United States District Court, D. Massachusetts
AMPHASTAR PHARMACEUTICALS, INC. and INTERNATIONAL MEDICATION SYSTEMS, LTD., Plaintiffs,
MOMENTA PHARMACEUTICALS, INC. and SANDOZ INC., Defendants.
MEMORANDUM & ORDER
NATHANIEL M. GORTON, UNITED STATES DISTRICT JUDGE
an antitrust case in which plaintiffs Amphastar
Pharmaceuticals, Inc. (“Amphastar
Pharmaceuticals”) and International Medication Systems,
“Amphastar” or “plaintiffs”) allege
that defendants Momenta Pharmaceuticals, Inc. (“Momenta
Pharmaceuticals”) and Sandoz Inc.
(“Sandoz”)(collectively, “Momenta” or
“defendants”) restricted trade and prevented
competition in the manufacture and sales of generic
before the Court are Momenta’s motion to dismiss the
complaint, which will be treated as a motion to dismiss the
amended complaint pursuant to the parties’ stipulation,
and Momenta’s request for judicial notice of certain
documents. For the following reasons, both motions will be
Amphastar Pharmaceuticals is a pharmaceutical company
presumably incorporated and doing business in California. It
develops, manufactures and sells pharmaceutical products
including generic enoxaparin throughout the United States.
Enoxaparin is an anticoagulant used to prevent blood clots.
IMS is a wholly-owned subsidiary of Amphastar Pharmaceuticals
with a principal place of business in California. It
manufactures the active ingredient in Amphastar’s
Momenta Pharmaceuticals is the assignee of United States
Patent No. 7, 575, 886 (“the ‘886 patent”)
which concerns a testing process used in manufacturing
enoxaparin. Momenta Pharmaceuticals acts as the contract
laboratory for defendant Sandoz and is a Delaware corporation
with a principal place of business in Massachusetts.
Sandoz distributes, markets and sells generic enoxaparin
products throughout the United States. It is a Colorado
corporation with a principal place of business in New Jersey.
It allegedly entered into a profit-sharing, contractual
relationship with Momenta which rendered it the exclusive
licensee of the ‘886 patent.
The alleged conduct
November, 2003, defendants entered into a Collaboration and
License Agreement (“Collaboration Agreement”) to
develop, market and sell “enoxaparin sodium
injection” in the United States. The Collaboration
Agreement granted an exclusive license of the ‘886
patent, which had not yet issued, to Sandoz. Plaintiffs claim
that the agreement “heavily” incentivized
anticompetitive behavior by requiring Sandoz to make
“milestone payments”, profit share payments and
royalty payments to Momenta Pharmaceuticals conditioned upon
defendants remaining the sole source of generic enoxaparin in
the United States.
before February, 2007, the United States Pharmacopeial
Convention (“USP”) commenced the process for
establishing a drug standard to test enoxaparin products. The
USP is a scientific and impartial nonprofit organization
which sets uniform standards for the identity, strength,
quality and purity of medicines, food ingredients and dietary
supplements. USP policy prohibits it from favoring one
manufacturer over another during the standard-setting process
and requires its committee members to disclose any conflicts
of interest to the organization. A member with a conflict
cannot attend the final discussion, deliberation or vote on
the conflicted issues.
(“Aventis”) proposed the standard known as USP
Method <207> (“the 207 Method”) to the USP.
Dr. Zachary Shriver (“Dr. Shriver”), an employee
and director of Momenta Pharmaceuticals who would later be
named as an inventor on the ‘886 patent, served as
Momenta’s representative on the USP panel tasked with
developing and approving the USP standard for enoxaparin.
Sandoz also participated in the panel discussions.
amended complaint alleges that Dr. Shriver and defendants
learned, during the USP’s consideration of the 207
Method, that Aventis had a pending patent application
containing claims which would read on the 207 Method.
Defendants purportedly demanded that Aventis abandon its
patent application so that any member of the public could
practice the enoxaparin standard adopted by the USP.
Plaintiffs proffer that demand as evidence that defendants
were “very familiar” with the 207 Method and the
USP policy on conflicts of interest.
November, 2008, the USP convened a panel meeting which
commenced with a review of the USP policy on conflicts.
Momenta Pharmaceuticals presented the 207 Method in a
“detailed” presentation to the USP. USP staff
reported that it was “not aware of any patent issue
that may cover the test”. Plaintiffs allege that
neither defendants nor Dr. Shriver, who was present at the
meeting, disclosed to the USP the conflicts posed by their
own pending application for the ‘886 patent and the
Collaboration Agreement. Plaintiffs assert that no other USP
panel member knew that the ‘886 patent, which
eventually issued in August, 2009, would cover the use of the
December, 2009, the USP approved and adopted the 207 Method
as its enoxaparin standard after Aventis agreed to abandon
its patent application. The USP convened two more panel
meetings in March and April of 2011. Plaintiffs claim that
Dr. Shriver and another Momenta representative participated
in the meetings and continued to violate their duty to
disclose their and defendants’ conflicts to the USP.
was the first entity to receive approval from the United
States Food and Drug Administration (“FDA”) to
sell generic enoxaparin in the United States in July, 2010.
Defendants thus became the sole source of generic enoxaparin
until Amphastar also received FDA approval to sell generic
enoxaparin in September, 2011. Plaintiffs allege that 1) the
FDA required them to comply with the 207 Method as a
condition of approval, 2) the 207 Method included steps
protected by the patented method, 3) the ‘886 patent
excluded unlicensed competitors from receiving FDA approval
and thus 4) the ‘886 patent excluded new entrants from
days after Amphastar received FDA approval, Momenta commenced
an action in this Court alleging that Amphastar infringed the
‘886 patent. Amphastar claims that the lawsuit
prevented it from selling generic enoxaparin in the relevant