`
`George F. Pappas (gpappas@cov.com)
`Jeffrey B. Elikan (jelikan@cov.com)
`Benjamin C. Block (bblock@cov.com)
`Eric R. Sonnenschein
`(esonnenschein@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`COVINGTON & BURLING LLP
`1201 Pennsylvania Ave., NW
`Washington, DC 20004-2401
`(202) 662-6000
`
`Counsel for Plaintiff
`Warner Chilcott Company, LLC
`
`
`William J. O’Shaughnessy
`(woshaughnessy@mccarter.com)
`Cynthia S. Betz (cbetz@mccarter.com)
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, NJ 07102
`Tel: (973) 622-4444
`Fax: (973) 624-7070
`
`
`Dominick A. Conde (dconde@fchs.com)
`Jason A. Leonard (jleonard@fchs.com)
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104
`Tel: (212) 218-2100
`Fax: (212) 218-2200
`
`
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`WARNER CHILCOTT COMPANY, LLC,
`
`
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`
`
`
`Plaintiff,
`
`
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`
`
`C. A. No.
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`
`
`
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MYLAN INC., MYLAN PHARMACEUTICALS
`INC. and FAMY CARE LTD.,
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 1
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 2 of 9 PageID: 2
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`
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`Plaintiff Warner Chilcott Company, LLC by its undersigned attorneys, brings this
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`action against Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Famy Care Ltd.
`
`(collectively “Defendants”), and hereby alleges as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Warner Chilcott Company, LLC (“Warner Chilcott”) is a limited
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`liability company organized and existing under the laws of Puerto Rico, having offices at Union
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`St., Road 195, Km 1.1, Fajardo, Puerto Rico.
`
`2.
`
`Upon information and belief, Defendant Mylan Inc. is a corporation
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`organized and existing under the laws of Pennsylvania, having an office and place of business at
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`1500 Corporate Drive, Canonsburg, Pennsylvania 15317.
`
`3.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc.
`
`(“Mylan Pharms”) is a corporation organized and existing under the laws of West Virginia,
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`having an office and place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia
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`26505. Upon information and belief, Mylan Pharms is a wholly-owned subsidiary of Mylan Inc.
`
`4.
`
`Upon information and belief, Defendant Famy Care Ltd. (“Famy Care”) is
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`organized and exists under the laws of the Republic of India and has a principal place of business
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`at 3rd Floor, Brady House, 12/14, Veer Nariman Road, Fort, Mumbai – 400 001, India.
`
`5.
`
`Upon information and belief, Mylan Inc. is doing business in New Jersey.
`
`Upon information and belief Mylan Inc. is registered to do business in New Jersey. Mylan Inc.,
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`directly, or through its subsidiaries, including Mylan Pharms, has engaged in continuous and
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`systematic contacts with New Jersey, and purposefully availed itself of this forum by, among
`
`other things, shipping, using, offering to sell, selling, or causing others to use, offer to sell, or sell
`
`
`
`2
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 2
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 3 of 9 PageID: 3
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`
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`pharmaceutical products in New Jersey and deriving substantial revenue from such activities,
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`and by filing counterclaims in New Jersey.
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`6.
`
`Upon information and belief, Mylan Pharms is doing business in New
`
`Jersey. Upon information and belief Mylan Pharms is registered to do business in New Jersey.
`
`Mylan Pharms has engaged in continuous and systematic contacts with New Jersey, and
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`purposefully availed itself of this forum by, among other things, shipping, using, offering to sell,
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`selling, or causing others to use, offer to sell, or sell pharmaceutical products in New Jersey and
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`deriving substantial revenue from such activities, and by filing counterclaims in New Jersey.
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`7.
`
`Upon information and belief, Famy Care has engaged in continuous and
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`systematic contacts with the United States by, among others things, on or about August 7, 2008,
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`entering into an agreement with Mylan Inc. to file ANDAs for generic contraceptive products
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`and to supply such products to customers in the United States.
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`JURISDICTION AND VENUE
`
`8.
