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`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 1 of 11
`RDS
`EDWARDS WILDMAN PALMER LLP
`Iì]HUNTINGTONAVENUE
`BOSION, MA 02I99
`N
`+l 617 239 0l 00 moin +l ó17 227 4420 lox
`edwordswildmon com
`
`David G. Conlin
`P artner
`+l 6t7 517 5515
`lax +1 888 325 9129
`dconl in@edwardswi ldman com
`
`October 3,2014
`
`VIA ECF
`
`Hon. Paul A. Crotty
`United States District Judge
`United States Courthouse
`500 Pearl Street, Room 735
`New York, NY 10007
`
`Re: Kowa Company, Ltd., et al. v Aurobindo Pharma Limited , et al., and related cases,l4-cv-
`2497-PAC, I4-cv-2647-PAC, l4-cv-2758,74-cv-2759,14-cv-27-60-PAC, and 14-cv-5575-PAC
`
`Dear Judge Crotty,
`
`'We represent plaintifß Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd. ("Plaintiffs") in this matter. V/e write on behalf of all parties,
`
`and respectfully submit this joint letter pursuant to Your Honor's Individual Practice Rule 6G,
`
`addressing the following:
`
`1. The names, addresses (including firm names), e-mail addresses, telephone, and fax
`numbers of trial counsel.
`
`Trial Counsel for Plaintifß Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.
`
`Anthony J. Vi o I a (av iola@edwardswildman. com)
`EDWARDS WILDMAN PALMER LLP
`750 Lexington Avenue
`New York, NY 10022
`Phone: (212)308-4411
`Fax: (212) 308-4844
`
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`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 2 of 11
`EDWARDS
`WILDMAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page2
`
`David G. Conlin (dconlin@edwardswildman.com)
`Kathleen B. Can (kcan@edwardswildman.com)
`Adam P. S amansky (asamansky @edw ardswildman. com)
`EDV/ARDS V/ILDMAN PALMER LLP
`111 Huntington Avenue
`Boston, I|;4'1'02199
`Phone: (617)239-0100
`Fax: (617) 227-4420
`
`Trial Counsel for Defendants Amneal Pharmaceuticals LLCI
`
`Andrew J. Miller (amiller@buddlarner.com)
`Constance S. Huttner (chuttner@buddlarner.com)
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078 -0999
`Phone: (973)379-4800
`Fax: (973) 379-7734
`
`Trial Counsel for Defendants Mylan Inc. and Mylan Pharmaceuticals Inc.
`
`Arnold B. Calmann (acalmann@saiber.com)
`Jakob Benj amin Halpern (bh@saiber.com)
`Saiber LLC
`18 Columbia Turnpike
`Suite 200
`Florham Park, NJ 01932
`Phone: (973) 622-8394
`Fax: (973) 622-3349
`
`'William A. Rakoczy (wrakoczy@rmmslegal.com)
`D e anne M. Mazzo chi (dmazzochi @rmm s I e gal . c o m)
`Amy D. Brody (abrody @rmmslegal. com)
`RAKOCZY MOLINO MAZZOCHI SIV/IK LLP
`6 West Hubbard Street, Suite 500
`
`t W. belieu e that Amneal is in agreement with this submission but have not yet received final
`confirmation.
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 3 of 11
`EDWARDS
`WILDAAAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 3
`
`Chicago, Illinois 60654
`Phone: (312)222-6301
`Fax: (312) 222-6321
`
`Trial Counsel for Defendants Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc
`
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgf.com)
`Chandrika Vira (cvira@skgf. com)
`STERNE, KESSLER, GOLDSTEiN & FOX, PLLC
`1100 New York Avenue
`V/ashington, DC 20005
`Phone: (202)772-8511
`Fax: (202) 371-2600
`
`Trial Counsel for Defendants Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited
`
`Steven J. Moore (smoore@kelleydrye.com)
`Vincent P. Rao II (vrao@kelleydrye.com)
`Elizabeth W. S wedo ck (e swedo ck@kelleydrye. com)
`Kelley Drye & Warren LLP
`101 Park Avenue
`New York, New York 10178
`Phone: (212) 808-7800
`Fax: (212) 808-7897
`
`Trial Counsel for Defendant Orient Pharma Co., Ltd.
