Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 1 of 17 PageID: 45
`
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`SAIBER LLC
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102-5311
`T: (973) 622-3333
`
` Timothy H. Kratz (tkratz@mcguirewoods.com)
` Robert L. Florence (rflorence@mcguirewoods.com)
` George J. Barry III (gbarry@mcguirewoods.com)
` Brie L.B. Buchanan (bbuchanan@mcguirewoods.com)
` Jessica M. Hauth (jhauth@mcguirewoods.com)
` MCGUIREWOODS LLP
` 1230 Peachtree Street N.E., Suite 2100
` Atlanta, Georgia 30309-3534
` T: (404) 443-5500
`
`Attorneys for Defendants/Counterclaim Plaintiffs
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`
`
`WARNER CHILCOTT COMPANY, LLC,
`
`
`Plaintiff,
`
`
`
`v.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`)
`
`)
`) Civil Action No. 3:13-cv-06560-JAP-TJB
`
`)
`
`)
`
`)
`
`)
`)
`)
`)
`)
`
`
`MYLAN INC., MYLAN PHARMACEUTICALS
`INC. and FAMY CARE LTD.,
`
`
`Defendants.
`
`
`DOCUMENT FILED ELECTRONICALLY
`
`
`
`
`
`
`ANSWER, DEFENSES AND COUNTERCLAIMS OF
`MYLAN INC. AND MYLAN PHARMACEUTICALS INC. TO
`PLAINTIFF’S COMPLAINT FOR PATENT INFRINGEMENT
`
`Defendants Mylan Inc. (“Mylan”) and Mylan Pharmaceuticals Inc. (“Mylan
`
`Pharmaceuticals”) (collectively, “Mylan” or “Defendants”) answer the Complaint of Plaintiff
`
`Warner Chilcott Company, LLC (“Warner Chilcott” or “Plaintiff”), as follows:
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 1
`
`

`
`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 2 of 17 PageID: 46
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`RESPONSE TO ALLEGATIONS PERTAINING TO THE PARTIES
`
`1. Plaintiff Warner Chilcott Company, LLC (“Warner Chilcott”) is a limited liability
`company organized and existing under the laws of Puerto Rico, having offices at
`Union St., Road 195, Km 1.1, Fajardo, Puerto Rico.
`
`ANSWER: Upon information and belief, Mylan admits that Plaintiff has offices at Union St.,
`
`Road 195, Km 1.1, Fajardo, Puerto Rico. Mylan lacks sufficient knowledge and information to
`
`form a belief as to the truth of the remaining allegations contained in paragraph 1 of the
`
`Complaint, and, on that basis, denies those allegations.
`
`2. Upon information and belief, Defendant Mylan Inc. is a corporation organized and
`existing under the laws of Pennsylvania, having an office and place of business at
`1500 Corporate Drive, Canonsburg, Pennsylvania 15317.
`
`ANSWER: Mylan admits that Mylan Inc. is a corporation organized and existing under the
`
`laws of the Commonwealth of Pennsylvania with an office located at 1500 Corporate Drive,
`
`Canonsburg, PA 15317. Mylan denies the remaining allegations in paragraph 2.
`
`3. Upon information and belief, Defendant Mylan Pharmaceuticals Inc. (“Mylan Pharms”)
`is a corporation organized and existing under the laws of West Virginia, having an
`office and place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia
`26505. Upon information and belief, Mylan Pharms is a wholly-owned subsidiary of
`Mylan Inc.
`
`ANSWER: Mylan admits that Mylan Pharmaceuticals is a corporation organized and existing
`
`under the laws of the State of West Virginia with an office at 781 Chestnut Ridge Road,
`
`Morgantown, West Virginia 26505, and that Mylan Pharmaceuticals is a wholly-owned
`
`subsidiary of Mylan Inc. Mylan denies the remaining allegations in paragraph 3.
`
`4. Upon information and belief, Defendant Famy Care Ltd. (“Famy Care”) is organized and
`exists under the laws of the Republic of India and has a principal place of business at
`3rd Floor, Brady House, 12/14, Veer Nariman Road, Fort, Mumbai – 400 001, India.
`
`ANSWER: Upon information and belief, Mylan admits Famy Care is a corporation
`
`organized under the laws of India with a place of business at 3rd Floor, Brady House, 12/14,
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 2
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 3 of 17 PageID: 47
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`Veer Nariman Road, Fort, Mumbai - 400 001, India. Mylan denies the remaining allegations in
`
`paragraph 4.
