Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 1 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 1 of 54
`
`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.
`
`Aurobindo Pharma Limited and
`Aurobindo Pharma USA Inc.,
`
`
`
`
`
`Defendants.
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`Civil Action No. I4-CV-2497 (PAC)
`
`ECEWE
`
`
`
`
`
`JUN 02 2015
`
`JUDGMENT CLERK’S
`O FlCE
`
`
`
`Civil Action No. l4—CV—2758 (PAC)
`
`Civil Action No. l4-CV-2647 (PAC)
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals LLC,
`
`Defendant.
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc, and
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`
`
`V.
`
`
`
`Mylan Inc. and Mylan Pharmaceuticals Inc.,
`
`
`
`Defendants.
`
`

`

`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 2 of 54 V
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 2 of 54
`
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc, and
`
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`V,
`
`Orient Pharma Co., Ltd.,
`
`Defendant.
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`V-
`
`Zydus Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Ltd. (dba Zydus Cadila),
`
`Defendants.
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`V-
`
`Sawai USA, Inc. and
`Sawai Pharmaceutical Co., Ltd.,
`
`Defendants.
`
`
`
`
`Civil Action No. 14—CV—2759 (PAC)
`
`Civil Action No. 14-CV—276O (PAC)
`
`Civil Action No. 14-CV—5575 (PAC)
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 3 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 3 of 54
`
`
`
`Kowa Company, Ltd,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd,
`
`Plaintiffs,
`
`V,
`
`Apotex, Inc. and Apotex Corp,
`
`Defendants.
`
`
`
`
`Civil Action No. I4—CV—7934 (PAC)
`
`DEFENDANTS’ APPLICATION FOR ISSUANCE OF LETTERS OF REQUEST
`FOR INTERNATIONAL JUDICIAL ASSISTANCE TO THE APPROPRIATE JUDICIAL
`
`AUTHORITIES OF THE SWISS CONFEDERATION PURSUANT TO THE HAGUE
`EVIDENCE CONVENTION
`
`Defendants Aurobindo Pharma Limited, Aurobindo Pharma USA Inc., Amneal
`
`Pharmaceuticals LLC, Mylan Inc., Mylan Pharmaceuticals Inc., Orient Pharrna Co., Ltd, Zydus
`
`Pharmaceuticals (USA) Inc., Cadila Healthcare Ltd. (dba Zydus Cadila), Sawai USA, Inc., Sawai
`
`Pharmaceutical Co., Ltd, Apotex, Inc, and Apotex Corp. (collectively, “Defendants”) respectfully
`
`request that the Court issue Letters of Request for International Judicial Assistance (the “Letters of
`
`Request”), attached hereto as Exhibits 1—2, pursuant to Article I of the Hague Convention of 18
`
`March 1970 on the Taking of Evidence Abroad in Civil or Commercial Matters, 23 U.S.T. 2555,
`
`847 U.N.T.S. 231, reprinted in 28 U.S.C. § 1781 (“Hague Evidence Convention”).
`
`Defendants request that their respective counsel be permitted to conduct depositions of the
`
`individuals named as inventors on the face of US. Patent No. 8,557,993 (the “’993 Patent”), a
`
`patent asserted by Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd. (collectively, “Plaintiffs”) in the above—referenced actions. Based
`
`on information currently available to Defendants,
`
`these individuals all reside and/or work in
`
`Switzerland. Counsel for Plaintiffs have stated that these individuals are not currently employed
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 4 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 4 of 54
`
`by, or otherwise under the control of, Plaintiffs. Counsel for Plaintiffs have further stated that they
`
`do not represent any of the inventors of the ’993 Patent. Plaintiffs’ counsel have otherwise not
`
`agreed to forego calling any of these individuals to any trial
`
`in these actions. As the named
`
`inventors of one of the patents-in-suit, the anticipated deposition testimony of these inventors is
`
`likely to be critical to these pending litigations; this is because the inventors likely will have
`
`knowledge of facts relevant to Defendants” non—infringement and invalidity positions, especially as
`
`such facts relate to the research and development of the alleged invention claimed in the ’993
`
`Patent.
`
`The most reasonable manner in which to obtain such information is through the
`
`depositions of these inventors.
