Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 1 of 7
`
`Anthony J. Viola
`Andre K. Cizmarik
`Jennifer L. Dereka
`Zachary W. Silverman
`EDWARDS WILDMAN PALMER LLP
`Attorneys for Plaintiffs
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.
`750 Lexington Ave.
`New York, NY 10022
`(212) 308-4411
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Civil Action No. 14-cv-2758 (PAC)
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals, LLC,
`
`Defendant.
`
`ANSWER TO COUNTERCLAIM
`
`Plaintiffs, Kowa Company, Ltd. (“KCL”), Kowa Pharmaceuticals America, Inc. (“KPA”)
`
`(collectively, “Kowa”), and Nissan Chemical Industries, Ltd. (“NCI”) (collectively,
`
`“Counterdefendants”) by their undersigned counsel, answer the counterclaim of defendant
`
`Amneal Pharmaceuticals, LLC (“Amneal” or “Counterplaintiff”), as follows:
`
`
`
`Anthony J. Viola
`Andre K. Cizmarik
`Jennifer L. Dereka
`Zachary W. Silverman
`EDWARDS WILDMAN PALMER LLP
`Attorneys for Plaintiffs
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.
`750 Lexington Ave.
`New York, NY 10022
`(212) 308-4411
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Civil Action No. 14-cv-2758 (PAC)
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals, LLC,
`
`Defendant.
`
`ANSWER TO COUNTERCLAIM
`
`Plaintiffs, Kowa Company, Ltd. (“KCL”), Kowa Pharmaceuticals America, Inc. (“KPA”)
`
`(collectively, “Kowa”), and Nissan Chemical Industries, Ltd. (“NCI”) (collectively,
`
`“Counterdefendants”) by their undersigned counsel, answer the counterclaim of defendant
`
`Amneal Pharmaceuticals, LLC (“Amneal” or “Counterplaintiff”), as follows:
`
`
`
`Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 2 of 7
`
`1.
`
`Paragraph 1 states a conclusion of law rather than an allegation of fact to which a
`
`response is required. Counterdefendants admit, insofar as a response is required, that
`
`Counterplaintiff’s counterclaim purports to arise under the patent laws of the United States and
`
`purports to be for declaratory judgment.
`
`2.
`
`Paragraph 2 states a conclusion of law rather than an allegation of fact to which a
`
`response is required. Counterdefendants admit, insofar as a response is required, that
`
`Counterplaintiff’s counterclaim purports to arise out of the same transactions and occurrences
`
`that are the subject of the claims asserted in the Complaint in the above-captioned action.
`
`3.
`
`Paragraph 3 states a conclusion of law rather than an allegation of fact to which a
`
`response is required. Counterdefendants admit, insofar as a response is required, that
`
`Counterplaintiff’s counterclaim purports to arise under the patent laws of the United States and
`
`purports to be for declaratory judgment.
`
`4.
`
`Paragraph 4 states a conclusion of law rather than an allegation of fact to which a
`
`response is required. Counterdefendants admit, insofar as a response is required, that venue is
`
`proper in this district under 28 U.S.C. §§ 1391(b) and (c).
`
`5.
`
`Counterdefendants admit, on information and belief, the allegations contained in
`
`paragraph 5.
`
`6.
`
`Denied as phrased. Admitted that Counterdefendant KCL is a Japanese
`
`corporation having its corporate headquarters and principal place of business in Aichi, Japan.
`
`7.
`
`Denied as phrased. Admitted that Counterdefendant KPA is a wholly owned U.S.
`
`subsidiary of KCL, and that KPA has its principal place of business and corporate headquarters
`
`in Montgomery, Alabama.
`
`8.
`
`Admitted that Counterdefendant NCI is a Japanese corporation having its
`
`principal place of business in Tokyo, Japan.
`
`2
`
`
`
`Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 3 of 7
`
`11.1 Admitted.
`
`12.
`
`15.2
`
`Admitted.
`
`Paragraph 15 states a conclusion of law rather than allegations of fact to which a
`
`response is required. Counterdefendants admit, insofar as a response is required, that
`
`Counterplaintiff has purported to establish an actual controversy with respect to the
`
`noninfringement and/or invalidity of U.S. Patent Nos. 5,856,336 (“the ‘336 patent”) and
`
`8,557,993 (“the ‘993 patent”) (collectively, “the patents-in-suit”).
`
`16.
`
`Counterdefendants admit, on information and belief, the allegations contained in
`
`paragraph 16.
`
`17.
`
`The allegations contained in paragraph 17 contain characterizations of a document
`
`which speaks for itself, and Counterdefendants deny the allegations contained in paragraph 17 to
`
`the extent incomplete or inconsistent with the Complaint. Further answering, Counterdefendants
`
`admit that Amneal’s act of submitting ANDA No. 20-5961 infringed the patents-in-suit.
`
`18.
`
`Admitted that Counterplaintiff denies that it infringes any valid and enforceable
`
`claim of the patents-in-suit.
`
`19.
`
`Paragraph 19 states a conclusion of law rather than allegations of fact to which a
`
`response is required. Counterdefendants admit, insofar as a response is required, that
`
`Counterplaintiff has purported to establish an actual controversy between itself and
`
`Counterdefendants with respect to whether it infringes any valid and enforceable claim of the
`
`patents-in-suit.
`
`1 Counterplaintiff’s counterclaim does not contain a paragraph 9 or a paragraph 10.
