Takeda Pharmaceuticals U.S.A., Inc. v. Genentech, Inc.

CourtCourt of Chancery of Delaware
DecidedMarch 26, 2019
DocketC.A. No. 2018-0384-MTZ
StatusPublished

This text of Takeda Pharmaceuticals U.S.A., Inc. v. Genentech, Inc. (Takeda Pharmaceuticals U.S.A., Inc. v. Genentech, Inc.) is published on Counsel Stack Legal Research, covering Court of Chancery of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Takeda Pharmaceuticals U.S.A., Inc. v. Genentech, Inc., (Del. Ct. App. 2019).

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE TAKEDA PHARMACEUTICALS U.S.A., ) INC., TAKEDA PHARMACEUTICALS ) AMERICA, INC., and MILLENNIUM ) PHARMACEUTICALS, INC., ) ) Plaintiffs, ) C.A. No. 2018-0384-MTZ ) v. ) ) GENENTECH, INC., ) ) Defendant. )

MEMORANDUM OPINION

Date Submitted: December 7, 2018 Date Decided: March 26, 2019

Philip A. Rovner & Jonathan A. Choa, POTTER ANDERSON CORROON LLP, Wilmington, Delaware; William F. Cavanaugh, Irena Royzman, Jacob F. Siegel, Eric B. LaPre, & Sara A. Arrow, PATTERSON BELKNAP WEBB & TYLER LLP, New York, New York, Attorneys for Plaintiffs Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals America, Inc., and Millennium Pharmaceuticals, Inc.

Kelly E. Farnan & Blake Rohrbacher, RICHARDS, LAYTON & FINGER, P.A., Wilmington, Delaware; Robert W. Trenchard, Jane M. Love, & Mark H. Mixon, Jr., GIBSON, DUNN & CRUTCHER LLP, New York, New York, Attorneys for Defendant Genentech, Inc.

ZURN, Vice Chancellor. Two biotechnology companies are engaged in patent litigation in multiple

European jurisdictions. In those cases, the alleged infringer has asserted a defense

that it holds a license based on an agreement with a third company. In hopes of

ending the foreign patent litigation, the alleged infringer then came to Delaware

and sued that third company, which is a subsidiary of the patentholder. The

alleged infringer seeks a declaratory judgment that it has a license and an anti-suit

injunction against the third company and anyone acting in active concert or

participation with it. Because the alleged infringer has an adequate remedy at law

in the form of its license defense in the foreign patent litigation, this Court does not

have subject matter jurisdiction over the alleged infringer’s request for declaratory

relief. The case is therefore dismissed.

I. BACKGROUND

A. The Parties’ Corporate and Contractual Relationships In 1997, defendant Genentech, Inc. (“Genentech”) and LeukoSite, Inc.

(“LeukoSite”) entered into a Development Collaboration and License Agreement,

dated December 18, 1997 (the “License Agreement”).1 LeukoSite was “the owner

or exclusive licensee of certain technology and other proprietary know-how” for

1 Aff. of Robert W. Trenchard in Supp. of Def. Genentech, Inc.’s Mot. to Dismiss (Docket Item (“D.I.”) 10), Ex. A. Delaware law governs the License Agreement. Id. § 13.3. certain identified products, which Genentech desired to use.2 LeukoSite and

Genentech agreed to collaborate to develop LDP-02, a monoclonal antibody.3

Plaintiff Millennium Pharmaceuticals, Inc. (“Millennium”) is the surviving

entity of a 1999 merger with LeukoSite.4 In 2004, Genentech and Millennium

agreed to terminate the License Agreement through a Termination Agreement

dated May 12, 2004 (the “Termination Agreement”).5 In the Termination

Agreement, the parties cross-licensed intellectual property from their work related

to LDP-02, and Genentech returned the rights to make, use, and sell LDP-02 to

Millennium.6 Genentech granted Millennium, among other things, “a non-

exclusive, paid-up, royalty free, world-wide license” for “GNE Patents.”7 GNE

Patents are defined as

any United States patent or patent application, including any division, continuation, or continuation-in-part thereof and any foreign patent or patent application or equivalent corresponding thereto and any letters patent or the equivalent thereof issuing thereon or reissue, re-examination, supplemental protection certificate or extension thereof, (i) which is owned or controlled by GNE or to which GNE has a transferable or sublicensable interest and (ii) which is necessary for the research, development or commercialization of LDP-02,