`
`The Court has the power to issue Letters of Request under the Hague Evidence Convention,
`
`of which both the United States and the Swiss Confederation are signatories. The Hague Evidence
`
`Convention provides the mechanism for gathering evidence abroad,
`
`including the taking of
`
`deposition testimony, through the issuance of Letters of Request. Pursuant to the Hague Evidence
`
`Convention, Letters of Request must provide the state whose assistance is being requested with
`
`certain information regarding the lawsuit and the information sought. Tulip Computers Int’l B V v.
`
`Dell Computer Corp, 254 F. Supp. 2d 469, 472 (D. Del. 2003). Specifically, Article 3 of the
`
`Hague Evidence Convention provides that Letters of Request shall specify certain information, all
`
`of which appears in Defendants’ proposed Letters of Request, attached hereto as Exhibits 1—21:
`
`1 Each Letter of Request must be addressed to the relevant cantonal authority in Switzerland, as
`determined by the witness’ location. Because the four individuals named as inventors on the
`’993 Patent are located throughout two different cantons, Defendants submit two proposed
`Letters of Request.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 5 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 5 of 54
`
`a)
`
`the authority requesting its execution and the authority requested to execute it (see
`
`proposed Letters of Request, Exs. l-2 1i 5);
`
`b)
`
`the names and addresses of the parties to the proceedings and their representatives
`
`(see proposed Letters of Request, Exs. 1-2 1] 6);
`
`c)
`
`the nature of the proceedings for which the evidence is requested (see proposed
`
`Letters of Request, Exs. 1—2 1i 7); and
`
`d)
`
`the evidence to be obtained (see proposed Letters of Request, Exs. 1-2 1i 8).
`
`Hague Evidence Convention, 23 U.S.T. 2555, Art. 3(a)—(d).
`
`In addition, Article 3 provides that “[w]here appropriate, the Letter shall specify”
`
`the questions to be put to the persons to be examined or a statement of the subject-matter about
`
`which they are to be examined (see proposed Letters of Request, Exs.
`
`1—2 1t 10). Hague
`
`Evidence Convention, 23 U.S.T. 2555, Art. 3(f). Defendants’ proposed Letters of Request
`
`contain each of these specifications where applicable.
`
`Finally, consistent with other provisions of the Hague Evidence Convention, Defendants
`
`have requested that the parties be notified of the time and place of the proposed depositions (see
`
`Hague Evidence Convention, 23 U.S.T. 2555, Art. 7; proposed Letters of Request, Exs. 1-2 ii 13).
`
`Defendants have requested that the relevant Swiss cantonal authority submit to this Court a note of
`
`fees and costs that are reimbursable under the Hague Evidence Convention (Hague Evidence
`
`Convention, 23 U.S.T. 2555, Art. 14 & 26; proposed Letters of Request, Exs.
`
`l—2 ll 14).
`
`Defendants will reimburse the relevant Swiss cantonal authorities in full for all costs incurred in
`
`the taking of the evidence sought.
`
`Accordingly, Defendants respectfully request that this Court issue the attached Letters of
`
`Request to take depositions of the individuals named as inventors on the face of the ’993 Patent in
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 6 of 54
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 6 of 54
`
`Switzerland. Defendants also respectfully request that the Court execute two copies of each of the
`
`Letters of Request, thus allowing one original of each to be retained in the Court file and one
`
`original of each to be returned to Defendants’ counsel for delivery to the proper Swiss authorities.
`
`Upon receipt of the executed Letters of Request, Defendants’ counsel will have them translated
`
`into Swiss German, and will cause the certified Swiss German translations and the English
`
`versions of the Letters of Request to be delivered to the proper Swiss authorities. Thereafter,
`
`Defendants’ counsel will provide to the Clerk of Court all papers received from the Swiss
`
`authorities for filing on the case dockets.
`
`DATED: June 2, 2015
`
`SAIBER LLC
`
`ALSTON &‘BIRD LLP
`
`
`
`Natalie C. Clayton
`(Natalie.Clayton@alston.com)
`Paki Banky (paki.banky@alston.co )
`90 Park Avenue, 15th Floor
`New York, New York 10016—1387
`(212) 210—9400 (telephone)
`
`A ttorneys for Defendant Orient Pharma C0,,
`Ltd.
