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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 1 of 14





IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS

___________________________________________

MOMENTA PHARMACEUTICALS, INC.
and SANDOZ INC.,





TEVA PHARMACEUTICALS USA, INC.




Defendant.

Plaintiffs,

v.









)
)
)
) Civil Action No. 1:10-cv-12079 (NMG)
)
)
)
)
)
)
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)





ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS

OF TEVA PHARMACEUTICALS USA, INC.







INTRODUCTION

Defendant Teva Pharmaceuticals USA, Inc. (“Teva USA”) hereby answers the Complaint

(the “Complaint”) filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively,

“Plaintiffs”) by denying each and every allegation contained therein, except those that are

specifically admitted, modified, or qualified in this Answer.

PARTIES

1.

On information and belief, Teva USA admits that Momenta is a Delaware

corporation with a principal place of business in Cambridge, Massachusetts. Teva USA is

without information sufficient to admit or deny the remaining allegations in paragraph 1 of the

Complaint and therefore denies the same.

2.

On information and belief, Teva USA admits that Sandoz is a Colorado

corporation with a principal place of business in Princeton, New Jersey. Teva USA is without

Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 2 of 14

information sufficient to admit or deny the remaining allegations in paragraph 2 of the Complaint

and therefore denies the same.

3.

Paragraph 3 makes allegations as to Teva Pharmaceutical Industries, Ltd. (“Teva

Ltd.”) only, and thus no response is required from Teva USA.

4.

Teva USA admits that it is a corporation organized and existing under the laws of

the State of Delaware, with a principal place of business at 1090 Horsham Road, North Wales,

Pennsylvania. Teva USA further admits that it is an indirect wholly-owned subsidiary of Teva

Ltd.

5.

Teva USA admits the allegations of paragraph 5 of the Complaint.

JURISDICTION AND VENUE

6.

7.

Teva USA admits the allegations of paragraph 6 of the Complaint.

To the extent that paragraph 7 makes allegations directed towards Teva Ltd., no

response is required from Teva USA. To the extent that paragraph 7 makes allegations directed

towards Teva USA, for the purposes of this case, Teva USA admits that this Court has personal

jurisdiction over Teva USA. Teva USA denies the remaining allegations in paragraph 7

8.

To the extent that paragraph 8 makes allegations directed towards Teva Ltd., no

response is required from Teva USA. To the extent that paragraph 8 makes allegations directed

towards Teva USA, for the purposes of this case, Teva USA admits that venue with respect to

Teva USA is proper in this judicial district. Teva USA denies the remaining allegations in

paragraph 8.

THE MOMENTA PATENTS

9.

Teva USA admits that according to the face of U.S. Patent No. 7,575,886 (the

“’886 patent”), the ‘886 patent is entitled “Analysis of Sulfated Polysaccharides.” Teva USA



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 3 of 14

admits that according to the face of the ‘886 patent, the ‘886 patent issued on August 18, 2009.

Teva USA further admits that what appears to be a true and correct copy of the ’886 patent was

attached to the Complaint as Exhibit A. Teva USA denies the remaining allegations in paragraph

9 of the Complaint.

10.

Teva USA admits that according to the face of the ‘886 patent, the ‘886 patent is

assigned to Momenta Pharmaceuticals, Inc. Teva USA is without information sufficient to admit

or deny the remaining allegations in paragraph 10 of the Complaint and therefore denies the

same.

11.

Teva USA is without information sufficient to admit or deny the allegations in

paragraph 11 of the Complaint and therefore denies the same.

12.

Teva USA admits that according that according to the face of U.S. Patent No.

7,790,466 (the “’466 patent”), the ‘466 patent is entitled “Evaluating Mixtures of Low Molecular

Weight Heparins by Chain Profiles or Chain Mapping.” Teva USA admits that according to the

face of the ‘466 patent, the ‘466 patent issued on September 7, 2010. Teva USA further admits

that what appears to be a true and correct copy of the ’466 patent was attached to the Complaint

as Exhibit B. Teva USA denies the remaining allegations in paragraph 12 of the Complaint.

