Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 1 of 9
`
`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-02647 (PAC)
`
`
`
`
`
`
`
`
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`v.
`
`
` Plaintiffs,
`
`
`
`Mylan Inc. and
`Mylan Pharmaceuticals, Inc.,
`
` Defendants.
`
`
`
`
`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 defendants
`
`Mylan Pharmaceuticals, Inc. (“MPI”) and Mylan Inc. (“Mylan Inc.”) (collectively,
`
`“Counterplaintiffs” or “Mylan”), as follows:
`
`AM 36091324.1
`
`
`
`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-02647 (PAC)
`
`
`
`
`
`
`
`
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`v.
`
`
` Plaintiffs,
`
`
`
`Mylan Inc. and
`Mylan Pharmaceuticals, Inc.,
`
` Defendants.
`
`
`
`
`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 defendants
`
`Mylan Pharmaceuticals, Inc. (“MPI”) and Mylan Inc. (“Mylan Inc.”) (collectively,
`
`“Counterplaintiffs” or “Mylan”), as follows:
`
`AM 36091324.1
`
`
`
`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 2 of 9
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`1.
`
`Counterdefendants admit, on information and belief, the allegations contained in
`
`The Parties
`
`paragraph 1.
`
`2.
`
`Counterdefendants admit, on information and belief, the allegations contained in
`
`paragraph 2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`Jurisdiction and Venue
`
`Paragraph 6 states a conclusion of law rather than an allegation of fact to which a
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`response is required. Counterdefendants admit, insofar as a response is required, that
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`Counterplaintiffs’ counterclaim purports to arise under the patent laws of the United States and
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`purports to be for declaratory judgment.
`
`7.
`
`Paragraph 7 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
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`Counterplaintiffs’ counterclaim purports to arise under 28 U.S.C. §§ 1331 and 1338(a).
`
`8.
`
`Paragraph 8 states a conclusion of law rather than an allegation of fact to which a
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`response is required. Counterdefendants admit, insofar as a response is required, that
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`Counterdefendants consent to jurisdiction in this district for the purpose of the above-captioned
`
`action.
`
`9.
`
`Paragraph 9 states a conclusion of law rather than an allegation of fact to which a
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`response is required. Counterdefendants admit, insofar as a response is required, that venue is
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`proper in this district under 28 U.S.C. §§ 1391(b) and 1400(b).
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`
`
`AM 36091324.1
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`2
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 3 of 9
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`Patents-In-Suit
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`Admitted.
`
`Admitted.
`
`Admitted.
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`Counterdefendants admit that NCI owns U.S. Patent Nos. 5,856,336 (“the ‘336
`
`10.
`
`11.
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`12.
`
`13.
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`patent”) and 8,557,993 (the “’993 patent”) and that NCI and KCL own U.S. Patent No.
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`6,465,477 (“the ‘477 patent”). Counterdefendants further admit that they have the right to
`
`enforce the ‘336 patent, the ‘477 patent and the ’993 patent (collectively “the patents-in-suit”).
`
`14.
`
`15.
`
`Admitted.
`
`The allegations contained in paragraph 15 contain characterizations of a document
`
`which speaks for itself, and Counterdefendants deny the allegations contained in paragraph 15 to
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`the extent incomplete or inconsistent with the Complaint. Further answering, Counterdefendants
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`admit that they filed the Complaint in this action on or about April 14, 2014, and that the
`
`Complaint alleges infringement of the patents-in-suit as set forth therein.
`
`Count I
`(Declaratory Judgment of Non-Infringement of the ‘336 Patent)
`
`In response to paragraph 16, Counterdefendants repeat and incorporate herein by
`
`16.
`
`reference their responses to paragraphs 1 through 15 above as if fully set forth herein.
`
`17.
`
`Paragraph 17 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
`
`Counterplaintiffs have purported to establish an actual controversy between themselves and
`
`Counterdefendants with respect to infringement of the ‘336 patent.
`
`18.
`
`In response to paragraph 18, Counterdefendants deny the allegations contained
`
`therein.
`
`AM 36091324.1
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`3
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 4 of 9
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`19.
`
`In response to paragraph 19, Counterdefendants deny the allegations contained
`
`therein.
`
`Count II
`(Declaratory Judgment of Non-Infringement of the ‘477 Patent)
`
`In response to paragraph 20, Counterdefendants repeat and incorporate herein by
`
`20.
`
`reference their responses to paragraphs 1 through 19 above as if fully set forth herein.
`
`21.
`
`Paragraph 21 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
`
`Counterplaintiffs have purported to establish an actual controversy between themselves and
`
`Counterdefendants with respect to infringement of the ‘477 patent.
`
`22.
`
`In response to paragraph 22, Counterdefendants deny the allegations contained
`
`therein.
`
`23.
`
`In response to paragraph 23, Counterdefendants deny the allegations contained
`
`therein.
`
`Count III
`(Declaratory Judgment of Non-Infringement of the ‘993 Patent)
`
`In response to paragraph 24, Counterdefendants repeat and incorporate herein by
`
`24.
`
`reference their responses to paragraphs 1 through 23 above as if fully set forth herein.
