Background
Valeant Pharmaceuticals North America LLC owned patents protecting Jublia®, an FDA-approved antifungal treatment for toenail infections. Mylan Pharmaceuticals Inc. and related entities filed an Abbreviated New Drug Application (ANDA) seeking FDA approval for a generic version of Jublia®, triggering a Hatch-Waxman lawsuit. Valeant filed its infringement suit in the District of New Jersey.
Mylan challenged venue, arguing that the only act of infringement in a Hatch-Waxman case — the submission of the ANDA to the FDA — occurred in West Virginia, where the domestic Mylan entity is headquartered, not in New Jersey. Valeant countered that because the generic drugs, if approved, would be distributed and sold in New Jersey, venue was proper there.
The district court agreed with Mylan and dismissed the case for improper venue. The question on appeal was what constitutes the “act of infringement” for venue purposes in a Hatch-Waxman case, following the Supreme Court’s 2017 decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, which tightened venue requirements for patent cases.
The Court’s Holding
The Federal Circuit affirmed the dismissal. The court held that in Hatch-Waxman litigation, the “act of infringement” for venue purposes under 28 U.S.C. § 1400(b) is the submission of the ANDA itself, not the future commercial manufacture or sale of the generic drug that would occur if the ANDA were approved. Under 35 U.S.C. § 271(e)(2), submitting an ANDA is a specially created act of infringement designed to give innovator companies a cause of action before any generic drug reaches the market. But because the act of infringement is the filing, venue is proper only where actions related to the ANDA submission occurred — typically where the generic company is headquartered or where the ANDA was prepared and filed.
The court emphasized that anticipated future sales or distributions of an approved generic do not constitute acts of infringement for venue purposes. Allowing venue wherever eventual sales might occur would essentially permit nationwide venue in any Hatch-Waxman case, circumventing the venue limitations the Supreme Court reinforced in TC Heartland.
Key Takeaways
- In Hatch-Waxman patent litigation, venue under 28 U.S.C. § 1400(b) is proper only where the ANDA submission occurred or where the ANDA filer is incorporated — not where the generic drug would be sold after approval.
- Generic drug manufacturers can use this ruling to defend against venue in districts that would be inconvenient or strategically unfavorable to them, forcing innovators to sue in the district where the ANDA submission originated.
- Branded pharmaceutical companies filing Hatch-Waxman suits after TC Heartland should identify where the generic defendant’s ANDA was submitted and where the defendant is incorporated when selecting venue.
- This decision closed a venue strategy that some branded companies had used: suing in districts where the generic product would eventually be sold as a proxy for where “infringement” would occur.
Why It Matters
Valeant v. Mylan was an important follow-on decision after the Supreme Court’s TC Heartland ruling, applying the new stricter venue framework to the specialized Hatch-Waxman pharmaceutical patent litigation context. Before this decision, courts had split over whether future sales of a proposed generic drug could support venue in a district, creating uncertainty about where to file Hatch-Waxman suits and where they could be defended.
The ruling has real practical consequences for pharmaceutical patent litigation strategy. By tying venue to the ANDA submission rather than anticipated sales, the decision means that most Hatch-Waxman cases must be filed in the home districts of major generic drug manufacturers, concentrating litigation in certain jurisdictions (like West Virginia, New Jersey, and Delaware) that are home to large generic pharmaceutical companies. It also reinforced the general principle that TC Heartland applies across patent litigation contexts, not just in non-pharmaceutical technology cases.