AstraZeneca AB v. Mylan Pharmaceuticals Inc.

CourtDistrict Court, D. Delaware
DecidedOctober 18, 2019
Docket1:18-cv-01562
StatusUnknown

This text of AstraZeneca AB v. Mylan Pharmaceuticals Inc. (AstraZeneca AB v. Mylan Pharmaceuticals 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
AstraZeneca AB v. Mylan Pharmaceuticals Inc., (D. Del. 2019).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ASTRAZENECA AB and : ASTRAZENECA : PHARMACEUTICALS LP, : Plaintiffs, : : Civil Action No. 18-1562-CFC Vv. : MYLAN PHARMACEUTICALS : INC. and 3M COMPANY :

Defendants. :

Michael P. Kelly, Daniel M. Silver, Alexandra M. Joyce, MCCARTER & ENGLISH, LLP, Wilmington, Delaware; Gary M. Rubman, Douglas A. Behrens, Anna Q. Han, COVINGTON & BURLINGTON LLP, Washington, District of Columbia Counsel for Plaintiffs Frederick L. Cottrell, I, Jason J. Rawnsley, Alexandra M. Ewing, RICHARDS, LAYTON & FINGER, P.A., Wilmington, Delaware; Shannon M. Bloodworth, PERKINS COIE LLP, Washington, District of Columbia; David L. Anstaett, Emily J. Greb, PERKINS COIE LLP, Madison Wisconsin Counsel for Defendants MEMORANDUM OPINION

October 18, 2019 Wilmington, Delaware

a aif F,. CONNOLLY, UNITED STATES DISTRICT JUDGE

Plaintiffs AstraZeneca AB and AstraZeneca Pharmaceuticals, LP (collectively, “AstraZeneca”) have sued Mylan Pharmaceuticals Inc. (“Mylan”) and 3M Company for patent infringement. Before me is Mylan’s motion to dismiss under Fed. R. Civ. P. 12(b)(3) for improper venue pursuant to 28 U.S.C. § 1400(b), D.I. 19, and 3M’s motion to transfer this case to the Northern District of West Virginia pursuant to 28 U.S.C. § 1404(a), or in the alternative, to dismiss the claims against it under Fed. R. Civ. P. 12(b)(7) for failure to join a party under Fed. R. Civ. P. 19, D.I. 32. The motions have been fully briefed. D.I. 20; D.I. 33; D.L 39; D.I. 49. Oral argument was held on October 10, 2019. For the reasons discussed below, I will deny Mylan’s motion to dismiss and grant-in-part and deny-in-part 3M’s motion to dismiss or transfer venue. I. BACKGROUND! AstraZeneca initiated this Hatch-Waxman action on October 11, 2018, accusing Mylan, Mylan Laboratories Limited, Mylan Inc., and Mylan N.V. of infringing United States Patent Nos. 7,759,328 (the “#328 patent”), 8,143,239 (the

1Tn considering a motion to dismiss for improper venue, I “accept as true all of the allegations in the complaint, unless those allegations are contradicted by the defendants’ affidavits.” Bockman v. First Am. Mktg. Corp., 459 F. App’x 157, 158 n.1 (3d Cir. 2012).

“#239 patent”), 8,575,137 (the “#137 patent”), and 7,967,011 (the #011 patent”). See DI. 1, 9 1. On December 19, 2018, AstraZeneca filed its First Amended Complaint, in which it added 3M as a defendant to the litigation. D.I. 13,95. On March 14, 2019, Mylan Laboratories Limited, Mylan Inc., and Mylan N.V. were dismissed as parties by stipulation and order. D.I. 46. On June 4, 2019, AstraZeneca filed its Second Amended Complaint, in which it added an additional patent to the lawsuit, United States Patent No. 10,166,247 (the “#247 patent”). See DI. 71,91. The Second Amended Complaint is the operative complaint in this lawsuit and the pleading to which Defendants’ pending motions apply. D.I. 68, {f (c)}(d). AstraZeneca Pharmaceuticals LP is the holder of New Drug Application (“NDA”) No. 021929, which covers its Symbicort Inhalation Aerosol product. DI. 71,98. Symbicort is administered through an inhaler and is “a prescription drug approved for the treatment of asthma . . . and maintenance treatment in patients with chronic obstructive pulmonary disease (‘COPD’) including bronchitis and emphysema.” Jd. Symbicort contains budesonide and formoterol fumarate dihydrate as its two active ingredients and is available in two dosages: 80 mcg budesonide/4.5 mcg formoterol fumarate dihydrate and 160 mcg budesonide/4.5

