Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.
686 F.3d 1348
| Fed. Cir. | 2012Background
- This is a patent dispute over a generic enoxaparin (Lovenox) product and the scope of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1).
- Momenta holds the '886 patent on analysis methods for sulfated polysaccharides; Amphastar seeks to manufacture and sell enoxaparin under an ANDA.
- District court granted Momenta a preliminary injunction based on alleged infringement of the '886 patent by Amphastar's batch testing.
- Amphastar argues its testing is protected by § 271(e)(1) because it is reasonably related to FDA regulatory information; the district court disagreed.
- This appeal asks whether post-approval testing (batch testing required for continued FDA approval) falls within the safe harbor.
- The Federal Circuit vacates the preliminary injunction and remands for reconsideration consistent with the proper interpretation of § 271(e)(1).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Scope of § 271(e)(1) | Momenta: safe harbor only preapproval activities. | Amphastar: safe harbor extends to post-approval testing essential to FDA requirements. | Safe harbor covers post-approval testing related to FDA requirements. |
| Submission requirement | Momenta: information must be submitted to FDA. | Amphastar: records/batch testing constitute information submitted under federal law and are exempt. | Submissions include post-approval testing and related batch records under FDA regulatory process. |
| Classen precedent | Momenta: Classen bars safe harbor for information routinely reported post-approval. | Amphastar: Classen does not control post-approval testing mandated by FDA. | Classen does not bar post-approval testing from safe harbor when tied to FDA requirements. |
| Post-approval activity as infringement | Momenta: Amphastar's use of patented method in manufacturing infringes. | Amphastar: uses are within safe harbor because they produce information for regulatory submission. | Likelihood of infringement not shown; post-approval testing falls within safe harbor. |
| Remedy | Momenta seeks to preserve injunction to protect patent rights. | Amphastar seeks dissolution of injunction given safe harbor. | Preliminary injunction vacated; remand for further proceedings. |
Key Cases Cited
- Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (U.S. 2005) (safe harbor extends to preclinical research reasonably related to regulatory submission)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (U.S. 1990) (expansive view of federal regulatory scheme scope for § 271(e)(1))
- Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) (safe harbor not extend to information routinely reported post-approval)
- Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997) (geared toward standard for evaluating preliminary injunctions)
- Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984) (pre-1984 Roche view reversed by Hatch-Waxman)