Biotech Values

[mouton29]

MNTA seems to have won some minor procedural motions in the District Court, the magistrate has found for them and ordered Amphastar to produce certain documents. Also, MNTA has filed an emergency motion to extend discovery and push back the trial date to January 2013, citing the delays in discovery. I have copied below the latest entries in the docket as well as the memo filed by MNTA in support of its motion to extent discovery. At the end of the motion is MNTA's proposed revised schedule.

06/12/2012 Magistrate Judge Robert B. Collings: ELECTRONIC ORDER entered granting in part 161 Motion to Compel. After hearing and a review of the numerous papers filed in connection with the motion, the Court allows the motion to the extent that the defendants are ORDERED, pursuant to Rule 37, Fed. R. Civ. P., to produce to counsel for the plaintiffs all documents sought by Requests ##5, 7, 11, 12 and 13 of Plaintiff's Second Set of Document Requests on or before the close of business on June 19, 2012. Any pages of documents previously produced in redacted form in response to these requests must be produced in unredacted form. As to any pages of any documents which were not previously produced, the defendants may redact in accordance with the Protective Order and disputes over the redactions shall be dealt with in accord with the procedures set forth in the Order. With respect to the complete ANDA (Request #5), the Court suggests that perhaps counsel can agree on a more expeditious method of dealing with those portions of the ANDA which the defendants claim are not relevant and contain highly confidential trade secret information. The suggestion is initially that defendants' counsel allow one or two of plaintiff's counsel to view the complete document (of which a copy would not be made) together with a redacted version which does not contain the purported irrelevant highly confidential trade secret information which the defendants would produce pursuant to the within order. In that manner, plaintiff's counsel can determine for themselves whether the material the defendants wish to withhold is material they consider relevant. Any material which plaintiff's counsel concedes is not relevant would not be produced and plaintiff's counsel would not have a copy of it. Any material which the plaintiff considered relevant and discoverable would be tagged and brought before the Court for resolution. (Entered: 06/12/2012)
06/13/2012 263 Emergency MOTION for Consideration and Relief Regarding Plaintiffs' Emergency Motion to Continue Fact Discovery and Trial Date for Limited Purposes [Plaintiffs' Motion for Emergency Consideration and Relief Regarding Plaintiffs' Emergency Motion to Continue Fact Discovery and Trial Date for Limited Purposes] by Momenta Pharmaceuticals, Inc., Sandoz Inc..(Murawski, Michael) (Entered: 06/13/2012)


UNITED STATES DISTRICT COURT
FOR THE DISTRICT OFMASSACHUSETTS
____________________________________________
)
MOMENTA PHARMACEUTICALS, INC. )
and SANDOZ INC., )
Plaintiffs, )
)
v. ) Civil Action No. 11-11681-NMG
)
AMPHASTAR PHARMACEUTICALS, INC., )
INTERNATIONALMEDICATION SYSTEMS, LTD.) Emergency Relief Requested
WATSON PHARMACEUTICALS, INC., and )
WATSON PHARMA, INC. )
Defendants. )
)
PLAINTIFFS’ EMERGENCY MOTION TO CONTINUE FACT
DISCOVERY AND TRIAL DATE FOR LIMITED PURPOSES
Pursuant to Fed. R. Civ. P. 40 and L.R. 40.3, Plaintiffs Momenta Pharmaceuticals, Inc.
and Sandoz, Inc. (collectively, “Momenta”) hereby move to continue fact discovery for limited
purposes, and to reschedule the trial date accordingly. As set forth herein, Defendants have yet
to produce documents under three motions to compel filed by Momenta, two of which the Court
has already granted and the third of which remains pending. The documents covered by these
motions are critical to numerous issues in this case, including infringement, the extent of
infringement, and damages. It is crucial for Momenta to receive, review and meaningfully use
these documents in depositions of Defendants that, under the current schedule, need to occur
before the close of fact discovery on June 25, 2012. In addition, these documents, and deposition
testimony concerning these documents, are necessary for expert reports that are due on July 9,
2012, almost immediately after fact discovery closes. For these reasons, and as more fully set
forth herein, Momenta respectfully requests that the Court adopt the Proposed Amended
Scheduling Order attached hereto as Exhibit A.