`
`25.
`
`Paragraph 25 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
`
`Counterplaintiffs have purported to establish an actual controversy between themselves and
`
`Counterdefendants with respect to infringement of the ‘993 patent.
`
`26.
`
`In response to paragraph 26, Counterdefendants deny the allegations contained
`
`therein.
`
`AM 36091324.1
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`4
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`
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 5 of 9
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`27.
`
`In response to paragraph 27, Counterdefendants deny the allegations contained
`
`therein.
`
`Count IV
`(Declaratory Judgment of Invalidity of the ‘336 Patent)
`
`In response to paragraph 28, Counterdefendants repeat and incorporate herein by
`
`28.
`
`reference their responses to paragraphs 1 through 27 above as if fully set forth herein.
`
`29.
`
`Paragraph 29 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
`
`Counterplaintiffs have purported to establish an actual controversy between themselves and
`
`Counterdefendants with respect to validity of the ‘336 patent.
`
`30.
`
`In response to paragraph 30, Counterdefendants deny the allegations contained
`
`therein.
`
`31.
`
`In response to paragraph 31, Counterdefendants deny the allegations contained
`
`therein.
`
`Count V
`(Declaratory Judgment of Invalidity of the ‘477 Patent)
`
`In response to paragraph 32, Counterdefendants repeat and incorporate herein by
`
`32.
`
`reference their responses to paragraphs 1 through 31 above as if fully set forth herein.
`
`33.
`
`Paragraph 33 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
`
`Counterplaintiffs have purported to establish an actual controversy between themselves and
`
`Counterdefendants with respect to validity of the ‘477 patent.
`
`34.
`
`In response to paragraph 34, Counterdefendants deny the allegations contained
`
`therein.
`
`AM 36091324.1
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`5
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`
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 6 of 9
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`35.
`
`In response to paragraph 35, Counterdefendants deny the allegations contained
`
`therein.
`
`Count VI
`(Declaratory Judgment of Invalidity of the ‘993 Patent)
`
`In response to paragraph 36, Counterdefendants repeat and incorporate herein by
`
`36.
`
`reference their responses to paragraphs 1 through 35 above as if fully set forth herein.
`
`37.
`
`Paragraph 37 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
`
`Counterplaintiffs have purported to establish an actual controversy between themselves and
`
`Counterdefendants with respect to validity of the ‘993 patent.
`
`38.
`
`In response to paragraph 38, Counterdefendants deny the allegations contained
`
`therein.
`
`39.
`
`In response to paragraph 39, Counterdefendants deny the allegations contained
`
`therein.
`
`WHEREFORE, Plaintiffs and Counterdefendants Kowa and NCI respectfully request
`
`that the Court enter judgment against the Defendants and Counterplaintiffs Mylan 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 Mylan’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;
`
`(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 Mylan’s pitavastatin drug
`
`product or any drug product containing pitavastatin, will induce the infringement
`
`AM 36091324.1
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`6
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 7 of 9
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`of at least one claim of one or more of the patents-in-suit;
`
`(c)
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`a declaratory judgment pursuant to 28 U.S.C. § 2201 et seq. that the making,
`
`using, offering for sale, selling and/or importing of Mylan’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
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`FDA approval for Mylan to commercially make, use, sell, offer to sell or import
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`their 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
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`patents-in-suit (as extended, if applicable);
`
`(e)
`
`a permanent injunction restraining and enjoining against any infringement by the
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`Defendants, their officers, agents, attorneys, employees, successors or assigns, or
`
`those acting in privity or concert with them, of the patents-in-suit, through the
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`commercial manufacture, use, sale, offer for sale or importation into the United
`
`States of Mylan’s pitavastatin drug product or any drug product containing
`
`pitavastatin, and/or any inducement of or contribution to the same;
`
`(f)
`
`That the Defendants and Counterplaintiffs take nothing by their First
`
`Counterclaim, Second Counterclaim, Third Counterclaim, Fourth Counterclaim,
`
`Fifth Counterclaim, and Sixth Counterclaim against the Plaintiffs and
`
`Counterdefendants, and that their First Counterclaim, Second Counterclaim,
`
`Third Counterclaim, Fourth Counterclaim, Fifth Counterclaim, and Sixth
`
`Counterclaim be dismissed with prejudice;
`
`AM 36091324.1
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`7
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`
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 8 of 9
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`(g)
`
`Declaring that this action is exceptional pursuant to 35 U.S.C. § 285, awarding
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`to the 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 Defendants and Counterplaintiffs as this Court may deem just and
`
`proper.
`
`Dated: New York, New York
`
`August 11, 2014
`
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.
`
`
`
`By their attorneys,
`
`s/Adam P. Samansky
`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
`
`AM 36091324.1
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`8
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`
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`Case 1:14-cv-02647-PAC Document 27 Filed 08/11/14 Page 9 of 9
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`CERTIFICATE OF SERVICE
`
`I, Adam P. Samansky, hereby certify that on August 11, 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/Adam P. Samansky
`Adam P. Samansky
`
`
`
`
`
`AM 36091324.1
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`9
`
`
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