Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 1 of 20
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`
`
`KOWA COMPANY, LTD., KOWA
`PHARMACEUTICALS AMERICA, INC.,
`and NISSAN CHEMICAL INDUSTRIES,
`LTD.,
`
`
`
`
`
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC. and
`MYLAN INC.,
`
`
`Defendants.
`
`
`
`
`
` Civil Action No. 14-cv-2647-PAC
` ECF Case
`
`
`
`DOCUMENT ELECTRONICALLY FILED
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`MYLAN PHARMACEUTICALS INC.’S AND MYLAN INC.’S
`ANSWER, SEPARATE DEFENSES AND COUNTERCLAIMS
`
`Defendants Mylan Pharmaceuticals Inc. (“Mylan Pharms”) and Mylan Inc. (collectively,
`
`“Mylan”) hereby answer
`
`the Complaint of Plaintiffs Kowa Company, Ltd., Kowa
`
`Pharmaceuticals America, Inc. (collectively, “Kowa”) and Nissan Chemical Industries, Ltd.
`
`(“Nissan”) (Kowa and Nissan, collectively, “Plaintiffs”) as follows:
`
`Jurisdiction and Venue
`
`1.
`
`Paragraph 1 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that this action purports to be an action for alleged
`
`patent infringement. Further answering, Mylan admits that subject matter jurisdiction is proper
`
`only for the claims directed solely against Mylan Pharms under 35 U.S.C § 271(e)(2)(A). Mylan
`
`denies that subject matter jurisdiction is proper as to Mylan Inc., and for any claims asserted
`
`under 35 U.S.C. §§ 271(b), (c) and 281-83. Mylan denies that Mylan Inc. is a proper party to
`
`this action. Solely to conserve the resources of the parties and the Court, Mylan does not contest
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`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 2 of 20
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`personal jurisdiction or venue in this judicial District for the limited purpose of this action only.
`
`Mylan denies all remaining allegations in Paragraph 1.
`
`Parties
`
`2.
`
`Mylan is without knowledge and information sufficient to form a belief as to the
`
`truth of the allegations in Paragraph 2, and therefore denies the same.
`
`3.
`
`Mylan is without knowledge and information sufficient to form a belief as to the
`
`truth of the allegations in Paragraph 3, and therefore denies the same.
`
`4.
`
`Mylan is without knowledge and information sufficient to form a belief as to the
`
`truth of the allegations in Paragraph 4, and therefore denies the same.
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`5.
`
`Mylan admits that Mylan Pharms is a West Virginia corporation with a place of
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`business in Morgantown, West Virginia. Mylan further admits that Mylan Pharms is a wholly-
`
`owned subsidiary of Mylan Inc. Mylan further admits that Mylan Pharms submitted an
`
`Abbreviated New Drug Application (“ANDA”), No. 206070, to the U.S. Food and Drug
`
`Administration (“FDA”) seeking approval for Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4
`
`mg. Mylan denies all remaining allegations in Paragraph 5.
`
`6.
`
`Paragraph 6 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that Mylan Inc. is a Pennsylvania corporation having
`
`its corporate headquarters in Canonsburg, Pennsylvania. Mylan denies all remaining allegations
`
`in Paragraph 6.
`
`7.
`
`Paragraph 7 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, denied.
`
`8.
`
`Paragraph 8 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that the current electronic records of the New York
`
`State Department of State, Division of Corporations, identify Mylan Pharms and Mylan Inc. as
`
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`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 3 of 20
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`“active” entities in the Corporation and Business Entity Database. Further answering, Mylan
`
`admits that Mylan Inc. is listed on the NASDAQ Global Select Market. Mylan also admits that
`
`Mylan Inc. identifies American Stock Transfer & Trust Company, LLC as its transfer agent.
`
`Mylan denies all remaining allegations in Paragraph 8.
`
`The New Drug Application
`
`9.
`
`Mylan admits that the electronic version of the FDA’s publication, Approved
`
`Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange
`
`Book”), identifies “KOWA CO” as the purported holder of New Drug Application (“NDA”) No.
`
`022363 for LIVALO® (Pitavastatin Calcium) Tablets, 1 mg, 2 mg and 4 mg. Mylan is without
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`knowledge and information sufficient to form a belief as to the truth of the remaining allegations
`
`in Paragraph 9, and therefore denies the same.