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 1 of 9
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Further grounds for this Motion are as follows:
1. This case is proceeding on an expedited basis. Fact discovery is currently
scheduled to close on June 25, 2012, less than two weeks from the date of this Motion. Initial
expert reports on infringement and damages are due on July 9, 2012, with related expert
deadlines quickly following. A pretrial conference is scheduled on September 25, 2012 at 3:00
p.m. Trial is currently scheduled to begin on October 9, 2012.
2. There have been no previous requests to extend the schedule in this case.
3. At the scheduling conference held on January 7, 2012, the Court noted that the
parties’ proposed Scheduling Order was “very aggressive,” and included an “aggressive
discovery schedule” for a large patent infringement case. Jan. 7, 2012 Hearing Tr., at 13, 19.
The case was scheduled on an expedited basis because of a preliminary injunction awarded to
Momenta on October 28, 2011. (D.I. 92). On January 25, 2012, however, the Federal Circuit
stayed this injunction pending appeal. Because the injunction has been stayed, Defendants will
suffer no prejudice by continuing the discovery deadlines or trial date as requested herein.
Further, Defendants will certainly suffer no unfair prejudice, given that the requested extension
is entirely necessitated by Defendants’ own failures to produce documents that this Court has
now found were improperly withheld.
4. Momenta has filed three (3) significant motions to compel discovery in this case.
The parties briefed and argued these motions before Magistrate Judge Collings on May 10, 2012
and June 4, 2012. Magistrate Judge Collings has acted expeditiously given the accelerated
schedule set in this case, but none of these motions has yet been fully resolved given the short
time frame: One of these three motions remains pending, and the other two motions, although
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 2 of 9
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recently granted by Magistrate Judge Collings, still await production of the documents by
Defendants as ordered by Magistrate Judge Collings.
5. As set forth below, the documents to be produced by Defendants under all three
motions to compel are critical to numerous issues in this case, including infringement, the extent
of infringement, and damages. All three of these motions concern documents that Plaintiffs need
to receive, review, and then use meaningfully in depositions of Defendants that must be
conducted before the close of fact discovery on June 25. Further, Momenta then needs to
evaluate and incorporate these documents and the related deposition testimony into its initial
expert reports on infringement and damages, due two weeks after the close of fact discovery.
6. The first motion, filed on March 12, 2012 (D.I. 161) (the “ANDA-Related
Motion”), sought production of Defendants’ Abbreviated New Drug Application(s) related to
enoxaparin (“ANDA”), related amendments and communications, and internal documents
relating to Defendants’ manufacturing release test procedures, analyses of 1,6-anhydro ring
structures, and analyses of tetrasaccharides. Yesterday, on June 12, 2012, Magistrate Judge
Collings granted the ANDA-Related Motion and issued an Order compelling Defendants to
produce “all documents sought by [Plaintiffs’ specific] Requests ##5, 7, 11, 12, and 13
[essentially all documents sought in the motion] . . . on or before the close of business on June
19, 2012.” 6/12/12 Order (emphasis in original). Thus, the Court agreed with Momenta that the
ANDA-Related documents to be produced by Defendants are relevant and were wrongfully
withheld. Additionally, the Court instructed the parties to resolve any remaining confidentiality
concerns regarding Defendants’ ANDA(s) by allowing Momenta’s counsel to view the ANDA(s)
themselves in their entirety, as well as redacted version(s), and then allowing Momenta to contest
any redacted portions of the ANDA(s). Despite this Order, however, and even assuming
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 3 of 9
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Defendants’ full compliance, Momenta will not receive these crucial documents until the end of
Tuesday, June 19, 2012, and may not receive any contested portions of Defendants’ ANDA(s)
until some time thereafter.
