Federal Circuit Holds Venue For Hatch-Waxman Cases Is Proper Only Where Acts Sufficiently Related To The ANDA Submission Occur

In Valeant Pharmaceuticals v. Mylan Pharmaceuticals, No. 2019-2402 Nov. 5, 2020, the Federal Circuit answered a question of first impression relating to where “acts of infringement” occur for venue purposes in ANDA cases, a point not addressed by SCOTUS’s TC Heartland decision. The underlying facts were that Mylan sent an ANDA submission from its offices in West Virginia to the FDA’s office in Maryland but was sued by Valeant in the District Of New Jersey. The decision hinged on whether venue should be interpreted to include places where future acts of infringement may occur. The Court held: “[I]n Hatch-Waxman cases, venue is not proper in all judicial districts where a generic product specified in an ANDA is likely to be distributed. It 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).” The Court also indicated that a foreign defendant was properly subject to venue in any judicial district. The decision affirmed the district court’s decision to dismiss the case for improper venue as to Mylan’s West Virginia and Pennsylvania corporations, but remanded the case for further proceedings with respect to the Indian entity. 

Lerner David has been successfully litigating Hatch Waxman cases for its clients for over 30 years. 

The decision is accessible at: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2402.OPINION.11-5-2020_1681030.pdf