In re Biogen 755 Patent Litig.
| Decision Date | 07 September 2018 |
| Docket Number | Civil Action No.: 10-2734 (CCC)(MF) (consolidated) |
| Citation | 335 F.Supp.3d 688 |
| Parties | IN RE BIOGEN '755 PATENT LITIGATION |
| Court | U.S. District Court — District of New Jersey |
The Court held a five-week jury trial in this patent infringement action beginning on January 18, 2018. On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe claims 1 and 2 of United States Patent No. 7,588,755 (the "'755 patent") when they administer or self-administer the product Rebif ® for the treatment of multiple sclerosis ("MS"), that Defendants EMD Serono, Inc. ("Serono") and Pfizer Inc. ("Pfizer") (collectively, "Defendants") have contributed to the infringement of claims 1 and 2 by selling or offering to sell Rebif ®, that neither Serono nor Pfizer has actively induced the infringement of claims 1 or 2, that claims 1, 2, and 3 of the '755 patent are not invalid for obviousness, lack of adequate written description, or lack of enablement, and that claims 1, 2, and 3 are invalid for anticipation. ECF No. 977 ("Verdict Form").
Now pending before the Court are renewed motions for judgment as a matter of law ("JMOL") pursuant to Federal Rule of Civil Procedure 50(b) by Plaintiff Biogen MA Inc. ("Biogen") and Defendants. ECF Nos. 980, 982. Specifically, Biogen moves for JMOL on the issues of anticipation, induced infringement by Serono and Pfizer, certain defenses that were not litigated at trial, and certain subsidiary damages-related issues. Biogen also moves conditionally and in the alternative for a new trial as to certain issues pursuant to Federal Rules of Civil Procedure 50(c) and 59, respectively. Defendants move for JMOL on the issues of patent eligibility, obviousness, enablement, written description, contributory infringement by Pfizer, and lost profits damages.
The Court heard oral argument on June 6, 2018. The parties also submitted letters following oral argument. ECF Nos. 1010, 1011, 1012, 1014, 1015, 1017, 1018. Having considered the parties' written submissions and oral presentations, and for the reasons discussed below, Biogen's JMOL motions with respect to anticipation, induced infringement against Serono and Pfizer, and certain non-litigated defenses are hereby GRANTED. The Court also conditionally orders a new trial on anticipation and induced infringement against Serono and Pfizer pursuant to Rule 50(c), and orders a new trial on all damages issues pursuant to Rule 59. Biogen's remaining JMOL motions and each of Defendants' JMOL motions are hereby DENIED.
On May 28, 2010, Biogen filed this patent infringement suit asserting claims of the '755 patent against Defendants, Bayer HealthCare Pharmaceuticals Inc. ("Bayer"), and Novartis Pharmaceuticals Corp. ("Novartis"). C.A. No. 10-2760, ECF No. 1 ("Compl."). Prior to trial, Biogen's infringement claims against Serono and Pfizer were severed from Biogen's infringement claims against Bayer and Novartis.1 ECF No. 743. Thus, only Biogen's claims against Serono and Pfizer (and Serono and Pfizer's defenses thereto) were tried before the jury and are the subject of the instant motions.
The '755 patent claims a method for immunomodulation, or treating viral diseases, cancers, or tumors, by administering to a patient a recombinant polypeptide—human interferon beta2 —that is produced by a non-human host transformed by a recombinant DNA molecule. The '755 patent includes three claims, of which only claim 1 is independent.3
Claim 1 of the '755 patent recites:
The Court previously construed claim 1 of the '755 patent as reciting a "one-step method of ‘administering’ to a patient in need the specified recombinant HuIFN-ß." ECF No. 403 ("Markman Op.") at 17. The Court also determined that the "produced" and "transformed" limitations of claim 1 are "merely descriptive of the recombinant polypeptide to be administered" as opposed to separate steps that must be shown to prove infringement. Id. at 14-15.
Biogen's infringement claims against Serono and Pfizer are based on the sale of recombinant interferon-ß product Rebif® in the United States for the treatment of MS. Compl. ¶¶ 32-49; Am. Compl. ¶¶ 42-59. In their Answers, Defendants assert that the 4 5 Rule 50(a) motions. 2/9/18 Tr. at 183:11-12; 2/21/18 Tr. at 75:26-77:4.
On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe the asserted claims of the '755 patent when they administer or self-administer Rebif ® for the treatment of MS. Verdict Form at 1, Q. 1. The jury also found that neither Serono nor Pfizer has actively induced the direct infringement of the asserted claims. Id. at 2-3, Qs. 2, 6. The jury further found that both Serono and Pfizer have contributed to the direct infringement of the asserted claims by selling or offering to sell Rebif® in the United States. Id. at 3, Qs. 7, 8. With respect to validity, although the jury found that the '755 patent claims were not invalid for obviousness, lack of adequate written description, or lack of enablement, (id. at 3-4, Qs. 9-11), it found that the claims were anticipated by prior-art uses of naturally-occurring (or native), human interferon-ß (id. at 4, Q. 12). Accordingly, the jury did not reach the issue of damages, leaving the damages questions on the Verdict Form blank. Id. at 5-6, Qs. 13-18.
Following the verdict, on March 16, 2018 the Court held a telephone conference with the parties to discuss a schedule for filing post-trial motions pursuant to Rule 50(b). In its Rule 50(b) JMOL motions, Biogen asks the Court to enter judgment that the '755 patent claims are not anticipated by prior-art uses of native, human interferon-ß and that Serono and Pfizer have each induced infringement of the asserted claims. ECF No. 980-1 ("Biogen Br."). Biogen also seeks a judgment in its favor on certain damages-related issues and as to certain non-litigated defenses. Biogen further asks the Court to conditionally grant a new trial under Rule 50(c) for each of those issues except for the non-litigated defenses, and alternatively moves for a new trial under Rule 59 for any of those issues on which the Court does not grant JMOL. Defendants oppose each of Biogen's motions. ECF No. 991 ("Defs. Opp."). In their Rule 50(b) JMOL motions, Defendants ask the Court to enter judgment that Pfizer has not contributed to the infringement of the asserted claims, that the motions. ECF No. 989 ("Biogen Opp."). The Court heard oral argument on June 6, 2018 ("6/6/18 Tr.").
Judgment as a matter of law is appropriate if "the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party" on an issue. Fed. R. Civ. P. 50(a)(1). "If the court does not grant a motion for judgment as a matter of law made under Rule 50(a), the court is considered to have submitted the action to the jury subject to the court's later deciding the legal questions raised by the motion." Fed. R. Civ. P. 50(b). In ruling on a Rule 50(b) motion, "the court may: (1) allow judgment on the verdict, if the jury returned a verdict; (2) order a new trial; or (3) direct the entry of judgment as a matter of law." Id.
To prevail on a renewed motion for JMOL under Rule 50(b) following a jury trial and verdict, the moving party "must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) implied by the jury's verdict cannot in law be supported by those findings." Power Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc. , 843 F.3d 1315, 1326...
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