7. Momenta’s second significant motion to compel, filed on May 16, 2012 (D.I. 225)
(the “Actual Testing Motion”), remains pending. This motion seeks the production of
Defendants’ actual testing records for the generic enoxaparin Defendants have sold, offered for
sale, and/or held in inventory for sale. These documents are the precise, and perhaps only,
records that will show: (i) whether and to what extent Defendants have in fact performed the
patented tests on the enoxaparin they have manufactured and sold or offered for sale, (ii) when
Defendants performed those tests (and whether within the patents’ terms); and (iii) on which
specific lots of enoxaparin they have performed the patented tests -- so that all of infringement,
the extent of infringement, and damages can be determined. If this motion is granted, which
Momenta believes will be the case, Defendants will be ordered to produce substantially more
highly relevant documents, which will necessitate a subsequent document review period for
Momenta before depositions can be taken concerning these documents. Even assuming the
Court orders expedited production of these documents by Defendants, as the Court has done on
the two motions to compel it has already granted, Defendants’ production deadline will be at
least a week or more (and could be weeks away) from the date of this Motion.
8. Momenta’s third (and hopefully final) significant motion to compel, filed on May
16, 2012 (D.I. 226) (the “Damages Motion”), sought Defendants’ documents pertaining to
damages. Magistrate Judge Collings granted the Damages Motion in part on June 11, 2012,
issuing an Order requiring Defendants to produce specific damages documents [essentially all
documents sought by the Damages Motion that Defendants admitted to having] “on or before
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 4 of 9
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the close of business on June 14, 2012.” 6/11/12 Order (emphasis in original). Again, the
Court thereby agreed with Momenta that such documents are entirely relevant and discoverable,
and were improperly withheld. Defendants have yet to produce a single document in response to
this Court Order, and even assuming full compliance by the final deadline these documents will
not be produced to Plaintiffs until the end of the day on June 14, 2012.
9. Fact discovery currently closes on Monday June 25, 2012, only eight (8) business
days from the date of this Motion. Plaintiffs’ expert reports on infringement and damages are
due only two weeks later on July 9, 2012. Even based on the limited production by Defendants
to date, Momenta is already scheduled to take in the next two weeks at least six personal
depositions and numerous Rule 30(b)(6) depositions of Defendants, all of which must occur
before the close of fact discovery. All of these depositions require the receipt, review and
intelligent use of the documents that will be produced by Defendants over the next two weeks
and thereafter. Under the current schedule, it will be impossible for Momenta to receive, review
and meaningfully use even the documents that Defendants have already been ordered to produce,
and therefore that Defendants’ improperly withheld throughout the fact discovery period, before
Momenta has to take depositions of Defendants and serve Momenta’s initial expert reports.
10. Momenta therefore respectfully seeks a continuance of the fact discovery
deadline. A continuance is necessary to allow Momenta to receive the numerous relevant
documents that this Court has already ruled were wrongfully withheld by Defendants, so that
Plaintiffs can conduct comprehensive and complete depositions of noticed Rule 30(b)(6) and
personal witnesses of Defendants. With the current discovery deadline a mere two weeks away,
Momenta awaits the Court-ordered production of Defendants’ documents pertaining to critical
infringement contentions, as well as damages. Assuming Defendants do perform and finally
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 5 of 9
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satisfy their long-standing discovery obligations, Momenta will still need adequate time to
review the documents, assess the information, and prepare for noticed depositions and expert
reports. With respect to the Court’s suggested arrangement regarding the ANDA, Momenta
fears that this discovery will involve protracted negotiations with opposing counsel, travel from
or to Boston or California, and potential Court involvement should a relevance dispute arise.
11. Moreover, because Momenta also anticipates a forthcoming ruling on its critical
Actual Testing Motion, and assuming a ruling on that Motion relatively soon, this extension
would allow Momenta to depose witnesses and prepare comprehensive expert reports using the
documents sought by this Motion as well.