`
`This is an action for patent infringement arising under the patent laws of
`
`the United States, Title 35, United States Code. This Court has subject matter jurisdiction over
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`this action based on 28 U.S.C. §§ 1331 and 1338(a).
`
`9.
`
`This Court has personal jurisdiction over Mylan Inc. and Mylan Pharms,
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`because, inter alia, Mylan Inc. and Mylan Pharms have purposefully availed themselves of the
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`rights and benefits of New Jersey law. Upon information and belief, Defendants Mylan Inc. and
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`Mylan Pharms engage in the sale of a range of generic pharmaceutical products within the
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`United States generally and New Jersey specifically.
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`10.
`
`This Court has personal jurisdiction over Famy Care at least under Federal
`
`Rule of Civil Procedure 4(k)(2).
`
`
`
`3
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 3
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 4 of 9 PageID: 4
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`
`
`11.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(b) and (c), and 28
`
`U.S.C. § 1400(b).
`
`BACKGROUND
`
`12. Warner Chilcott is the holder of New Drug Application (“NDA”) No. 22-
`
`501, for Lo Loestrin® Fe, which contains the active ingredients norethindrone acetate and ethinyl
`
`estradiol. Lo Loestrin® Fe was approved by the FDA on October 21, 2010 and is indicated for
`
`the prevention of pregnancy in women who elect to use it as a method of contraception. Lo
`
`Loestrin® Fe is sold as a 28-day oral contraceptive regimen which includes 24 active tablets
`
`comprising 1 mg norethindrone acetate and 0.01 mg ethinyl estradiol, 2 active tablets comprising
`
`0.01 mg ethinyl estradiol, followed by 2 ferrous fumarate tablets (placebo).
`
`13.
`
`U.S. Patent No. 7,704,984 (“the ’984 patent”) entitled “Extended Estrogen
`
`Dosing Contraceptive Regimen” lawfully issued from the United States Patent and Trademark
`
`Office on April 27, 2010. A copy of the ’984 patent is attached as Exhibit A.
`
`14. Warner Chilcott is the sole owner of the ’984 patent.
`
`15.
`
`The ’984 patent claims, inter alia, a method of female contraception which
`
`comprises administering (a) a first composition containing a progestin in an amount equivalent to
`
`about 0.3 to about 1.5 mg norethindrone acetate wherein the progestin is selected from
`
`norethindrone acetate or norethindrone and 5 to 15 mcg of ethinyl estradiol for 24 days, (b) a
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`second composition containing 5 to 15 mcg of ethinyl estradiol and substantially free of a
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`progestin for 2 days, and (c) a third composition that is a placebo, wherein the sequential
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`administration of the first composition, the second composition and the third composition, is
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`performed on a daily basis over a 28 day cycle.
`
`
`
`4
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 4
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 5 of 9 PageID: 5
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`
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`16.
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`The ’984 patent covers the use of Lo Loestrin® Fe in accordance with the
`
`respective labeling approved by the FDA and is listed in the FDA Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (“the Orange Book”) for that product.
`
`17.
`
`Upon information and belief, Famy Care, together with its U.S. agent,
`
`Mylan Pharms, submitted to the FDA an Abbreviated New Drug Application (“ANDA”) filed
`
`under 21 U.S.C. § 355(j), to obtain approval to engage in the commercial manufacture, use, or
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`sale of a generic version of Lo Loestrin® Fe (the “Defendants’ ANDA Product”) prior to the
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`expiration of the ’984 patent.
`
`18.
`
`Upon information and belief, Defendants’ ANDA directed to its proposed
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`generic Lo Loestrin® Fe product has been assigned No. 20-5049.
`
`19.
`
`Upon information and belief, the composition that is the subject of
`
`Defendants’ ANDA is directed to 24 tablets containing 1 mg norethindrone acetate and 0.01 mg
`
`ethinyl estradiol, 2 tablets containing 0.01 mg ethinyl estradiol and 2 tablets containing ferrous
`
`fumarate (placebo).