`2 Counterplaintiff’s counterclaim does not contain a paragraph 13 or a paragraph 14.
`
`3
`
`
`
`Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 4 of 7
`
`20.
`
`In response to paragraph 20, Counterdefendants lack information sufficient to
`
`form a belief as to Counterplaintiff’s beliefs, and therefore deny the allegations contained in
`
`paragraph 20.
`
`21.
`
`In response to paragraph 21, Counterdefendants deny the allegations contained
`
`therein.
`
`First Counterclaim- Noninfringement of the '336 and '993 Patents
`
`22.
`
`In response to paragraph 22, Counterdefendants repeat and incorporate herein by
`
`reference their responses to paragraphs 1 through 21 above.
`
`23.
`
`In response to paragraph 23, Counterdefendants deny the allegations contained
`
`therein.
`
`Second Counterclaim- Invalidity of the '336 and '993 Patents
`
`24.
`
`In response to paragraph 24, Counterdefendants repeat and incorporate herein by
`
`reference their responses to paragraphs 1 through 23 above.
`
`25.
`
`In response to paragraph 25, Counterdefendants deny the allegations contained
`
`therein.
`
`WHEREFORE, Plaintiffs and Counterdefendants Kowa and NCI respectfully request
`
`that the Court enter judgment against Defendant and Counterplaintiff Amneal Pharmaceuticals,
`
`LLC as follows:
`
`(a)
`
`a declaratory judgment pursuant to 28 U.S.C. § 2201 et seq. that making, using,
`
`selling, offering to sell and/or importing Amneal’s pitavastatin drug product for
`
`which it seeks FDA approval or any drug product containing pitavastatin will
`
`infringe at least one claim of one or more of the patents-in-suit;
`
`4
`
`
`
`Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 5 of 7
`
`(b)
`
`a declaratory judgment pursuant to 28 U.S.C. § 2201 et seq. that the making,
`
`using, offering for sale, selling and/or importing of Amneal’s pitavastatin drug
`
`product or any drug product containing pitavastatin, will induce the infringement
`
`at least one claim of one or more of the patents-in-suit;
`
`(c)
`
`a declaratory judgment pursuant to 28 U.S.C. § 2201 et seq. that the making,
`
`using, offering for sale, selling and/or importing of Amneal’s pitavastatin drug
`
`product or any drug product containing pitavastatin, will contribute to the
`
`infringement of at least one claim of one or more of the patents-in-suit;
`
`(d)
`
`a declaratory judgment pursuant to 28 U.S.C. § 2201 et seq. and an order
`
`pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of any
`
`FDA approval for Amneal to commercially make, use, sell, offer to sell or
`
`import its pitavastatin drug product or any drug product containing pitavastatin
`
`be no earlier than the date following the expiration date of the last to expire of
`
`the patents-in-suit (as extended, if applicable);
`
`(e)
`
`a permanent injunction restraining and enjoining against any infringement by
`
`defendant, its officers, agents, attorneys, employees, successors or assigns, or
`
`those acting in privity or concert with them, of the patents-in-suit, through the
`
`commercial manufacture, use, sale, offer for sale or importation into the United
`
`States of Amneal’s pitavastatin drug product or any drug product containing
`
`pitavastatin, and/or any inducement of or contribution to the same;
`
`(f)
`
`That Counterplaintiff take nothing by its First Counterclaim and Second
`
`Counterclaim against Counterdefendants, and that its First Counterclaim and
`
`Second Counterclaim be dismissed with prejudice;
`
`5
`
`
`
`Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 6 of 7
`
`(g)
`
`Declaring that this action is exceptional pursuant to 35 U.S.C. § 285, awarding
`
`to Plaintiffs and Counterdefendants the costs and reasonable attorneys’ fees
`
`incurred in connection with this action; and
`
`(h)
`
`Such further and other relief in favor of Plaintiffs and Counterdefendants and
`
`against Defendant and Counterplaintiff as this Court may deem just and proper.
`
`Dated: New York, New York
`July 7, 2014
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`By their attorneys,
`
`s/Kathleen B. Carr
`Anthony J. Viola
`Andre K. Cizmarik
`Jennifer L. Dereka
`Zachary W. Silverman
`EDWARDS WILDMAN PALMER LLP
`750 Lexington Avenue
`New York, NY 10022
`(212) 308-4411
`aviola@edwardswildman.com
`acizmarik@edwardswildman.com
`jdereka@edwardswildman.com
`zsilverman@edwardswildman.com
`
`David G. Conlin (admitted pro hac vice)
`Kathleen B. Carr (admitted pro hac vice)
`Adam P. Samansky
`EDWARDS WILDMAN PALMER LLP
`111 Huntington Avenue
`Boston, MA 02199
`(617) 239-0100
`dconlin@edwardswildman.com
`kcarr@edwardswildman.com
`asamansky@edwardswildman.com
`
`6
`
`
`
`Case 1:14-cv-02758-PAC Document 21 Filed 07/07/14 Page 7 of 7
`
`CERTIFICATE OF SERVICE
`
`I, Kathleen B. Carr, hereby certify that on July 7, 2014, a true and correct copy of the
`foregoing was filed pursuant to the Electronic Case Filing (ECF) system with service to be
`completed by Notification of Electronic Filing (NEF) on counsel of record for all parties from
`the Court.
`
`s/ Kathleen B. Carr
`Kathleen B. Carr
`
`7
`
`
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