Supreme Court Affirms Federal Circuit Decision in Amgen v. Sanofi
May 18, 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 ‘when combined with three parts of water and with alkali.’ ” Id., at 256.
Amgen presented three arguments that the Federal Circuit erred by applying (1) an enablement test unmoored to the statute, (2) raised the bar for enablement, and (3) that “affirmance risks destroying incentives for breakthrough inventions.” Slip op. at pages 18 and 19. The Court dismissed the first argument because the Court saw the same problem as the Federal Circuit. The second argument was dismissed because it understood the Federal Circuit to have recognized the more a party claims for itself the more it must enable which followed both the direction of Congress and the Court’s precedents. As to the third argument the Court stated:
But striking the proper balance between incentivizing inventors and ensuring the public receives the full benefit of their innovations is a policy judgment that belongs to Congress. Since 1790, Congress has included an enablement mandate as one feature among many designed to achieve the balance it wishes. Our only duty in this case lies in applying that mandate faithfully.
While the claims here were to antibodies, it is a clear warning to be careful in presenting claims with broad Markush groups drawn from only minimal examples and a generic description in arts where there is an element of unpredictability such as the life sciences.