13.

Teva USA admits that according to the face of the ‘466 patent, the ‘466 patent is

assigned to Momenta Pharmaceuticals, Inc. Teva USA is without information sufficient to admit

or deny the remaining allegations in paragraph 13 of the Complaint and therefore denies the

same.

14.

Teva USA is without information sufficient to admit or deny the allegations in

paragraph 14 of the Complaint and therefore denies the same.



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 4 of 14

MOMENTA AND SANDOZ’S GENERIC ENOXAPARIN PRODUCT

15.

Teva USA is without information sufficient to admit or deny the allegations in

paragraph 15 of the Complaint and therefore denies the same.

16.

17.

Teva USA denies the allegations in paragraph 16 of the Complaint.

On information and belief, Teva USA admits the allegations in paragraph 17 of

the Complaint.

18.

Teva USA admits that all of the claims of the ‘886 patent claim, inter alia, “[a]

method for analyzing an enoxaparin sample for the presence or amount of a non naturally

occurring sugar associated with peak 9 of FIG. 1. that results from a method of making

enoxaparin that included ß-eliminative cleavage with a benzyl ester and depolymerization.” The

remaining allegations of paragraph 18 of the Complaint state conclusions of law and therefore,

no response is required. Further answering, Teva USA states that the ‘886 patent speaks for

itself.

19.

20.

Teva USA denies the allegations in paragraph 19 of the Complaint.

The allegations of paragraph 20 of the Complaint state a conclusion of law and

therefore, no response is required. Further answering, Teva USA states that the ‘466 patent

speaks for itself.

21.

Teva USA denies the allegations in paragraph 21 of the Complaint.

TEVA’S INFRINGING CONDUCT

22.

Teva USA admits that it plans to market generic enoxaparin in the United States

after it receives FDA approval. Teva USA denies the remaining allegations in paragraph 22 of

the Complaint.

23.

Teva USA admits the allegations of paragraph 23 of the Complaint.



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 5 of 14

24.

Teva USA admits that it plans to market generic enoxaparin in the United States

after it receives FDA approval. Teva USA is without information sufficient to admit or deny

whether a true and correct copy of Teva’s Q4 2009 Earnings Conference Transcript, dated

February 16, 2010, is attached to the Complaint as Exhibit C and therefore denies the same.

Further answering, Teva USA states that the conference call speaks for itself. Teva USA denies

the remaining allegations of paragraph 24 of the Complaint.

25.

Teva USA is without information sufficient to admit or deny whether a true and

correct copy of Teva’s Q1 2010 Earnings Conference Transcript, dated May 4, 2010, is attached

to the Complaint as Exhibit D and therefore denies the same. Further answering, Teva USA

states that the conference call speaks for itself. Teva USA denies the remaining allegations of

paragraph 25 of the Complaint.

26.

Teva USA admits that what appears to be a true and correct copy of a press

release, dated July 23, 2010, is attached to the Complaint as Exhibit E. Teva USA is without

information sufficient to admit or deny whether a true and correct copy of Teva’s Q2 2010

Earnings Conference Transcript, dated July 27, 2010, is attached to the Complaint as Exhibit F

and therefore denies the same. Further answering, Teva USA states that the press release and the

conference call speak for themselves. Teva USA denies the remaining allegations of paragraph

26 of the Complaint.

27.

Teva USA admits that what appears to be a true and correct copy of an article

entitled “Teva Copy of Lovenox® May Be Close,” Reuters, dated August 5, 2010, is attached to

the Complaint as Exhibit G. Further answering, Teva USA states that the article speaks for

itself. Teva USA denies the remaining allegations of paragraph 27 of the Complaint.



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28.

