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Ethypharm S.A. Fr. v. Abbott Labs.

United States Court of Appeals for the Third Circuit

September 25, 2012, Argued; January 23, 2013, Filed

No. 11-3602

Opinion

 [*225]  OPINION OF THE COURT

JORDAN, Circuit Judge.

Ethypharm S.A. France ("Ethypharm") appeals the judgment of the United States District Court for the District of Delaware granting Abbott Laboratories ("Abbott") summary judgment on Ethypharm's antitrust and state law claims. Although the District Court ruled in Abbott's favor, it had earlier denied Abbott's motion  [**2] to dismiss, a motion premised on the assertion that Ethypharm lacked standing to bring antitrust claims under §§ 1 and 2 of the Sherman Antitrust Act. Abbott has pressed its standing argument on appeal, and we conclude that the District Court erred in holding there is antitrust standing in this case. Because Ethypharm's state law claims have not been argued on appeal, the District Court's judgment on those claims will remain undisturbed, but we will vacate the District Court's grant of summary judgment as to the federal claims and will remand with directions that they be dismissed for Ethypharm's lack of standing.

I. Background

A. Facts1

Ethypharm is a privately held French corporation that develops and manufactures  [*226]  pharmaceutical drug products. The drug at issue in this case is a fenofibrate2 developed and manufactured by Ethypharm and carrying the brand name Antara®. Because, as Ethypharm observes, entry into the United States pharmaceutical market requires "substantial time and resources," it does not sell Antara directly in the United States. (J.A. at 122.) Instead, its business model was to "enter into a license and distribution agreement with a company in the United States." (J.A. at 122.) Thus, in 2001, it entered into a Development, License, and Supply Agreement ("DLS") with Reliant Pharmaceuticals, Inc. ("Reliant"), an American company, pursuant to which Reliant would sell Antara in this country. The DLS stated that Ethypharm would provide Reliant with the finished pharmaceutical product, or, at Reliant's option, the drug in bulk, which could then be encapsulated.

Reliant "was responsible for obtaining regulatory approval for the drug, preparing appropriate packaging material, and then marketing the drug through the efforts of a large, motivated, and experienced sales force." (J.A. at 122.) To that end, the DLS granted exclusive rights to Reliant in the United States and allowed it to seek approval with the U.S. Food and Drug Administration ("FDA") to market and sell Antara.3 Ethypharm explains in its Complaint4 that Reliant's role in exclusively marketing, selling, and obtaining FDA approval for Antara was critical because, without the "mechanism of the license and distribution agreement, Ethypharm would be foreclosed from the United States market." (J.A. at 122.) Thus, without Reliant's, or some similar distributor's, willingness to take on the risk and expense of gaining FDA approval and marketing Antara, the drug could never have reached the United States market.

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707 F.3d 223 *; 2013 U.S. App. LEXIS 1567 **; 2013-1 Trade Cas. (CCH) P78,232; 2013 WL 238794

ETHYPHARM S.A. FRANCE, Appellant v. ABBOTT LABORATORIES

Prior History:  [**1] On Appeal from the United States District Court for the District of Delaware. (D.C. No. 08-cv-00126). District Judge: Hon. Sue L. Robinson.

Ethypharm S.A. France v. Abbott Labs., 805 F. Supp. 2d 59, 2011 U.S. Dist. LEXIS 93879 (D. Del., 2011)

CORE TERMS

antitrust, manufacturer, patent, FDA, pharmaceutical, Entity, fenofibrate, competitor, offerings, license, vaccine, compete, rights, nursing home, marketing, branded, pharmacists, anti trust law, anticompetitive, distributor, consumers, retailers, Products, generic, inextricably intertwined, relevant market, oriental rug, Sales, drugs, summary judgment

Antitrust & Trade Law, Private Actions, Standing, Sherman Act, Civil Procedure, Appeals, Standards of Review, General Overview, Responses, Defenses, Demurrers & Objections, Motions to Dismiss, Regulated Practices, Intellectual Property, Consumer Protection, Regulated Industries, Sherman Act, Scope, Monopolization Offenses, Appellate Briefs, Reviewability of Lower Court Decisions, Preservation for Review, De Novo Review, Pleadings, Complaints, Requirements for Complaint, Jurisdiction, Subject Matter Jurisdiction, Constitutional Law, Case or Controversy, Prioritizing Resources & Organization for Intellectual Property Act, Requirements, Remedies, Governments, Courts, Judicial Precedent, Federal Government