`
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102
`(973) 622—3333 (telephone)
`
`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)
`Allorneysfbr Defendants Mylan
`Pharmaceuticals Inc. and Mylan Inc.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 7 of 54
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 7 of 54
`
`Switzerland. Defendants also respectfully request that the Court execute two copies of each of the
`
`Letters of Request, thus allowing one original of each to be retained in the Court file and one
`
`original of each to be returned to Defendants’ counsel for delivery to the proper Swiss authorities.
`
`Upon receipt of the executed Letters of Request, Defendants” counsel will have them translated
`
`into Swiss German, and will cause the certified Swiss German translations and the English
`
`versions of the Letters of Request to be delivered to the proper Swiss authorities. Thereafter,
`
`Defendants’ counsel will provide to the Clerk of Court all papers received from the Swiss
`
`authorities for filing on the case dockets.
`
`DATED: June 2, 2015
`
`ALSTON & BIRD LLP
`
`Natalie C. Clayton
`(Natalie.Clayton@alston.com)
`Paki Banky (paki.banky@alston.com)
`90 Park Avenue, 15th Floor
`New York, New York 10016—1387
`(212) 210—9400 (telephone)
`
`Attorneys for Defendant Orient Pharma Ca,
`Ltd.
`
`
`
`Newark“, New Jersey
`(973) 622—3333 (telephone)
`
`,7
`
`r
`
`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)
`Attorneys for Defendants Mylan
`Pharmaceuticals Inc. and Mylan Inc.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 8 of 54
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 8 of 54
`
`STERNE, KESSLER, GOLDSTEIN & Fox PLLC
`
`Bum) LARNER, P.C.
`
`/é//
`
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgf.corn)
`Chandrika Vira (cvira@skgf.com)
`1100 New York Avenue
`
`Washington, DC. 20005
`(202) 772-8511 (telephone)
`
`Attorneys for Defendants Aurobindo Pharma
`Ltd. and Aurobindo Pharma USA Inc.
`
`Andrew J. Miller (amiller@budd1arner.com)
`Constance S. Huttner
`
`(chuttner@buddlarner.corn)
`Caroline Sun (csun@buddlarner.corn)
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078-2703
`(973) 379—4800 (telephone)
`
`Attorneys for Defendant Amneal
`Pharmaceuticals LLC
`
`KELLEY DRYE & WARREN LLP
`
`SUGHRUE MION, PLLC
`
`Steven J. Moore (smoore@kelleydrye.com)
`Vincent P. Rao 11 (vrao@kelleydrye.com)
`Elizabeth W. Swedock
`
`(eswedock@ke11eydrye.com)
`101 Park Avenue
`
`New York, New York 10178
`(212) 808—7800 (telephone)
`
`Attorneys for Defendants Zydus
`Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Limited
`
`Chidambaram S. Iyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk
`(mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`2100 Pennsylvania Avenue, NW
`Washington, DC. 20037—3213
`(202) 293-7060 (telephone)
`
`Attorneys for Defendants Sawai USA, Inc.
`and Sawai Pharmaceutical C0., Ltd.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 9 of 54
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 9 of 54
`
`STERNE, KESSLER, GOLDSTEIN & Fox PLLC
`
`BUDDLARNER,P.C. /
`
`.2? ,,
`g
`.'/-
`L & flu'Jév,‘L Mt‘é
`
`7
`_.;;“'
`,l :6.“ [LL
`
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgf.com)
`Chandrika Vira (cvira@skgf.com)
`1100 New York Avenue
`
`Washington, DC. 20005
`(202) 772-8511 (telephone)
`
`Attorneys for Defendants Aurobz’ndo Pharma
`Ltd. and Aurobindo Pharma USA Inc.
`
`Andrew J. Miller (amiller@buddlarner.com)
`Constance S. Huttner
`
`(chuttner@buddlarner.com)
`Caroline Sun (csun@budd1arner.com)
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078-2703
`(973) 379-4800 (telephone)
`
`Attorneys for Defendant Amneal
`Pharmaceuticals LLC
`
`KELLEY DRYE & WARREN LLP
`
`SUGHRUE MION, PLLC
`
`Steven J. Moore (smoore@kelleydrye.com)
`Vincent P. Rao 11 (vrao@kelleydrye.com)
`Elizabeth W. Swedock
`
`(eswedock@kelleydrye.com)
`101 Park Avenue
`
`New York, New York 10178
`(212) 808-7800 (telephone)
`
`Attorneys for Defendants Zydus
`Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Limited
`
`Chidambaram S. Iyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk
`(mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`2100 Pennsylvania Avenue, NW
`Washington, DC. 20037-3213
`(202) 293—7060 (telephone)
`
`Attorneys for Defendants Sawai USA, Inc.
