Baxalta Inc. v. Genentech, Inc.

Baxalta Inc. v. Genentech, Inc.

Opinion

MEMORANDUM OPINION

Pending before the [*2]  court is Genentech's motion for summary judgment. Genentech moves for summary judgment of 1) invalidity of claims 1-4, 19, and 20 of the '590 patent for lack of written description and enablement, 2) non-infringement under a doctrine-of-equivalents theory, and 3) no willful infringement. For the reasons stated below, the court GRANTS Genentech's motion for summary judgment of invalidity for lack of enablement and need not address Genentech's motion in all other respects.

I. Procedural History

On May 4, 2017, Baxalta Inc. and Baxalta GmbH (together, "Baxalta") brought suit against Genentech, Inc. and Chugai Pharmaceutical Co., Ltd., alleging infringement of U.S. Patent No. 7,033,590 ("the '590 patent") by the manufacture, use, sale, offer to sell, and importation of an antibody used to treat hemophilia A and known as emicizumab or ACE910, marketed under the brand name Hemlibra. Compl., ECF No. 1, ¶¶ 37-51. Chugai was subsequently dismissed from the case.¹ Genentech answered on June 30, denying Baxalta's allegations and counterclaiming for declaratory judgment of noninfringement and invalidity on grounds of lack of enablement and written description support. Answer & Countercl., ECF No. 9, ¶¶ 37-51, 120-49.

On December 14, [*3]  2017, Baxalta moved for a preliminary injunction against Genentech. See Mot. for Prelim. Inj., ECF No. 41. On August 7, 2018, the court denied Baxalta's motion, finding that it had not proven a likelihood of success with respect to infringement and invalidity, and that even if it had, "given the ample evidence of medical need, the public interest weigh[ed] strongly against issuing a preliminary injunction since Hemlibra has unique medical benefits not available from Baxalta's competing products." Prelim. Inj. Order, ECF No. 262, at 24; id. at 28-29.

On December 3, 2018, following a Markman hearing, the court issued a claim construction decision in which it construed the term "antibody" to exclude bispecific antibodies. See Claim Construction Order, ECF No. 330, at 22-23. Thereafter, the parties stipulated to non-infringement of the asserted claims under the court's claim construction. See Stipulations, ECF Nos. 331-332. The court entered judgment in Genentech's favor on February 1, 2019. See Stip. & Final J., ECF No. 337. Baxalta appealed, and on August 27, 2020, the Federal Circuit issued a decision rejecting this court's construction of the terms "antibody" and "antibody fragment," [*4]  determining that the term antibody included bispecific antibodies, and vacating the judgment of non-infringement and remanding for further proceedings. See Baxalta Inc. v. Genentech, Inc., 972 F.3d 1341, 1343, 1349 (Fed. Cir. 2020) (construing antibody to mean "an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains)" and "antibody fragment" to mean "a portion of an antibody"). Upon remand, the case proceeded with fact and expert discovery.

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