Apicore US LLC v. Beloteca, Inc.

CourtDistrict Court, N.D. Illinois
DecidedApril 18, 2019
Docket1:19-cv-02638
StatusUnknown

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

Bluebook
Apicore US LLC v. Beloteca, Inc., (N.D. Ill. 2019).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION

APICORE US LLC, MYLAN § INSTITUTIONAL LLC, § §

§ Plaintiffs, §

§ v. CIVIL ACTION NO. 2:19-CV-00077-JRG §

§ BELOTECA, INC., § § Defendant. §

MEMORANDUM AND OPINION ORDER Before the Court is Defendant Beloteca, Inc’s (“Beloteca”) Motion to Dismiss for Lack of Personal Jurisdiction, Improper Venue, and Prior Pending Action (the “Motion”). (Dkt. No. 21.) Having considered the Motion and the relevant authorities, the Court is of the opinion that the Motion should be DENIED-IN-PART and GRANTED-IN-PART to the extent set forth herein. I. BACKGROUND Plaintiff Apicore US LLC (“Apicore”) owns U.S. Patent Nos. 8,969,616 (the “’616 Patent”) and 9,353,050 (the “’050 Patent”) (collectively, the “Asserted Patents”). (Dkt. No. 1 ¶ 28.) The claims of the Asserted Patents cover a highly pure isosulfan blue (“ISB”) active pharmaceutical ingredient (“API”) and methods for making the same. (See Dkt. No. 1-1 at Abstract (the ’616 Patent); Dkt. No. 1-2 at Abstract (the ’050 Patent).) On March 4, 2019, Apicore and Co-plaintiff Mylan Institutional LLC (“Mylan”) (collectively, “Plaintiffs”) filed a Declaratory Judgment Action Of Infringement based on the Asserted Patents against Beloteca for its intended “manufacture, use, offer to sell, sale, and/or import into the United States an [ISB] injection product” (the “Accused ISB Product”) corresponding to Abbreviated New Drug Application (“ANDA”) No. 210714. (Dkt. No. 1 ¶¶ 1–2.)1,2 Beloteca submitted ANDA No. 210714 to the Food and Drug Administration (“FDA”) on July 26, 2017, and the FDA approved ANDA No. 210714 on January 16, 2019. (Dkt. No. 37-3;

Beloteca, Inc. v. Apicore US LLC, No. 1:19-cv-00360 (N.D. Ill. Jul. 26, 2017) (the “Illinois Action”), Dkt. No. 1 ¶ 27.) One day later, Beloteca filed a declaratory judgment action of non- infringement and invalidity in the Northern District of Illinois directed to the ’616 Patent, the ’050 Patent, and U.S. Patent No. 7,662,992 (the “’992 Patent”).3 (Illinois Action, Dkt. No. 1 ¶ 1.) Apicore is a Delaware limited liability company with a place of business at 49 Napoleon Court, Somerset, New Jersey 08873. (Dkt. No. 1 ¶ 6.) Mylan is a Delaware limited liability company with a place of business at 1718 Northrock Court, Rockford, Illinois 61103. (Dkt. No. 1 ¶ 9.) Mylan is the exclusive licensee of the Asserted Patents for incorporating Apicore’s API into an ISB product. (Id. ¶ 29; see also Dkt. No. 5 at 3.) Mylan also filed and obtained an ANDA with the FDA based on the Asserted Patents. See Mylan Institutional LLC v. Aurobindo Pharma Ltd.,