`and Sawai Pharmaceutical Ca, Ltd.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 10 of 54
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 10 of 54
`
`STERNE, KESSLER, GOLDSTEIN & Fox PLLC
`
`BUDD LARNER, P.C.
`
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgf.com)
`Chandrika Vira (cvira@skgf.com)
`1100 New York Avenue
`
`Washington, DC. 20005
`(202) 772-8511 (telephone)
`
`Attorneys for Defendants Aurobindo Pharma
`Ltd and Aurobindo Pharma USA Inc.
`
`Andrew J. Miller
`
`(amiller@buddlarner.com)
`Constance S. Huttner
`
`(chuttner@buddlarner.com)
`Caroline Sun (csun@buddlamer.c0m)
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078—2703
`(973) 379—4800 (telephone)
`
`Attorneys for Defendant Amneal
`Pharmaceuticals LLC
`
`WITH 5 BERGMAN LLP
`
`SUGHRUE MION, PLLC
`
`
`
`Steven J.
`
`(smoore@kelleydrye.com)
`or
`Withers Berg an
`157 Church Street
`
`New Haven, CT 06502
`(203) 302-4069 (telephone)
`
`Attorneysfor Defendants Zydus
`Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Limited
`
`Chidambaram S. Iyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk
`(mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`2100 Pennsylvania Avenue, NW
`Washington, DC. 20037-3213
`(202) 293—7060 (telephone)
`
`Attorneys for Defendants Sawai USA, Inc.
`and Sawai Pharmaceutical C0., Ltd.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 11 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 11 of 54
`
`STERNE, KESSLER, GOLDSTEIN & Fox PLLC
`
`BUDD LARNER, P.C.
`
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgf.corn)
`Chandrika Vira (cvira@skgf. com)
`1100 New York Avenue
`
`Washington, DC. 20005
`(202) 772-8511 (telephone)
`
`Attorneys for Defendants Aurobindo Pharma
`Ltd. and Aurobindo Pharma USA Inc.
`
`Andrew J. Miller (amiller@buddlarner. com)
`Constance S. Huttner
`
`(chuttner@buddlarner.com)
`Caroline Sun (csun@buddlarner.com)
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078—2703
`(973) 379—4800 (telephone)
`
`Attorneys for Defendant Amneal
`Pharmaceuticals LLC
`
`KELLEY DRYE & WARREN LLP
`
`SUGHRUE MION, PLLC
`
`Steven J. Moore (smoore@kelleydrye.com)
`Vincent P. Rao 11 (vrao@kelleydrye.com)
`Elizabeth W. Swedock
`
`(eswedock@kelleydrye.com)
`101 Park Avenue
`
`New York, New York 10178
`(212) 808—7800 (telephone)
`
`Attorneys for Defendants Zydus
`Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Limited
`
`Alfie/e
`
`Chidarnbaram S. Iyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk
`(mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`2100 Pennsylvania Avenue, NW
`Washington, DC. 20037—3213
`(202) 293-7060 (telephone)
`
`Attorneys for Defendants Sawaz' USA, Inc.
`and Sawai Pharmaceutical Ca, Ltd.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 12 of 54
`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 12 of 54
`
`
`
`I hree World Financial Center
`
`New York, NY 10281-2101
`(212) 415-8600 (telephone)
`
`Keith D. Parr (kparr@lockelord.com)
`David B. Abramowitz
`
`(dabramowitz@lockelord.com)
`Andy J. Miller (amiller@lockelord.com)
`Nina Vachhani (nvachhani@lockelord.com)
`111 South Wacker Drive
`
`Chicago, IL 60606
`(312) 443-0700 (telephone)
`
`Attorneys for Defendants Apotex Inc. and
`Apotex Corp.
`
`Attachments:
`Exhibit 1 — Letter of Request to the Canton of Basel-Landschaft, Swiss Confederation
`Exhibit 2 — Letter of Request to the Canton of Basel-Stadt, Swiss Confederation
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 13 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 13 of 54
`
`EXHIBIT 1
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 14 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 14 of 54
`
`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‘
`
`Aurobindo Pharma Limited and
`
`Aurobindo Pharma USA Inc,
`
`Defendants.
