Supreme Court of the United States

“ One part of this effort has focused on the creation of antibodies to treat patients with high LDL cholesterol. A silent killer, LDL cholesterol can contribute to the formation of plaque in the arteries that may lead to cardiovascular disease, heart attacks, and strokes. For many people with high LDL cholesterol, drugs called statins offer an effective treatment. For others, statins do not work well or come with unwelcome side effects. In those cases, a relatively new antibody-based treatment known as a PCSK9 inhibitor may be appropriate. See Amgen Inc. ”

“ Failing in its primary argument that it has enabled all of the antibodies it claims, Amgen tries a few alternative lines of attack. First, it suggests that the Federal Circuit erred by applying an enablement test unmoored from the statutory text. As Amgen sees it, that court conflated the question whether an invention is enabled with the question how long may it take a person skilled in the art to make every embodiment within a broad claim. ”

“ As part of its submission to the patent office, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions, and it depicted the three-dimensional structures of two of these 26 antibodies. 987 F. 3d, at 1083. But beyond that, Amgen only offered scientists two methods to make other antibodies that perform the binding and blocking functions it described. The first method is what Amgen calls the “roadmap.” Brief for Petitioners 13. At a high level, the roadmap directs scientists to: (1) generate a range of antibodies in the lab ”

“ But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. ”

“ The immune system produces antibodies as a defense to foreign agents called antigens. When a particular antigen—a virus, for example—enters the body, the immune system generates antibodies to attack it. In a successful attack, the antibodies target and bind to the antigen, stopping it from causing harm to the body. ”

“ 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 company had taught scientists to make. In the end, both the district court and Federal Circuit sided with Sanofi. The question we face is whether to disturb their judgment. ”

“ Nor is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing. In Wood, a patent claimed a process for making bricks by mixing coal dust into clay. ”

“ Cutter, 29 F. Cas. 1120, 1122 (No. 17,600) (CC Mass. 1813) (Story, J.) (“If therefore [the disclosure] be 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.”) .
This Court has addressed the enablement requirement on many prior occasions. See, e.g., 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) ; Holland Furniture Co. ”