In re Biogen 755 Patent Litig.

• Decision Date: 09 January 2018
• Docket Number: Civil Action No.: 10-2734 (CCC)(JBC) (consolidated)
• Citation: In re Biogen '755 Patent Litig., Civil Action No.: 10-2734 (CCC)(JBC) (consolidated) (D. N.J. Jan 09, 2018)
• Parties: IN RE BIOGEN '755 PATENT LITIGATION
• Court: U.S. District Court — District of New Jersey

IN RE BIOGEN '755 PATENT LITIGATION

Civil Action No.: 10-2734 (CCC)(JBC) (consolidated)

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

January 9, 2018

OPINION

CECCHI, District Judge.

Before the Court are: (1) EMD Serono, Inc. and Pfizer Inc.'s ("Serono") Motion for Summary Judgment of Invalidity Under 35 U.S.C. § 103 (ECF No. 505); (2) Serono's Motion for Summary Judgment of Invalidity Under 35 U.S.C. § 112 (ECF No. 501); (3) Bayer Healthcare Pharmaceuticals Inc.'s ("Bayer") Motion for Summary Judgment of Invalidity No. 1 - Obviousness-Type Double Patenting (ECF No. 503); (4) Bayer's Motion for Summary Judgment of Invalidity No. 2 - Anticipation by the Treatment References (ECF No. 506); (5) Bayer's Motion for Summary Judgment of Invalidity No. 3 - Lack of Written Description (ECF No. 509); (6) Bayer's Motion for Summary Judgment of Invalidity No. 4 - Anticipation by the Goeddel Patent (ECF No. 513); (7) Bayer's Motion for Summary Judgment No. 5 - Partial Summary Judgment Limiting Damages (ECF No. 517); and (8) Bayer's Motion for Summary Judgment No. 6 - Anticipation by the Weissmann Patent (ECF No. 624). Biogen MA, Inc. ("Biogen") opposes each motion. ECF Nos. 557, 558, 559, 560, 561, 562, 563, 633. The Court heard oral argument on August 10, 2017 and August 11, 2017. The Court has considered the parties' written submissions and oral presentations, including additional briefing subsequent to oral argument (ECF Nos. 656, 659). For the reasons discussed below, the Court denies each motion.

I. BACKGROUND

A. The Patent-In-Suit

In this patent infringement action, Biogen has asserted claims from U.S. Patent No. 7,588,755 (the "'755 patent" or "patent-in-suit") against Bayer, Serono, and Novartis Pharmaceuticals Corp. ("Novartis"). 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 beta ("interferon-ß" or "HuIFN-ß")—that is produced by a non-human host transformed by a recombinant DNA molecule.

Claim 1 of the '755 patent recites:

1. A method for immunomodulation or treating a viral conditions [sic], 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-pBR322(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.

As discussed in the Court's claim construction Opinion, (ECF No. 403), the interferon relevant to this action is a "small, acid stable (glyco)-protein[] that render[s] cells resistant to viral infection." ('755 patent at 1:39-40.) "Human interferon . . . has been classified into three groups a, ß and ?." (Id. at 1:49-50.) Interferon-ß is a protein natively produced by the human body. Bayer's Reply to Biogen's Response to Bayer's Statement of Undisputed Material Facts ("SOF") (Motion No. 2), ECF No. 598-1 ¶ 12.¹ Specifically, interferon-ß is produced in "diploid fibroblast cells" and "in minor amounts . . . in lymphoblastoid cells." ('755 patent at 1:50-53.) "[Hu]IFN-ß is usually not detectable in normal or healthy cells." (Id. at 2:40.) Instead, "the protein is produced as a result of the cell's exposure to an IFN inducer." (Id. at 2:41-42.) Such IFN-inducers "are usually viruses but may also be non-viral in character, such as natural or synthetic double-stranded RNA, intra-cellular microbes, microbial products and various chemical agents." (Id. at 2:43-46.)

"Interferon therapy against viruses and tumors or cancers has been conducted," (id. at 2:53-54), and "in addition to its use as an antiviral agent, HuIFN-ß has potential application in antitumor and, anticancer therapy." (Id. at 3:57-59.) "However, large-scale use of IFN as an antiviral agent requires larger amounts of IFN" than previously available. (Id. at 3:14-16.) Specifically, HuIFN-ß "produced by human cell lines grown in tissue culture" resulted in a "low yield, expensive process." (Id. at 4:49-50.) This problem was eventually solved by

locating and separating DNA sequences that code for the expression of HuIFN-ß in an appropriate host thereby providing DNA sequences, recombinant DNA molecule and methods by which a host is transferred to produce a polypeptide displaying an immunological or biological activity of human fibroblast interferon.

