Ethypharm S.A. France v. Abbott Laboratories
2013 U.S. App. LEXIS 1567
| 3rd Cir. | 2013Background
- Ethypharm S.A. France developed fenofibrate Antara and used Reliant Pharmaceuticals as the US exclusive distributor under a Development, License, and Supply Agreement (DLS).
- Reliant obtained FDA approval for Antara under § 505(b)(2) and marketed it in the United States, with Ethypharm providing the drug and know‑how but not direct US sales.
- Abbott filed patent litigation against Reliant; the parties settled in 2006 with a Settlement Term Sheet granting Reliant a non‑exclusive license to certain patents in exchange for royalties, and Abbott’s consent restrictions limited assignments to Restricted Entities.
- Reliant later sold Antara rights to Oscient; Ethypharm declined its right of first refusal, and Abbott blocked broader assignment, limiting future licensees to specific Abbott patents.
- Antara’s market share in the US declined dramatically after Oscient’s bankruptcy and subsequent Lupin acquisition; Ethypharm sued Abbott in district court claiming antitrust and state law injuries, including a lack of antitrust standing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is Ethypharm barred from antitrust standing? | Ethypharm argues it directly competes via finished fenofibrate product and thus is a competitor in the US market. | Abbott contends Ethypharm cannot compete in the US fenofibrate market and lacks antitrust injury. | Ethypharm lacks antitrust standing; not a US competitor and injuries not the type antitrust laws protect. |
| Does the inextricably intertwined exception apply? | Ethypharm contends its injury is intertwined with Abbott’s conduct. | Exception limited to cases where both parties sell in the same market with direct competition. | Exception does not apply; Ethypharm cannot compete in the US fenofibrate market, so injuries are not inextricably intertwined. |
| Should other AGC standing factors be reached? | If standing is shown, other AGC factors would support relief. | Standing failed, so other factors need not be addressed. | Not reached; holding that standing is lacking suffices to dispose of federal claims. |
Key Cases Cited
- Associated Gen. Contractors of California, Inc. v. California State Council of Carpenters, 459 U.S. 519 (U.S. 1983) (establishes AGC factors for antitrust standing)
- Barton & Pittinos, Inc. v. SmithKline Beecham Corp., 118 F.3d 178 (3d Cir. 1997) (drug market plaintiff must be a competitor in the market to have standing)
- Carpet Group Intl. v. Oriental Rug Importers Ass’n, Inc., 227 F.3d 62 (3d Cir. 2000) (antitrust standing where direct competition exists; cross‑elasticity of demand)
- Gulfstream III Associates, Inc. v. Gulfstream Aerospace Corp., 995 F.2d 425 (3d Cir. 1993) (discusses inextricably intertwined antitrust injury)
- West Penn Power Co. v. Western Pennsylvania Power Co., 147 F.3d 264 (3d Cir. 1998) (articulates AGC factors and standing analysis)
- Blue Shield of Virginia v. McCready, 457 U.S. 465 (U.S. 1982) (foundational discussion of “inextricably intertwined” injury)