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Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc.

United States Court of Appeals, Federal Circuit

July 1, 2014

ABBVIE DEUTSCHLAND GMBH & CO., KG, ABBVIE BIORESEARCH CENTER, INC., AND ABBVIE BIOTECHNOLOGY, LTD., Plaintiffs-Appellants,
v.
JANSSEN BIOTECH, INC. AND CENTOCOR BIOLOGICS, LLC, Defendants-Appellees. JANSSEN BIOTECH, INC., Plaintiff-Appellee,
v.
ABBVIE DEUTSCHLAND GMBH & CO., KG, Defendant-Appellant

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Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV.

WILLIAM F. LEE, Wilmer Cutler Pickering Hale and Dorr LLP, of Boston, Massachusetts, argued for appellants. With him on the brief were ROBERT J. GUNTHER, JR., JANE M. LOVE, and VIOLETTA WATSON, of New York, New York; WILLIAM G. MCELWAIN, THOMAS G. SAUNDERS, RACHEL L. WEINER, and MATTHEW GUARNIERI, of Washington, DC; and ARTHUR W. COVIELLO, of Palo Alto, California. Of counsel was MARK C. FLEMING, of Boston, Massachusetts.

DIANNE B. ELDERKIN, Akin Gump Strauss Hauer & Feld LLP, of Philadelphia, Pennsylvania, argued for appellees. With her on the brief were BARBARA L. MULLIN, STEVEN D. MASLOWSKI, ANGELA VERRECCHIO, and MATTHEW A. PEARSON; and EMILY C. JOHNSON, of Washington, DC.

JAMES J. KELLEY, Eli Lilly and Company, of Indianapolis, Indiana, for amicus curiae Eli Lilly and Company. With him on the brief were TED J. EBERSOLE, ALEXANDER WILSON, and SANJAY JIVRAJ. On the brief for amicus curiae Pfizer Inc. was JEFFREY J. OELKE, White and Case LLP, of New York, New York.

OSKAR LIIVAK, Cornell Law School, of Ithaca, New York, for amicus curiae Professor Oskar Liivak.

Before LOURIE, O'MALLEY, and CHEN, Circuit Judges. OPINION filed by Circuit Judge LOURIE. Concurring opinion filed by Circuit Judge O'MALLEY.

OPINION

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Lourie, Circuit Judge .

AbbVie Deutschland GmbH & Co., KG, AbbVie Biore-search Center, Inc., and AbbVie Biotechnology Ltd. (formerly Abbott, collectively " AbbVie" ) appeal from the final judgments of the United States District Court for the District of Massachusetts in a patent infringement action and a patent interference action. In the infringement action, patent owner AbbVie sued Janssen Biotech, Inc. and Centocor Biologics, LLC (collectively " Centocor" ) for infringement of claims 29, 30, and 32 and claim 64 as depending from claim 29 of U.S. Patent 6,914,128 (the " '128 patent" ) and claim 11 as depending from claim 2 of U.S. Patent 7,504,485 (the " '485 patent" ) (collectively " the asserted claims" ).[1] In the interference action, Centocor sought the district court's review under 35 U.S.C. § 146 (2006) of the decisions of the United

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States Patent and Trademark Office (" PTO" ) Board of Patent Appeals and Interferences (the " Board" ) in an interference between U.S. Patent Application 10/912,994 (the " '994 application" ) owned by Centocor and AbbVie's '128 patent, in which the Board awarded priority to AbbVie and held that the contested claims in the '128 patent were not invalid for obviousness.[2]

After a trial on validity in the infringement action, the jury determined that all of the asserted claims were invalid on the grounds of written description, enablement, and obviousness. The district court denied AbbVie's post-trial motions for judgment as a matter of law (" JMOL" ), and in the alternative, for a new trial, and entered judgments of invalidity in both the infringement and the interference actions.

In these consolidated appeals, AbbVie challenges the district court's denial of: (1) its motion for summary judgment, in which the district court held that Centocor was not collaterally estopped from raising invalidity defenses in the infringement action after the interference proceeding at the PTO; (2) its motion for JMOL on the issues of written description and enablement; and (3) its motion for a new trial for alleged errors in the court's evidentiary rulings and jury instructions. See Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc., 870 F.Supp.2d 206 (D. Mass. 2012) (summary judgment order); Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc., 971 F.Supp.2d 171 (D. Mass. 2013) (order denying JMOL); Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc., No. 09-11340, ECF No. 542 (D. Mass. Mar. 14, 2013) (bench ruling denying new trial).

We conclude that because the interference action under § 146 was pending at the district court, the Board's decision lacked the requisite finality for purposes of collateral estoppel. We also hold that record evidence sufficiently supported the jury verdict that the asserted claims lacked adequate written description under 35 U.S.C. § 112, ¶ 1 (2006).[3] We further find no reversible error in the contested evidentiary rulings and jury instructions relating to the issue of written description sufficient to warrant a new trial. Because all of the asserted claims are invalid for failing to satisfy the written description requirement, we need not address AbbVie's validity arguments concerning enablement or its procedural challenges to the district court's obviousness judgments. We therefore affirm the judgments of invalidity in both the infringement and the interference actions.

