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Amphastar Pharmaceuticals Inc. v. Momenta Pharmaceuticals, Inc.

United States Court of Appeals, First Circuit

March 6, 2017

AMPHASTAR PHARMACEUTICALS INC.; INTERNATIONAL MEDICATION SYSTEMS LTD., Plaintiffs, Appellants,
v.
MOMENTA PHARMACEUTICALS, INC.; SANDOZ INC., Defendants, Appellees.

         APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS [Hon. Nathaniel M. Gorton, U.S. District Judge]

          Chul Pak, with whom Jonathan M. Jacobson, Jeffrey C. Bank, Daniel P. Weick, Seth C. Silber, Elyse Dorsey, Wilson Sonsini Goodrich & Rosati, P.C., Alan D. Rose, Sr., Meredith W. Doty, Michael L. Chinitz, and Rose Chinitz & Rose were on brief, for appellants.

          Robert S. Frank, Jr., with whom Robert M. Buchanan, Jr., Sophie F. Wang, Greta A. Fails, Choate Hall & Stewart LLP, Michael P. Kenny, Teresa T. Bonder, Matthew D. Kent, D. Andrew Hatchett, and Alston & Bird LLP were on brief, for appellees.

          Deborah L. Feinstein, Director, Bureau of Competition, Bradley S. Albert, Deputy Assistant Director, Bureau of Competition, Heather M. Johnson, Attorney, Bureau of Competition, Rajesh James, Attorney, Bureau of Competition, June Im, Attorney, Bureau of Competition, David C. Shonka, Acting General Counsel, Federal Trade Commission, Joel Marcus, Deputy General Counsel, Federal Trade Commission, and Imad D. Abyad, Attorney, Federal Trade Commission, on brief for amicus curiae Federal Trade Commission.

          David A. Balto, Bradley A. Wasser, Matthew C. Lane, and Law Offices of David A. Balto on brief for amici curiae Consumer Action, National Health Law Program, and United States Public Interest Research Group.

          Before Howard, Chief Judge, Lynch and Lipez, Circuit Judges.

          HOWARD, Chief Judge.

         Plaintiff-Appellant Amphastar Pharmaceuticals Inc. and its wholly owned subsidiary International Medication Systems Ltd. (collectively, "Amphastar") appeal from the district court's dismissal of their complaint alleging antitrust violations by Defendant-Appellees Sandoz Inc. ("Sandoz") and Momenta Pharmaceuticals, Inc. ("Momenta"). Amphastar and Sandoz are competitors in the United States market for generic enoxaparin, an anticoagulant. Momenta serves as Sandoz's contract laboratory.

         Amphastar's suit is predicated upon the defendants' alleged misrepresentations to the United States Pharmacopeial Convention ("USP"), a private standard-setting organization ("SSO") charged with ensuring the quality of drugs. According to the complaint, the defendants, in violation of a duty imposed by the USP, knowingly failed to disclose to the standard-setting body that a proposed method for testing generic enoxaparin might be covered by Momenta's pending patent application. The USP, in reliance on the defendants' misrepresentations, adopted the method, and the Food and Drug Administration ("FDA") required Amphastar to comply with it.

         The defendants promptly brought an infringement suit against Amphastar, resulting in a temporary restraining order ("TRO") and subsequent preliminary injunction prohibiting Amphastar from selling enoxaparin. Although the preliminary injunction was ultimately vacated, it did prevent Amphastar from selling its generic enoxaparin for a period of roughly three months.

         Amphastar responded with the instant suit under the Sherman Act, see 15 U.S.C. §§ 1, 2, seeking damages for profits lost during the pendency of the TRO and injunction. The district court dismissed Amphastar's complaint under the so-called Noerr-Pennington doctrine, which immunizes good-faith petitioning of government entities from antitrust liability. Because its Noerr-Pennington ruling was dispositive, the court expressly declined to address the defendants' other arguments for dismissal. We hold that the district court erroneously applied Noerr-Pennington. Accordingly, we reverse the dismissal of Amphastar's complaint and remand for the district court to consider the defendants' other arguments in the first instance.

         I.

         In reviewing the district court's dismissal under Fed.R.Civ.P. 12(b)(6), we take as true the facts from the well-pled allegations in Amphastar's complaint. See, e.g., In re Loestrin 24 Fe Antitrust Litig., 814 F.3d 538, 549 (1st Cir. 2016).

         In November 2003, Sandoz and Momenta entered into a collaboration agreement for the development and commercialization of enoxaparin. The agreement granted Sandoz an exclusive license to Momenta's (as yet unissued) United States Patent No. 7, 575, 886 ("'886 patent"). It also created heavy incentives to ensure that Sandoz remained the sole provider of generic enoxaparin, including milestone and profit share payments to Momenta. Sandoz benefited because, ...


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