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 the generic drug
before the Court is Momenta's motion for certification of
an interlocutory appeal (Docket No. 159). For the following
reasons, that motion will be denied.
case has followed a long and protracted road to this point.
This action was filed in the Central District of California
in September, 2015. In December, 2015, Momenta filed a motion
to dismiss and a separate motion to transfer the case to the
District of Massachusetts based upon “substantial
overlap” of issues, claims, witnesses and evidence
between the instant case and the prior patent action in this
Court. The District Court for the Central District of
California allowed the motion to transfer and the case was
assigned to this session in January, 2016. Amphastar filed a
writ of mandamus to the Ninth Circuit Court of Appeals
(“the Ninth Circuit”) to revoke the transfer on
personal jurisdiction grounds and the Ninth Circuit denied
that petition in May, 2016.
July, 2016, this Court allowed Momenta's motion to
dismiss on the grounds that Amphastar's claims were
precluded by the Noerr-Pennington doctrine.
Amphastar appealed that order to the First Circuit Court of
Appeals (“the First Circuit”) which reversed the
order and remanded the case, directing this Court to consider
defendants' alternative arguments for dismissal. In
March, 2018, after careful consideration of those arguments,
this Court denied defendants' motion to dismiss.
April, 2018, defendants filed the pending motion for
certification of an interlocutory appeal, seeking a (second)
review by the First Circuit of this Court's disposition
of their motion.
Motion for Certification of an Interlocutory
District courts may certify an otherwise non-appealable order
for interlocutory review by the Court of Appeals if the order
1) involves a controlling question of law 2) as to which
there are grounds for a substantial difference of opinion and
3) an immediate appeal would materially advance the ultimate
termination of the litigation. 28 U.S.C. § 1292(b);
Carabello-Seda v. Municipality of Hormigueros, 395
F.3d 7, 9 (1st Cir. 2005). The First Circuit has emphasized
that interlocutory certification “should be used
sparingly and only in exceptional circumstances”.
Carabello-Seda, 395 F.3d at 9. Generally, the First
Circuit will not certify interlocutory appeals from a denial
of a motion dismiss. Id. Interlocutory appeals may
be necessary, however, “in long-drawn-out cases, such
as antitrust and conspiracy cases.” Milbert v.
Bison Lab., 260 F.2d 431, 433 (3d Cir. 1958) (citing
House Report No. 1667, 85 Cong. 2d Sess., pp. 1, 2).
contends that interlocutory review is appropriate here to
resolve two controlling questions of law. Momenta submits
that the First Circuit has not yet considered (1) whether
antitrust liability in the standard-setting context requires
that the alleged misconduct cause the standard-setting
organization to eliminate alternative technologies and (2)
whether antitrust plaintiffs must allege that the
standard-setting organization would not have adopted the
patented technology but for the defendant's
disputes whether there is a difference of opinion on a
controlling question of law. It asserts that the allegations
in the complaint are consistent with well-established
precedent that deception before a standard-setting
organization which leads to the exclusion of competitors can
form the basis for antitrust liability. Amphastar emphasizes
that (1) the question of whether or not the adoption of the
207 Method by the United States Pharmacopeial Convention
(“USP”) represented a mandatory method is a
factual dispute not appropriate for resolution at the motion
to dismiss stage and (2) Momenta's second proposed
question on causation is also fact-intensive because it
depends on the existence of alternative technologies in the
of an interlocutory appeal from a denial of a motion to
dismiss is disfavored in the First Circuit.
Caraballo-Seda, 395 F.3d at 9 (citing In re
Heddendorf, 263 F.2d 887, 889 (1st Cir. 1959) (noting a
general preference against “piecemeal”
litigation)). In denying Momenta's motion to dismiss, the
Court determined that Amphastar had plausibly alleged that
the 207 Method had been made mandatory by the USP's
adoption of the method and the FDA's subsequent
incorporation of the method into the approval process. The
Court noted that the question of whether the method was
mandatory, such that it created the requisite lock-in to
create antitrust liability under Broadcom Corp. v.
Qualcomm, Inc., 501 F.3d 297, 315-17 (3d Cir. 2007), was
a fact-intensive question that could not be resolved at the
motion to dismiss stage. Amphastar has sufficiently alleged
that the adoption of the 207 Method resulted in a lock-in of
competitors through the standard-setting process and whether
a lock-in did in fact occur will turn on the factual
development in the case. See, e.g., Johansen v.
Liberty Mutual Grp., Inc., 15-cv-12920, 2017 WL 937712,
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