`
`
`Kowa Company, Ltd,
`Kowa Pharmaceuticals America, Inc, and
`
`Nissan Chemical Industries, Ltd,
`
`Plaintiffs,
`
`V,
`
`Amneal Pharmaceuticals LLC,
`
`Defendant.
`
`
`Kowa Company, Ltd,
`Kowa Pharmaceuticals America, Inc, and
`
`Nissan Chemical Industries, Ltd,
`
`Plaintiffs,
`
`Civil Action No. l4—CV—2497 (PAC)
`
`Civil Action No. l4-CV-2758 (PAC)
`
`
`
`V,
`
`Civil Action No. 14-CV-2647 (PAC)
`
`Mylan Inc. and Mylan Pharmaceuticals Inc,
`
`Defendants.
`
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 15 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 15 of 54
`
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`V~
`
`Orient Pharma Co., Ltd.,
`
`
`
`
`Civil Action No. l4—CV—2759 (PAC)
`
`Civil Action No. l4-CV-2760 (PAC)
`
`Civil Action No. I4—CV—5575 (PAC)
`
`Defendant.
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`V‘
`
`Zydus Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Ltd. (dba Zydus Cadila),
`
`Defendants.
`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd.,
`
`Plaintiffs,
`
`V-
`
`Sawai USA, Inc. and
`Sawai Pharmaceutical Co., Ltd,
`
`Defendants.
`
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 16 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 16 of 54
`
`
`
`Kowa Company, Ltd,
`Kowa Pharmaceuticals America, Inc., and
`
`Nissan Chemical Industries, Ltd,
`
`Plaintiffs,
`
`V.
`
`
`
`Civil Action No. 14—CV—7934 (PAC)
`
`Apotex, Inc. and Apotex Corp,
`
`Defendants.
`
`LETTER OF REQUEST FOR INTERNATIONAL JUDICIAL ASSISTANCE
`PURSUANT TO THE HAGUE CONVENTION ON THE
`
`TAKING OF EVIDENCE ABROAD IN CIVIL OR COMMERCIAL MATTERS
`
`The United States District Court for the Southern District of New York presents its
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`compliments to the judicial authorities of the Canton of Basel—Landschaft, Swiss Confederation,
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`and requests international judicial assistance to obtain evidence to be used in civil proceedings
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`before this Court.
`
`This Request
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`is made pursuant
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`to, and in conformity with, Article 1 of the Hague
`
`Convention on the Taking of Evidence Abroad in Civil or Commercial Matters (“Hague
`
`Convention”), to which both the United States and the Swiss Confederation are parties.
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`This Court requests assistance in obtaining evidence relevant to the disposition of the
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`matters in dispute between the Plaintiffs and respective Defendants to the above-referenced
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`actions. Specifically, this Court requests that deposition testimony be taken of the non—party
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`witnesses identified herein, who are residents of or are employees within your jurisdiction, to be
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`examined under oath as to their knowledge of the facts relevant to the issues in these cases.
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`This Request fully complies with Swiss reservations under the Hague Convention.
`
`In
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`particular, it is accompanied by a translation of this Request into Swiss German, which is the
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`official language of the Canton of Basel—Landschaft.
`
`1
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`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 17 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 17 of 54
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`1.
`
`SENDER
`
`H. Keeto Sabharwal (keetos@skgf.corn)
`Paul A. Ainsworth (painsworth@skgf.com)
`Chandrika Vira (cvira@skgf.com)
`Sterne, Kessler, Goldstein & Fox PLLC
`1100 New York Avenue
`
`Washington, DC. 20005
`(202) 772—8511 (telephone)
`
`Attorneys for Defendants Aurobinda Pharma Limited and Aurobindo Pharma USA Inc.