`
`10. Mylan admits that according to FDA’s electronic searchable catalog of approved
`
`drugs, the current approved Prescribing Information for LIVALO® provides, in relevant part, that
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`LIVALO® is “indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC),
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`low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and
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`to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.”
`
`Mylan is without knowledge and information sufficient to form a belief as to the truth of the
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`remaining allegations in Paragraph 10, and therefore denies the same.
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`11. Mylan admits that the electronic version of FDA’s Orange Book identifies August
`
`3, 2009 as the approval date for LIVALO®. Mylan is without knowledge and information
`
`sufficient to form a belief as to the truth of the remaining allegations in Paragraph 11, and
`
`therefore denies the same.
`
`12. Mylan is without knowledge and information sufficient to form a belief as to the
`
`truth of the allegations in Paragraph 12, and therefore denies the same.
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`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 4 of 20
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`The Patents in Suit
`
`13.
`
`Paragraph 13 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that, according to the electronic records of the U.S.
`
`Patent and Trademark Office (“PTO”), on or about January 5, 1999, the PTO issued U.S. Patent
`
`No. 5,856,336 (“the ‘336 patent”), entitled “QUINOLINE TYPE MEVALONOLACTONES,” to
`
`Yoshiro Fujikawa, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki Sakashita and Masaki Kitahara; that
`
`the electronic records of the PTO identify “Nissan Chemical Industries Ltd.” as the purported
`
`“assignee” to the ‘336 patent; and that what purports to be a copy of the ‘336 patent is attached
`
`to the Complaint as Exhibit A. Mylan denies that the ‘336 patent was “duly issued,” and any
`
`suggestion or implication that the ‘336 patent is valid or enforceable. Mylan denies all
`
`remaining allegations in Paragraph 13.
`
`14.
`
`Paragraph 14 contains legal conclusions to which no answer is required. Mylan
`
`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
`
`allegations in Paragraph 14, and therefore denies all such allegations.
`
`15.
`
`Paragraph 15 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that, according to the electronic records of the PTO,
`
`on or about October 15, 2002, the PTO issued U.S. Patent No. 6,465,477 B1 (“the ‘477 patent”),
`
`entitled “STABLE PHARMACEUTICAL COMPOSITION,” to Toyojiro Muramatsu, Katsumi
`
`Mashita, Yasuo Shinoda, Hironori Sassa, Hiroyuki Kawashima, Yoshio Tanizawa and Hideatsu
`
`Takeuchi; that the electronic records of the PTO identify “Kowa Company, Ltd.” and “Nissan
`
`Chemical Industries Ltd.” as the purported “assignees” to the ‘477 patent; and that what purports
`
`to be a copy of the ‘477 patent is attached to the Complaint as Exhibit B. Mylan denies that the
`
`‘477 patent was “duly issued,” and any suggestion or implication that the ‘477 patent is valid or
`
`enforceable. Mylan denies all remaining allegations in Paragraph 15.
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 5 of 20
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`16.
`
`Paragraph 16 contains legal conclusions to which no answer is required. Mylan
`
`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
`
`allegations in Paragraph 16, and therefore denies all such allegations.
`
`17.
`
`Paragraph 17 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that, according to the electronic records of the PTO,
`
`on or about October 15, 2013, the PTO issued U.S. Patent No. 8,557,993 B2 (“the ‘993 patent”),
`
`entitled “CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM,” to Paul Adriaan Van der
`
`Schaaf, Fritz Blatter, Martin Szelagiewicz and Kai-Uwe Schoening; that the electronic records of
`
`the PTO identify “Nissan Chemical Industries Ltd.” as the purported “assignee” to the ‘993
`
`patent; and that what purports to be a copy of the ‘993 patent is attached to the Complaint as
`
`Exhibit C. Mylan denies that the ‘993 patent was “duly issued,” and any suggestion or
`
`implication that the ‘993 patent is valid or enforceable. Mylan denies all remaining allegations
`
`in Paragraph 17.
`
`18.
`
`Paragraph 18 contains legal conclusions to which no answer is required. Mylan
`
`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
`
`allegations in Paragraph 18, and therefore denies all such allegations.
`
`19.
