Motion for limited expedited discovery.
This seems to be the only substantive document filed. There is a affidvit by an attorney with many exhibits but these are all public, like the FDA requirements for sameness, the label, Amphastar public annoucnements, etc.
Here is the argument section from the motion for discovery. MNTA sought this v. TEVA and was denied and in this argument they distinguish the denial of expedited discovery in the TEVA case.
II. ARGUMENT
Under Rule 26(d)(1) of the Federal Rules of Civil Procedure, a party must show good
cause to obtain expedited discovery before the Rule 26(f) Conference. Courts typically employ
one of two tests to evaluate whether good cause exists for expedited discovery: (1) a four-part
inquiry, akin to a preliminary injunction analysis, articulated in Notaro v. Koch, 95 F.R.D. 403,
405 (S.D.N.Y. 1982); or (2) the “reasonableness of the request in light of all the surrounding
circumstances.” Momenta Pharms., Inc. v. Teva Pharms. Indus. Ltd., 765 F. Supp. 2d 87, 89 (D.
Mass. 2011) (Gorton, J.). The First Circuit has not adopted either test, though this Court has
previously applied the reasonableness standard.2 Momenta Pharms., 765 F. Supp. 2d at 89.
Where, as here, a preliminary injunction is pending, “it makes sense to examine the discovery
request . . . on the entirety of the record to date and the reasonableness of the request in light of
2 Nonetheless, Plaintiffs would be entitled to limited expedited discovery under the four-part test as outlined in
Notaro v. Koch. Notaro v. Koch, 95 F.R.D. at 405. Factors relevant to the Notaro test are: (1) irreparably injury; (2)
probability of success on the merits; (3) connection between expedited discovery and the avoidance of irreparable
injury; and (4) evidence that injury will result without expedited discovery looms greater than the injury that the
defendant will suffer if the expedited relief is granted. As demonstrated in Plaintiffs’ Motion for Preliminary
Injunction, Plaintiffs are both likely to succeed on the merits and likely to suffer irreparable harm absent preliminary
injunctive relief. Since Plaintiffs are seeking limited expedited discovery to aid them in definitively proving that
they are entitled to preliminary relief, Plaintiffs risk significant irreparable harm should this motion be denied.
Further, the expedited discovery requested is extremely narrow and easily accessible to Defendants. Thus, any
minimal burden to Defendants in responding to Plaintiffs’ limited discovery is far outweighed by the risk of
irreparable harm to Plaintiffs.
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all of the surrounding circumstances.” Merrill Lynch, Pierce, Fenner & Smith v. O’Connor, 194
F.R.D. 618, 624 (N.D. Ill. 2000); see Semitool, Inc. v. Tokyo Electron Am., Inc., 208 F.R.D. 273,
275 (N.D. Cal. 2002).
A. Legal Standard
Under the “reasonableness” analysis, “[g]ood cause may be found where the need for
expedited discovery, in consideration of the administration of justice, outweighs the prejudice to
the responding party.” Semitool, Inc., 208 F.R.D. at 276. In determining whether good cause
exists, courts frequently consider factors analogous to those required in granting a motion for
preliminary injunction. McMann v. Doe, 460 F. Supp. 2d 259, 265 (D. Mass. 2006). These
factors include: (1) purpose for the discovery; (2) ability of discovery to preclude irreparable
harm; (3) movant’s likelihood of success on the merits; (4) burden of expedited discovery on
non-movant; and (5) degree of prematurity. See Momenta Pharms., 765 F.Supp. 2d at 89.
Courts also consider: (6) whether a preliminary injunction is pending; and (7) the breadth of the
requests propounded. American LegalNet, Inc. v. Davis, 673 F. Supp. 2d 1063, 1067 (C.D. Cal.
2009). “[C]ourts have recognized that good cause is frequently found in cases involving claims
of infringement and unfair competition.” Semitool, Inc., 208 F.R.D. at 276 (citing Benham
Jewelry Corp. v. Aron Basha Corp., No. 97-civ-3841-RWS, 1997 WL 639037 at *20 (S.D.N.Y.
Oct. 14, 1997)).