`
`Andrew J. Miller (amiller@buddlarner.com)
`Constance S. Huttner (chuttner@buddlarner.com)
`Caroline Sun (csun@buddlarner.com)
`Budd Larner, PC.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078-2703
`(973) 379—4800 (telephone)
`
`Attorneys for Defendant Amneal Pharmaceuticals LLC
`
`William A. Rakoczy (wrakoczy@rmmslegal.com)
`Deanne M. Mazzochi (dmazzochi@rmmslegal.com)
`Amy D. Brody (abrody@rmmslegal.corn)
`Luke T. Shannon (lshannon@rmmslegal.corn)
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`
`Chicago, Illinois 60654
`(312) 222—6301 (telephone)
`
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`Saiber LLC
`
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102
`(973) 622—3333 (telephone)
`
`Attorneys for Defendants Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 18 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 18 of 54
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`Natalie C. Clayton (Natalie.Clayton@alston.com)
`Paki Banky (paki.banky@alston.com)
`Alston & Bird LLP
`
`90 Park Avenue, 15th Floor
`
`New York, New York 10016—1387
`(212) 210—9400 (telephone)
`
`Attorneys for Defendant Orient Pharma Ca, Ltd.
`
`Steven J. Moore (smoorechwithersworldwide.com)
`Withers Bergman LLP
`157 Church Street
`
`New Haven, Connecticut 06502
`(203) 302-4069 (telephone)
`
`
`James E. Nealon (iames.nealothhersworldwide.com)
`Withers Bergman LLP
`430 Park Avenue
`
`New York, New York 10022—3505
`(212) 848-9800 (telephone)
`
`Attorneys for Defendants Zydus Pharmaceuticals (USA) Inc., and Cadila Healt‘hcare Ltd. (dba
`Zydas Cadila)
`
`Chidambaram S. Iyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk (mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`Sughrue Mion, PLLC
`2100 Pennsylvania Avenue, NW
`Washington, DC. 20037-3213
`(202) 293-7060 (telephone)
`
`Attorneys for Defendants Sawai USA, Inc, and Sawai Pharmaceutical Ca, Ltd.
`
`Joseph N. Froehlich (jfroehlich@lockelord.com)
`Locke Lord LLP
`
`Three World Financial Center
`
`New York, NY 10281—2101
`(212) 415—8600 (telephone)
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 19 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 19 of 54
`
`Keith D. Parr (kparr@lockelord.corn)
`David B. Abramowitz (dabramowitz@lockelordcom)
`Andy J. Miller (amiller@lockelord.com)
`Nina Vachhani (nvachhani@lockelord.com)
`Locke Lord LLP
`
`111 South Wacker Drive
`
`Chicago, IL 60606
`(312) 443-0700 (telephone)
`
`Attorneys for Defendants Apotex Inc. and Apotex Corp.
`
`On behalf of:
`
`Hon. Paul A. Crotty
`United States District Court
`
`Southern District of New York
`
`500 Pearl Street
`
`New York, New York 10007-1312
`United States of America
`
`2.
`
`CENTRAL AUTHORITY OF THE REQUESTED STATE
`
`Kantonsgericht Basel—Landschaft
`Justizverwaltung
`Bahnhofplatz 16
`Postfach 635
`
`4410 Liestal
`
`Swiss Confederation
`
`3.
`
`PERSON(S) TO WHOM THE EXECUTED REQUEST IS TO BE RETURNED
`
`Natalie C. Clayton
`Alston & Bird LLP
`
`90 Park Avenue
`
`New York, New York 10016
`
`Telephone: (212) 210-9573
`Fax: (212) 922—3845
`Email: Natalie.Clayton@alston.com
`
`On behalf of:
`
`Hon. Paul A. Crotty
`United States District Court
`
`Southern District of New York
`
`500 Pearl Street
`
`New York, New York 10007—1312
`United States of America
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 20 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 20 of 54
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`4.
`
`SPECIFICATION OF THE DATE BY WHICH THE REQUESTING
`AUTHORITY REQUIRES RECEIPT OF THE RESPONSE TO THE LETTER OF
`REQUEST
`
`This Court notes that the fact discovery deadline in these civil actions is October 12,
`
`2015, and requests that the depositi0n(s) be held prior to that date.
`
`5.
`
`IN CONFORMITY WITH ARTICLE 3 OF THE CONVENTION, THE
`UNDERSIGNED APPLICANT HAS THE HONOUR TO SUBMIT THE
`
`FOLLOWING REQUEST:
`
`a.
`
`REQUESTING JUDICIAL AUTHORITY (Article 3, a)
`
`Hon. Paul A. Crotty
`United States District Court
`
`Southern District of New York
`
`500 Pearl Street
`
`New York, New York 10007—1312
`United States of America
`
`b.