`
`Paragraph 19 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that the electronic version of the FDA’s Orange Book
`
`identifies NDA No. 022363 in connection with LIVALO® (Pitavastatin Calcium) Tablets 1 mg, 2
`
`mg and 4 mg. Mylan lacks knowledge and information sufficient to form a belief as to the truth
`
`of the remaining allegations in Paragraph 19, and therefore denies all such allegations.
`
`20. Mylan lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in Paragraph 20, and therefore denies all such allegations.
`
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 6 of 20
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`21.
`
`Denied.
`
`COUNT I
`
`INFRINGEMENT OF THE ‘336 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)
`
`22. Mylan restates and incorporates by reference its answers to the allegations in
`
`Paragraphs 1 through 21.
`
`23. Mylan admits that Mylan Pharms filed an ANDA with FDA seeking approval for
`
`Pitavastatin Calcium Tablets, 1 mg, 2 mg and 4 mg. Mylan denies all remaining allegations in
`
`Paragraph 23.
`
`24.
`
`Paragraph 24 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Mylan admits that Mylan Pharms’ ANDA contains the
`
`bioavailability and/or bioequivalence data and/or bioequivalence waiver required by FDA.
`
`Mylan denies all remaining allegations in Paragraph 24.
`
`25. Mylan admits that Mylan Pharms filed an ANDA with FDA seeking approval for
`
`Pitavastatin Calcium Tablets, 1 mg, 2 mg and 4 mg prior to the expiration of, among others, the
`
`‘336 patent. Mylan denies all remaining allegations in Paragraph 25.
`
`26. Mylan admits that, in a letter dated February 27, 2014, Mylan Pharms gave
`
`written notification to, among others, Kowa Pharmaceuticals America, Inc., Kowa Company,
`
`Ltd. and Nissan Chemical Industries, Ltd. that Mylan Pharms filed an ANDA with FDA for
`
`approval of Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4 mg, which ANDA contains a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii). Mylan denies all remaining allegations in
`
`Paragraph 26.
`
`27. Mylan admits that, in a letter dated February 27, 2014, Mylan Pharms gave
`
`written notification to, among others, Kowa Pharmaceuticals America, Inc., Kowa Company,
`
`Ltd. and Nissan Chemical Industries, Ltd. that Mylan Pharms filed an ANDA with FDA for
`
`- 6 -
`
`

`

`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 7 of 20
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`approval of Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4 mg, which ANDA contains a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii) stating, among other things, that in Mylan
`
`Pharms’ opinion and to the best of its knowledge, the ‘336 patent is invalid, unenforceable
`
`and/or not infringed. Mylan denies all remaining allegations in Paragraph 27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT II
`
`INFRINGEMENT OF THE METHOD CLAIM OF THE ‘336 PATENT
`UNDER 35 U.S.C. § 271(b)
`
`32. Mylan restates and incorporates by reference its answers to the allegations in
`
`Paragraphs 1 through 31.
`
`33.
`
`34.
`
`35.
`
`36.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT III
`
`INFRINGEMENT OF THE METHOD CLAIM OF THE ‘336 PATENT
`UNDER 35 U.S.C. § 271(c)
`
`37. Mylan restates and incorporates by reference its answers to the allegations in
`
`Paragraphs 1 through 36.
`
`38.
`
`39.
`
`40.
`
`Denied.
`
`Denied.
`
`Denied.
`
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 8 of 20
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`41.
`
`42.
`
`43.
`
`44.
`
`45.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT IV
`
`INFRINGEMENT OF THE ‘477 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)
`
`46. Mylan restates and incorporates by reference its answers to the allegations in
`
`Paragraphs 1 through 45.
`
`47. Mylan admits that, in a letter dated February 27, 2014, Mylan Pharms gave
`
`written notification to, among others, Kowa Pharmaceuticals America, Inc., Kowa Company,
`
`Ltd. and Nissan Chemical Industries, Ltd. that Mylan Pharms filed an ANDA with FDA seeking
`
`approval for Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4 mg, before the expiration of the
`
`‘477 patent. Mylan denies all remaining allegations in Paragraph 47.
`
`48. Mylan admits that, in a letter dated February 27, 2014, Mylan Pharms gave
`
`written notification to, among others, Kowa Pharmaceuticals America, Inc., Kowa Company,
`
`Ltd. and Nissan Chemical Industries, Ltd. that Mylan Pharms filed an ANDA with FDA for
`
`approval of Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4 mg, which ANDA contains a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii) stating, among other things, that in Mylan
`
`Pharms’ opinion and to the best of its knowledge, the ‘477 patent is invalid, unenforceable
`
`and/or not infringed. Mylan denies all remaining allegations in Paragraph 48.
