AstraZeneca AB v. Mylan Pharms., Inc.

Symbicort® (budesonide and formoterol)

July 12, 2022

GENERICally Speaking

Case Name: AstraZeneca AB v. Mylan Pharms., Inc., No. 22-cv-35, 2022 WL 2707729 (N.D.W.V. July 12, 2022) (Bailey, J.)

Drug Product and Patent(s)-in-Suit: Symbicort® (budesonide and formoterol); U.S. Patent No. 11,311,558 (“the ’558 patent”)

Nature of the Case and Issue(s) Presented: On June 26, 2018, Mylan submitted an ANDA seeking approval to market a generic version of AstraZeneca’s Symbicort. Mylan submitted a paragraph IV certification to the then-in-existence Orange Book patents (“Round I Patents”). Thereafter, Mylan submitted an additional paragraph IV certification to a new-to-issue Orange Book patent (“Round II Patent”). Based on the court’s claim construction, the parties stipulated that Mylan did not infringe the Round I Patents. The court held a bench trial on the Round II Patent in May 2022.

The FDA granted final approval of Mylan’s ANDA on March 15, 2022. Shortly thereafter, the 558 patent issued on April 26, 2022. AstraZeneca filed suit on April 29, 2022, asserting infringement under 35 U.S.C. § 271(e)(2)(A). Mylan moved to dismiss, which the court denied.

Why AstraZeneca Prevailed: Mylan argued that §271(e)(2)(A) was inapplicable because the 558 patent was not even in existence when its ANDA was approved. More specifically, Mylan argued that AstraZeneca’s infringement claim under § 271(e)(2)(A) must fail because Mylan’s ANDA “was already approved before the 558 patent issued,” thereby mooting the requirement that it amend its ANDA to include a Paragraph IV certification to the 558 patent.

In response, AstraZeneca argued that (i) a paragraph IV certification is not a prerequisite to a § 271(e)(2) claim, (ii) that FDA approval does not bar assertion of claims under § 271(e)(2), and (iii) that the Court retained authority to award relief even absent a claim under § 271(e).

The court found that at the motion-to-dismiss phase, the Complaint “alleges enough facts to state a claim to relief that is plausible on its face for infringement under § 271(e)(2) because it identifies the ANDA and alleges that the proposed ANDA product will infringe.” The court additionally explained that “Plaintiffs’ Complaint [went] well beyond plausibility” and concluded that “Plaintiffs have sufficiently pled infringement on one or more claims of the 558 patent.”

Oren D. Langer


Managing Partner, New York Office

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