2 Trenchard Aff. Ex. A at 1. 3 Id. at 1, § 1.26. 4 Compl. ¶ 7. All citations to the Complaint are to Plaintiffs’ Verified Complaint. D.I. 1. 5 Compl. ¶ 23. Delaware law governs the Termination Agreement. Trenchard Aff. Ex. B § 13(d). 6 Compl. ¶ 23; Trenchard Aff. Ex. B at §§ 3, 4. 7 Trenchard Aff. Ex. B § 4. Derivatives or Antibody Products, including without limitation GNE’s interest in Joint Patents. Notwithstanding the foregoing, “GNE Patents” shall not include (a) the Excluded GNE Patents, or (b) any claim of a GNE Patent directed to a use of LDP-02, a Derivative or an Antibody Product in the Field for a disease indication other than an inflammatory bowel disease, which use is conceived and reduced to practice after the Effective Date.8

The Termination Agreement defined “Excluded GNE Patents” as several identified

patents not relevant here, as well as “any other patents or intellectual property

owned by a Third Party for which direct licenses are generally available from such

Third Party.”9 A “Third Party” is defined as “a person or entity who or which is

not a party” to the License Agreement.10

In 2008, plaintiff Takeda Pharmaceuticals U.S.A., Inc. acquired Millennium.

Millennium and plaintiff Takeda Pharmaceuticals America, Inc. are wholly owned

subsidiaries of Takeda Pharmaceuticals U.S.A.11

Between 1990 and 2009, Roche was a majority stockholder of Genentech.12

In 2009, Roche acquired the rest of Genentech’s stock, and Genentech became a

8 Id. § 1(e). 9 Id. § 1(c)(i). 10 Trenchard Aff. Ex. A § 1.53 (definition of Third Party in License Agreement), Ex. B § 8 (identifying which definitions of License Agreement survived the termination of that Agreement). 11 Compl. ¶¶ 2, 6-7. Takeda and Roche operate through subsidiaries in different countries, and this opinion simplifies those corporate structures by referring only to Takeda and Roche unless it is necessary to identify the specific entity, such as Millennium. wholly owned subsidiary of Roche.13 Takeda alleges that after Genentech became

a wholly owned subsidiary of Roche, Roche “consolidated all of its U.S

pharmaceutical operations” in Genentech.14 Genentech’s campus is now allegedly

Roche’s headquarters for its United States pharmaceutical operations, and the two

companies share office space at Roche’s principal place of business in New

Jersey.15

The parties worked to develop the LDP-02 antibody, which eventually

became an active ingredient in ENTYVIO.16 ENTYVIO treats adult ulcerative

colitis and adult Crohn’s disease, and was first approved by the FDA in 2014.17

Takeda’s fiscal year 2017 sales of ENTYVIO were nearly $1.8 billion.18

B. Roche Files For Patent Rights Related To Antibody Technology. In 2006, Roche filed patent applications in the United States and Europe,

including United States Patent Application 14/195,066 (the “‘066 Application”).19

12 Id. ¶ 36. The ultimate corporate parent of Roche is Roche Holding AG, a publicly traded company organized and existing under the laws of Switzerland. Id. ¶ 8. 13 Id. ¶ 36. 14 Id. ¶ 38. 15 Id. ¶¶ 38-41. 16 Id. ¶¶ 17-18, 20-21. 17 Id. ¶ 13. 18 Id. ¶ 19. This figure was based on exchange rates when Takeda filed the Complaint. 19 Trenchard Aff. Exs. C & D. This Court may take judicial notice of these patent applications and accompanying documents. See Wilkin v. Narachi, 2018 WL 1100372, at *2 n.3 (Del. Ch. Feb. 28, 2018) (taking judicial notice of a World Intellectual Property For each application, the applicant and assignee were Roche entities, not

Genentech.20 European Patent No. 2,007,809 (the “‘809 Patent”) is a foreign

counterpart of the ‘066 Application.21 The European Patent Office granted the

‘809 Patent in September 2012.22

The ‘066 Application included a power of attorney (“the Power of

Attorney”) through which Roche authorized several agents to prosecute that

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