Allergan, Inc. v. Athena Cosmetics, Inc.
738 F.3d 1350
Fed. Cir.2013Background
- Athena Cosmetics marketed RevitaLash eyelash products containing prostaglandin derivatives; FDA has not regulated these products. Allergan sells FDA‑approved prescription drug Latisse (a prostaglandin derivative) for eyelash growth.
- Allergan sued Athena for patent infringement and for unfair competition under California Business & Professions Code § 17200, alleging Athena sold unapproved "new drugs" in violation of Cal. Health & Safety Code § 111550 (which incorporates FDCA definitions).
- The district court denied Athena’s motion that the FDCA preempted Allergan’s UCL claim, granted Allergan summary judgment that Athena’s products are drugs under California law, and entered a nationwide injunction barring sale/marketing of any "eyelash growth" products nationwide.
- Parties stipulated to summary judgment of noninfringement as to one patent (the ’105 patent) and later the patent claims were dismissed without prejudice; the Federal Circuit found it retains jurisdiction because the parties’ legal positions were altered by the earlier summary judgment ruling.
- The Ninth Circuit reviewed: held FDCA does not impliedly preempt the UCL claim; affirmed summary judgment that Athena’s objective intent made the products drugs; vacated and remanded the nationwide injunction as an abuse of discretion under the Commerce Clause and California law.
Issues
| Issue | Plaintiff's Argument (Allergan) | Defendant's Argument (Athena) | Held |
|---|---|---|---|
| Whether FDCA impliedly preempts Allergan's UCL claim | FDCA does not preempt; California law parallels FDCA and state enforcement is permissible | Claim is preempted under Buckman/PhotoMedex because it would interfere with FDA authority and depends on federal standards | FDCA does not impliedly preempt the UCL claim; state action not a clear conflict with federal purpose |
| Whether Athena's products qualify as "drugs" under California law (summary judgment) | Products are drugs because Athena objectively intended them to affect eyelash structure (marketing, founder statements, reseller training) | Genuine dispute exists about Athena's objective intent; later formulations and labeling limited to cosmetic appearance | No genuine dispute: evidence shows objective intent to cause eyelash growth; summary judgment for Allergan affirmed |
| Scope of injunction: whether a nationwide injunction was appropriate | Nationwide injunction needed because Athena marketed/sold nationwide and California injury is affected by out‑of‑state conduct | Nationwide injunction is impermissible extraterritorial application of California law and violates Commerce Clause | Nationwide injunction vacated; injunction must be limited to conduct occurring in California |
| Appellate jurisdiction (Federal Circuit) | Allergan: prior patent summary judgment altered legal relations preserving appellate jurisdiction | Athena: dismissal without prejudice of patent claims strips Federal Circuit jurisdiction | Federal Circuit has jurisdiction under 28 U.S.C. § 1295(a)(1) because prior summary judgment on the ’105 patent altered legal position |
Key Cases Cited
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (state law claims grounded solely on FDCA reporting requirements may be preempted)
- Wyeth v. Levine, 555 U.S. 555 (no implied preemption where state and federal requirements can coexist)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (presumption against preemption in traditional state police power areas)
- PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir.) (fraud‑on‑FDA claims implicating FDA’s enforcement authority may be preempted)
- Healy v. Beer Institute, Inc., 491 U.S. 324 (Commerce Clause bars extraterritorial application of state law)
- Chamberlain Grp. v. Skylink Techs., Inc., 381 F.3d 1178 (Fed. Cir.) (dismissal without prejudice may not divest appellate jurisdiction if parties’ legal positions changed)
- Sullivan v. Oracle Corp., 254 P.3d 237 (Cal.) (UCL not intended to operate extraterritorially)
- Columbia Pictures Indus., Inc. v. Fung, 710 F.3d 1020 (9th Cir.) (standard of review for injunctive relief scope)