`
`COUNT I
`CLAIM FOR INFRINGEMENT OF THE ’984 PATENT
`
`Upon information and belief, Defendants’ ANDA was submitted with a
`
`20.
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) of the Federal Food, Drug and
`
`Cosmetic Act that the ’984 patent is purportedly invalid, unenforceable, and/or will not be
`
`infringed by the manufacture, use or sale of Defendants’ ANDA Product.
`
`21.
`
`Upon information and belief, Defendants sent notice of that certification to
`
`Warner Chilcott on or about September 19, 2013. Warner Chilcott received Defendants’ notice
`
`letter on or about September 20, 2013.
`
`
`
`5
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 5
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 6 of 9 PageID: 6
`
`
`
`22.
`
`By filing the Defendants’ ANDA under 21 U.S.C. § 355(j) for the purpose
`
`of obtaining approval to engage in the manufacture, use or sale of their ANDA Product before
`
`the expiration of the ’984 patent, Famy Care and its U.S. agent, Mylan Pharms, have committed
`
`an act of infringement pursuant to 35 U.S.C. § 271(e)(2)(A). Further, the manufacture, use or
`
`sale of Defendants’ ANDA Product will also infringe one or more claims of the ’984 patent.
`
`23.
`
`Upon approval of Defendants’ ANDA, Defendants will actively induce
`
`and/or contribute to infringement of the ’984 patent.
`
`24.
`
`Upon information and belief, the acts of Mylan Pharms and Famy Care
`
`complained of herein were done and are being done at the direction of, with the authorization of,
`
`and/or with the cooperation, participation and assistance of, and at least in part for the benefit of,
`
`Mylan Inc.
`
`25. Warner Chilcott is entitled to relief provided by 35 U.S.C. § 271(e)(4),
`
`including an order from this Court that the effective date of the approval of Defendants’ ANDA
`
`be a date that is not earlier than the expiration date of the ’984 patent, or any later expiration of
`
`exclusivity to which Warner Chilcott is or becomes entitled.
`
`26.
`
`This is an exceptional case, and Warner Chilcott is entitled to its costs and
`
`reasonable attorney fees.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff respectfully requests the following relief:
`
`(a)
`
`Judgment that Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and
`
`Famy Care Ltd. have infringed one or more claims of the ’984 patent by submitting ANDA No.
`
`20-5049;
`
`
`
`6
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 6
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 7 of 9 PageID: 7
`
`
`
`(b)
`
`A permanent injunction be issued restraining and enjoining Defendants
`
`Mylan Inc., Mylan Pharmaceuticals Inc., and Famy Care Ltd., their officers, agents, attorneys,
`
`and employees, and those acting in privity or concert with them, and their successors and
`
`assigns, from engaging in the commercial manufacture, use, offer to sell, or sale within the
`
`United States, or importation into the United States, of compositions that would infringe, induce
`
`infringement and/or contribute to infringement of the ’984 patent;
`
`(c)
`
`An order that the effective date of any approval of Defendants’ ANDA
`
`No. 20-5049, be a date that is not earlier than the expiration of the ’984 patent, or any later
`
`expirations of exclusivity to which Plaintiff is or becomes entitled;
`
`(d)
`
`Declaring this to be an exceptional case and awarding Plaintiff its attorney
`
`fees under 35 U.S.C. § 285; and
`
`(e)
`
`Such other and further relief as the Court may deem just and proper.