meg formoterol fumarate dihydrate. Id.

Mylan is the sole holder of Abbreviated New Drug Application (“ANDA”) No. 211699 and it seeks “FDA approval for a generic version of budesonide and formoterol fumarate dihydrate inhalation aerosol, 160/4.5 mcg and 80/4.5 mcg.” D.I. 20 at 2 (citing D.I. 21, J] 25-26); see also D.I. 71, § 21. 3M Drug Delivery System, a division of 3M, submitted the ANDA in June 2018. D.I. 21, 927. 3M also submitted the Paragraph IV certifications against the asserted patents. D.I. 41, Ex. B. On August 15, 2018, the FDA sent 3M a Paragraph IV acknowledgment letter and instructed 3M to provide notice of 3M’s Paragraph IV certification to AstraZeneca. Id., Ex. C at 1,2. On August 17, 2018, 3M allegedly transferred the ANDA to Mylan. D.I. 21, 928. On August 30, 2018, Mylan notified AstraZeneca of the ANDA and its intent to manufacture and sell a generic version of Symbicort. D.I. 41, Ex. J at 2. In the notice letter, Mylan stated that “Mylan submitted to the FDA an ANDA.” Jd., Ex. J at 3. According to a declaration submitted by Mylan and not challenged by AstraZeneca, “3M will manufacture the ANDA product for [Mylan]’ but “will not be involved in any marketing, promotion, distribution or sale of Mylan’s ANDA product.” D.I. 21, 729.

Il. DISCUSSION A. Mylan’s Motion to Dismiss Under Fed. R. Civ. P. 12(b)(3) Mylan moves to dismiss the case against it under Federal Rule of Civil Procedure 12(b)(3) for improper venue under § 1400(b). D.I. 19. Venue in patent infringement cases is controlled exclusively by 28 U.S.C. § 1400(b). See TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 8. Ct. 1514, 1518 (2017). Section 1400(b) provides that a patent infringement case “may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” 28 U.S.C. § 1400(b). Like its predecessor statutes, § 1400(b) “is intended to be restrictive of venue in patent cases compared with the broad general venue provision.” In re ZTE (USA) Inc., 890 F.3d 1008, 1014 (Fed. Cir. 2018). “(U]pon motion by the Defendant challenging venue in a patent case, the Plaintiff bears the burden of establishing proper venue.” Jd. at 1013. In considering a motion to dismiss for improper venue, courts “accept as true all of the allegations in the complaint, unless those allegations are contradicted by the defendants’ affidavits.” Bockman, 459 F. App’x at 158 n.1. Courts may also consider affidavits submitted by plaintiffs. See Bristol-Myers Squibb Co. v. Aurobindo Pharm USA Inc., 2018 WL 5109836, at *2 (D. Del. Oct. 18, 2018). Ifa

court determines that venue is improper, the court “shall dismiss, or if it be in the interest of justice, transfer such case to any district or division in which it could have been brought.” 28 U.S.C. § 1406(a); see also Belden Techs., Inc. v. LS Corp., 829 F. Supp. 2d 260, 272 (D. Del. 2010) (“A court may sua sponte cure jurisdictional and venue defects by transferring a suit under the federal transfer statutes, 28 U.S.C. §§ 1406(a)

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