Efinaconazole - USA

On Nov. 05, 2020 Federal Circuit affirmed-in-part district court’s interpretation of proper venue in Hatch-Waxman cases.

Mylan (Mylan Pharmaceuticals Inc. (MPI)/ Mylan Laboratories Ltd.(MLL)/ Mylan Inc.) in Jun.2018 filed ANDA with  USFDA to market generic version of Jublia®. Plaintiff (Valeant pharma / Dow pharma) on Sep 26, 2018 filed suit in New Jersey district court. The next day, Valeant filed an essentially identical protective suit against Mylan in the Northern District of West Virginia. In Jan. 2019, Mylan moved to dismiss Valeant’s New Jersey District Court complaint against MPI and Mylan Inc. for improper venue pursuant to Federal Rule of Civil Procedure 12(b)(3). Mylan argued that venue was improper under § 1400(b) because no Mylan defendant resides in New Jersey, the only alleged act of infringement—submission of the ANDA—did not occur in New Jersey, and the Mylan defendants do not have regular and established places of business in New Jersey. In response, Valeant argued that it is unduly narrow to limit “an act of infringement” under § 1400(b) to the act of submitting the ANDA. Valeant contended that “the Court must consider Mylan’s planned, future acts.” In August 2019, the district court granted Mylan’s motion to dismiss the complaint against all defendants based on improper venue. Valeant appealed.

Federal Circuit said that under Hatch-Waxman cases, it is an act of infringement to submit an ANDA (artificial infringement). Federal Circuit further said that the question in this appeal, therefore, is whether the act of infringement identified in § 1400(b) occurs only when and where an ANDA-filer submits its ANDA to the FDA or occurs wherever future distribution of the generic is contemplated. Court said that they are bound by the decision of Supreme Court in “TC Heartland”. Court said that both parties agreed that § 1400(b) requires a past act of infringement.  Specifically, “has committed acts of infringement,” a present perfect phrase, counsels that the acts accused of infringement must have already occurred.  However, in Hatch-Waxman cases no actual infringement occurs. Therefore, it is the submission of the ANDA, and only the submission, that constitutes an act of infringement in this context.  Since, MPI has not submitted ANDA from New Jersey, it not a proper venue for this case. Proper venue would be West Virginia from where MPI submitted an ANDA, as district court correctly found. Distribution of product in future has no relevance here. Therefore, it does not matter if future sell would occur in New Jersey. Venue is proper only in those districts that are sufficiently related to the ANDA submission—in those districts where acts occurred that would suffice to categorize those taking them as a “submitter” under § 271(e).

Federal Circuit reversed with respect to the entity, MLL. Court said that as this is a foreign entity, it is subject to venue in any judicial district, including the District of New Jersey. Whether MLL can be held answerable to claims of infringement in this case turns on whether MLL’s involvement in the submission of the ANDA is sufficient for it to be considered a “submitter,” and thus, amenable to suit. The district court’s conclusion dismissing the complaint as to all defendants after only evaluating Mylan’s venue argument is, therefore, incongruous. Federal Circuit, thus, reversed the district court’s venue-based dismissal of MLL and remanded for further consideration.