B. Plaintiffs are entitled to limited expedited discovery to definitively prove
their case for injunctive relief
In Momenta Pharms., Inc. v. Teva Pharms., Indus. Ltd., this Court denied Plaintiffs’
motion for expedited discovery holding that the motion was premature because Teva had not
released a generic enoxaparin product, Plaintiffs had not demonstrated irreparable harm, and
Plaintiffs had not filed a motion for preliminary injunction. Momenta Pharms., 765 F. Supp. 2d
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at 89. Each of the elements that the Court found lacking in Momenta v. Teva is unquestionably
present here: (a) Amphastar has FDA approval; (b) Amphastar and Watson have indicated that
they intend to launch their product in the fourth quarter (which begins October 1), causing
Plaintiffs irreparable harm through loss of reputation, goodwill, and price/market share erosion;
and (c) Plaintiffs have filed a Motion for a Temporary Restraining Order and Preliminary
Injunction. Expedited discovery motions are routinely granted where, as here, a preliminary
injunction motion is pending and the discovery is limited in scope, will allow the Court to reach
the core issues more quickly and imposes minimal burden on the opposing party. See, e.g.,
Wheeler v. HXI, LLC, 2010 WL 3023518 at *3; Wachovia Sec., L.L.C. v. Stanton, 571 F. Supp.
2d 1014, 1049 (N.D. Iowa 2008).
As set forth fully in Plaintiffs’ Motion for a Temporary Restraining Order and
Preliminary Injunction, Plaintiffs are likely to succeed on the merits of their infringement claims.
To secure FDA approval Amphastar had to demonstrate sameness with Lovenox®. To
demonstrate sameness Amphastar and IMS will almost assuredly have included Momenta’s
patented methods in their manufacturing process. Plaintiffs have gathered all the information
they could from publicly available sources; now they need to confirm the Defendants’ infringing
process with this narrowly focused discovery. Additionally, absent a preliminary injunction
preventing Defendants from launching their infringing generic enoxaparin product, Plaintiffs will
suffer immediate and irreparable harm in the market.
C. Requested expedited discovery is narrowly tailored, easily obtainable, and
minimally burdensome to Defendants.
A request for expedited discovery should be allowed when the scope of discovery is
narrow and central to a preliminary injunction motion, and the burden on the non-movant is
modest. See Wheeler, 2010 WL 3023518 at *2. Where the discovery request “is both
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‘particularized’ and ‘necessary . . . to prevent undue prejudice’ to plaintiffs” courts often grant
the expedited request. In re Websecure, Inc. Secs. Litig., No. 97-10662-GAO, 1997 WL 770414
at *4 (D. Mass. Nov. 26, 1997) (internal citations omitted).
The discovery requested by Plaintiffs is narrow, focused, and limited as much as possible
to ease any burden on Defendants. Plaintiffs seek production of:
1. Amphastar’s ANDA, including amendments to the ANDA, and any Drug Master
File for enoxaparin. The FDA requires Defendants to disclose in their ANDA and
DMF the processes Defendants use to manufacture generic enoxaparin.
2. Amphastar’s correspondence with the FDA regarding its ANDA. These
documents will contain information concerning Defendants’ manufacturing and
release testing methods.
3. Batch records (including certificates of testing and/or certificates of analysis) for
any batch of generic enoxaparin that has been produced, in whole or in part, by or
for Defendants since August 18, 2009. These documents will disclose the details
of any release testing that Defendants have conducted and will allow the Court to
determine whether Defendants’ enoxaparin was manufactured subsequent to the
date that Momenta’s '886 patent issued.
4. Documents sufficient to describe Defendants’ plans for launch and distribution of
commercial quantities of generic enoxaparin in the United States, including
anticipated launch dates.
This limited, early discovery will only minimally burden Defendants. This is not a
request for discovery that should require comprehensive and expensive document collection
efforts. To the contrary, by virtue of the FDA requirements, the requested documents are
necessarily readily accessible. See Semitool, Inc., 208 F.R.D. at 277. Defendants almost
certainly maintain separate regulatory files with their ANDA, Drug Master File, and FDA
correspondence. They will exist in electronic form in Defendants’ regulatory files allowing them
to be located and produced with limited effort. Similarly, the requested manufacturing records
and launch plans should be in readily accessible locations. The time period as to which batch
records are requested – August 2009 to the present – also is as limited as possible.
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The expedited discovery is necessary for Plaintiffs to protect themselves from irreparable
harm and protect their patent rights. Given Defendants’ imminent launch and the substantial
irreparable harm it will create, Plaintiffs plainly have an “urgent and compelling need for the
requested discovery.” Momenta Pharms., 765 F. Supp. 2d at 90.
III. CONCLUSION
For the foregoing reasons, the Court should grant Plaintiffs’ Motion for Limited
Expedited Discovery and order Defendants to respond to the First Requests for Production of
Documents and Things within fifteen days.
Respectfully submitted,
MOMENTA PHARMACEUTICALS, INC. and
SANDOZ INC.,