`
`TO THE COMPETENT AUTHORITY OF (Article 3, a)
`
`Kantonsgericht Basel—Landschaft
`Justizverwaltung
`Bahnhofplatz 16
`Postfach 635
`
`4410 Liestal
`
`Swiss Confederation
`
`c.
`
`NAMES OF THE CASE(S) AND ANY IDENTIFYING NUMBER(S)
`
`The following cases are related:
`
`-
`
`-
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. v. Aurobindo Pharma Limited and Aurobindo Pharma
`USA Inc.
`
`Civil Action No. 14-CV—2497 (PAC);
`
`Kowa Company, Ltd, Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. v. Amneal Pharmaceuticals LLC
`
`Civil Action No. 14—CV—2758 (PAC);
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 21 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 21 of 54
`
`o
`
`0
`
`0
`
`-
`
`o
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. V. Mylan Inc. and Mylan Pharmaceuticals Inc.
`Civil Action No. 14-CV—2647 (PAC);
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. V. Orient Pharma Co., Ltd.
`Civil Action No. 14-CV-2759 (PAC);
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. V. Zydus Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Ltd. (dba Zydus Cadila)
`Civil Action No. l4—CV—2760 (PAC);
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. v. Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd.
`Civil Action No. I4—CV-5575 (PAC); and
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`Chemical Industries, Ltd. v. Apotex, Inc. and Apotex Corp.
`Civil Action No. 14~CVA7934 (PAC).
`
`6.
`
`NAMES AND ADDRESSES OF THE PARTIES AND THEIR
`
`REPRESENTATIVES (Article 3, b)
`
`a.
`
`PLAINTIFFS
`
`Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical
`Industries, Ltd.
`
`Represented by:
`David G. Conlin (DGConlin@mintz.com)
`Kathleen B. Carr (KBCarr@mintz.com)
`Adam P. Samansky (APSamansky@mintz.com)
`Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.
`One Financial Center
`
`Boston, Massachusetts 02111
`
`(617) 542-6000 (telephone)
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 22 of 54
`Case 1:14-cv-02758—PAC Document 65 Filed 06/02/15 Page 22 of 54
`
`b.
`
`DEFENDANTS
`
`Aurobindo Pharma Limited and Aurobindo Pharma USA Inc.
`
`Represented by:
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgficom)
`Chandrika Vira (cvira@skgf.com)
`Sterne, Kessler, Goldstein & Fox PLLC
`1100 New York Avenue
`
`Washington, DC. 20005
`(202) 772-8511 (telephone)
`
`Amneal Pharmaceuticals LLC
`
`Represented by:
`Andrew J. Miller (amiller@buddlarner.com)
`Constance S. Huttner (chuttner@buddlarner.com)
`Caroline Sun (csun@buddlarner.eom)
`Budd Larner, PC.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078—2703
`(973) 379-4800 (telephone)
`
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`Represented by:
`William A. Rakoezy (wrakoczy@rmmslegal.com)
`Deanne M. Mazzochi (dmazzochi@rmmslegal.com)
`Amy D. Brody (abrody@rmmslegal.com)
`Luke T. Shannon (lshannon@rmmslegal.com)
`Rakoezy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`(312) 222—6301 (telephone)
`
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`Saiber LLC
`
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102
`(973) 622-3333 (telephone)
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 23 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 23 of 54
`
`Orient Pharma C0., Ltd.
`
`Represented by:
`Natalie C. Clayton (Natalie.Clayton@alston.com)
`Paki Banky (paki.banky@alston.com)
`Alston & Bird LLP
`
`90 Park Avenue, 15th Floor
`
`New York, New York 10016~l387
`
`(212) 210—9400 (telephone)
`
`Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. (dba Zydus Cadila)
`
`Represented by:
`Steven J. Moore (smoore@withersworldwide.com)
`Withers Bergman LLP
`157 Church Street
`
`New Haven, Connecticut 06502
`(203) 302-4069 (telephone)
`
`James E. Nealon ('1ames.nealongagwithersworldwide.com)
`Withers Bergman LLP
`430 Park Avenue
`
`New York, New York 100223505
`(212) 848—9800 (telephone)
`
`Sawai USA, Inc., and Sawai Pharmaceutical Co., Ltd.
