Abbott GMBH & Co. v. Centocor Ortho Biotech, Inc.

• Decision Date: 08 March 2013
• Docket Number: Civil Action No. 09–11340–FDS.
• Citation: 971 F.Supp.2d 171
• Court: U.S. District Court — District of Massachusetts
• Parties: ABBOTT GMBH & CO., KG; Abbott Bioresearch Center, Inc.; and Abbott Biotechnology Ltd., Plaintiffs, v. CENTOCOR ORTHO BIOTECH, INC., and Centocor Biologics, Inc., Defendants.

971 F.Supp.2d 171

ABBOTT GMBH & CO., KG; Abbott Bioresearch Center, Inc.; and Abbott Biotechnology Ltd., Plaintiffs,

v.CENTOCOR ORTHO BIOTECH, INC., and Centocor Biologics, Inc., Defendants.

Civil Action No. 09–11340–FDS.

United States District Court, D. Massachusetts.

March 8, 2013.

William F. Lee, Boston, MA, for Plaintiffs.

MEMORANDUM AND ORDER ON MOTION FOR JUDGMENT AS A MATTER OF LAW

SAYLOR IV, District Judge.

This is a patent infringement action involving a class of antibodies developed to treat certain auto-immune diseases. Plaintiffs AbbVie Deutschland GmbH & Co., KG; AbbVie Bioresearch Center, Inc.; and AbbVie Biotechnology Ltd. (collectively “Abbott”) and defendants Janssen Biotech, Inc. and Centocor Biologics, Inc. (collectively “Centocor”) are pharmaceutical companies. ¹ Abbott and Centocor have both developed antibodies capable of treating diseases associated with the overproduction of a naturally-occurring protein in the human body called interleukin–12 (“IL–12”).

In 2009, Abbott brought suit seeking a judgment under 35 U.S.C. § 271 that its U.S. Patent No. 6,914,128 (the “'128 patent”) and U.S. Patent No. 7,504,485 (the “'485 patent”) are infringed by the drug Stelara, which Centocor manufactures. The case proceeded to trial in late 2012. At trial, Centocor did not contest the issue of infringement. Rather, it contested liability by contending that the asserted patent claims were invalid under 35 U.S.C. §§ 102, 103, and 112. Centocor raised four invalidity defenses: written description, enablement, obviousness, and anticipation.

Following an eleven-day jury trial, the jury returned a verdict that the claims at issue were invalid. They found invalidity on three independent bases: written description, enablement, and obviousness.² Abbott has filed a renewed motion for judgment as a matter of law on all three bases. For the reasons set forth below, Abbott's motion will be denied.

I. Background

The Court will assume familiarity with the facts and procedural background of this case, and will provide only a brief summary of the technology at issue.

This case involves a class of antibodies developed to treat diseases associated with the overproduction of interleukin–12, a naturally-occurring protein in the human body. When functioning properly, IL–12 assists the immune system by binding to receptors on the surfaces of certain cells as part of the body's inflammation response to infection. In some individuals, the body can over-produce IL–12, causing auto-immune diseases such as psoriasis. One way of treating such diseases is by inhibiting or blocking the effects of IL–12 through the use of antibodies. Antibodies are proteins that attach themselves to a target molecule—called an “antigen” for that antibody—by binding with a portion of that antigen called an “epitope.” The immune system produces antibodies that typically target antigens such as viruses, foreign bacteria, or other foreign substances, but an antibody may also target a non-foreign antigen such as IL–12.

The immune system naturally develops antibodies as a response to foreign antigens in the body. Because, however, IL–12 is a naturally-occurring human protein, the immune system does not naturally produce antibodies against it. Treatment of the over-production of IL–12 therefore requires the artificial creation of such antibodies. The subject matter of Abbott's '128 and '485 patents is a set of antibodies for IL–12. Likewise, Stelara contains an antibody developed by Centocor that also targets human IL–12.

There are multiple methods for creating antibodies to IL–12. Of these, two technologies allow the development of “fully human” antibodies that target human antigens with minimal risk of triggering adverse immune reactions. The first method, phage display technology, involves the use of bacteria that have been transfected with viral DNA that contains DNA corresponding to human antibody variable regions. The bacteria create viruses that have those variable regions expressed as proteins on their surfaces. The viruses that display antibody proteins with desired binding properties are screened (or “panned”) by bringing them in contact with the target antigen and removing those that bind to it. The DNA encoding the corresponding antibody is then isolated and replicated. An antibody produced by this method is “recombinant,” meaning that it is created by splicing and recombining DNA. This is the method used by scientists at Abbott to obtain the antibodies to IL–12 disclosed in the '128 and '485 patents.

