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In a November 5 opinion, the Federal Circuit reaffirmed in Celgene v. Mylan that venue for domestic entities in Hatch-Waxman disputes resides where the act of preparing the ANDA occurred or where it is submitted – neither of which was in New Jersey where the case was filed.  Here, Celgene initiated its action against Mylan Inc. and Mylan Pharmaceuticals, both West Virginia corporation, and Mylan N.V., a foreign entity.  The domestic Mylan companies asserted improper venue and Mylan N.V. asserted a failure to state a claim, and the district court and ultimately the Federal Circuit agreed.

Starting with venue, the Court articulated the venue standards arising from 28 U.S.C. § 1400(b) and the burden placed on the plaintiff.  Because Celgene did not argue that the Mulan defendants resided in New Jersey, the arguments centered on whether Celgene’s evidence sufficiently demonstrated that the domestic entities “committed acts of infringement” in New Jersey.  Looking to Valeant v. Mylan, 978 F.3d 1374, 1381-83 (Fed. Cir. 2020), the Court reiterated that “it is the submission of the ANDA and only the submission that constitutes an act of infringement in this context.”  (Slip Op. at 9).  The Court noted that venue could not be shown through reliance on future contemplated conduct.

Celgene offered two primary arguments to support New Jersey venue: (1) the nationwide effect of an ANDA filing and (2) the fact that Mylan sent a notice letter to Celgene’s New Jersey office.  The Court (like the district court) rejected both.  First, the Court held that Valeant put the nationwide effect of ANDA infringement to bed.  Second, the panel note that the statutory mandate of the Paragraph IV notice letter.  Celgene argued that the notice letter is part and parcel of the ANDA submission and therefore is part of the act of infringement.  The Court disagreed.  Rather, the infringement required under the Hatch-Waxman statute is complete upon submission, and later acts, like the notice letter, do not change the infringement.  The Court also held that Celgene’s evidence of contacts with New Jersey were too minimal to support venue. Finally on venue, the Court refused to impute a defunct Mylan company’s offices as venue support for use against the Mylan domestic entities under an alter ego theory.  The Court noted that while there was evidence of ownership, there was no evidence showing a lack of corporate separateness that would impute New Jersey residence to the domestic entities.  (Slip Op. at 22).

The Court then affirmed the district court’s determination that the complaint failed to state a claim against Mylan N.V.  The opinion framed the question as whether Celgene had sufficiently pled facts demonstrating that (1) Mylan N.V. was actively involved in the ANDA filing or (2) whether MPI (the ANDA filer) acted as Mylan N.V.’s alter ego.  The Court rejected both challenges.  In short, none of Celgene’s evidence demonstrated that the foreign entity had acted in the preparation or filing of the ANDA.  With respect to the alter ego allegations, the Court held that the conclusory assertions in the complaint of control were simply too thin to bring Mylan N.V. to court.

The key takeaways from the Celgene case are that (1) it is the ANDA submission that is the focal point of the venue analysis in the Hatch-Waxman context for domestic entities, (2) an after-submission notice letter sent to the jurisdiction will be insufficient to establish venue, and (3) complaint against foreign entities must include a clear indication through plausible pleadings that the company has had actual involvement in the preparation and submission of the ANDA.

If you have questions, please contact Philip L. Hirschhorn at or (215)-965-1257.

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