Biogen Ma Inc. v. EMD Serono, Inc.

• Decision Date: 28 September 2020
• Docket Number: 2019-1133
• Citation: 976 F.3d 1326
• Parties: BIOGEN MA INC., Plaintiff -Appellee v. EMD SERONO, INC., Pfizer Inc., Defendants-Appellants Bayer Healthcare Pharmaceuticals Inc., Novartis Pharmaceuticals Corporation, Defendants
• Court: U.S. Court of Appeals — Federal Circuit

976 F.3d 1326

BIOGEN MA INC., Plaintiff -Appellee

v. EMD SERONO, INC., Pfizer Inc., Defendants-AppellantsBayer Healthcare Pharmaceuticals Inc., Novartis Pharmaceuticals Corporation, Defendants

2019-1133

United States Court of Appeals, Federal Circuit.

Decided: September 28, 2020

Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, argued for plaintiff-appellee. Also represented by Peter Sandel, Eric Alan Stone, Jenny Chia Cheng Wu, Josephine Young ; David J. Ball, Jr., Washington, DC; John D. Tortorella, Kevin H. Marino, Marino Tortorella & Boyle, PC, Chatham, NJ.

Mark Andrew Perry, Gibson, Dunn & Crutcher LLP, Washington, DC, argued for defendants-appellants. Also represented by Christine Ranney, Denver, CO; Wayne M. Barsky, Timothy P. Best, Los Angeles, CA; Jaysen Chung, San Francisco, CA.

Bruce Genderson, Williams & Connolly LLP, Washington, DC, for amicus curiae Bayer Healthcare Pharmaceuticals Inc. Also represented by David I. Berl, Seth Bowers, David M. Krinsky.

Before Newman, Linn, and Hughes, Circuit Judges.

Linn, Circuit Judge.

This appeal arises from a suit filed by Biogen MA, Inc. ("Biogen") against EMD Serono, Inc. and Pfizer, Inc. (collectively "Serono") in the District of New Jersey.¹ The suit alleged contributory and induced infringement of Biogen's U.S. Patent Number 7,588,755 ("’755 patent") by the sale and marketing in the United States of Rebif, a recombinant interferon-ß ("IFN-ß") product used for the treatment of Multiple Sclerosis ("MS"). After a five-week trial, a jury found that the ’755 patent claims were anticipated by two references teaching the use of native IFN-ß to treat viral diseases: Kingham et al. , Treatment of HBsAg-positive Chronic Active Hepatitis with Human Fibroblast Interferon , 19(2) Gut 91 (1978) ("Kingham") and Sundmacher et al. , Human Leukocyte and Fibroblast Interferon in a Combination Therapy of Dendritic Keratitis , 208(4) Albrecht von Graefes Archiv für Klinische & Experimentelle Opthalmologie 229 (1978) ("Sundmacher"). The jury also held the asserted claims not invalid for lack of enablement or written description, or for obviousness. Finally, the jury held that patients and prescribers directly infringed the asserted claims and that Serono contributorily infringed the claims but did not induce infringement thereof.

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. In re Biogen ’755 Patent Litig. , 335 F. Supp. 3d 688 (D.N.J. 2018) (" Biogen I "). The district court also ruled in favor of Biogen: sustaining the jury's verdict of no invalidity based on written description or enablement; overturning the verdict of no induced infringement; sustaining the verdict of contributory infringement; and holding that the ’755 patent claims were not patent ineligible. Id. Serono appeals the district court's JMOL rulings on anticipation, written description, enablement, contributory infringement, induced infringement and patent eligibility. We have jurisdiction under 28 U.S.C. § 1295(a).

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's JMOL of no anticipation and its conditional grant of new trial on that ground. We remand with instructions to reinstate the jury verdict of anticipation. We need not and do not address the other grounds asserted on appeal.

I

The ’755 patent is 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-ß ("IFN-ß"). The human immune system naturally produces IFN-ß in small amounts, and it is undisputed that IFN-ß harvested from human cells ("native IFN-ß") was used in the prior art to treat viral conditions. See ’755 patent, col. 2, l. 53–col. 4, l. 22.

Representative claim 1 of the ’755 patent reads:

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 GpBR322(Pst)/HFIF7 (DSM 1793) under hybridizing conditions of 0.75 M NaCl at 68° C. and washing conditions of 0.3 M NaCl at 68° C., and which code for a polypeptide displaying antiviral activity, and

(b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a);

said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.