`
`49.
`
`50.
`
`51.
`
`Denied.
`
`Denied.
`
`Denied.
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 9 of 20
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`COUNT V
`
`INFRINGEMENT OF THE ‘993 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)
`
`52. Mylan restates and incorporates by reference its answers to the allegations in
`
`Paragraphs 1 through 51.
`
`53. Mylan admits that, in a letter dated February 27, 2014, Mylan Pharms gave
`
`written notification to, among others, Kowa Pharmaceuticals America, Inc., Kowa Company,
`
`Ltd. and Nissan Chemical Industries, Ltd. that Mylan Pharms filed an ANDA with FDA seeking
`
`approval for Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4 mg, before the expiration of the
`
`‘993 patent. Mylan denies all remaining allegations in Paragraph 53.
`
`54. Mylan admits that, in a letter dated February 27, 2014, Mylan Pharms gave
`
`written notification to, among others, Kowa Pharmaceuticals America, Inc., Kowa Company,
`
`Ltd. and Nissan Chemical Industries, Ltd. that Mylan Pharms filed an ANDA with FDA for
`
`approval of Pitavastatin Calcium Tablets, 1 mg, 2 mg, and 4 mg, which ANDA contains a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii) stating, among other things, that in Mylan
`
`Pharms’ opinion and to the best of its knowledge, the ‘993 patent is invalid, unenforceable
`
`and/or not infringed. Mylan denies all remaining allegations in Paragraph 54.
`
`55.
`
`56.
`
`57.
`
`Denied.
`
`Denied.
`
`Denied.
`
`*
`
`*
`
`*
`
`Mylan denies that Plaintiffs are entitled to any of the relief prayed for in Paragraphs (a)
`
`through (g) or to any relief whatsoever, and further requests that judgment be entered in favor of
`
`Mylan, dismissing Plaintiffs’ Complaint with prejudice, awarding Mylan attorneys’ fees and
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 10 of 20
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`costs incurred defending this action under 35 U.S.C. § 285, and granting further relief as this
`
`Court may deem just and proper.
`
`Mylan denies each allegation not specifically admitted or otherwise responded to herein.
`
`SEPARATE DEFENSES
`
`Without prejudice to the denials set forth in its Answer, without admitting any averments
`
`of the Complaint not otherwise admitted, and without undertaking any of the burdens imposed
`
`by law on the Plaintiffs, Mylan avers and asserts the following defenses to the Complaint:
`
`First Defense
`
`The claims of U.S. Patent No. 5,856,336 (“the ‘336 patent”) are invalid for failure to
`
`comply with one or more of the conditions for patentability set forth in Title 35 of the United
`
`States Patent Code.
`
`Second Defense
`
`The manufacture, use, sale, offer for sale, or importation of Mylan Pharms’ proposed
`
`Pitavastatin Calcium Tablet products that are the subject of its Abbreviated New Drug
`
`Application (“ANDA”), would not infringe, either directly or indirectly, any valid and
`
`enforceable claim of the ‘336 patent, either literally or under the doctrine of equivalents.
`
`Mylan has not and will not induce, or contribute to, infringement of any valid and
`
`Third Defense
`
`enforceable claim of the ‘336 patent.
`
`Fourth Defense
`
`The claims of U.S. Patent No. 6,465,477 B1 (“the ‘477 patent”) are invalid for failure to
`
`comply with one or more of the conditions for patentability set forth in Title 35 of the United
`
`States Patent Code.
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 11 of 20
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`Fifth Defense
`
`The manufacture, use, sale, offer for sale, or importation of Mylan Pharms’ proposed
`
`Pitavastatin Calcium Tablet products that are the subject of its ANDA, would not infringe, either
`
`directly or indirectly, any valid and enforceable claim of the ‘477 patent, either literally or under
`
`the doctrine of equivalents.
`
`Sixth Defense
`
`Mylan has not and will not induce, or contribute to, infringement of any valid and
`
`enforceable claim of the ‘477 patent.