Teva USA is without information sufficient to admit or deny whether a true and

correct copy of Teva’s Q3 2010 Earnings Conference Transcript, dated November 2, 2010, is

attached to the Complaint as Exhibit H and therefore denies the same. Further answering, Teva

USA states that the conference call speaks for itself. Teva USA denies the remaining allegations

of paragraph 28 of the Complaint.

29.

30.

Teva USA denies the allegations of paragraph 29 of the Complaint.

Teva USA denies the allegations of paragraph 30 of the Complaint.

(Infringement of U.S. Patent No. 7,575,886)

COUNT I

31.

Teva USA incorporates each of the preceding paragraphs as if fully set forth

herein.

32.

33.

Teva USA denies the allegations of paragraph 32 of the Complaint.

Teva USA admits that it has not obtained a license to use the methods claimed in

the ‘886 patent. Teva USA denies the remaining allegations of paragraph 33 of the Complaint.

34.

35.

Teva USA denies the allegations of paragraph 34 of the Complaint.

Teva USA denies the allegations of paragraph 35 of the Complaint.

(Infringement of U.S. Patent No. 7,790,466)

COUNT II

36.

Teva USA incorporates each of the preceding paragraphs as if fully set forth

herein.

37.

38.

Teva USA denies the allegations of paragraph 37 of the Complaint.

Teva USA admits that it has not obtained a license to use the methods claimed in

the ‘466 patent. Teva USA denies the remaining allegations of paragraph 38 of the Complaint.

39.

Teva USA denies the allegations of paragraph 39 of the Complaint.



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40.

Teva USA denies the allegations of paragraph 40 of the Complaint.

(Declaratory Judgment of Infringement of the ‘886 Patent)

COUNT III

41.

Teva USA incorporates each of the preceding paragraphs as if fully set forth

herein.

42.

Teva USA admits that there is a justiciable controversy between Plaintiffs and

Teva USA as to the alleged infringement of the ‘886 patent. Teva USA denies the remaining

allegations of paragraph 42 of the Complaint.

43.

44.

45.

Teva USA denies the allegations of paragraph 43 of the Complaint.

Teva USA admits the allegations of paragraph 44 of the Complaint.

Teva USA denies the allegations of paragraph 45 of the Complaint.

(Declaratory Judgment of Infringement of the ‘466 Patent)

COUNT IV

46.

Teva USA incorporates each of the preceding paragraphs as if fully set forth

herein.

47.

Teva USA admits that there is a justiciable controversy between Plaintiffs and

Teva USA as to the alleged infringement of the ‘466 patent. Teva USA denies the remaining

allegations of paragraph 47 of the Complaint.

48.

49.

50.

Teva USA denies the allegations of paragraph 48 of the Complaint.

Teva USA admits the allegations of paragraph 49 of the Complaint.

Teva USA denies the allegations of paragraph 50 of the Complaint.

Teva USA denies each and every allegation contained in the Complaint not expressly

admitted above. The headings within the Complaint do not require a response. To the extent

that a response is required, Teva USA denies any allegations in the headings of the Complaint.



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 8 of 14

Teva USA denies that Plaintiffs are entitled to the judgment and relief prayed for in paragraphs

(a) through (h).

AFFIRMATIVE DEFENSES

FIRST AFFIRMATIVE DEFENSE

The Complaint fails to state a claim against Teva USA upon which relief can be







51.

granted.

52.

SECOND AFFIRMATIVE DEFENSE

Teva USA has not (either directly or indirectly) infringed, does not infringe, and

will not infringe any valid and enforceable claim of the ‘886 patent or the ‘466 patent.

THIRD AFFIRMATIVE DEFENSE

53.

Plaintiffs’ claims are barred in whole or in part by 35 U.S.C. § 271(e)(1).

FOURTH AFFIRMATIVE DEFENSE

54.

One or more of the claims of the ‘886 patent or the ‘466 patent are invalid for

failure to comply with 35 U.S.C. §§ 101, 102, 103 and/or 112, and the rules, regulations, and

laws pertaining thereto.