’755 patent, col. 49, l. 59–col. 50, l. 12. Dependent claim 2 replaces the "capable of hybridizing" limitation with a selection from two particular DNA sequences, one of which is the DNA sequence of human interferon-beta. Id. at col. 50, ll. 13–52. Claims 1 and 2 thus define the claimed polypeptide by reference to the DNA sequence inserted into the host during the recombinant manufacture of the polypeptide. Claim 3, dependent from claim 1, limits the polypeptide to a particular linear polypeptide sequence. Because the claimed IFN-ß DNA and polypeptide sequences are derived from human IFN-ß, it is indisputable that native human IFN-ß is capable of hybridizing with the DNA sequences in claim 1, is produced by one of the DNA sequences laid out in claim 2, and comprises the amino acid sequence set out in claim 3. See J.A. 47784 (Fiers Aff. to the Canadian Patent Office, indicating that the recombinant IFN-ß was derived from human IFN-ß cDNA); J.A. 77897 (Dr. Green Test., testifying that the sequences claimed in claim 1 are "DNA that will hybridize to one of the four human beta interferon clones"); J.A. 77904 (Dr. Green Test., testifying that accused-product Rebif is capable of hybridizing to one or more of the DNA inserts because the DNA sequence it used is identical to the published sequence of human IFN-ß). For purposes of this opinion, we refer to "recombinant IFN-ß" as shorthand for the recombinant protein that meets these claim limitations.

During Markman , the district court held that claim 1 covers a "one-step method of ‘administering’ to a patient in need the specified recombinant HuIFN-ß." Markman Opinion at 17, Mar. 28, 2016, ECF No. 403. The district court considered the claimed "produced" and "transformed" steps "merely descriptive of the recombinant polypeptide to be administered," i.e. merely source limitations. Id. at 15. The district court also held that it was "unclear that [the] method of treatment claim can be treated as a product-by-process claim," and that it was "aware of no binding precedent requiring method of treatment claims to be treated as product-by-process claims in the claim construction context." Id. at 14. The district court did not construe "polypeptide," "therapeutically effective amount," or "antiviral activity," and neither party asked the court to consider whether the claims covered the linear sequence of amino acids or the three-dimensional structure of the protein.

Biogen, Serono, and Bayer all moved for summary judgment. Before Bayer was severed, Bayer argued that it was entitled to summary judgment of anticipation because the claimed recombinant IFN-ß and the prior art native IFN-ß shared the same linear amino acid sequence. The district court denied Bayer's motion, holding, inter alia , that the claims require the polypeptide to have "antiviral activity" and be administered in a "therapeutically effective amount." Summary Judgment Opinion at 28, Jan. 9, 2018, ECF No. 892. The district court concluded that those requirements necessitate that the polypeptide "be folded into its appropriate three-dimensional structure," and that Bayer was therefore not entitled to summary judgment of anticipation by merely showing that the amino acid sequence of recombinant IFN-ß and the amino acid sequence of native IFN-ß were identical. Id.

After a five-week trial, Biogen and Serono both moved for JMOL under Federal Rule of Civil Procedure 50(a). The district court deferred ruling until the jury verdict. Among other issues, the court submitted anticipation, obviousness, enablement, written description, and contributory and induced infringement to the jury. In its charge on anticipation, the district court told the jury that "[t]he term ‘polypeptide’ means ‘a linear array of amino acids connected one to the other by peptide bonds between the aamino and carboxy groups of adjacent amino acids,’ " and that the jury "must accept my definition of these words in the claims as correct." Final Jury Instructions at 17, Feb. 21, 2018, ECF No. 968. Biogen did not object to these instructions and did not request any instruction defining the polypeptide in terms of its three-dimensional structure or requiring identity of the three-dimensional structures of native IFN-ß and recombinant IFN-ß proteins to establish anticipation.

The jury held, inter alia , that all claims in the ’755 patent were invalid as anticipated by native IFN-ß; not invalid for obviousness, lack of enablement or lack of written description; and that Serono was liable for contributory infringement but not induced infringement. Jury Verdict Form at 1–6, Feb. 23, 2018, ECF No. 977.

Both parties renewed their JMOL motions. As relevant here, the district court granted Biogen's motion of no anticipation as a matter of law. Biogen I , 335 F. Supp. 3d at 713. In a comprehensive opinion, the district court held that no reasonable jury could find anticipation under Serono's reading of the claims. First, applying a structural...