In Biogen MA, Inc. v. EMD Serono, Inc., the Court of Appeals for the Federal Circuit has reconfirmed, and to an extent clarified, that an existing product and known method of treatment using that product are not patentable even if the claims contain a limitation related to a new process of manufacturing the product. See 976 F.3d 1326 (Fed. Cir. 2020). More specifically, a claim to using a recombinant polypeptide to treat viral diseases is not novel when the recombinant polypeptide is identical to the native polypeptide and the prior art teaches a method of treating viral diseases using the native polypeptide.

A limitation related to a new process of manufacture (recombinant technology) did not impart novelty to an old method of administration of an old product. In drafting a patent, points of novelty other than the manufacture, such as dosage or a new indication, should be disclosed and claimed. Further, any new property possessed by the claimed product, such as a three-dimensional structure, should be explicitly covered by the claims.

Case Background

Biogen MA, Inc. (“Biogen”)-owned U.S. Patent No. 7,588,755 (“755 patent”), directed to a method of treating a viral condition, a viral disease, cancers or tumors, by administration of a pharmaceutically effective amount of a recombinant polypeptide related to human interferon-β (“IFN-β”). IFN-β is naturally produced by the human immune system in small amounts. IFN-β harvested from human cells (native IFN-β) was used in the prior art to treat viral conditions. The amino acid sequences of the claimed recombinant IFN-β and the prior art native IFN-β are identical.

Biogen sued EMD Serono, Inc. and Pfizer, Inc. for contributory and induced infringement of the ‘755 patent by the sale and marketing in the United States of Rebif, a recombinant IFN-β product. The jury found the ‘755 patent claims invalid, as anticipated, by two prior art references teaching the use of native IFN-β to treat viral diseases.

The District Court granted Biogen judgment as matter of law on anticipation, holding that the claims were not anticipated because the identified prior art did not disclose treatment “with a therapeutically effective amount” of “recombinant interferon- β polypeptide produced in a ‘non-human host’ that had been ‘transformed by a recombinant DNA molecule.’” Id. at 1330. Likewise, the district court found no anticipation under a product-by-process analysis because the claims, as interpreted by the District Court, required the recombinant IFN-β to have a folded three-dimensional structure not possessed by native IFN-β.

Appellate Decision

The Federal Circuit reversed the District Court’s determination on obviousness, holding that the district court erred in: (1) not applying a product-by-process analysis; and (2) improperly requiring structural identity between the recombinant IFN-β and native IFN-β where the claim language did not recite such a structure.

“[A]n old product is not patentable even if it is made by a new process.” Id. at 1332 (quoting Amgen Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340, 1366 (Fed. Cir. 2009)). As previously held by the Federal Circuit in Amgen, a claim to recombinant DNA is not novel over the identical native DNA. Production “by recombinant technology” is not a structural limitation and does not distinguish over the prior art. That the claim is directed to a method of treatment is immaterial—the process by which the therapeutic product is made cannot confer novelty. As stated by the Federal Circuit, “[A]n old method of administration of an old product made by a new process is not novel and cannot be patented.” Id. at 1334.

The claims related to the administration of a “polypeptide,” which was defined for the jury as a “linear array of amino acids connected one to the other by peptide bonds between the α-amino and carboxy groups of adjacent amino acids.” Id. at 1336. The definition did not encompass the structure of the protein, and the “therapeutically effective amount” and “anti-viral activity” limitations did not recite the specific folded three-dimensional structure that gave rise to the claimed anti-viral activity. Further, Biogen “did not ask for a jury instruction on anticipation that required comparing the three-dimensional protein structure of prior art IFN-β and the claimed recombinant IFN-β.” Id. The jury finding of anticipation was supported by sufficient evidence because the prior art taught the administration of native IFN-β that had the identical sequence to the claimed recombinant IFN-β and that showed anti-viral activity.