolation from what is specifically disclosed what is claimed, noting Supreme Court authority, such as Wood and Minerals Separation, where that extrapolation was reasonable, based on only a reasonable amount of experimentation being required to make and use the invention. Although the Court did not specifically draw the distinction, it is noteworthy that the Amgen patents claim the antibodies by their functions (i.e. binding and blocking), much like the claims found to lack enablement in the Morse (“electric or galvanic current . . . however developed for marking or printing intelligible characters, signs, or letters, at any distances”) and Holland (“starch glue which, [when] combined with about three parts or less by weight of water, will have substantially the same properties as animal glue”) cases.
Turning to the Amgen patents, the Court agreed that Amgen’s specification enables the 26 exemplary antibodies it identifies by their amino acid sequences. However, Amgen argued that all antibodies were enabled because scientists can make and use every undisclosed but functional antibody if they simply follow the company’s “roadmap” or its proposal for “conservative substitution.” The Court disagreed, finding that those two approaches amount to little more than research assignments, offering the following analogy:
“Imagine a combination lock with 100 tumblers, each of which can be set to 20 different positions.” Brief for Intellectual Property Law Professors and Scholars as Amici Curiae 20. “Through trial and error, imagine that an inventor finds and discloses 26 different successful lock combinations.” Ibid. But imagine, too, “that the inventor tries to claim much more, namely all successful combinations,” while instructing others “to randomly try a large set of combinations and then record the successful ones.” Id., at 21. Sure enough, that kind of “roadmap” would produce functional combinations. Ibid. But it would not enable others to make and use functional combinations; it would instead leave them to “random trial-and-error discovery.” Ibid. Like many analogies, this one may oversimplify a bit, but it captures the gist of the problem.”
Now that the Supreme Court has spoken, it remains clear that genus claims can work, but the specification needs to identify general, common qualities that would allow reasonable extrapolation from specific disclosure to a broader claim. It will be interesting to see how patentees attempt, in the particular facts and circumstances of their patents, to bridge that gap.