`
`
`
`7
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 7
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 8 of 9 PageID: 8
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
` /s/ William J. O’Shaughnessy
`William J. O’Shaughnessy
`(woshaughnessy@mccarter.com)
`Cynthia S. Betz (cbetz@mccarter.com)
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, NJ 07102
`Tel: (973) 622-4444
`Fax: (973) 624-7070
`
`
`Counsel for Plaintiff
`Warner Chilcott Company, LLC
`
`
`
`
`
`
`October 30, 2013
`
`
`
`
`
`George F. Pappas (gpappas@cov.com)
`Jeffrey B. Elikan (jelikan@cov.com)
`Benjamin C. Block (bblock@cov.com)
`Eric R. Sonnenschein
`(esonnenschein@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`COVINGTON & BURLING LLP
`1201 Pennsylvania Ave., NW
`Washington, DC 20004-2401
`(202) 662-6000
`Dominick A. Conde (dconde@fchs.com)
`Jason A. Leonard (jleonard@fchs.com)
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104
`Tel: (212) 218-2100
`Fax: (212) 218-2200
`
`
`
`
`8
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 8
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1 Filed 10/30/13 Page 9 of 9 PageID: 9
`
`
`
`
`
` CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`Plaintiff, by its undersigned counsel, hereby certifies pursuant to L. Civ. R. 11.2 that the
`
`matters in controversy in the instant action overlap with the subject matter of two other pending
`
`actions in this Court regarding the same patent (U.S. Patent No. 7,704,984) and the same
`
`product, Lo Loestrin® Fe. The first of these two other actions was filed on September 1, 2011
`
`and is captioned Warner Chilcott Company, LLC v. Lupin Ltd. et al., 11-cv-05048-JAP-TJB.
`
`The second of these two other actions was filed on May 16, 2012 and is captioned Warner
`
`Chilcott Company, LLC v. Amneal Pharmaceuticals, LLC et al., 12-cv-02928-JAP-TJB. The
`
`Court held a joint bench trial in these two actions between October 7, 2013 and October 17,
`
`2013.
`
`Respectfully submitted,
`
`
`
`
`
` /s/ William J. O’Shaughnessy
`William J. O’Shaughnessy
`(woshaughnessy@mccarter.com)
`Cynthia S. Betz (cbetz@mccarter.com)
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, NJ 07102
`Tel: (973) 622-4444
`Fax: (973) 624-7070
`
`
`Counsel for Plaintiff
`Warner Chilcott Company, LLC
`
`
`
`October 30, 2013
`
`
`
`George F. Pappas (gpappas@cov.com)
`Jeffrey B. Elikan (jelikan@cov.com)
`Benjamin C. Block (bblock@cov.com)
`Eric R. Sonnenschein
`(esonnenschein@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`COVINGTON & BURLING LLP
`1201 Pennsylvania Ave., NW
`Washington, DC 20004-2401
`(202) 662-6000
`Dominick A. Conde (dconde@fchs.com)
`Jason A. Leonard (jleonard@fchs.com)
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104
`Tel: (212) 218-2100
`Fax: (212) 218-2200
`
`
`
`
`
`
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 9
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1-1 Filed 10/30/13 Page 1 of 5 PageID: 10
`
`
`Exhibit A
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 10
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1-1 Filed 10/30/13 Page 2 of 5 PageID: 11
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 11
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1-1 Filed 10/30/13 Page 3 of 5 PageID: 12
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 12
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1-1 Filed 10/30/13 Page 4 of 5 PageID: 13
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 13
`
`
`
`Case 3:13-cv-06560-JAP-TJB Document 1-1 Filed 10/30/13 Page 5 of 5 PageID: 14
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 14
`
`
`
`-6 5HY
`
`Case 3:13-cv-06560-JAP-TJB Document 1-2 Filed 10/30/13 Page 1 of 2 PageID: 15
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`I. (a) PLAINTIFFS
`WARNER CHILCOTT COMPANY, LLC
`
`DEFENDANTS
`MYLAN INC., MYLAN PHARMACEUTICALS INC. and FAMY CARE
`LTD.
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`11-cv-5048; 12-cv-2928
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`VI. CAUSE OF ACTION
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`VII. REQUESTED IN
` COMPLAINT:
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`VIII. RELATED CASE(S)
` IF ANY
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`10/30/2013
`FOR OFFICE USE ONLY
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 1
`
`
`
`-6 5HYHUVH 5HY
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`Case 3:13-cv-06560-JAP-TJB Document 1-2 Filed 10/30/13 Page 2 of 2 PageID: 16
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`INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
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`Date and Attorney Signature. 'DWH DQG VLJQ WKH FLYLO FRYHU VKHHW
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2028, Pg. 16