`
`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., directly, or through its subsidiaries, including Mylan Pharms, has engaged in
`continuous and 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 pharmaceutical products in New Jersey and
`deriving substantial revenue from such activities, and by filing counterclaims in New
`Jersey.
`
`ANSWER: Mylan admits that Mylan Inc. is registered to do business in New Jersey, but
`
`denies that Mylan Inc. is a proper party to this litigation. Mylan denies the remaining
`
`allegations contained in paragraph 5.
`
`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 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 pharmaceutical
`products in New Jersey and deriving substantial revenue from such activities, and by
`filing counterclaims in New Jersey.
`
`ANSWER: Mylan admits that Mylan Pharmaceuticals is registered to do business in New
`
`Jersey. Mylan Pharmaceuticals does not contest jurisdiction for the limited purpose of this
`
`action only. Mylan denies the remaining allegations in paragraph 6.
`
`7. Upon information and belief, Famy Care has engaged in continuous and systematic
`contacts with the United States by, among others things, on or about August 7, 2008,
`entering into an agreement with Mylan Inc. to file ANDAs for generic contraceptive
`products and to supply such products to customers in the United States.
`
`ANSWER: Mylan denies the allegations in paragraph 7 of the Complaint.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 3
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 4 of 17 PageID: 48
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`RESPONSE TO ALLEGATIONS PERTAINING TO 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
`this action based on 28 U.S.C. §§ 1331 and 1338(a).
`
`ANSWER: Paragraph 8 contains legal conclusions and allegations to which no answer is
`
`required. To the extent that an answer is required, Mylan admits that Plaintiff purports to bring
`
`this action under the laws of the United States and that this Court has subject matter jurisdiction
`
`over the claims this action, but denies that Mylan Inc. is a proper party to this action. Mylan
`
`denies the remaining allegations in paragraph 8 of the Complaint.
`
`9. This Court has personal jurisdiction over Mylan Inc. and Mylan Pharms, because, inter
`alia, Mylan Inc. and Mylan Pharms have purposefully availed themselves of the
`rights and benefits of New Jersey law. Upon information and belief, Defendants
`Mylan Inc. and Mylan Pharms engage in the sale of a range of generic pharmaceutical
`products within the United States generally and New Jersey specifically.
`
`ANSWER: Mylan Pharmaceuticals does not contest personal jurisdiction for the purposes of
`
`this action only. Mylan denies the remaining allegations in paragraph 9 of the Complaint.
`
`10. This Court has personal jurisdiction over Famy Care at least under Federal Rule of Civil
`Procedure 4(k)(2).
`
`ANSWER: Mylan lacks sufficient knowledge and information to form a belief as to the truth
`
`of the allegations contained in paragraph 10, and, on that basis, denies those allegations.
`
`11. Venue is proper in this Court under 28 U.S.C. §§ 1391(b) and (c), and 28 U.S.C. §
`1400(b).
`
`ANSWER: Mylan does not contest venue in this judicial district for the limited purpose of
`
`this action, but specifically denies that this judicial district is the most appropriate and
`
`convenient venue for this action. Mylan denies the remaining allegations in paragraph 11 of the
`
`Complaint.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 4
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 5 of 17 PageID: 49
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`RESPONSE TO ALLEGATIONS PERTAINING TO 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).
`
`ANSWER: Mylan admits that Warner Chilcott is indicated in the records of the FDA as the
`
`holder of NDA No. 22-501 for Lo Loestrin® Fe, which contains the active ingredients
`
`norethindrone acetate and ethinyl estradiol, and which was approved by the FDA on October 21,
`
`2010 and is indicated for the prevention of pregnancy in women. Mylan lacks sufficient
`
`knowledge and information to form a belief as to the truth of the remaining allegations
`
`contained in paragraph 12 of the Complaint, and, on that basis, denies those allegations.
`
`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.
`
`ANSWER: Mylan admits that the ’984 patent is entitled “Extended Estrogen Dosing
`
`Contraceptive Regimen” and purports to have issued from the United States Patent and
`
`Trademark Office on April 27, 2010. Mylan further admits that Plaintiff purports to attach a
`
`copy of the ’984 patent as Exhibit A to the Complaint. Mylan denies that the ’984 patent was
`
`lawfully issued.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 5
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 6 of 17 PageID: 50
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`14. Warner Chilcott is the sole owner of the ’984 patent.
`
`ANSWER: Mylan lacks sufficient knowledge and information to form a belief as to the truth
`
`of the allegations contained in paragraph 14 of the Complaint, and, on that basis, denies those
`
`allegations.
