Supreme Court Affirms Federal Circuit Decision In Amgen v. Sanofi

• Jurisdiction: United States,Federal
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Patent, Trials & Appeals & Compensation, Biotechnology & Nanotechnology
• Author: Mr Richard D. Kelly
• Published date: 29 May 2023

In a unanimous opinion the Court decided that the Federal Circuit's decision was correct.

The Court noted that that while the amino acid sequence of an antibody may be known, they have three-dimensional shapes and simply because and antibody may bind an antigen it does not necessarily mean it can block the antigen. The Court quoted Amgen's expert testimony that going from the sequence to the three-dimensional structure is not fully understood and will get someone a Nobel prize for translating structure into a three-dimensional structure. The Court as it often does in patent cases began with a review of the history of the enablement requirement noting it had remained essentially unchanged from the 1790 statue. It quoted from United States v. Dubilier Condenser Corp., 289 U. S. 178, 187 (1933) ('This is necessary in order to give the public, after the privilege shall expire, the advantage for which the privilege is allowed, and is the foundation of the power to issue a patent.'); see also Grant v. Raymond, 6 Pet. 218, 247 (1832) (Marshall, C. J.) ('This is necessary in order to give the public, after the privilege shall expire, the advantage for which the privilege is allowed, and is the foundation of the power to issue a patent.'); Whittemore v. Cutter, 29 F. Cas. 1120, 1122 (No. 17,600) (CC Mass. 1813) (Story, J.) ('If therefore [the disclosure] be so obscure, loose, and im-perfect, that this cannot be done, it is defrauding the public of all the consideration, upon which the monopoly is granted.').

The Court then listed the 'numerous prior occasions' it had addressed the enablement requirement. 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. v. Perkins Glue Co., 277 U. S. 245 (1928). Interesting is its discussion of Holland Furniture where the key ingredient of the claimed glue was claimed in functional terms rather than its physical characteristics ' 'starch ingredient' with 'such qualities' that it would yield a product 'as good as animal glue' for wood veneering...