re MNTA v TEVA suit
mnta has in fact filed for expedited discovery in the case (see item 9 below - taken from the docket in the case). the argument for expedited discovery is clearly the near-term guidance by teva for lovenox approval in their various conference calls. there is an amusing exchange (items 4-5) where teva's counsel asks for a delay in responding to the complaint and mnta agrees if teva provides a copy of the ANDA and drug master file (nice try mnta!)
i think this is supportive of the notion that at least in part the impetus for this suit is to get at what teva has in their ANDA. ostensibly it is to see if their process infringes, but like others i think mnta suspects the ANDA is deficient and likely doesn't infringe, but at least they can then come to the street with firmer conviction that teva is not close to approval
i also think this may explain teva's aggressive end of jan guidance for word on their generic lovenox application. in the survey pertaining to what teva would guide i answered that they will say they haven't heard back from the FDA. I'd like to change my answer in light of this. i now think it is more likely they will announce some delay and use that to argue against expedited discovery. just my hunch since i see no other real reason to pigeon-hole themselves to a deadline a week away. the realist in me doesn't think teva will completely take their foot off mnta's throat, but rather announce a more minor delay (but a delay sufficient to lend credence to an argument against expedited discovery)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
)
MOMENTA PHARMACEUTICALS, INC. )
and SANDOZ, INC., ) Civil Action No. 1:10-cv-12079 NMG
)
Plaintiffs, )
)
v. )
)
TEVA PHARMACEUTICAL INDUSTRIES LTD. )
and TEVA PHARMACEUTICALS USA, INC. )
)
Defendants. )
----------------)
DECLARATION OF ELAINE HERRMANN BLAIS IN SUPPORT OF DEFENDANTS'
OPPOSITION TO PLAINTIFFS' MOTION FOR EXPEDITED DISCOVERY
I, Elaine Herrmann Blais, declare as follows:
1. I am a partner at Goodwin Procter LLP and counsel for Defendants Teva
Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. ("Teva USA") (collectively,
"Teva") in this matter. I am licensed to practice before all courts in the Commonwealth of
Massachusetts, and this Court, and submit this Declaration in support of Teva's Opposition to
Plaintiffs' Motion for Expedited Discovery.
2. I have personal knowledge of the matters set forth herein, and if called upon
would testify as follows.
3. I am not aware of any requests from plaintiffs to Teva for any information about
Teva's analysis or characterization of generic enoxaparin prior to the filing of the instant lawsuit.
I am not aware of any notice plaintiffs provided to Teva indicating that plaintiffs believed Teva
was infringing U.S. Patent Nos. 7,575,886 and 7,790,466 prior to filing this lawsuit.
4. On December 13,2010, I called counsel for Momenta Pharmaceuticals, Inc.
("Momenta"), Eric J. Marandett, and proposed waiving service on Teva Pharmaceutical Ltd.
Case 1:10-cv-12079-NMG Document 29 Filed 01/13/11 Page 1 of 4
("Teva Ltd.") in exchange for a 60-day extension for both Teva defendants to respond to the
complaint.
5. On December 14,2010, Mr. Marandett called me to say that plaintiffs would
agree to the requested extension ifTeva agreed to provide its ANDA and DMF on an expedited
basis.
6. I returned Mr. Marandett's call that same day and stated that Teva did not agree to
his proposal but expected the professional courtesy of an extension without having to provide
one-sided expedited discovery.
7. Mr. Marandett and I then discussed the possibility of a shorter extension until
January 19,2011 for Teva to respond to the complaint. The parties stipulated to that extension
on December 17,2010.
8. Mr. Marandett did not at any point tell me that Momenta and/or Sandoz intended
to file the pending discovery motion ifTeva did not agree to providing its enoxaparin ANDA or
Drug Master File.
9. On December 28, 2010, plaintiffs filed the Motion for Expedited Discovery.
10. On December 29,2010, plaintiffs filed a Certificate of Consultation Pursuant to
LR 7.1. The Certificate of Conference stated:
The undersigned counsel for Momenta Pharmaceuticals, Inc. hereby certifies that
counsel for the Plaintiffs has conferred with Defendants' counsel in a good faith
effort to resolve or narrow the issues concerning expedited production of
documents that are the subject of Plaintiffs' Motion for Limited Expedited
Discovery (Dkt. No. 20), without success.
11. At no time did counsel for plaintiffs have any other discussion regarding the
possibility of an expedited discovery schedule. Specifically:
A. Plaintiffs never proposed a meet and confer regarding the instant motion.
2
Case 1:10-cv-12079-NMG Document 29 Filed 01/13/11 Page 2 of 4
B. Plaintiffs never informed Teva that they planned to move the Court to obtain the
discovery set forth at Dkt. 20-1.
