In a recent order, Judge John Bailey from the Western District of Virginia denied Defendant Mylan’s 12(b)(6) motion to dismiss § 271(e) infringement claims despite the USPTO issuing Plaintiff AstraZeneca’s patent after the FDA approved Mylan’s ANDA. AstraZeneca AB v. Mylan Pharmaceuticals Inc_, 2022 U.S. Dist. LEXIS 123111. Mylan’s ANDA application was approved on March 15, 2022, while AstraZeneca’s patent, U.S. Patent No. 11,311,558 (the ’558 patent), directed to its asthma and COPD treatment Symbicort®, was issued on April 26, 2022. That same day, AstraZeneca filed its complaint.

Mylan, in support of the motion, argued that the ’558 patent was not in existence during the time in which the ANDA was awaiting FDA approval and that approval of the ANDA prior to the ’558 patent issuance mooted the need to amend the ANDA to include a Paragraph IV certification. Therefore, Mylan argued, the Hatch-Waxman Act does not apply.  In its motion, Mylan further cited caselaw from the District of New Jersey in which the plaintiffs’ patent was issued over two years after the ANDA was approved. Ferring B.V. v. Activis, Inc., 2016 U.S. Dist. LEXIS 69328, (D. N.J. May 26, 2016). The court in that case dismissed the claim, finding that the plaintiffs could not bring a 35 U.S.C. § 271(e)(2)(A) claim on the facts.

AstraZeneca, opposing the motion, argued that Mylan’s legal propositions were not supported by the text of § 271(e) nor by Federal Circuit precedent. AstraZeneca cited a District of Delaware case that rejected a motion to dismiss a claim that followed a fact pattern “indistinguishable” from the pattern here. Research Foundation v. Mylan Pharms., Inc., 2012 U.S. Dist. LEXIS 80737 (D. Del. May 25, 2012).

In a brief discussion, and without addressing either party’s arguments, Judge Bailey found that AstraZeneca alleged enough facts to state a claim that is plausible on its face for infringement under § 271(e)(2). Judge Bailey found that AstraZeneca identified the ANDA and alleged that the proposed ANDA products will infringe and denied the motion to dismiss, allowing the case to proceed.

Thanks to Keane Nowlan, Tulane University Law School student, for his contributions to this post.