`
`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 second composition containing 5 to 15 mcg of ethinyl estradiol and
`substantially free of a progestin for 2 days, and (c) a third composition that is a
`placebo, wherein the sequential administration of the first composition, the second
`composition and the third composition, is performed on a daily basis over a 28 day
`cycle.
`
`ANSWER: Mylan avers that the ’984 patent speaks for itself and is the best evidence of its
`
`content. Mylan denies the remaining allegations in paragraph 15.
`
`16. 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.
`
`ANSWER: Mylan admits that the ’984 patent is listed in the electronic version of the FDA’s
`
`Orange Book for Lo Loestrin® Fe. Mylan denies the remaining allegations in paragraph 16.
`
`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 sale of a generic version of Lo Loestrin® Fe (the “Defendants’ ANDA Product”)
`prior to the expiration of the ’984 patent.
`
`ANSWER: Mylan admits that Famy Care filed ANDA No. 20-5049 with the FDA in
`
`accordance with 21 U.S.C. § 355(j) and that ANDA No. 20-5049 lists Mylan Pharmaceuticals
`
`Inc. as its U.S. Agent. Mylan avers that ANDA No. 20-5049 speaks for itself and is the best
`
`evidence of its contents. Mylan denies the remaining allegations in paragraph 17.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 6
`
`

`
`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 7 of 17 PageID: 51
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`18. Upon information and belief, Defendants’ ANDA directed to its proposed generic Lo
`Loestrin® Fe product has been assigned No. 20-5049.
`
`ANSWER: Mylan admits that Famy Care’s ANDA was assigned No. 20-5049. Mylan avers
`
`that ANDA No. 20-5049 speaks for itself and is the best evidence of its contents. Mylan denies
`
`the remaining allegations in paragraph 18.
`
`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).
`
`ANSWER: Mylan avers that ANDA No. 20-5049 speaks for itself and is the best evidence of
`
`its contents. Mylan denies the remaining allegations in paragraph 19.
`
`RESPONSE TO ALLEGATIONS PERTAINING TO FIRST COUNT
`(Alleged Infringement of U.S. Patent No. 7,704,984)
`
`20. Upon information and belief, Defendants’ ANDA was submitted with a 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.
`
`ANSWER: Mylan admits that Famy Care’s ANDA was submitted to the FDA with the
`
`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’984 patent is invalid,
`
`unenforceable, and/or will not be infringed by the product that is the subject of ANDA No. 20-
`
`5049. Mylan denies the remaining allegations in paragraph 20 of the Complaint.
`
`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.
`
`ANSWER: Mylan admits that Mylan Pharmaceuticals and Famy Care sent notice of the
`
`certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) to Plaintiff by letter dated
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 7
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 8 of 17 PageID: 52
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`September 19, 2013, and upon information and belief, that Plaintiff received such notice on
`
`September 20, 2013. Mylan denies the remaining allegations in paragraph 21.
`
`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.
`
`ANSWER: Mylan denies the allegations in paragraph 22 of the Complaint.
`
`23. Upon approval of Defendants’ ANDA, Defendants will actively induce and/or contribute
`to infringement of the ’984 patent.
`
`ANSWER: Mylan denies the allegations in paragraph 23 of the Complaint.
`
`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.
`
`ANSWER: Mylan denies the allegations in paragraph 24 of the Complaint.
`
`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.
`
`ANSWER: Mylan denies the allegations in paragraph 25 of the Complaint.
`
`26. This is an exceptional case, and Warner Chilcott is entitled to its costs and reasonable
`attorney fees.
`
`ANSWER: Paragraph 26 contains legal conclusions and allegations to which no answer is
`
`required. To the extent that an answer is required, Mylan denies the allegations in paragraph 26
`
`of the Complaint.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 8
`
`

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`GENERAL DENIAL
`
`Any allegation in Plaintiff’s Complaint not expressly admitted by Mylan is hereby
`
`denied. Having answered Plaintiff’s Complaint, Mylan denies that Plaintiff is entitled to the
`
`relief requested in Plaintiff’s Prayer for Relief or to any relief whatsoever.
