Amgen v. Sanofi: Antibody Claiming Strategies Must Change
Amgen v. Sanofi: Antibody Claiming Strategies Must Change

In Amgen v. Sanofi (Case No. No. 21–757), the U.S. Supreme Court affirmed the lower courts’ holdings that Amgen’s patent claims to antibodies were invalid. These claims were claims 19 and 29 of U.S. Patent No. 8,829,165 and claim 7 of U.S. Patent No. 8,859,741.

The ‘traditional manner’ of antibody claim was to recite the epitope to which the antibody binds plus the effect of the binding. This has been the format since at least In Re Wands (858 F.2d 731) in 1988. For example, see claims 1 and 7 of Amgen’s U.S. Patent 8,859,741:

1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.

7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.

Amgen argued that the skilled artisan could make and use the claimed antibody based on the specification, which disclosed (A) a “roadmap” and (B) a “conservative substitution” protocol, where either could be followed to produce every antibody within the scope of the claims.

The roadmap “directs scientists to: (1) generate a range of antibodies in the lab; (2) test those antibodies to determine whether any bind to PCSK9; (3) test those anti- bodies that bind to PCSK9 to determine whether any bind to the sweet spot as described in the claims; and (4) test those antibodies that bind to the sweet spot as described in the claims to determine whether any block PCSK9 from binding to LDL receptors.”

The conservative substitution protocol “requires scientists to: (1) start with an antibody known to perform the described functions; (2) replace select amino acids in the antibody with other amino acids known to have similar properties; and (3) test the resulting antibody to see if it also performs the described functions.”

According to Amgen, either the roadmap or the conservative substitution protocol would allow the skilled artisan to generate antibodies and sort the millions of variants to obtain only those that meet the limitations of the claims.

The Court did not discuss the Federal Circuit’s “Wands Factors,” which had been the standard for determining whether antibody claims, and many other broad molecular claims, passed the enablement test. Instead, the Court reviewed its precedent from O’Reilly v. Morse, 15 How. 62, The Incandescent Lamp Patent, 159 U. S. 465, and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245. Also, footnote 1 cites to Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U. S. 358, 385 (1928) and its reasoning “rejecting claims to process of treating rubber with ‘a disubstituted guanidine’ because ‘between fifty and one hundred substances’ fit that description and the specification did not disclose ‘any general quality common to disubstituted guanidines which makes them all effective’.”

The Court then reflected the same reasoning in application to Amgen’s roadmap and conservative substitution protocol: “Whether methods like a “roadmap” or “conservative substitution” might suffice to enable other claims in other patents—perhaps because, as this Court suggested in Incandescent Lamp, the inventor identifies a quality common to every functional embodiment, supra, at 13—they do not here.” The Court also stated that “Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error’.”

Going forward, a broad antibody claim, and by extension any broad molecular claim, should identify “a quality common to every functional embodiment.” Structural features, rather than functional statements, must be recited. For antibody claims, features of complementarity-determining regions could be recited as the common quality, while retaining variability otherwise. The effect of binding should also be recited in order show how the common quality results in a specified function. Amgen v. Sanofi may also be applied to claims reciting chemical structures having a common core, nucleic acid sequences, and other proteins.

Further, practitioners in technologies outside of the life sciences, chemistry, pharmaceuticals, and biotechnology should not dismiss this case. Mechanical device claims often include a “configure to” or “adapted to” clause. Claims to machines, systems, and methods embodying software routinely define components by what they do, rather than by physical structure. The Court in Amgen v. Sanofi responded to Amgen’s argument that a unique enablement requirement was being fashioned, rather than applying a universal standard that would be applied in all cases:  “Here, too, we agree with Amgen in principle: There is one statutory enablement standard. But, once more, we do not understand the Federal Circuit to have thought differently. Instead, we understand that court to have recognized only that the more a party claims for itself the more it must enable. As we have seen, that much is entirely consistent with Congress’s directive and this Court’s precedents.”



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