`
`Represented by:
`Chidambaram S. lyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk (mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`Sughrue Mion, PLLC
`2100 Pennsylvania Avenue, NW
`Washington, DC. 20037-3213
`(202) 293-7060 (telephone)
`
`Apotex Inc. and Apotex Corp.
`
`Represented by:
`Joseph N. Froehlich (jfroehlich@lockelord.com)
`Locke Lord LLP
`
`Three World Financial Center
`
`New York, NY 10281-2101
`
`(212) 415-8600 (telephone)
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 24 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 24 of 54
`
`Keith D. Parr (kparr@1ockelord.com)
`David B. Abramowitz (dabramowitz@1ockelord.com)
`Andy J. Miller (amiller@lockelord.com)
`Nina Vachhani (nvachhani@lockelord.com)
`Locke Lord LLP
`
`111 South Wacker Drive
`
`Chicago, IL 60606
`(312) 443-0700 (telephone)
`
`7.
`
`a.
`
`NATURE AND PURPOSE OF THE PROCEEDINGS (Article 3, c)
`
`Certain of Defendants have filed Abbreviated New Drug Applications (“ANDA”) with
`
`the US. Food and Drug Administration (“FDA”) seeking approval for generic versions of
`
`Livalo® (pitavastatin calcium) Tablets in the United States. As a result of these ANDA filings,
`
`Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc, and Nissan Chemical
`
`Industries, Ltd. (collectively, “Plaintiffs”) brought suit against Defendants for infringement of
`
`one or more of US. Patent Nos. 5,856,336, 6,465,477, and 8,557,993 (collectively, the “Patents-
`
`in—Suit”), all of which are listed in FDA’s “Orange Book” in connection with Livalo®. This
`
`Court has accepted all of the above—captioned civil actions as related; these actions are further
`
`coordinated for all pre—trial proceedings.
`
`b.
`
`SUMMARY OF COMPLAINT(S)
`
`Plaintiffs allege that Defendants’ ANDA filings infringe one or more of the Patents—in-
`
`Suit. As relevant to this Request, Plaintiffs have asserted US. Patent No. 8,557,993 (the “’993
`
`Patent”) against each of the Defendants.
`
`In their Complaints, Plaintiffs have requested that this
`
`Court enjoin Defendants from the manufacture, use, sale, offer for sale, or importation into the
`
`United States of their respective pitavastatin drug products that are the subject of their respective
`
`proposed ANDAs.
`
`

`

`Case 1:14-cv-02758-PAC Document 65 Filed 06/02/15 Page 25 of 54
`Case 1:14-cv—02758—PAC Document 65 Filed 06/02/15 Page 25 of 54
`
`c.
`
`SUMMARY OF DEFENCE AND COUNTERCLAIMS
`
`In each respective action identified above,
`
`the relevant Defendant(s) have filed an
`
`Answer denying the substantive allegations in Plaintiffs” Complaint, including that the proposed
`
`pitavastatin products that are the subject of their respective ANDAs infringe on the Patents—in-
`
`Suit. Defendants have asserted counterclaims of non—infringement and that the Patents—in—Suit
`
`are invalid and/or unenforceable.
`
`8.
`
`a.
`
`EVIDENCE TO BE OBTAINED (Article 3, d)
`
`Defendants Wish to obtain sworn videotaped deposition testimony of the below-listed
`
`individuals who are listed as inventors on one of the Patents-in-Suit, specifically the ’993 Patent.
`
`b.
`
`PURPOSE OF THE EVIDENCE SOUGHT
`
`The purpose for obtaining the deposition testimony of the ’993 Patent inventors is to
`
`make such evidence available during the pretrial phase and trial(s) conducted in these civil
`
`proceedings, to the extent that such evidence is relevant and useful for said pretrial and trial
`
`proceedings.
`
`9.
`
`IDENTITY AND ADDRESS OF ANY PERSON TO BE EXAMINED (Article 3, e)
`
`This Court has determined that it is relevant and useful for the due determination of the
`
`matters in dispute between the parties to the above-captioned civil proceedings that you cause the
`
`following witnesses, who are residents and/or employees within your jurisdiction,
`
`to be
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`examined. The names and addresses of the witnesses are as follows:
`
`10
`
`

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`Case 1:14-cv-02758-PAC Doc