On May 18, 2023, the Supreme Court held claims of two patents owned by Amgen, Inc. to be invalid for failing to enable persons skilled in the art to practice the invention as required by 35 U.S.C. §112. Amgen, Inc., et al. v. Sanofi, et al. ___ U.S. ___, No. 21-757 (2023). Specifically, the Supreme Court held the genus claims to be invalid because the patents did not enable persons skilled in the art to practice all species falling within the genus.
The Amgen patents covered engineered antibodies that help reduce levels of low-density lipoprotein (LDL) cholesterol, sometimes called bad cholesterol. To treat patients with high LDL cholesterol, scientists explored how antibodies might be used to inhibit PCSK9—a naturally occurring protein that binds to and degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream.
In 2011, Amgen obtained a patent for the antibody employed in its drug, and Sanofi received one covering the antibody used in its drug. A few years later, Amgen received two more patents that claimed the entire genus of antibodies that (1) bind to specific amino acid residues on PCSK9, and (2) block PCSK9 from binding to LDL receptors. The genus included the antibody for which Sanofi had received its patent. In the patent specification, Amgen identified amino acid sequences of 26 antibodies.
Sanofi argued that Amgen’s relevant claims were invalid under Section 112 of the Patent Act, i.e., that Amgen’s claimed genus was not enabled. The Court noted that although a specification is not necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing, such experimentation to make and use a patented invention should be a reasonable amount. What is reasonable in any case will depend on the nature of the invention and the underlying art. Amgen at 14-15.
Sanofi characterized the methods Amgen outlined for generating additional antibodies as unreasonable, amounting to little more than a trial-and-error process of discovery, and thus contended that Amgen’s patents failed to meet the enablement requirement for potentially millions more antibodies than they had taught persons skilled in the art to make.
The Supreme Court summarized the patent bargain as including an inventor receiving a limited term of protection from competitive exploitation in exchange for bringing “new designs and technologies into the public domain through disclosure” for the benefit of all. Amgen at 7 (citing Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 151 (1989)).
The Court addressed its prior review of the enablement requirement many times in landmark cases including 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); Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928) as reinforcing the statutory requirement that 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. Amgen at 13. The Court noted “[t]he record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a “vast” number of additional antibodies that it has not. 987 F. 3d, at 1085, 1088; see 2019 WL 4058927, *8 (“at least millions of candidates”); see also Tr. of Oral Arg. 52–53.” Amgen at 16. In the Court’s view, Amgen sought to monopolize an entire class of things defined by their function, which is improper. Id.
Amgen argued that its broad claims are 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.” Amgen at 16. The Court did not agree stating “[t]hese two approaches amount to little more than two research assignments” that would leave scientists “forced to engage in ‘painstaking experimentation’ to see what works … That is not enablement.” Id. at 16-17.
Amgen will likely reduce the breadth with which future biotechnology patents are written. Indeed, the decision may lead to more detailed specifications for these types of inventions. But Amgen’s impact on other types of inventions remains uncertain. Notably, the Supreme Court stated that “[d]espite recent advances, aspects of antibody science remain unpredictable.” Id. at 3. Such a characterization may preclude applying Amgen to predictable arts such as mechanical or electronic inventions. The Court, however, agreed with the principle that there is a universal enablement standard for all inventions. Id. at 18.