C. Plaintiffs never provided Teva with a copy of the discovery requests attached to
Plaintiffs' Motion for Expedited Discovery until that Motion was filed on
December 28,2010.
D. The discovery requests attached to plaintiffs' motion extend beyond the materials
Mr. Marandett mentioned during our discussion on December 14,2010.
E. Plaintiffs' did not provide Teva with a copy of the proposed Protective Order until
I requested it on December 30,2010.
12. Attached hereto as Exhibit A is a true and correct copy of a press release, Teva
Comments on Patent Infringement Lawsuit Filed by Momenta and Sandoz, dated December 2,
2010.
I declare, under penalty of perjury, that the foregoing is true and correct to the best of my
knowledge.
Executed this ll-t!;; of January, 2011, at Boston, Massachusetts.
~~
Elaine Herrmann Blais
3
Case 1:10-cv-12079-NMG Document 29 Filed 01/13/11 Page 3 of 4
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 paper copies
will be sent to those indicated as non-registered participants on January 13, 2011.
/s/ Elaine Herrmann Blais___
Case 1:10-cv-12079-NMG Document 29 Filed 01/13/11 Page 4 of 4
EXHIBIT A
Case 1:10-cv-12079-NMG Document 29-1 Filed 01/13/11 Page 1 of 3
Search
Press Release
Teva Comments on Patent Infringement Lawsuit Filed by Momenta and Sandoz
Jerusalem, Israel, December 2, 2010 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) commented
today on the patent infringement lawsuit filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc.
Teva received a copy of the complaint which claims that the manufacture of its generic Lovenox®
(enoxaparin sodium) injection, which is still under active review at U.S. Food and Drug Administration, has
infringed Momenta's U.S. Patent Nos. 7,575,886 (the "'886 patent") and 7,790,466 (the "'466 patent"), and
will infringe those patents once it is officially approved and marketed in the United States. Teva's version of
generic Lovenox, which is manufactured and tested outside of the U.S., does not infringe either of these
patents. Teva believes that this lawsuit is without merit, and Teva intends to seek reimbursement for all legal
fees in fighting these baseless allegations.
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company,
committed to increasing access to high-quality healthcare by developing, producing and marketing affordable
generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of
more than 1,250 molecules and a direct presence in approximately 60 countries. Teva's branded businesses
focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva's leading
innovative product, Copaxone®, is the number one prescribed treatment for multiple sclerosis. Teva employs
more than 40,000 people around the world and reached $13.9 billion in net sales in 2009.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of
management. Such statements are based on management's current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our future results, performance or
achievements to differ significantly from the results, performance or achievements expressed or implied by
such forward-looking statements. Important factors that could cause or contribute to such differences include
risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products,
the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity
for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity
periods, potential liability for sales of generic products prior to a final resolution of outstanding patent
litigation, including that relating to the generic versions of Neurontin®, Lotrel®, Protonix® and Yaz®, the
extent to which any manufacturing or quality control problems damage our reputation for high quality
production, the effects of competition on sales of our innovative products, especially Copaxone® (including
potential generic and oral competition for Copaxone®), the impact of continuing consolidation of our
Case 1:10-cv-12079-NMG Document 29-1 Filed 01/13/11 Page 2 of 3
distributors and customers, our ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of ratiopharm), interruptions in our supply chain or problems with our information
technology systems that adversely affect our complex manufacturing processes, intense competition in our
specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid
reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability,
major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny
in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of
our patents and other protections for innovative products, our ability to achieve expected results through our
innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines
Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory
pathway for the registration and approval of biotechnology-based products, potentially significant
impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges
to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered
by insurance, the termination or expiration of governmental programs or tax benefits, current economic
conditions, any failure to retain key personnel or to attract additional executive and managerial talent,
environmental risks and other factors that are discussed in this report and in our other filings with the U.S.
Securities and Exchange Commission ("SEC").
# # #
Company Contacts:
Investor Relations:
Elana Holzman
Teva Pharmaceutical Industries
972 (3) 926-7554
or
Kevin Mannix
Teva North America
(215) 591-8912
Media:
Yossi Koren
Teva Pharmaceutical Industries
972 (3) 926-7687
or
Denise Bradley
Teva North America
(215) 591-8974
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Case 1:10-cv-12079-NMG Document 29-1 Filed 01/13/11 Page 3 of 3
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