AstraZeneca AB v. Mylan Pharms. Inc.

Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 18-1562-CFC, 2019 U.S. Dist. LEXIS 180264 (D. Del. Oct. 18, 2019) (Connolly, J.)

Drug Product and Patent(s)-in-Suit: Symbicort® (budesonide/formoterol fumarate dihydrate); U.S. Patents Nos. 7,759,328 (“the ’328 patent”), 8,143,239 (“the ’239 patent”), 8,575,137 (“the ’137 patent”), and 7,967,011 (“the ’011 patent”)

Nature of the Case and Issue(s) Presented: AstraZeneca sued various Mylan entities on Oct. 11, 2018. On Dec. 19, 2018, AstraZeneca filed a first amended complaint, adding 3M Company (“3M”) as a defendant. On Mar. 14, 2019, certain of the Mylan defendants were dismissed by stipulation and order. AstraZeneca was the holder of the NDA that covered Symbicort. Mylan was the sole holder of the ANDA seeking approval to make and sell a generic version of Symbicort. According to Mylan, 3M would have manufactured the ANDA product for Mylan but would not have been involved in any marketing, promotion, distribution or sale of Mylan’s ANDA product.

Mylan moved to dismiss under Fed. R. Civ. P. 12(b)(3) for improper venue pursuant to 28 U.S. C. § 1400(b) and 3M moved 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. The court denied Mylan’s motion to dismiss and granted-in-part and denied-in-part 3M’s motion to dismiss or transfer venue.

Why the Case Was Transferred to the N.D.W.V.: Turning first to Mylan’s motion, it was undisputed that (i) Mylan was a West Virginia corporation and did not “reside” in Delaware under § 1400(b); and (ii) Mylan did not have a regular and established place of business in Delaware. But AstraZeneca argued that venue was proper in Delaware for 3M because 3M was a Delaware corporation and therefore venue was also proper as to Mylan because: (i) Mylan was 3M’s successor-in-interest in the ANDA; (ii) Mylan was 3M’s agent; and (iii) Mylan and 3M had attempted to manipulate venue by devising a scheme through which they sought to deprive AstraZeneca of the ability to sue the party who submitted the ANDA in the district where it and AstraZeneca resided. The court disposed of all three arguments. It found that while Mylan accepted the responsibility to perform 3M’s duties under the ANDA, Mylan did not assume 3M’s place of residency in doing so. AstraZeneca’s pure agency argument failed because AstraZeneca had not established that the court should impute the residency of 3M to Mylan based on an agency relationship between 3M and Mylan. Finally, although Mylan’s communications with AstraZeneca could reasonably be described as deceptive and even manipulative insofar as they hid from AstraZeneca the role 3M played in the ANDA process, Mylan did nothing that deprived AstraZeneca of the ability to sue 3M—the party that submitted the ANDA—in Delaware. Thus, Delaware was an improper venue for Mylan. But in lieu of dismissal, the court transferred AstraZeneca’s claims against Mylan to the Northern District of West Virginia.

Turning next to 3M’s motion to transfer, the court weighed the various Jumara factors underlying its decision. Of the twelve Jumara factors, seven factors were neutral, one factor weighed against transfer, and four factors—defendant’s forum preference, the convenience of the parties as indicated by their relative physical and financial condition, practical considerations, and relative administrative difficulty due to court congestion—weighed in favor of transfer. Therefore, 3M’s motion to dismiss for failure to join Mylan as a party was rendered moot.