AMPHASTAR PHARMACEUTICALS INC.; INTERNATIONAL MEDICATION SYSTEMS LTD., Plaintiffs, Appellants,
MOMENTA PHARMACEUTICALS, INC.; SANDOZ INC., Defendants, Appellees.
FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS [Hon. Nathaniel M. Gorton, U.S. District Judge]
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.
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
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.
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.
Howard, Chief Judge, Lynch and Lipez, Circuit Judges.
HOWARD, Chief Judge.
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
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.
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.
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.
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).
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, ...