`
`Don J. Mizerk (don.mizerk@huschblackwell.com)
`Katherine E. Rohlf (katherine.rohlf@huschblackwell.com)
`Husch Blackwell LLP
`120 S. Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Phone: (312) 655-1500
`Fax: (312) 655-1501
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 4 of 11
`EDWARDS
`WILDMAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 4
`
`Trial Counsel for Defendants Sawai USA, Inc., and Sawai Pharmaceutical Co., Ltd.
`
`Craig S. Kesch (ckesch@fzwz.com)
`Flemming Ztilack'Williamson Zauder er LLP
`One Liberty Plaza
`New York, NY 10006-1404
`Phone: (212) 412-9500
`
`Chidambaram S. lyer (ciy er @sughrue. com)
`Michael D zw onczyk (mdzwon czyk@sughrue. c om)
`Azy S. Kokabi (akokabi@sughrue.com)
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., N. V/.
`V/ashington, DC 20037
`Phone: 202-775-7542
`Fax:202-293-7860
`
`2. A brief description of the case, including the factual and legal bases for the claim(s) and
`defense(s).
`
`Kowa Pharmaceuticals America, Inc. ("KPA") sells pharmaceutical products containing
`
`the active ingredient pitavastatin calcium under the trade name Livalo@ in the United States
`
`pursuant to the United States Food and Drug Administration's ("FDA") approval of New Drug
`
`Application No. 22-363 ("pitavastatin NDA"). Kowa Company, Ltd., ("KCL") represents it is
`
`the holder of the pitavastatin NDA. Nissan Chemical Industries, Ltd. ("NCI") represents it has
`
`been and still is the owner through assignment of United States Patent No. 5,856,336 ("the '336
`
`patent"). KCL and KPA represent that they are licensed under the '336 patent. KCL and NCI
`
`represent that they have been and still are the owners through assignment of United States Patent
`
`No. 6,465,477 ("the'477 patent"). KPA represents it is licensed under the'477 patent. NCI
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 5 of 11
`EDWARDS
`WILDAAAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 5
`
`represents it has been and still is the owner through assignment of United States Patent No.
`
`8,557,993 ("the '993 patent"). KCL and KPA represent they are licensed under the '993 patent.
`
`The '336 patent, '477 patent, and'993 patent (collectively the "patents-in-suit") are listed in the
`
`Orange Book for pitavastatin calcium.
`
`These are Hatch-Waxman cases (35 U.S.C. $ 271(e)) involving the submission of various
`
`separately owned and developed Abbreviated New Drug Applications ("ANDA") with the FDA
`
`under 21 U.S.C. $ 355(l). Various defendants in these civil actions filed these ANDAs, which
`
`seek approval to market drug products comprising pitavastatin calcium. Various of the
`
`defendants in these civil actions also served Plaintiffs with a "Parugraph IV" notice letter
`
`pursuant to 21 U.S.C. $ 355(jX2XB), contending that one or more of the patents-in-suit are
`
`invalid andlor will not be infringed by the individual defendants' sale of their pitavastatin drug
`
`products. In response, Plaintiffs have filed these patent infringement suits seeking relief against
`
`each defendant for, inter alia, infringement under the Hatch-V/axman Act, 35 U.S.C. $ 271(e)(2),
`
`inducing infringement under 35 U.S.C. $ 271(b), andlor contributory infringement under 35
`
`u.S.C. $ 271(c).
`
`3. A brief statement by plaintiff as to the basis of subject-matter jurisdiction and a brief
`statement by each other party as to the presence or absence of subject-matter jurisdiction.
`Such statements shall include citations to all statutes relied on and relevant facts as to
`citizenship and jurisdictional amount.
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 6 of 11
`EDWARDS
`WILDMAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 6
`
`Plaintiffs:
`
`This is an action for patent infringement arising under the patent laws of the United
`
`States, Title 35, United States Code and arising under 35 U.S.C. $$ 271(e)(2),271(b), andlor
`
`271(c), and28l-283. Subject matter jurisdiction is proper under 28 U.S.C. $$ 1331 and 1338(a).
