Horizon Medicines LLC v. Apotex Inc.

CourtDistrict Court, D. Delaware
DecidedNovember 7, 2022
Docket1:22-cv-00640
StatusUnknown

This text of Horizon Medicines LLC v. Apotex Inc. (Horizon Medicines LLC v. Apotex Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Horizon Medicines LLC v. Apotex Inc., (D. Del. 2022).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

HORIZON MEDICINES LLC, HORIZON ) THERAPEUTICS IRELAND DAC, HZNP ) MEDICINES LLC, AND HZNP FINANCE ) LTD., ) ) Plaintiffs, ) ) v. ) Civil Action No. 22-640-CJB ) APOTEX INC. and APOTEX CORP., ) ) Defendants. )

Karen E. Keller, Andrew E. Russell, Nathan R. Hoeschen and Emily S. DiBenedetto, SHAW KELLER LLP, Wilmington, DE; Sanya Sukduang, Johnathan R. Davis and Allison E. Elkman, COOLEY LLP, Washington, DC; Mazda Antia and Erin Trenda, COOLEY LLP, San Diego, CA; Attorneys for Plaintiffs.

Kenneth L. Dorsney and Cortlan S. Hitch, MORRIS JAMES LLP, Wilmington, DE; Deepro R. Mukerjee and Lance A. Soderstrom, KATTEN MUCHIN ROSENMAN LLP, New York, NY; Joseph M. Janusz, KATTEN MUCHIN ROSENMAN LLP, Charlotte, NC; Attorneys for Defendants.

MEMORANDUM OPINION

November 7, 2022 Wilmington, Delaware In this patent action filed by Plaintiffs Horizon Medicines LLC, Horizon Therapeutics Ireland DAC, HZNP Medicines LLC and HZNP Finance Ltd. (collectively, “Horizon’’) against Defendant Apotex Inc. and Apotex Corp. (collectively, “Apotex”), Horizon alleges infringement of claim 12 of United States Patent No. 9,066,913 (the “913 patent”). (D.I. 1 at 9.1) Presently pending before the Court is Apotex’s motion for summary judgment (the “Motion”). (D.I. 31) Horizon opposes the Motion. For the reasons set forth below, the Motion is GRANTED. ! I. BACKGROUND A. Factual Background The key relevant background facts are not disputed. In January 2013, Apotex entered into a settlement agreement (the “2013 Settlement Agreement”) with Nuvo Research Inc. (“Nuvo”), Mallinckrodt Inc. and Mallinckrodt LLC (together with Mallinckrodt Inc., “Mallinckrodt”) to resolve litigation between the parties over a 1.5% strength of diclofenac sodium topical solution product (referred to herein as “PENNSAID® 1.5%”). (D.I. 33, ex. 2) At the time, Nuvo was the owner of United States Patent Nos. 8,217,078 (the ‘“078 patent”) and 8,252,838 (the “838 patent”). (/d. at 1) Mallinckrodt was an exclusive licensee of the '078 and '838 patents and the holder of the New Drug Application for PENNSAID® 1.5%. (/d.) The 2013 Settlement Agreement granted Apotex a license to certain patents relating to PENNSAID® 1.5% and also granted Apotex rights relating to potential future manufacture and commercialization of a generic version of a 2% strength topical diclofenac

The parties have jointly consented to the Court’s jurisdiction to conduct all proceedings in this case, including trial, the entry of final judgment and all post-trial proceedings. (D.I. 24)

sodium product (referred to herein as “PENNSAID® 2%”). The relevant license provision, Section 6.1, provides that: Mallinckrodt and Nuvo hereby grant, to the extent that they lawfully may, to Apotex, on and after the 2.0% Launch Date and terminating on the 2.0% Termination Date, a non-exclusive, royalty-free and fully paid-up, non-sublicensable, non-transferable (except as expressly permitted by Section 11.3 of this Agreement) right and license under their respective rights in and to the '078 Licensed Patent and to the '838 Licensed Patent, and to any other patent that they now own or that they may acquire in the future, sufficient to allow Apotex to make, have made, use, sell, offer to sell, import, and distribute the Apotex 2.0% Product in and for the Territory, or to make or have made the Apotex 2% Product in the nation of Canada for the sole purpose of thereafter importing the Apotex 2.0% Product from the nation of Canada into the Territory and to sell, offer to sell, and distribute the Apotex 2.0% Product in and for the Territory.