`
`SEPARATE DEFENSES
`
`Without prejudice to the denials set forth in its Answer to the Complaint, and without
`
`admitting any allegations of the Complaint not otherwise admitted, Mylan asserts the following
`
`separate defenses to the Complaint without assuming the burden of proof on any such defense
`
`that would otherwise rest on the Plaintiff:
`
`FIRST SEPARATE DEFENSE
`
`
`
`The manufacture, use, sale, offer for sale, or importation of the product that is the subject
`
`of Famy Care’s ANDA No. 20-5049 has not infringed, does not infringe, and would not, if
`
`marketed, manufactured, used, sold, offered for sale, or imported, infringe any valid or
`
`enforceable claim of the ’984 patent.
`
`SECOND SEPARATE DEFENSE
`
`
`
`One or more claims of the ’984 patent are invalid for failure to satisfy one or more of the
`
`conditions for patentability contained in 35 U.S.C. §§ 101, 102, 103, 112 and/or 116.
`
`THIRD SEPARATE DEFENSE
`
`
`
`By virtue of the prosecution proceedings before the United States Patent and Trademark
`
`Office of the patent application leading to the ’984 patent, Plaintiff is estopped from maintaining
`
`that any valid or enforceable claim of the ’984 patent is infringed by the product that is the
`
`subject of Famy Care’s ANDA No. 20-5049.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 9
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 10 of 17 PageID: 54
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`FOURTH SEPARATE DEFENSE
`
`
`
`Plaintiff has failed to state a claim upon which relief can be granted.
`
`FIFTH SEPARATE DEFENSE
`
`
`
`Any and all additional defenses and counterclaims that discovery may reveal.
`
`COUNTERCLAIMS
`
`For
`
`its counterclaims against Plaintiff/Counterclaim Defendant Warner Chilcott
`
`Company, LLC (“Warner Chilcott” or “Counterclaim Defendant”), Defendant/Counterclaim
`
`Plaintiff Mylan Pharmaceuticals Inc. (“Mylan Pharmaceuticals”) states as follows:
`
`PARTIES
`
`1.
`
`Upon information and belief, Counterclaim Defendant is a limited liability
`
`company organized and existing under the laws of Puerto Rico, having offices at Union St., Road
`
`195, Km 1.1, Fajardo, Puerto Rico.
`
`2.
`
`Mylan Pharmaceuticals is a corporation organized under the laws of the State of
`
`West Virginia, having a place of business at 781 Chestnut Ridge Road, Morgantown, West
`
`Virginia 26505.
`
`JURISDICTION AND VENUE
`
`3.
`
`These counterclaims arise under the Patent Laws of the United States, 35
`
`U.S.C. § 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`4.
`
`The Court has original jurisdiction over the subject matter of these counterclaims
`
`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`5.
`
`The Court has personal jurisdiction over Counterclaim Defendant because
`
`Counterclaim Defendant has availed itself of the rights and privileges of this forum by filing suit
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 10
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 11 of 17 PageID: 55
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`against Counterclaim Plaintiff in this judicial District and, upon information and belief, because
`
`of Counterclaim Defendant’s systematic and continuous contacts with New Jersey by virtue of
`
`Counterclaim Defendant’s distribution of drugs for sale and use in New Jersey.
`
`6.
`
`Venue for these Counterclaims is proper in this judicial District pursuant to 28
`
`U.S.C. §§ 1391(b) and 1400(b).
`
`PATENTS-IN-SUIT
`
`7.
`
`On or about April 27, 2010, the United States Patent and Trademark Office
`
`(“USPTO”) issued United States Patent No. 7,704,984 (“the ’984 patent”), titled “Extended
`
`Estrogen Dosing Contraceptive Regimen.” Upon information and belief, Counterclaim
`
`Defendant is indicated in the records of the USPTO as the owner or assignee of the ’984 patent.
`
`8.
`
`Upon information and belief, Counterclaim Defendant is indicated in the records
`
`of the United States Food and Drug Administration as the holder of New Drug Application No.
`
`22-501 for 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), marketed by
`
`Counterclaim Defendant as Lo Loestrin® Fe.
`
`9.
`
`The ’984 patent is listed in the electronic version of the Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in association with
`
`New Drug Application No. 22-501 covering Lo Loestrin® Fe.
`
`10.
`
`In accordance with 21 U.S.C. § 355(j)(2)(B), Counterclaim Plaintiff notified
`
`Counterclaim Defendant in writing (the “Notice Letter”) that Famy Care had filed ANDA No.
`
`20-5049 with a certification provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’984
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 11
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 12 of 17 PageID: 56
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`patent is invalid, unenforceable, and/or will not be infringed by the product that is the subject of
`
`ANDA No. 20-5049.
`
`11.
