Background
Celgene Corporation markets pomalidomide, a drug for treating multiple myeloma, under the brand name Pomalyst. In 2017, Mylan Pharmaceuticals Inc. (MPI) submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to sell a generic version of Pomalyst. As required by the Hatch-Waxman Act, Mylan sent Celgene a Paragraph IV certification letter — a formal notice that Mylan contended Celgene’s Orange Book-listed patents were either invalid or would not be infringed by the generic product.
Celgene filed suit in the District of New Jersey — where Celgene is headquartered — alleging patent infringement under the Hatch-Waxman Act’s 35 U.S.C. § 271(e)(2), which makes the submission of an ANDA for a patented drug an act of infringement. Mylan moved to dismiss for improper venue. MPI is based in West Virginia, not New Jersey, and none of the Mylan entities had a regular and established place of business in New Jersey. The district court dismissed the case.
The Court’s Holding
The Federal Circuit affirmed. Writing for a unanimous panel, Judge Prost held that under 28 U.S.C. § 1400(b) — the patent venue statute as interpreted by the Supreme Court’s 2017 TC Heartland decision — venue in an ANDA infringement suit is proper only where the defendant committed an act of infringement and has a regular and established place of business. The relevant act of infringement for a Hatch-Waxman case is the submission of the ANDA, which occurred in West Virginia where MPI is headquartered, not in New Jersey.
Celgene argued that venue should also be proper in New Jersey because that’s where it received Mylan’s Paragraph IV notice letter — a document Mylan is legally required to send under the Hatch-Waxman Act. The Federal Circuit rejected this argument: receiving a mandatory notice letter is not part of the act of infringement and cannot independently supply the venue anchor that § 1400(b) requires. Similarly, the court rejected Celgene’s argument that venue was appropriate based on where Mylan might eventually distribute its generic drugs — future infringement by future distribution is not the act of infringement that Hatch-Waxman creates.
Key Takeaways
- In Hatch-Waxman ANDA cases, the act of infringement under 35 U.S.C. § 271(e)(2) is the submission of the ANDA, so venue is proper where the ANDA was submitted and where the defendant has a regular place of business.
- Receipt of a Paragraph IV notice letter by the patent holder does not establish venue in the patent holder’s home district.
- Anticipated future distribution of a generic drug does not create venue in the states where those drugs will be sold.
- Brand pharmaceutical companies must litigate Hatch-Waxman cases in districts where the generic company has a substantial presence — which is often not the brand’s preferred home forum.
Why It Matters
Celgene v. Mylan resolved a recurring question in Hatch-Waxman litigation: given the Supreme Court’s 2017 TC Heartland decision restricting patent venue, where can brand-name pharmaceutical companies bring suit when a generic competitor files an ANDA? The answer is now clear: look to where the ANDA was filed and where the generic company has a place of business — not to where the brand is headquartered or where it received the notice letter.
This ruling forced many brand pharmaceutical companies to rethink their litigation strategies. Companies headquartered in New Jersey, California, or other state-friendly forums can no longer automatically sue generic competitors there. Instead, they must file in districts like West Virginia, Pennsylvania, or wherever the generic manufacturer is actually based. This decision, combined with TC Heartland, has substantially shifted the geography of ANDA patent litigation away from historically plaintiff-friendly forums.