FIFTH AFFIRMATIVE DEFENSE



55.

By reason of the proceedings in the Patent Office during the prosecution of the

‘886 patent and/or the ‘466 patent, and by reason of amendments, positions, concessions,

statements and/or representations taken or made by or on behalf of the applicant, Plaintiffs are

estopped from asserting the ‘886 patent and/or the ‘466 patent against any product made, used,

offered for sale or sold by Teva USA.



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 9 of 14

SIXTH AFFIRMATIVE DEFENSE

56.

Plaintiffs are not entitled to equitable relief from this Court due to their unclean

hands in attempting to enforce the ’886 patent and ‘466 patent in bad faith, knowing that the ‘886

patent and ‘466 patent are invalid, and without a reasonable basis to believe that Teva USA has

infringed the ‘886 patent or ‘466 patent.

SEVENTH AFFIRMATIVE DEFENSE

57.

Plaintiffs’ claim for damages, if any, are limited to the extent that Plaintiffs failed

to provide notice, or otherwise meet the requirements of 35 U.S.C. § 287.

EIGHTH AFFIRMATIVE DEFENSE

58.

Plaintiffs have failed to plead or meet the requirements of 35 U.S.C. §§ 284, 286

and/or 287, and have otherwise failed to show that they are entitled to any damages.

NINTH AFFIRMATIVE DEFENSE

59.

Teva USA has not, does not and/or will not willfully infringe any valid or

enforceable claim of the ‘886 patent or the ‘466 patent, and Plaintiffs are not entitled to enhanced

damages.

TENTH AFFIRMATIVE DEFENSE

60.

Teva USA reserves the right to raise further additional defenses as may be

available upon the facts to be developed and under applicable substantive law.

WHEREFORE, Teva USA prays that this Court:

PRAYER FOR RELIEF



A.

Enter an order dismissing the Complaint, with prejudice, and denying Plaintiffs

the relief requested in the Complaint and any relief whatsoever;



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 10 of 14



B.

Declare this case exceptional and award Teva USA reasonable attorneys’ fees and

costs pursuant to 35 U.S.C. § 285;





C.

D.

Award Teva USA its costs; and

Grant such other and further relief as this Court may deem just.

COUNTERCLAIMS

PARTIES

1.

Teva Pharmaceuticals USA, Inc. (“Teva USA”) is a Delaware corporation with a

principal place of business at 1090 Horsham Road, North Wales, Pennsylvania 19454.

2.

On information and belief, Momenta Pharmaceuticals, Inc. (“Momenta”) is a

Delaware corporation with a principal place of business at 675 West Kendall Street, Cambridge,

Massachusetts 02142.

3.

On information and belief, Sandoz Inc. (“Sandoz”) is a Colorado corporation with

a principal place of business at 506 Carnegie Center, Princeton, New Jersey 08540.

JURISDICTION AND VENUE

4.

This is an action for a declaration that each claim of the U.S. Patent No. 7,575,886

(the “’886 patent”) and U.S. Patent No. 7,790,466 (the “’466 patent”) (collective, the “Patents in

Suit”) is invalid and/or not infringed pursuant to the Patent Laws of the United States, 35 U.S.C.

§ 101 et seq. Accordingly, subject matter jurisdiction of this Court exists under the Federal

Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 28 U.S.C. §§ 1331 and 1338(a).

5.

Momenta and Sandoz (collectively, “Plaintiffs”) have subjected themselves to the

Court’s personal jurisdiction by filing the Complaint in the above action in this Court.

6.

Venue is proper in this District pursuant to 28 U.S.C. §§ 1391(b), 1391(c), and

1400(b).



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 11 of 14

FIRST COUNTERCLAIM

(Declaratory Judgment of Non-Infringement)

Teva USA incorporates by reference paragraphs 1 through 6 as if fully set forth



7.

herein.