`
`In accordance with 21 U.S.C. § 355(j)(2)(B)(iv)(ii), the Notice Letter included a
`
`detailed statement of the factual and legal basis for the certification that the ’984 patent is
`
`invalid, unenforceable, and/or will not be infringed by the product that is the subject of ANDA
`
`No. 20-5049.
`
`12.
`
`On October 30, 2013, Counterclaim Defendant sued Counterclaim Plaintiff
`
`alleging infringement of the ’984 patent.
`
`FIRST CLAIM FOR RELIEF
`(Declaratory Judgment of Non-Infringement of the ’984 patent)
`
`13.
`
`Counterclaim Plaintiff restates and realleges each of the foregoing paragraphs as
`
`if fully set forth herein.
`
`14. Warner Chilcott has accused Counterclaim Plaintiff of infringing the ’984 patent.
`
`15.
`
`Counterclaim Plaintiff denies infringement of the ’984 patent and alleges that the
`
`manufacture, use, sale, offer for sale, or importation of the product that is the subject of Famy
`
`Care’s ANDA No. 20-5049 has not infringed, does not infringe, and would not, if manufactured,
`
`used, sold, offered for sale, or imported, infringe, either directly, indirectly or contributorily, and
`
`would not induce infringement of, any valid or enforceable claim of the ’984 patent.
`
`16.
`
`A definite and concrete, real and substantial, justiciable, and continuing case or
`
`controversy exists between Counterclaim Plaintiff and Counterclaim Defendant regarding the
`
`infringement of the ’984 patent that is of sufficient immediacy and reality to warrant the issuance
`
`of a Declaratory Judgment.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 12
`
`

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`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 13 of 17 PageID: 57
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`17.
`
`Counterclaim Plaintiff is entitled to a judicial declaration that the manufacture,
`
`use, sale, offer for sale, or importation of the product that is the subject of Famy Care’s ANDA
`
`No. 20-5049 has not infringed, does not infringe, and would not infringe, either directly,
`
`indirectly or contributorily, if manufactured, used, sold, offered for sale, or imported, and would
`
`not induce infringement of, any valid or enforceable claim of the ’984 patent.
`
`SECOND CLAIM FOR RELIEF
`(Declaratory Judgment of Invalidity of the ’984 patent)
`
`18.
`
`Counterclaim Plaintiff restates and realleges each of the foregoing paragraphs as
`
`
`
`if fully set forth herein.
`
`19. Warner Chilcott has accused Counterclaim Plaintiff of infringing the ’984 patent.
`
`20.
`
`Counterclaim Plaintiff denies infringement of the ’984 patent and alleges that the
`
`‘984 patent is invalid for failure to comply with one or more of the requirements for patentability
`
`set forth in Title 35 of the U.S. Patent Code, including 35 U.S.C. §§ 101, 102, 103, 112, and/or
`
`116.
`
`21.
`
`For example, one or more claims of the ’984 patent are invalid as anticipated
`
`and/or obvious under 35 U.S.C. §§ 102 and/or 103 over one or more of at least the following:
`
`WO 97/41868 (“the ’868 published application”); EP 0 253 607 (“the ’607 application”); U.S.
`
`Patent No. 5,980,940 (“the ’940 patent”); U.S. Patent No. 5,552,394 (“the ’394 Patent”);
`
`LOESTRIN® 1/20; LOESTRIN® 21; and/or LOESTRIN® Fe.
`
`22.
`
`A definite and concrete, real and substantial, justiciable, and continuing case or
`
`controversy exists between Counterclaim Defendant and Counterclaim Plaintiff regarding the
`
`infringement and validity of the ’984 patent that is of sufficient immediacy and reality to warrant
`
`the issuance of a Declaratory Judgment.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 13
`
`

`
`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 14 of 17 PageID: 58
`
`23.