12. Without the requested extension, Momenta foresees having to take numerous
deposition without the use of critical documents necessary for those depositions, followed by
additional depositions of those previously deposed witnesses in light of future document
productions and an impending third discovery ruling on the Actual Testing Motion. Similarly,
Momenta is concerned that it will have to prepare its expert reports without the use of key
documents, and the deposition testimony based on those documents, that are necessary for those
reports. These preliminary reports would then need to be followed by supplemental reports (and
potentially even multiple expert depositions), based upon future document productions.
13. Momenta believes a continuance is necessary to prevent substantial unfair
prejudice to Momenta, and to alleviate the need for potentially duplicative, time-consuming and
costly discovery proceedings. More importantly, such an extension would protect Momenta
from the burdensome disadvantage of having to take depositions either (i) entirely without the
benefit of critical documents that Defendants have improperly withheld for months, and (ii)
without the benefit of having adequate time to review these critical documents that Defendants
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 6 of 9
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have withheld for months. It would be grossly unfair for Defendants to have withheld numerous
categories of highly relevant documents until the end (or after the end) of fact discovery, and
then force Momenta to take depositions, issue expert reports, and move forward with their case
without the benefit of meaningful use of that wrongfully withheld discovery.
14. Therefore, as set forth in the Proposed Amended Scheduling Order attached as
Exhibit A, Momenta requests that the fact discovery deadline be extended from June 25, 2012 to
July 19, 2012 for the limited purpose of allowing Plaintiffs to take meaningful personal and Rule
30(b)(6) depositions of Defendants.1 Similarly, because of the tight schedule that had previously
been set, Momenta respectfully requests that the trial date be rescheduled from October 9, 2012
to January 7, 2013 (or some other date close in time that is convenient for the Court) to allow the
parties to complete expert discovery and to prepare for trial,2 with the expert and dispositive
motions deadlines to be reset as set forth in Exhibit A.
15. Finally, Momenta respectfully reserves and requests the right to seek a further
extension of the fact discovery or other deadlines should the present discovery disputes remain
outstanding or any Court-ordered discovery remain unproduced by June 29, 2012.
WHEREFORE, for the reasons set forth, Momenta respectfully requests that the Court
grant this Motion and adopt the Proposed Amended Scheduling Order attached as Exhibit A.
1 Momenta still plans to attempt to take several personal and Rule 30(b)(6) depositions of Defendants related to
damages during June 2012, assuming that Defendants produce the further damages documents by June 14, 2012 as
ordered by the Court. Momenta reserves the right, however, to reschedule those depositions or to schedule further
damages depositions in July 2012 if Defendants do not produce all required damages documents by June 14, 2012, if
upon receipt it is impractical to review and use the documents within such a short time frame, or depositions of
Defendants reveal that Defendants have withheld further documents that should have been produced.
2 It is Momenta’s understanding that the Court’s schedule may accommodate a trial date in January 2013. Because
of the Court’s prospective availability, Momenta respectfully requests a trial date in January 2013.
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 7 of 9
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Respectfully submitted,
MOMENTA PHARMACEUTICALS, INC.
By their attorneys,
/s/ Michael E. Murawski
Robert S. Frank, Jr. (BBO #177240)
[e-mail]
Eric J. Marandett (BBO #561730)
[e-mail]
Daniel C. Winston (BBO #562209)
[e-mail]
Michael E. Murawski (BBO #669857)
[e-mail]
CHOATE, HALL & STEWART LLP
Two International Place
Boston, MA 02110
Tel.: [phone]
Fax: [phone]
SANDOZ INC.
By their attorneys,
/s/ Thomas P. Steindler
Sarah Chapin Columbia (BBO #550155)
[e-mail]
Melissa Nott Davis (BBO #654546)
[e-mail]
MCDERMOTT WILL & EMERY LLP
28 State Street
Boston, MA 02109
Tel.: [phone]
Fax: [phone]
Dated: June 13, 2012
- and -
Thomas P. Steindler (admitted pro hac vice)
[e-mail]
MCDERMOTT WILL & EMERY LLP
600 13th Street, N.W.