(Id. at § 6.1) The “'838 Licensed Patent” is defined in the 2013 Settlement Agreement as the “['838 patent] and any patents that issue from any divisions, continuations, reissues or reexaminations thereof.” (Id. at § 1.8) The '913 patent asserted in this case is entitled “Diclofenac Topical Formulation” and it is a continuation of the '838 patent. (D.I. 1, ex. A; D.I. 32 at 4 & n.1) The '913 patent issued from United States Patent Application No. 14/497,096 (the “'096 application”). (D.I. 1, ex. A) The '096 application was filed by Nuvo on September 25, 2014. (Id.; D.I. 33, ex. 4 at 5) On October 17, 2014—less than a month after Nuvo filed the '096 application—Nuvo and Horizon entered into an Asset Purchase Agreement (“APA”) by which Horizon acquired PENNSAID® 2% and Nuvo’s related patent rights. (D.I. 33, ex. 6) The intellectual property that Horizon purchased included the '096 application (and the '838 patent). (Id., ex. 7 at 3 Schedule 1) The '096 application later issued to Horizon as the '913 patent on June 30, 2015. (D.I. 1, ex. A)2 On August 4, 2020, Apotex received tentative approval from the United States Food and Drug Administration (“FDA”) for its generic PENNSAID® 2% product (the “Apotex 2.0%

Product”). (D.I. 33, ex. 9) The FDA informed Apotex that it was “unable to grant final approval to [Apotex’s Abbreviated New Drug Application (‘ANDA’)]” because “[p]rior to the submission of [Apotex’s] ANDA, another applicant . . . submitted a substantially complete ANDA” for a generic PENNSAID® 2% product. (Id. at 3) Accordingly, the FDA stated that Apotex’s ANDA would be eligible for final approval on a date that is 180 days following the commercial marketing date by a first filer. (Id.) At the time, Actavis held first-filer status for generic PENNSAID® 2%. (See D.I. 32 at 7; D.I. 52 at 2) However, on May 5, 2022, Actavis’s first-filer status was “[e]xtinguished.” (D.I. 33, ex. 10) As a result, on May 6, 2022, Apotex received FDA approval to market its generic PENNSAID® 2% product and immediately launched its Apotex 2.0% Product. (Id., ex.

11; see also D.I. 32 at 7; D.I. 52 at 8) Additional relevant facts will be set out as necessary in Section III below. B. Procedural Background Horizon commenced this action on May 13, 2022. (D.I. 1) Apotex filed the instant Motion on June 24, 2022. (D.I. 31)3 The Motion was fully briefed as of July 29, 2022. (D.I. 64)

2 The '838 and '913 patents share the same specification describing the invention discussed therein, and they have the same title, abstract, and inventors. (D.I. 69 at 1 n.2 (citing id., exs. 1-2))

3 Four days after commencing this action, Horizon filed a motion for preliminary injunction. (D.I. 7) Apotex subsequently agreed to forego argument on preliminary injunction 4 The Court heard argument on the Motion on August 23, 2022. (D.I. 67 (hereinafter “Tr.”)) The parties submitted supplemental letter briefs on August 30, 2022. (D.I. 68; D.I. 69) II. STANDARD OF REVIEW Summary judgment is appropriate where “the movant shows that there is no genuine

dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 585 n.10 (1986). If the moving party has sufficiently demonstrated the absence of such a dispute, the nonmovant must then “come forward with specific facts showing that there is a genuine issue for trial.” Id. at 587 (internal quotation marks, citation and emphasis omitted). If the nonmoving party fails to make a sufficient showing in this regard, then the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

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