The second method for producing human antibodies involves use of the immune system of a transgenic mouse. In a transgenic mouse, some of the genes that encode the mouse's antibodies have been replaced with human antibody genes. When a human antigen such as IL–12 is introduced into a transgenic mouse, the mouse's immune system recognizes the antigen as foreign and develops antibodies that target it. Because the genes from which the transgenic animal's cells build the antibody are human, the resulting antibody will be appropriate for human patients. Antibodies with desired binding properties can then be reproduced using what is known as the hybridoma technique. This is the method used by scientists at Centocor to obtain the antibody to IL–12 known as Stelara.

II. Legal Standard

In a patent case, this Court analyzes a motion for judgment as a matter of law according to the law of the First Circuit. August Tech. Corp. v. Camtek, Ltd., 655 F.3d 1278, 1281 (Fed.Cir.2011).

A party that seeks to overturn a jury verdict “faces an uphill battle.” Monteagudo v. Asociacion de Empleados del Estado Libre Asociado de P.R., 554 F.3d 164, 170 (1st Cir.2009). To grant judgment as a matter of law, the Court must determine that the “evidence points so strongly and overwhelmingly in favor of the moving party that no reasonable jury could have returned a verdict adverse to that party.” Malone v. Lockheed Martin Corp., 610 F.3d 16, 20 (1st Cir.2010). All evidence presented to the jury, and all reasonable inferences drawn therefrom, must be viewed in the light most favorable to the verdict. Osorio v. One World Techs., Inc., 659 F.3d 81, 84 (1st Cir.2011). The jury's verdict should stand unless the evidence, viewed in such a favorable light, nonetheless “points unerringly to an opposite conclusion.” Zimmerman v. Direct Fed. Credit Union, 262 F.3d 70, 75 (1st Cir.2001).

At trial, all patents were presumed valid. To overcome that presumption, defendant was required to present clear and convincing evidence of invalidity. Thus, the key question is whether a reasonable jury could have found that there was clear and convincing evidence that the patents were invalid.

III. AnalysisA. Written Description

1. Legal Standard

To satisfy the written description requirement, the disclosures in a patent specification must “clearly allow [a person] of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.Cir.2010). When the patent claims a genus, the specification must describe the invention in a way that makes it clear that the genus has been invented, not just a species of the genus. Carnegie Mellon Univ. v. Hoffmann–La Roche Inc., 541 F.3d 1115, 1124 (Fed.Cir.2008). This is particularly true when the patent claims a genus defined by functional language, because such claims run the risk of “simply claim[ing] a desired result ... without describing species that achieve that result.” Ariad, 598 F.3d at 1349.

The Federal Circuit has set forth two possible ways to claim a genus: a party may disclose either a “representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Only the “representative species” test is at issue in this case.

There is no simple definition for what constitutes a “representative number of species.” There are no “bright-line rules” governing the number of species that a patent must disclose in order to satisfy the representative species test. Rather, it is a case-by-case question of whether “the species which are adequately described are representative of the entire genus.” Carnegie Mellon, 541 F.3d at 1124. When there is substantial variation within the genus, one must describe “a sufficient variety of species to reflect the variation within the genus.” Id. at 1124.

2. Jury Verdict on Written Description

The jury found by clear and convincing evidence that all five claims of the ' 128 patent and the '485 patent at issue in this case failed to meet the written-description requirement, and were therefore invalid. Plaintiff contends that there was not substantial evidence to support the jury's verdict, and that it is entitled to judgment as a matter of law on the question of written description.

The adequacy of the written description essentially turns on whether the patents disclosed sufficient representative species to support a claim to the genus. Plaintiff does not contend that defendant did not put forth evidence on this issue; rather, it challenges the relevance of defendant's evidence. Plaintiff essentially raises two different relevancy challenges. First, plaintiff asserts that the only evidence that defendant put forward to support its contention that the disclosed antibodies are not representative of other members of the genus was based on structural difference. Plaintiff contends that because the claims are functional, not structural, structural difference is irrelevant. Second, plaintiff asserts that defendant only put forward evidence of differences between the disclosed antibodies and the allegedly infringing product, Stelara. Plaintiff contends that this is the wrong inquiry; the patent must disclose species that are representative of the genus, not of the allegedly...