Washington, D.C. 20005-3096
Tel.: [phone]
Fax: [phone]
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 8 of 9
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5259299398338v32v2
CERTIFICATE PURSUANT TO LOCAL RULE 7.1
I hereby certify that counsel for Plaintiffs has conferred with counsel for Defendants in a
good faith attempt to resolve or narrow the issue presented by this motion on June 11, 2012 and
thereafter and that Defendants do not assent to this motion.
/s/ Kara B. Coen
Kara B. Coen
CERTIFICATE OF SERVICE
I hereby certify that this document filed through the ECF system will be sent
electronically to the registered participants as identified on the Notice of Electronic Filing (NEF)
and that paper copies will be sent to those non-registered participants (if any) on June 13, 2012.
/s/ Kara B. Coen
Kara B. Coen
Case 1:11-cv-11681-NMG Document 264 Filed 06/13/12 Page 9 of 9
Exhibit A
Case 1:11-cv-11681-NMG Document 264-1 Filed 06/13/12 Page 1 of 4
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OFMASSACHUSETTS
____________________________________________
)
MOMENTA PHARMACEUTICALS, INC. )
and SANDOZ INC., )
Plaintiffs, )
)
v. ) Civil Action No. 11-11681-NMG
)
AMPHASTAR PHARMACEUTICALS, INC., )
INTERNATIONALMEDICATION SYSTEMS, LTD.)
WATSON PHARMACEUTICALS, INC., and )
WATSON PHARMA, INC. )
Defendants. )
)
[PROPOSED] AMENDED
SCHEDULING ORDER
For the reasons set forth in Plaintiffs’ Emergency Motion to Continue Fact Discovery and
Trial Date for Limited Purposes, the Court hereby adopts the amended scheduling order set forth
below:
1. Fact Discovery:
(a) Fact discovery will close on July 26, 2012. Fact discovery shall be
extended from and after June 25, 2012 for the limited purpose of the taking of depositions of
Defendants.
(b) If a ruling on claim construction is made after the fact discovery period
has expired, and upon motion or stipulation of the parties, the Court may grant additional time
for discovery. Such additional discovery shall be limited to issues of infringement, invalidity, or
unenforceability depending on the claim construction.
Case 1:11-cv-11681-NMG Document 264-1 Filed 06/13/12 Page 2 of 4
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2. Expert Discovery:
(a) On August 15, 2012, the parties shall exchange expert reports on issues as
to which that party bears the burden of proof at trial. The parties shall exchange rebuttal expert
reports on September 13, 2012.
(b) Expert depositions shall be completed, and expert discovery shall close on
October 26, 2012.
(c) If a ruling on claim construction is made after the expert discovery has
been substantially conducted, and upon motion or stipulation of the parties, the Court may grant
additional time for supplemental expert discovery. Such additional discovery shall be limited to
issues of infringement, invalidity, or unenforceability dependent on the claim construction.
3. Summary Judgment and Trial:
(a) All dispositive motions shall be filed by November 8, 2012.
(b) All oppositions to dispositive motions shall be filed by November 29,
2012.
(c) A Pretrial Conference shall be held on December 12, 2012 at 3:00 p.m.
(d) The trial in this case shall begin on January 7, 2013 at 9:00 a.m.
SO ORDERED.
Dated: June ____, 2012
Judge Nathaniel M. Gorton
United States District Court Judge
Case 1:11-cv-11681-NMG Document 264-1 Filed 06/13/12 Page 3 of 4
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5350360861891v91v1
CERTIFICATE OF SERVICE
I hereby certify that this document filed through the ECF system will be sent
electronically to the registered participants as identified on the Notice of Electronic Filing (NEF)
and that paper copies will be sent to those non-registered participants (if any) on June 13, 2012.
/s/ Kara B. Coen
Kara B. Coen
Case 1:11-cv-11681-NMG Document 264-1 Filed 06/13/12 Page 4 of 4