`
`Seventh Defense
`
`The claims of U.S. Patent No. 8,557,993 B2 (“the ‘993 patent”) are invalid for failure to
`
`comply with one or more of the conditions for patentability set forth in Title 35 of the United
`
`States Patent Code.
`
`Eighth Defense
`
`The manufacture, use, sale, offer for sale, or importation of Mylan Pharms’ proposed
`
`Pitavastatin Calcium Tablet products that are the subject of its ANDA, would not infringe, either
`
`directly or indirectly, any valid and enforceable claim of the ‘993 patent, either literally or under
`
`the doctrine of equivalents.
`
`Ninth Defense
`
`Mylan has not and will not induce, or contribute to, infringement of any valid and
`
`enforceable claim of the ‘993 patent.
`
`Tenth Defense
`
`Mylan Inc. is not a proper defendant under 35 U.S.C. §§ 271(e)(2)(A), 271(b), 271(c) or
`
`281-83.
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 12 of 20
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`Eleventh Defense
`
`The Court lacks subject matter jurisdiction over any and all claims asserted against
`
`Mylan Inc.
`
`Twelfth Defense
`
`The Court lacks personal jurisdiction over any and all claims asserted against Mylan Inc.
`
`and Mylan Pharmaceuticals Inc.
`
`Thirteenth Defense
`
`The Complaint fails to state a claim upon which relief can be granted.
`
`Fourteenth Defense
`
`The Complaint fails to state a claim for willful infringement and/or exceptional case.
`
`Fifteenth Defense
`
`Any additional defenses or counterclaims that discovery may reveal, including
`
`unenforceability.
`
`*
`
`*
`
`*
`
`- 12 -
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`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 13 of 20
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`COUNTERCLAIMS
`
`
`
`Without prejudice to their denials set forth in the Answer or to their Separate Defenses,
`
`Defendants/Counterclaim-Plaintiffs Mylan Pharmaceuticals Inc. (“Mylan Pharms”) and Mylan
`
`Inc. (collectively “Mylan”), for their Counterclaims against Plaintiffs/Counterclaim-Defendants
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Nissan Chemical Industries,
`
`Ltd. (collectively, “Plaintiffs”), allege as follows:
`
`The Parties
`
`1.
`
`Mylan Pharmaceuticals Inc. (“Mylan Pharms”) is a corporation organized under
`
`the laws of the State of West Virginia, having an office and place of business at 781 Chestnut
`
`Ridge Road, Morgantown, West Virginia 26505.
`
`2.
`
`Mylan Inc. is a corporation organized under the laws of the State of Pennsylvania,
`
`having an office and place of business at 1000 Mylan Boulevard, Canonsburg, Pennsylvania
`
`15317.
`
`3.
`
`Kowa Company Ltd. purports to be a Japanese corporation, having its principal
`
`place of business at 6-29, Nishiki 3-chome, Naka-ku, Nagoya, Aichi 460-8625, Japan.
`
`4.
`
`Kowa Pharmaceuticals America, Inc. purports to be a corporation organized and
`
`existing under the laws of the State of Delaware, having a place of business at 530 Industrial
`
`Park Boulevard, Montgomery, Alabama 36117.
`
`5.
`
`Nissan Chemical Industries, Ltd. (“Nissan”) purports
`
`to be a Japanese
`
`corporation, having its principal place of business at 7-1, Kanda Nishiki-cho 3-chome, Chiyoda-
`
`ku, Tokyo 101-0054, Japan.
`
`Jurisdiction and Venue
`
`6.
`
`These Counterclaims arise under the Patent Laws of the United States, 35 U.S.C.
`
`§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 14 of 20
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`7.
`
`This Court has original jurisdiction over the subject matter of these Counterclaims
`
`under 28 U.S.C. §§ 1331 and 1338(a).
`
`8.
`
`This Court has personal jurisdiction over Plaintiffs because Plaintiffs have availed
`
`itself of the rights and privileges, and subjected itself to the jurisdiction, of this forum by suing
`
`Mylan in this District, and/or because Plaintiffs conduct substantial business in this District.
`
`9.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391(b) and 1400(b).
`
`Patents-in-Suit
`
`10.
`
`On or about January 5, 1999, the U.S. Patent and Trademark Office (“PTO”)
`
`issued U.S. Patent No. 5,856,336 (“the ‘336 patent”), entitled “QUINOLINE TYPE
`
`MEVALONOLACTONES,” to Yoshiro Fujikawa, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki
`
`Sakashita and Masaki Kitahara.