(Id. at 6:48-53.) By virtue of this discovery, it was "possible to obtain polypeptides displaying an immunological or biological activity of HuIFN-ß for use in antiviral, antitumor or anticancer agents and methods." (Id. at 6:54-59.)

Certain additional scientific concepts are relevant to the motions discussed below. The protein interferon-ß is made up of building blocks called amino acids. DNA sequences are made up of nucleotides that each contains a base—adenine ("A"), cytosine ("C"), guanine ("G"), or thymine ("T"). Bayer's Reply to Biogen Response to Bayer's SOF (Motion No. 6), ECF No. 643-1 ¶ 14. A triplet of DNA nucleotides is known as a "codon," which codes for a specific amino acid. Id. ¶ 15. Many amino acids have multiple corresponding codons. Id. ¶ 16. Different DNA sequences that code for the same protein are called "degenerate" sequences. Id.

DNA is normally double-stranded, with each base of each nucleotide pairing with its complement on the other strand to form a double helix. ECF No. 633 at 7. The bonds connecting the bases can be reversibly broken, resulting in complementary single strands. Id. Those single strands can then reassociate to form a double-stranded structure in a process called "hybridization." Id. When two single strands of DNA come into proximity they may hybridize if the strands are sufficiently complementary. Bayer's Reply to Biogen's Response to Bayer's SOF (Motion No. 6), ECF No. 643-1 ¶ 17. A hybridization experiment, such as a "Southern blot" test, assesses whether two DNA sequences are sufficiently complementary to hybridize. In such an experiment, DNA sequences that hybridize under one set of testing conditions may not hybridize under different conditions. Id. ¶ 24.

B. Prosecution of the '755 Patent

Dr. Walter Charles Fiers is the sole named inventor on '755 patent. The '755 patent issued on September 15, 2009 from U.S. Application No. 08/449,930 (the "'930 application"), filed on May 25, 1995. The '755 patent claims priority to U.S. Application No. 06/250,609 (the "'609 application"), filed on April 3, 1981, and a patent application filed in Great Britain on June 6, 1980 (the "British Application").² During prosecution of the '609 application, on April 15, 1982, the U.S. Patent and Trademark Office ("PTO") made a restriction requirement separating the pending claims into five groups, one of which included a claim directed to a method of treatment. Biogen's Response to Bayer's SOF (Motion No. 1), ECF No. 589 ¶ 10. The '609 application was abandoned in 1994. Id. ¶ 14.

Between the PTO's restriction requirement in April of 1982 and the filing of the '930 application in May of 1995, Biogen filed two divisional applications that contained method-of-treatment claims. Specifically, on July 28, 1989, Biogen filed divisional application U.S. Application No. 07/289,503. The PTO initially proceeded to examine those claims, but ultimately issued a restriction requirement on February 4, 1994. Bayer's Reply to Biogen's Response to Bayer's SOF (Motion No. 1), ECF No. 597-1 ¶¶ 41-42. On June 3, 1994, Biogen filed its second divisional application, U.S. Application No. 08/253,843. The PTO issued another restriction requirement on December 21, 1994. Id. ¶¶ 43-44. On March 12, 1998, the PTO suspended prosecution of the '930 application "indefinitely" due to a potential interference, and the application remained suspended until January 15, 2003. Id. ¶¶ 36-37.

II. PROCEDURAL HISTORY

On May 27, 2010, Bayer filed suit against Biogen seeking a declaration that Bayer does not infringe the '755 patent claims and that the '755 patent claims are invalid. ECF No. 1. On May 28, 2010, Biogen initiated a separate proceeding by filing suit against Bayer, Serono, and Novartis. C.A. No. 10-2760, ECF No. 1. Biogen's infringement claims against Bayer and Novartis are based on the sale of interferon-ß products Betaseron^® and Extavia^® in the United States for the treatment of MS via immunomodulation.³ C.A. No. 10-2760, ECF No. 1 at ¶¶ 50-73, ECF No. 61 at ¶¶ 60-83. Biogen's infringement claims against Serono are based on the sale of interferon-ß product Rebif^® in the United States for the treatment of MS via immunomodulation. C.A. No. 10-2760, ECF No. 1 at ¶¶ 32-49, ECF No. 61 at ¶¶ 42-59. Bayer, Novartis, and Serono claim that the '755 patent claims are invalid, not infringed, and/or unenforceable. On October 1, 2010, the previous Magistrate Judge entered a Pretrial Scheduling Order consolidating Bayer's declaratory judgment action with Biogen's patent infringement suit. ECF No. 37.

On March 28, 2016, the Court 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 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...