Background

The technology in these appeals involves antibodies that are useful for treating diseases. An antibody is a protein that binds to a foreign substance, called an antigen, to facilitate its removal from the body. The portion of the antigen that binds to the antibody is called the epitope. Each antibody consists of four chains of amino acids, two identical heavy chains and two identical light chains, which are folded into

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a three-dimensional structure. Each of the heavy and light chains consists of a constant region and a variable region. The variable region is the portion of the antibody in its three-dimensional structure that binds to the antigen and each variable region has three complementarity determining regions (" CDRs" ) that interact closely with the epitope of the antigen. Among human antibodies, the variable region of the heavy chains can be divided into seven families: VH1 to VH7; and the variable region of the light chains can be divided into two classes: Kappa and Lambda. The binding affinity of an antibody to an antigen can be measured by koff, the rate at which the antigen dissociates from the antibody after binding, wherein a smaller koff value represents a tighter binding.

AbbVie owns the '128 and '485 patents, directed to fully human antibodies that bind to and neutralize the activity of human interleukin 12 (" IL-12" ). IL-12 is a signaling protein secreted by the human body, the over-production of which can cause psoriasis and rheumatoid arthritis. Because the human body does not typically make antibodies to neutralize its own proteins, it does not produce IL-12 antibodies naturally. Antibodies from a non-human species often lack the desirable safety profile of a drug because non-human antibodies can cause adverse immune reactions in human patients. Researchers therefore sought to genetically engineer fully human IL-12 antibodies that are derived from human DNA and thus less likely to trigger an immune response.

The techniques that could be used to develop a fully human IL-12 antibody have included phage display and transgenic mice. AbbVie developed its IL-12 antibodies using phage display, which involved creating a large library of human DNA fragments and screening for those fragments that encoded an antibody fragment with IL-12 binding affinity. AbbVie identified a lead through screening that it named " Joe-9", which had the ability to bind to and neutralize the activity of IL-12, albeit with low affinity. '128 patent col. 104 ll. 23-29. In order to improve IL-12 affinity, AbbVie introduced mutations to the CDRs of Joe-9 and identified an improved antibody that it named " Y61" . Id. col. 104 l. 39-col. 107 l. 6. AbbVie then used site-directed mutagenesis to alter individual amino acids at selected positions in Y61 and generated additional antibodies, among which an antibody that it named " J695" showed a significant increase in IL-12 binding and neutralizing activity. Id. col. 108 ll. 14-65.

The '128 and '485 patents share the same written description and both claim priority from a provisional application filed in 1999. The patents describe the amino acid sequence of about 300 antibodies having a range of IL-12 binding affinities. Id. fig. 1A-2H, col. 95-102. Joe-9, the initial lead, has VH3 type heavy chains and Lambda type light chains. Id. col. 104 ll. 33-35. Because the IL-12 antibodies described in the patents were all derived from Joe-9, they all have VH3 type heavy chains and Lambda type light chains. J.A. 7547-52. The described antibodies share a 90% or more amino acid sequence similarity in the variable regions. Id. And over 200 of those antibodies were generated by site-directed mutagenesis of Y61 and thus differ from Y61 by only one amino acid and share a 99.5% sequence similarity in the variable regions. '128 patent fig. 2A-2H; J.A. 7008.

The '128 and '485 patents also teach that " the amino acid sequence identity within the entire VH3 family is high," which " results in certain amino acid residues being present at key sites in the CDR and framework regions of the VH chain," and thus that " other VH3 family members

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could also be used to generate antibodies that bind to human IL-12." '128 patent col. 41 ll. 15-17, 27-31, 54-57. The patents similarly teach that " other Vλ 1 [Lambda 1] family members may also be used to generate antibodies that bind to human IL-12." Id. col. 42 ll. 5-8. The patents, however, do not describe any IL-12 antibody having heavy chains outside of the VH3 family or light chains outside of the Lambda family. J.A. 7549.

The claims of the '128 and '485 patents at issue in these appeals define the claimed antibodies by their function, i.e., IL-12 binding and neutralizing characteristics, rather than by structure. Claim 29 of the '128 patent is representative and reads as follows:

29. A neutralizing isolated human antibody, or antigen-binding portion thereof that binds to human IL-12 and disassociates from human IL-12 with a koff rate constant of 1x10(##RefNum=-2 FootnoteNum=4##) s(##RefNum=-1 FootnoteNum=5##) or less, as determined by surface plasmon resonance.

