Last year, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit confirmed that 28 U.S.C. § 1400(b) is the sole venue provision for domestic defendants in Hatch-Waxman actions.¹ On Friday 5 November 2021, the Federal Circuit provided even greater clarity on venue rules in such cases, concluding that, for venue purposes, only submission of the ANDA qualifies as an act of infringement, not any action related to the submission.²

In 2017, Mylan Pharmaceuticals (MPI) submitted an ANDA for a generic pomalidomide and included a paragraph IV certification as to Celgene’s four Orange-Book-listed patents. Celgene sued MPI, Mylan Inc., and Mylan N.V. in the District of New Jersey. After two years of venue-related discovery, the district court concluded that venue was improper as to the domestic defendants and that Celgene had failed to state a claim against Mylan N.V.

On appeal, Celgene argued that venue was proper because MPI and Mylan Inc. had committed acts of infringement in New Jersey. In Celgene’s view, these acts included “artificial acts of infringement stemming from the ANDA submission extend[ing] nationwide” and, second, MPI’s transmittal of a paragraph IV notice letter to Celgene in New Jersey. The Federal Circuit rejected both arguments. Valeant foreclosed the first because “[v]enue must be predicated on past acts of infringement,” meaning submission of the ANDA, not “wherever future distribution of the generic is contemplated.”³

As to the second argument, the Federal Circuit concluded that receipt of the mandatory notice letter is not part of the act of infringement for venue purposes. Celgene had argued that the notice letter was an essential part of the ANDA submission itself, but the court noted that both statute and regulations treated them as different things. For example, the ANDA applicant cannot send the notice letter until after the FDA confirms receipt of the ANDA, and the notice letter must state that the ANDA “has been submitted.”⁴ And the applicant need not send a copy of the notice letter to the FDA.⁵

Finally, the notice letter triggers a 45-day cutoff for the patentee to file suit and receive an automatic 30-month stay of FDA approval of the ANDA, but it does not trigger the cause of action itself. Thus, because sending the paragraph IV notice letter does not fall within “submitting” the ANDA, Celgene could not show that the Mylan defendants had committed acts of infringement in New Jersey.

The Federal Circuit’s Celgene decision is notable because it provides even greater clarity on what satisfies Section 1400(b)’s venue requirements in Hatch-Waxman cases. Only the act of submitting the ANDA itself will trigger venue—acts merely related to that submission are too attenuated for venue purposes.

Footnotes

1. 978 F.3d 1374, 1381–82 (Fed. Cir. 2020)

2. Celgene Corp. v. Mylan Pharms. Inc., No. 2021-1154 (Fed. Cir. Nov. 5, 2021)

3. Valeant, 978 F.3d at 1378–79

4. See 21 U.S.C. § 355(j)(2)(B), 21 C.F.R. § 314.95

5. 21 C.F.R. § 314.95(b)(3), (e)