`
`11.
`
`On or about October 15, 2002, the PTO issued U.S. Patent No. 6,465,477 B1
`
`(“the ‘477 patent”), entitled “STABLE PHARMACEUTICAL COMPOSITION,” to Toyojiro
`
`Muramatsu, Katsumi Mashita, Yasuo Shinoda, Hironori Sassa, Hiroyuki Kawashima, Yoshio
`
`Tanizawa and Hideatsu Takeuchi.
`
`12.
`
`On or about October 15, 2013, the PTO issued U.S. Patent No. 8,557,993 B2
`
`(“the ‘993 patent”), entitled “CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM,” to
`
`Paul Adriaan Van der Schaaf, Fritz Blatter, Martin Szelagiewicz and Kai-Uwe Schoening.
`
`13.
`
`Nissan purports and claims to own, and to have the right to enforce, the ‘336, ‘477
`
`and ‘993 patents.
`
`14.
`
`Plaintiffs submitted the ‘336, ‘477 and ‘993 patents to the United States Food and
`
`Drug Administration (“FDA”) for listing in FDA’s publication, Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”), in connection
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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 15 of 20
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`with approved New Drug Application No. 22-363 for LIVALO® (Pitavastatin Calcium) Tablets,
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`1 mg, 2 mg and 4 mg.
`
`15.
`
`On or about April 14, 2014, Plaintiffs sued Mylan in this District alleging
`
`infringement of the ‘336, ‘477 and ‘993 patents under 35 U.S.C. §§ 271(e)(2)(A), 271(b), 271(c)
`
`and 281-83.
`
`Count I
`(Declaratory Judgment of Non-Infringement of the ‘336 Patent)
`
`16. Mylan re-asserts and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`17.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Mylan and Plaintiffs regarding non-infringement of the ‘336 patent that is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`18.
`
`The manufacture, use, sale, offer for sale, or importation of the Pitavastatin
`
`Calcium Tablets that are the subject of Mylan Pharms’ ANDA have not infringed, do not
`
`infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the ‘336
`
`patent.
`
`19. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for
`
`sale, and/or importation of the Pitavastatin Calcium Tablets that are the subject of Mylan
`
`Pharms’ ANDA have not infringed, do not infringe, and would not, if marketed, infringe any
`
`valid and/or enforceable claim of the ‘336 patent.
`
`Count II
`(Declaratory Judgment of Non-Infringement of the ‘477 Patent)
`
`20. Mylan re-asserts and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`- 15 -
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`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 16 of 20
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`21.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Mylan and Plaintiffs regarding non-infringement of the ‘477 patent that is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`22.
`
`The manufacture, use, sale, offer for sale, or importation of the Pitavastatin
`
`Calcium Tablets that are the subject of Mylan Pharms’ ANDA have not infringed, do not
`
`infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the ‘477
`
`patent.
`
`23. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for
`
`sale, and/or importation of the Pitavastatin Calcium Tablets that are the subject of Mylan
`
`Pharms’ ANDA have not infringed, do not infringe, and would not, if marketed, infringe any
`
`valid and/or enforceable claim of the ‘477 patent.
`
`Count III
`(Declaratory Judgment of Non-Infringement of the ‘993 Patent)
`
`24. Mylan re-asserts and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`25.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Mylan and Plaintiffs regarding non-infringement of the ‘993 patent that is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`26.
`
`The manufacture, use, sale, offer for sale, or importation of the Pitavastatin
`
`Calcium Tablets that are the subject of Mylan Pharms’ ANDA have not infringed, do not
`
`infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the ‘993
`
`patent.
`
`27. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for
`
`sale, and/or importation of the Pitavastatin Calcium Tablets that are the subject of Mylan
`
`- 16 -
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`

`

`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 17 of 20
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`Pharms’ ANDA have not infringed, do not infringe, and would not, if marketed, infringe any
`
`valid and/or enforceable claim of the ‘993 patent.
`
`Count IV
` (Declaratory Judgment of Invalidity of the ‘336 Patent)
`
`28. Mylan re-asserts and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`29.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Mylan and Plaintiffs regarding the invalidity of the ‘336 patent that is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`30.
`
`The claims of the ‘336 patent are invalid for failure to comply with one or more of
`
`the conditions for patentability set forth in Title 35 of the United States Patent Code.