`
`Defendants:
`
`Defendant Amneal Pharmaceuticals LLC does not contest this Court's subject matter
`
`jurisdiction under Title 35, United States Code.
`
`Defendants Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. (collectively
`
`"Aurobindo") do not contest this Court's subject matter jurisdiction under Title 35, United States
`
`Code with respect to Civil Action No: 1 :I4-cv-02497.
`
`The Court lacks subject matter jurisdiction over any and all claims asserted against
`
`Mylan Inc., as Mylan Inc. is not a proper defendant under 35 U.S.C. $$ 271(e)(2)(A),271(b),
`
`271(c), or 281-283 and has engaged in no activity otherwise sufficient to create subject matter
`
`jurisdiction.
`
`Defendant Orient Pharma Co., Ltd. ("Orient") does not contest this Court's subject matter
`
`jurisdiction under 28 U.S.C. $ 1338(a).
`
`Defendants Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited
`
`(collectively, "Zydus") admit that this action purports to be an action for alleged patent
`
`infringement arising under the patent laws of the United States, Title 35, United States Code and
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 7 of 11
`EDWARDS
`WILDMAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 7
`
`arising under 35 U.S.C. $$ 271(e)(2), 2l|(b), andlor 271(c), and 281-283. Subject matter
`
`jurisdiction is proper under 28 U.S.C. $$ 1331 and 1338(a).
`
`4. A brief summary by each party of the claim(s) and defense(s) that party has asserted
`which remain to be tried, without recital of evidentiary matter but including citations to all
`statutes relied on. Such summaries shall identiff all claims and defenses previously asserted
`which are not to be tried.
`
`Plaintiffs
`
`Plaintiffs have filed patent infringement suits seeking relief against each defendant for,
`
`inter alia, infringement under the Hatch-Waxman Act, 35 U.S.C. $ 27I(e)(2), inducing
`
`infringement under 35 U.S.C. $ 271(b), and contributory infringement under 35 U.S.C. $ 27I(c),
`
`and have asserted the '336 patent, the'477 patent andlor the'993 patent against each defendant.
`
`All of the individual suits and each of the recited causes of action remain to be tried.
`
`Amneal: Same as Mylan, below, with possible exception of fourth sentence if it refers to
`
`the'477 patent, which is not asserted against Amneal.
`
`Aurobindo Aurobindo denies Plaintiffs can meet their burden to prove infringement of
`
`any valid patent claim under 35 U.S.C. S 271(e)(2), 35 U.S.C. $ 271(b), and contributory
`
`infringement under 35 U.S.C. $ 271(c) as to all patents. Aurobindo intends to raise invalidity
`
`defenses under, at least e.g.,35 U.S.C. S 101; $ 102; $ 103; $ 112 (indefiniteness, non-
`
`enablement, written description); and for obviousness-type double-patenting. Aurobindo notes
`
`that there are further invalidity andlor unenforceability defenses that may arise, but such defenses
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 8 of 11
`EDWARDS
`WILDAAAN
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 8
`
`require discovery from Plaintiffs. All of the individual suits and each of the recited causes of
`
`action remain to be tried.
`
`Mylan: Mylan denies Plaintiffs can meet their burden to prove infringement of any valid
`
`patent claim under 35 U.S.C. $ 271(e)(2), 35 U.S.C. $ 271(b), and contributory infringement
`
`under 35 U.S.C. $ 271(c) as to all patents. Mylan intends to raise invalidity defenses under, at
`
`least e.9.,35 U.S.C. $ 101; $ 102; $ 103; $ 112 (indefiniteness, non-enablement, written
`
`description); and for obviousness-type double-patenting. Mylan notes that there are further
`
`invalidity andlor unenforceability defenses that may arise, but such defenses require discovery
`
`from Plaintifß. Mylan further intends to challenge Plaintiffs' demand for remedy on the patents
`
`(e.g., Plaintiffs are asserting one patent that is set to expire before FDA-related regulatory
`
`exclusivities expire). All of the individual suits and each of the recited causes of action remain
`
`to be tried. Mylan further incorporates by reference Orient's statement below.
