Amphastar Pharmaceuticals, Inc. et al v. Momenta Pharmaceuticals, Inc. et al

Filing 167

Judge Nathaniel M. Gorton: ORDER entered. MEMORANDUM AND ORDER, denying 159 MOTION for Certification of an Interlocutory Appeal re 148 Memorandum & ORDER filed by Momenta Pharmaceuticals, Inc., Sandoz Inc..(Lima, Christine)

Case 1:16-cv-10112-NMG Document 167 Filed 06/01/18 Page 1 of 7

United States District Court
District of Massachusetts
)
AMPHASTAR PHARMACEUTICALS, INC. )
and INTERNATIONAL MEDICATION
)
SYSTEMS, LTD.,
)
)
Plaintiffs,
)
)
v.
)
)
)
MOMENTA PHARMACEUTICALS, INC.
)
and SANDOZ INC.,
)
)
Defendants.
)

Civil Action No.
16-10112-NMG

MEMORANDUM & ORDER
GORTON, J.
This is an antitrust case in which plaintiffs Amphastar
Pharmaceuticals, Inc. (“Amphastar Pharmaceuticals”) and
International Medication Systems, Ltd. (“IMS”)(collectively,
“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 enoxaparin.
Pending before the Court is Momenta’s motion for
certification of an interlocutory appeal (Docket No. 159).
the following reasons, that motion will be denied.

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I.

Procedural Background
This 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.
In 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.
March, 2018, after careful consideration of those arguments,
this Court denied defendants’ motion to dismiss.
In April, 2018, defendants filed the pending motion for
certification of an interlocutory appeal, seeking a (second)
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review by the First Circuit of this Court’s disposition of their
motion.
II.

Motion for Certification of an Interlocutory Appeal
A.

Legal Standard

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); CarabelloSeda 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).
B.

Application

Momenta contends that interlocutory review is appropriate
here to resolve two controlling questions of law.

Momenta

submits that the First Circuit has not yet considered
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(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 standardsetting organization would not have adopted the patented
technology but for the defendant’s misrepresentation.
Amphastar 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 wellestablished 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 marketplace.
Certification of an interlocutory appeal from a denial of a
motion to dismiss is disfavored in the First Circuit. CaraballoSeda, 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
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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, at *1 (D. Mass. March 7, 2017) (“A
controlling question of law usually involves a question of
meaning of a statutory or constitutional provision, regulation
or common law doctrine rather than an application of law to
facts.”) (quoting Ahrenholz v. Bd. Of Trs. of Ill., 219 F.3d
674, 676 (7th Cir. 2000)).
With respect to its second proposed question for
certification, Momenta maintains that Amphastar was required to
allege that alternative technologies existed and were considered
by the USP.

In denying Momenta’s motion to dismiss, this Court

held that Amphastar plausibly alleged that it was required to
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use the 207 Method to obtain FDA approval and that factintensive questions about the “feasibility, availability and
even existence” of alternative methods remained.

In Broadcom,

the Third Circuit Court of Appeals rejected the defendant’s
contention that specific allegations of an alternative method
were necessary to survive a motion to dismiss. Broadcom, 501
F.3d at 315 (noting that although defendant “makes much of the
Complaint’s failure to allege that there were viable
technologies competing . . . for inclusion in the [applicable]
standard”, the complaint sufficiently pled that the
organization’s adoption of the standard eliminated competing
technologies).

As that Court explained, even if the method in

question was “the only candidate for inclusion in the standard”,
the allegations that the method would not be selected but for
the relevant alleged deceptive conduct were sufficient to
survive a motion to dismiss. Id.
Accordingly, the two issues proposed by Momenta for appeal
do not represent controlling questions of law and both involve
questions of fact and the application of law to facts.

For that

reason, certification of an interlocutory appeal would not
materially advance the ultimate termination of this litigation
and is therefore inappropriate.

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ORDER
For the foregoing reasons, defendants’ motion for
certification of an interlocutory appeal (Docket No. 159) is
DENIED.

So ordered.

/s/ Nathaniel M. Gorton_____
Nathaniel M. Gorton
United States District Judge
Dated June 1, 2018

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