857 F.3d 858, 863 (Fed. Cir. 2017). Although Mylan’s ISB API is designated by the FDA as the

1 Plaintiffs previously enforced the Asserted Patents against Aurobindo Pharma Ltd. (Aurobindo) for its entry into the ISB market, and Plaintiffs successfully obtained a preliminary injunction. See Mylan Institutional LLC v. Aurobindo Pharma Ltd., No. 2:16-cv-00491-RWS-RSP, Dkt. No. 101 at 16–20, 26–47 (E.D. Tex. Nov. 21, 2016), aff’d, Mylan Institutional LLC v. Aurobindo Pharma Ltd., 857 F.3d 858, 873 (Fed. Cir. 2017). 2 Plaintiffs contemporaneously filed a Motion for Temporary Restraining Order (the “TRO Motion”) asking this Court to issue a “temporary restraining order prohibiting Beloteca from engaging in the commercial manufacture, use, offer to sell, or sale within the United States of, or importing into the United States their ISB product, while the parties undergo expedited discovery and the Court resolves a motion for preliminary injunction.” (Dkt. No. 5 at 24.) Since Beloteca agreed to not launch the Accused ISB Product until June 5, 2019, (Dkt. No. 19), the Court advised the parties that the TRO Motion would be treated as a request for a preliminary injunction. Plaintiffs subsequently filed a Supplemental Motion for Preliminary Injunction (the “Supplemental Motion”) (Dkt. No. 38), and Beloteca filed a Response to the TRO Motion and the Supplemental Motion (Dkt. No. 63). In view of the rulings herein, the Court leaves resolution of Plaintiffs’ request for injunctive relief to the transferee court. 3 Apicore also owns the ’992 Patent, which also covers a process for making ISB API. (Dkt. No. 5 at 3 n.4.) Although Plaintiffs have not asserted the ’992 Patent here, they expressly reserved the right to do so in the future. (Id.) Reference Standard4 product, the Asserted Patents were not listed in the FDA’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”).5,6 (See Dkt. No. 1 at ¶ 24.) Beloteca is a California corporation having a place of business at 10525 Vista Sorrento

Parkway, Suite 100, San Diego, California 92121. (Illinois Action, Dkt. No. 1 ¶ 3; Dkt. No. 21-1 ¶ 2 (Declaration of Fred Defesche, CEO of Beloteca).) Beloteca is not licensed to do business in Texas, does not have a registered agent in Texas, does not have a Texas Taxpayer Number, is not licensed with the Texas Department of State Health Services, and is not licensed as a distributor of prescription drugs sold in Texas. (Dkt. No. 21-1 ¶¶ 3, 7–9.) To market and sell the Accused ISB Product, Beloteca has entered into a sales, marketing, and distribution agreement (the “TruPharma Agreement”) with TruPharma, LLC (“TruPharma”), a Delaware limited liability company with its principal place of business in Florida. (Dkt. No. 37-6 at Background). Since February 3, 2016, TruPharma has been licensed to sell pharmaceutical drugs in Texas. (Dkt. No. 58-5 (Texas HHS website showing license).) Under the TruPharma Agreement, “TruPharma will

sell, market and distribute [Beloteca’s generic pharmaceutical products] on an exclusive basis in the Territory [i.e., United States].” (See Dkt. No. 37-6 at Background, § 1(y).) The TruPharma Agreement, which does not exclude Texas from the scope of the agreement, also requires TruPharma to “use all commercially reasonable efforts to market and distribute the Product(s) in the Territory” and to “use commercially reasonable efforts to maximize Net Profit.” (Id. § 3(a).)

4 A “[r]eference standard is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval.” 21 CFR § 314.3. 5 This is because Mylan was not a New Drug Application (“NDA”) filer and thus was not required to submit the Asserted Patents to the FDA for inclusion in the Orange Book. Cf. 21 C.F.R. § 314.53 (“Who must submit patent information. This section applies to any applicant who submits to FDA an NDA or an amendment to it . . . .”). The ISB product previously sold by the NDA filer (Covidien, Ltd.) is no longer commercially available. (Dkt. No. 1 ¶ 24.) 6 Since the Asserted Patents were not listed in the Orange Book, Beloteca was not required to—and did not—submit a paragraph IV certification along with ANDA No. 210714. (Dkt. No. 37 at 22.) In the instant Motion, Beloteca seeks dismissal of the above-styled case under Federal Rule of Civil Procedure 12(b)(2) and (3) for lack of personal matter jurisdiction, in favor of the forum corresponding to the first-filed action, and for improper venue. (Dkt. No. 21 at 2.) As an alternative to dismissal, Beloteca requests transfer pursuant to 28 U.S.C. § 1406

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