`
`Orient: Orient denies Plaintifß' allegations of infringement of fhe'336,'471 and'993
`
`patents, and has asserted in its responsive pleading that the manufacture, use, sale, offer for sale,
`
`or importation of the pitavastatin tablets that are the subject of Orient's ANDA will not infringe,
`
`directly or indirectly, any valid andlor enforceable claim of the'336,'477 andlor '993 patents,
`
`either literally or under the doctrine of equivalents. In addition, Orient has asserted that the
`
`claims of the '336, '477 and '993 patents are invalid for failure to comply with the statutory
`
`provisions of Title 35 of the United States Code, including without limitation, one or more of
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 9 of 11
`EDWARDS
`WILDMAN
`
`Hon. Paul A. Crotty
`October 3,2074
`Page 9
`
`sections I0I, I02, 103, 1ll, Il2, 116, 135,256,and287,or other judicially-createdbasesfor
`
`invalidation and enforceability. Orient has also asserted a number of other afhrmative defenses,
`
`including: (1) prosecution history estoppel, (2) lack of standing by Plaintiff Kowa Company,
`
`Ltd., (3) lack of personal jurisdiction, (4) improper venue, (5) res judicata andlor collateral
`
`estoppel, and (6) failure to state a claim upon which relief may be granted under at least 35
`
`U.S,C. $ 271(b) and $ 271 (c). Orient notes that further defenses may arise during the course of
`
`discovery.
`
`Sawai: Same as Mylan.
`
`Z\tdus: Same as Mylan.
`
`5. Any contemplated motions.
`
`Plaintiffs - None at present.
`
`Amneal: Same as Mylan, below, with exception of first sentence referring to'477 patent.
`
`Aurobindo: Aurobindo contemplates that there may be issues ripe for summary judgment
`
`on at least one or more of the asserted patents, but believes that at the present time, it is
`
`appropriate to at least initially proceed with discovery
`
`M)¡lan: Mylan may seek judgment on the pleadings andlor summary judgment on at least
`
`the'477 patent. Mylan contemplates that there may be issues ripe for summary judgment on at
`
`least one or more of the remaining asserted patents, but believes that at the present time, it is
`
`appropriate to at least initially proceed with discovery. Mylan further notes that there are alarge
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 10 of 11
`DWARDS
`DMAN
`
`E
`wlL
`
`Hon. Paul A. Crotty
`October 3,2074
`Page 10
`
`number of inventors listed on the asserted patents who purport to reside in a foreign country and
`
`who may wish to testiff in a foreign language. Plaintiffs should agree to present named
`
`inventors or witnesses testifying under Rule 30(b)(6) for deposition in the United States for an
`
`appropriate period of time (particularly to account for translation time); this may be a source of
`
`motions to compel if the parties cannot reach agreement.
`
`Orient: Same as Mylan. In addition, as provided for in Federal Rule of Civil Procedure
`
`12, Orient has included in its responsive pleading objections and affirmative defenses to personal
`
`jurisdiction and venue. Pursuant to Federal Rule of Civil Procedure 12(i), Orient defers to the
`
`Court as to its preference for the timing and manner of addressing such objections during the
`
`course ofthe case.
`
`Sawai: Same as Mylan. In addition, Sawai Pharmaceuticals Co., Ltd., is seeking
`
`permission from the court to file a motion to dismiss under Rule 12(b)(2) of the Federal Rules of
`
`Civil Procedure for lack of personal jurisdiction.
`
`Zydus: Same as Mylan.
`
`6. A statement by each party as to whether the case is to be tried with or without a jury,
`and the number of trial days needed.
`
`The case is to be tried without a jury. The parties' present best estimate for the number
`
`of trial days needed is 14 to 2I days.
`
`7. A statement as to whether or not all parties have consented to trial of the case by a
`magistrate judge (without identifying which parties have or have not so consented).
`
`
`
`Case 1:14-cv-02758-PAC Document 23 Filed 10/03/14 Page 11 of 11
`
`Hon. Paul A. Crotty
`October 3,2014
`Page 1 1
`
`All parties have not consented to trial of the case by a magistrate judge.
`
`r
`
`David G. Conlin
`cc: Counsel of Record
`
`