8.

Plaintiffs allege that Momenta is the assignee and owner of the Patents in Suit,

that Sandoz is an exclusive licensee under the Patents in Suit, that the Patents in Suit are valid

and enforceable, and that Teva USA infringes or will infringe the Patents in Suit.

9.

Teva USA denies that it infringes or induces the infringement of any asserted

claim of the Patents in Suit, and contends that each asserted claim is not infringed by Teva USA.

Moreover, the activities alleged in the Complaint do not constitute infringement under 35 U.S.C.

§ 271(e)(1).

10.

There is actual controversy between Plaintiffs and Teva USA, redressable by

judgment of this Court, as to the alleged infringement of the Patents in Suit.

11.

Teva USA is entitled to a judgment declaring that Teva USA does not infringe

any valid and asserted claim of the Patents in Suit.

12.

Teva USA is entitled to an award of costs and expenses, including reasonable

attorneys fees, to be assessed against Plaintiffs in accordance with the provisions of 35 U.S.C.

§ 285 or such other authorities as the Court deems applicable.

SECOND COUNTERCLAIM

(Declaratory Judgment of Invalidity)

13.

Teva USA incorporates by reference paragraphs 1 through 12 as if fully set forth



herein.



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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 12 of 14

14.

Plaintiffs allege that Momenta is the assignee and owner of the Patents in Suit,

that Sandoz is an exclusive licensee under the Patents in Suit, that the Patents in Suit are valid

and enforceable, and that Teva USA infringes or will infringe the Patents in Suit.

15.

Teva USA denies that any asserted claim of the Patents in Suit is valid, and

contends that each asserted claim is invalid for failure to comply with 35 U.S.C. §§ 101, 102,

103 and/or 112, and the rules, regulations, and laws pertaining thereto.

16.

There is actual controversy between Plaintiffs and Teva USA, redressable by

judgment of this Court, as to the validity of each asserted claim of the Patents in Suit.

17.

Teva USA is entitled to a judgment declaring that each asserted claim of the

Patents in Suit is invalid.

18.

Teva USA is entitled to an award of costs and expenses, including reasonable

attorneys fees, to be assessed against Plaintiffs in accordance with the provisions of 35 U.S.C.

§ 285 or such other authorities as the Court deems applicable.

PRAYER FOR RELIEF

WHEREFORE, Teva USA respectfully requests that this Court grant the following relief against
Plaintiffs:



A judgment that Teva USA does not infringe any valid and asserted claim of the

A.

‘886 patent or ‘466 patent;



B.

A judgment that each and every asserted claim of the ‘886 patent and ‘466 patent

is invalid;



C.

A determination that this is an exceptional case and award Teva USA reasonable

attorneys’ fees and costs pursuant to 35 U.S.C. § 285;

D.

E.







Award Teva USA its costs; and

Such other and further relief as this Court may deem just.

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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 13 of 14



Dated: January 19, 2011

Respectfully submitted,

GOODWIN PROCTER LLP


By: /s/ James C. Rehnquist


James C. Rehnquist (BBO # 552602)
Elaine Herrmann Blais (BBO #656142)
Adam R. Wichman (BBO #678324)
Robert Frederickson III (BBO #670111)
GOODWIN PROCTER LLP
Exchange Place
53 State Street
Boston, MA 02109
Tel.: (617) 570-1000
Fax: (617) 523-1231
[email protected]
[email protected]
[email protected]
[email protected]

David M. Hashmall (pro hac vice)
GOODWIN PROCTER LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018
Tel.: (212) 813-8800
Fax: (212) 355-3333
[email protected]


Attorneys for Defendant
TEVA PHARMACEUTICALS USA, INC.















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Case 1:10-cv-12079-NMG Document 30 Filed 01/19/11 Page 14 of 14

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 19,

2011.








LIBA/2138003.3

/s/ James C. Rehnquist _



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