'128 patent col. 386 ll. 55-59. Claims 30 and 32 likewise require the koff rates to be 1x10(##RefNum=-4 FootnoteNum=6##) s(##RefNum=-1 FootnoteNum=7##) or less and 1x10(##RefNum=-3 FootnoteNum=8##) s(##RefNum=-1 FootnoteNum=9##) or less, respectively. Id. col. 386 ll. 60-63, col. 387 ll. 1-4. Claim 64 is directed to a pharmaceutical composition comprising the functionally claimed antibody. Id. col. 389 ll. 1-4. Claim 11 of the '485 patent similarly defines the claimed antibody by its IL-12 binding profile. '485 patent col. 381 ll. 33-40, col. 382 ll. 40-44.

Centocor developed its human IL-12 neutralizing antibody drug marketed under the brand name Stelara® (" Stelara" ) using the transgenic mice technology, which involved mice that are genetically modified with human antibody genes and capable of producing human antibodies when exposed to an antigen such as IL-12. Stelara has VH5 type heavy chains, not VH3, and Kappa type light chains, not Lambda, and about 50% sequence similarity in the variable regions as compared to the Joe-9 antibodies described in the '128 and '485 patents, which is significantly lower than the 90% sequence similarity shared among the Joe-9 antibodies. J.A. 14958. The U.S. Food and Drug Administration approved Stelara in 2009. Abbott, 870 F.Supp.2d at 218.

Centocor filed the '994 application directed to human IL-12 antibodies, which claimed priority from two provisional applications filed in 2000, and provoked an interference with the '128 patent on December 12, 2007. Id. Claims 1-15, 27-40, and 50-64 of the '128 patent correspond to the sole count of the interference. Although Centocor indicated at an early stage of the interference that it intended to challenge the validity of the '128 claims on the grounds of written description, enablement, definiteness, and obviousness, Centocor only filed invalidity motions on the issue of obviousness. Centocor also filed motions on the priority issue. On August 6, 2009, the Board awarded priority to AbbVie, held that the '128 patent claims were not invalid for obviousness, and therefore entered judgment in favor of AbbVie. Centocor, Inc. v. Abbott GmbH & Co., Interference No. 105,592, Paper No. 417, 418, 419 (B.P.A.I. Aug. 6, 2009) (priority decision, nonobviousness decision, and judgment, respectively).

On August 10, 2009, AbbVie filed an infringement action against Centocor in the district court for the District of Massachusetts, asserting that Stelara infringed the '128 and '485 patents. Abbott, 870 F.Supp.2d at 218. Shortly thereafter, on August 28, 2009, Centocor filed two actions in the district court for the District of Columbia, seeking judicial review of the Board's interference decisions under § 146 and seeking a declaratory judgment of noninfringement and invalidity of the '128 and '485 patents. Id. Centocor's two actions were transferred to Massachusetts,

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where the district court consolidated the declaratory judgment action with the infringement action for all purposes and consolidated the interference action with the infringement action for purposes of discovery. Id.

AbbVie moved for summary judgment that Centocor was collaterally estopped from challenging the validity of the '128 patent in the infringement action because Centocor had failed to invalidate the '128 patent claims in the interference proceeding at the PTO. The district court denied the motion, reasoning that the Board's decisions were not final for purposes of collateral estoppel in view of the pending § 146 action. Id. at 223. The court also decided to proceed with the infringement action first in order to preserve Centocor's right to a jury trial. Id. at 226.

After construing the claims, the court entered summary judgment that Centocor infringed claims 29, 32, and 64 of the '128 patent and claim 11 of the '485 patent. Id. at 249. The parties then stipulated that claim 30 of the '128 patent was also infringed. Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc., No. 09-11340, ECF No. 400 (D. Mass. Aug. 10, 2012). AbbVie also stipulated that it would only assert those five claims in the infringement action and Centocor stipulated that it would not seek review of the PTO's nonobviousness ruling with respect to other claims of the '128 patent that were at issue in the interference action. Abbott GmbH & Co. v. Centocor Ortho Biotech, Inc., No. 09-11340, ECF No. 454 (D. Mass. Sept. 7, 2012).

The validity of the asserted claims was tried before a jury in the infringement action. The district court excluded evidence of the PTO interference proceeding under Federal Rule of Evidence 403. J.A. 323, 6421-22, 6467-69, 6780-81. The court allowed AbbVie's expert, Dr. Marks, to testify that the PTO had considered the issues of written description, enablement, and obviousness and concluded that the asserted claims met those requirements before it granted the patents. Id. at 7260-63, 7284. The court, however, precluded Dr. Marks from testifying in detail about the reasoning of the PTO or prosecution arguments considered by the PTO. Id. at 7281-86.

Centocor raised four invalidity defenses on the bases of written description, enablement, obviousness, and anticipation by prior invention. To support its invalidity challenges under ยง 112, Centocor presented evidence seeking to establish that the antibodies described in AbbVie's patents were not representative of other members of the functionally claimed genus, which included Stelara. Centocor presented expert testimony that the antibodies ...


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