`
`Counterclaim Plaintiff is entitled to a judicial declaration that one or more of the
`
`claims of the ’984 patent are invalid.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Counterclaim Plaintiff respectfully prays for judgment in its favor and
`
`against Counterclaim Defendant:
`
`(a)
`
`Declaring that the manufacture, use, sale, offer for sale, or importation of the
`
`product that is the subject of Famy Care’s ANDA No. 20-5049 has not infringed, does not
`
`infringe and would not infringe any valid or enforceable claim of the ’984 patent, either literally
`
`or under the doctrine of equivalents;
`
`(b)
`
`Declaring that the manufacture, use, sale, offer for sale, or importation of the
`
`product that is the subject of Famy Care’s ANDA No. 20-5049 has not, does not, and would not
`
`induce the infringement of any valid or enforceable claim of the ’984 patent, either literally or
`
`under the doctrine of equivalents;
`
`(c)
`
`Declaring that the manufacture, use, sale, offer for sale, or importation of the
`
`product that is the subject of Famy Care’s ANDA No. 20-5049 has not, does not, and would not
`
`contributorily infringe any valid or enforceable claim of the ’984 patent, either literally or under
`
`the doctrine of equivalents;
`
`(d)
`
`(e)
`
`Declaring that the claims of the ’984 patent are invalid;
`
`Ordering that Counterclaim Defendant’s Complaint be dismissed with prejudice
`
`and judgment entered in favor of Counterclaim Plaintiff;
`
`(f)
`
`Declaring this case exceptional and awarding Counterclaim Plaintiff their
`
`reasonable attorney’s fees and costs of these Counterclaims pursuant to 35 U.S.C. § 285; and
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 14
`
`

`
`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 15 of 17 PageID: 59
`
`(g)
`
`Awarding Counterclaim Plaintiff such other and further relief as the Court may
`
`deem just and proper.
`
`
`Dated: May 20, 2014
`
` Respectfully submitted,
`
`SAIBER LLC
`
`_/s Arnold B. Calmann_________________
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`SAIBER LLC
`
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102-5311
`T: (973) 622-3333
`
` Timothy H. Kratz (tkratz@mcguirewoods.com)
` Robert L. Florence (rflorence@mcguirewoods.com)
` George J. Barry III (gbarry@mcguirewoods.com)
` Brie L.B. Buchanan (bbuchanan@mcguirewoods.com)
` Jessica M. Hauth (jhauth@mcguirewoods.com)
` MCGUIREWOODS LLP
` 1230 Peachtree Street N.E., Suite 2100
` Atlanta, Georgia 30309-3534
` T: (404) 443-5500
`
`Attorneys for Defendants/Counterclaim Plaintiffs
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 15
`
`

`
`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 16 of 17 PageID: 60
`
`
`
` Certification Pursuant to Local Civil Rule 11.2
`
`Mylan Pharmaceuticals Inc. and Mylan Inc., by their undersigned counsel, hereby certify
`
`that the matter in controversy is not the subject of any pending actions or arbitration or
`
`administrative proceedings.
`
`Dated: May 20, 2014
`
`
`
`Respectfully submitted,
`
`SAIBER LLC
`
`_/s Arnold B. Calmann_________________
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`SAIBER LLC
`
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102-5311
`T: (973) 622-3333
`
` Timothy H. Kratz (tkratz@mcguirewoods.com)
` Robert L. Florence (rflorence@mcguirewoods.com)
` George J. Barry III (gbarry@mcguirewoods.com)
` Brie L.B. Buchanan (bbuchanan@mcguirewoods.com)
` Jessica M. Hauth (jhauth@mcguirewoods.com)
` MCGUIREWOODS LLP
` 1230 Peachtree Street N.E., Suite 2100
` Atlanta, Georgia 30309-3534
` T: (404) 443-5500
`
`Attorneys for Defendants/Counterclaim Plaintiffs
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 16
`
`

`
`Case 3:13-cv-06560-JAP-TJB Document 19 Filed 05/20/14 Page 17 of 17 PageID: 61
`
`Certification Pursuant to Local Civil Rule 201.1
`
`Under Local Civil Rule 201.1, Mylan Pharmaceuticals Inc. and Mylan Inc., by their
`
`undersigned counsel, hereby certify that the parties seek injunctive and declaratory relief, and
`
`therefore this action is not appropriate for compulsory arbitration.
`
`Dated: May 20, 2014
`
`
`
`Respectfully submitted,
`
`SAIBER LLC
`
`_/s Arnold B. Calmann_________________
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`SAIBER LLC
`
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102-5311
`T: (973) 622-3333
`
` Timothy H. Kratz (tkratz@mcguirewoods.com)
` Robert L. Florence (rflorence@mcguirewoods.com)
` George J. Barry III (gbarry@mcguirewoods.com)
` Brie L.B. Buchanan (bbuchanan@mcguirewoods.com)
` Jessica M. Hauth (jhauth@mcguirewoods.com)
` MCGUIREWOODS LLP
` 1230 Peachtree Street N.E., Suite 2100
` Atlanta, Georgia 30309-3534
` T: (404) 443-5500
`
`Attorneys for Defendants/Counterclaim Plaintiffs
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`
`
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2029, Pg. 17