Biogen Ma Inc. v. Emd Serono, Inc.

• Publication year: 2022
• Author: D. Benjamin Borson

BIOGEN MA INC. V. EMD SERONO, INC.

D. Benjamin Borson
Borson Law Group P.C.

Biogen MA Inc. v. EMD Serono, Inc., United States Court of Appeals for the Federal Circuit, 976 F.3d 1326 (2020).

BACKGROUND

Biogen MA, Inc. ("Biogen") is the owner of U.S. Patent No. 7,588,755 (the "'755" patent), drawn to methods for treating viral diseases using recombinant interferon-ß. EMD Serono, Inc. ("Serono") sold a competing product, "Rebif" for treating multiple sclerosis (MS).

Biogen sued Serono, Pfizer Inc., Bayer Healthcare Pharmaceuticals Inc., and Novartis Pharmaceuticals Corporation in the district Court of New Jersey for direct and contributory infringement of the '755 patent. Serono asserted that the claims of the '755 patent were anticipated by two references that taught the use of native interferon-ß to treat viral diseases.

Bayer's case was severed prior to the Federal Circuit decision.

The Federal Circuit panel was composed of Judges Newman, Linn and Hughes. The court's decision, authored by Judge Linn reviewed the holdings of the New Jersey District Court. A jury found that the '755 claims were anticipated by the two references, that disclose native human interferon-ß (also "INF-ß"). The jury also found that the claims were not invalid for lack of enablement or written description, and were not invalid as obvious. The jury also found that patients and prescribers directly infringed the claims, that Serono contributorily infringed the claims, but did not induce infringement.

Discussions of the infringement matters are beyond the scope of this article, which focusses on anticipation.

On cross-motions, the district court granted judgment as a matter of law ("JMOL") of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation.

However, Judge Linn reinstated the jury verdict of anticipation, stating:

Because a reasonable jury could find the claims of the '755 patent anticipated on the record presented in this case, we reverse the district court' JMOL, of no anticipation and its conditional grant of new trial." 976 F.3d 1326 at 1328.

THE INVENTION

The '755 patent is directed to a method for treating a viral infection, disease, cancers or tumors. Claim 1 is

[Page 51]

reproduced below.

1. A method for immunomodulation or treating a viral condition, a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
A recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
(a) DNA sequences which are capable of hybridizing to any of the DNA inserts of G-pBR322(Pst)/HFIF1, G-pBR322(Pst)/HFIF3 (DSM 1791), G-pBR322(Pst)/HFIF6 (DSM 1792), and G-pB R322(Pst)/HFIF7 (DMS 1793) under hybridizing conditions of 0.75M NaCl at 68ºC, and washing conditions of 0.3M NaCl. at 68ºC, and which code for a polypeptide displaying

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