`
`31. Mylan is entitled to a judicial declaration that the claims of the ‘336 patent are
`
`invalid.
`
`Count V
`(Declaratory Judgment of Invalidity of the ‘477 Patent)
`
`32. Mylan re-asserts and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`33.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Mylan and Plaintiffs regarding the invalidity of the ‘477 patent that is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`34.
`
`The claims of the ‘477 patent are invalid for failure to comply with one or more of
`
`the conditions for patentability set forth in Title 35 of the United States Patent Code.
`
`35. Mylan is entitled to a judicial declaration that the claims of the ‘477 patent are
`
`invalid.
`
`- 17 -
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`

`

`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 18 of 20
`
`Count VI
`(Declaratory Judgment of Invalidity of the ‘993 Patent)
`
`36. Mylan re-asserts and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`37.
`
`There is an actual, substantial, and continuing justiciable case or controversy
`
`between Mylan and Plaintiffs regarding the invalidity of the ‘993 patent that is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`38.
`
`The claims of the ‘993 patent are invalid for failure to comply with one or more of
`
`the conditions for patentability set forth in Title 35 of the United States Patent Code.
`
`39. Mylan is entitled to a judicial declaration that the claims of the ‘993 patent are
`
`invalid.
`
`Prayer for Relief
`
`
`
`
`WHEREFORE, Mylan respectfully prays for judgment in its favor and against Plaintiffs:
`
`(a)
`
`Declaring that the manufacture, use, sale, offer for sale, or importation of the
`
`Pitavastatin Calcium Tablet products that are the subject of Mylan Pharms’
`
`ANDA have not infringed, do not infringe, and would not, if marketed, infringe
`
`any valid and/or enforceable claim of the ‘336 patent;
`
`(b)
`
`Declaring that the manufacture, use, sale, offer for sale, or importation of the
`
`Pitavastatin Calcium Tablet products that are the subject of Mylan Pharms’
`
`ANDA have not infringed, do not infringe, and would not, if marketed, infringe
`
`any valid and/or enforceable claim of the ‘477 patent;
`
`(c)
`
`Declaring that the manufacture, use, sale, offer for sale, or importation of the
`
`Pitavastatin Calcium Tablet products that are the subject of Mylan Pharms’
`
`- 18 -
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`

`

`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 19 of 20
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`ANDA have not infringed, do not infringe, and would not, if marketed, infringe
`
`(d)
`
`(e)
`
`(f)
`
`(g)
`
`any valid and/or enforceable claim of the ‘993 patent;
`
`Declaring that the claims of the ‘336 patent are invalid;
`
`Declaring that the claims of the ‘477 patent are invalid;
`
`Declaring that the claims of the ‘993 patent are invalid;
`
`Ordering that Plaintiffs’ Complaint be dismissed with prejudice and judgment
`
`entered in favor of Mylan;
`
`(h)
`
`Declaring this case exceptional and awarding Mylan its reasonable attorneys’ fees
`
`and costs of these Counterclaims under 35 U.S.C. § 285; and
`
`(i)
`
`Awarding Mylan such other and further relief as the Court may deem just and
`
`proper.
`
`DEMAND FOR JURY TRIAL
`
`
`
`Mylan hereby demands a jury trial on all issues so triable.
`
`
`
`
`
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`- 19 -
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`

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`Case 1:14-cv-02647-PAC Document 25 Filed 07/16/14 Page 20 of 20
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`Dated: July 16, 2014
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`
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`
`
`Respectfully submitted,
`
`SAIBER LLC
`
`
`By: s/ Jakob B. Halpern
`Jakob B. Halpern (jbh@saiber.com)
`SAIBER LLC
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102
`(973) 622-3333 (telephone)
`(973) 622-3349 (facsimile)
`
`Of Counsel
`William A. Rakoczy (wrakoczy@rmmslegal.com)
`Deanne M. Mazzochi (dmazzochi@rmmslegal.com)
`Amy D. Brody (abrody@rmmslegal.com)
`Luke T. Shannon (lshannon@rmmslegal.com)
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`(312) 222-6301 (telephone)
`(312) 222-6321 (facsimile)
`
`
`
`Counsel for Defendants/Counterclaim-Plaintiffs
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`- 20 -
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`