Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 1 of 21
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MARYLAND
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`WARNER CHILCOTT COMPANY, LLC,
`
`Union St., Road 195, Km. 1.1
`
`Fajardo, Puerto Rico
`
`Plaintiff,
`
`V.
`
`C.A. No.
`
`LUPIN ATLANTIS HOLDINGS SA
`
`Miihlentalstrasse 2
`
`8200 Schaffhausen
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`Schaffhausen, Switzerland
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`LUPIN LTD.
`
`B/4 Laxmi Towers,
`
`Bandra Kurla Complex, Bandra (E),
`Mumbai 400 051 India
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`LUPIN PHARMACEUTICALS, INC.
`
`111 S. Calvert Street,
`
`21st Floor,
`
`Baltimore, MD 21202
`
`Baltimore City
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 1 of 9)
`
`
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MARYLAND
`
`WARNER CHILCOTT COMPANY, LLC,
`
`Union St., Road 195, Km. 1.1
`
`Fajardo, Puerto Rico
`
`Plaintiff,
`
`V.
`
`C.A. No.
`
`LUPIN ATLANTIS HOLDINGS SA
`
`Miihlentalstrasse 2
`
`8200 Schaffhausen
`
`Schaffhausen, Switzerland
`
`LUPIN LTD.
`
`B/4 Laxmi Towers,
`
`Bandra Kurla Complex, Bandra (E),
`Mumbai 400 051 India
`
`LUPIN PHARMACEUTICALS, INC.
`
`111 S. Calvert Street,
`
`21st Floor,
`
`Baltimore, MD 21202
`
`Baltimore City
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 1 of 9)
`
`
`
`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 2 of 21
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`Plaintiff Warner Chilcott Company, LLC, by its undersigned attorneys, brings this
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`action against Defendants Lupin Atlantis Holdings SA; Lupin Ltd. ; and Lupin
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`Pharmaceuticals, Inc. (collectively “Lupin”), and hereby alleges as follows:
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`THE PARTIES
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`1.
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`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
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`Union St., Road 195, Km 1.1, Fajardo, Puerto Rico.
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`2.
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`Upon information and belief, Defendant Lupin Limited (“Lupin Ltd.”) is a
`
`corporation organized and existing under the laws of India.
`
`3.
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`Upon information and belief, Defendant Lupin Atlantis Holdings SA (“Lupin
`
`Atlantis”) is a wholly-owned subsidiary of Lupin Ltd., and is a corporation organized and
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`existing under the laws of Switzerland.
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`4.
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`Upon information and belief, Defendant Lupin Pharmaceuticals, Inc. (“Lupin
`
`Pharmaceuticals”) is a wholly-owned subsidiary of Lupin Ltd. and is a corporation
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`organized and existing under the laws of the Commonwealth of Virginia. Lupin
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`Pharmaceuticals has a principal place of business located at 11 1 S. Calvert Street, 2 1st
`
`Floor, Baltimore, MD 21202.
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`5.
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`Upon information and belief, Lupin Ltd. has engaged in continuous and
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`systemic contacts with the United States by, among other things, filing with the United
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`States Food and Drug Administration (“FDA”) Abbreviated New Drug Applications
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`(“ANDAs”) to sell various products in the United States. Upon information and belief,
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 2 of 9)
`
`
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`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 3 of 21
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`Lupin Ltd. manufactures generic drug products for sale and use in the United States,
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`including in this judicial district.
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`6.
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`Upon information and belief, Lupin Ltd., Lupin Atlantis, and Lupin
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`Pharmaceuticals are agents of each other with respect to the development, regulatory
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`approval, marketing, sale and/or distribution of generic pharmaceutical products. Upon
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`information and belief, Lupin Ltd. and Lupin Pharmaceuticals, through their affiliate,
`
`agent, and alter-ego Lupin Atlantis, filed the ANDA with FDA that is at issue in this
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`patent infringement suit. Upon information and belief, the acts of Lupin Atlantis
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`complained of herein were done and are being done with the cooperation, participation,
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`and assistance of, and at least in part for the benefit of, Lupin Ltd. and Lupin
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`Pharmaceuticals.
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`JURISDICTION AND VENUE
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`7.
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`This is an action for patent infringement arising under the patent laws of the
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`United States, 35 U.S.C. § 271(e)(2) and 21 U.S.C. § 355. This Court has subject matter
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`jurisdiction over this action based on 28 U.S.C. §§ 1331 and 1338(a).
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`8.
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`This Court has personal jurisdiction over Lupin Pharmaceuticals by virtue of,
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`at least, its principal place of business in Baltimore, MD.
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`9.
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`This Court has personal jurisdiction over Lupin Atlantis at least under
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`Federal Rule of Civil Procedure 4(k)(2).
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`10.
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`This Court has personal jurisdiction over Lupin Ltd. at least under Federal
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`Rule of Civil Procedure 4(k)(2).
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 3 of 9)
`
`
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`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 4 of 21
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`11.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`COUNT I: CLAIM FOR INFRINGEMENT OF THE ’050 PATENT
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`12. Warner Chilcott LLC is the holder of New Drug Application (“NDA”) No.
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`203667 for Minastrin® 24 Fe, which contains the active ingredients ethinyl estradiol and
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`norethindrone acetate. Minastrin® 24 Fe was approved by FDA on May 8, 2013, and is
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`indicated for use by women to prevent pregnancy. Minastrin® 24 Fe is sold as a 28-day
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`oral contraceptive regimen that includes 24 chewable tablets comprising 1.0 mg
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`norethindrone acetate and 0.020 mg ethinyl estradiol, and 4 chewable ferrous fumarate
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`tablets (placebo).
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`13.
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`U.S. Patent No. 6,667,050 (the “’050 Patent”) entitled “Chewable Oral
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`Contraceptive” was lawfully issued by the United States Patent and Trademark Office on
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`December 23, 2003. A copy of the ’050 Patent is attached as Exhibit A.
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`14. Warner Chilcott is the sole owner of the ’050 Patent.
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`15.
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`The ’050 Patent claims, among other things, chewable, palatable oral
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`contraceptive tablets; methods of administering said tablets to a human female; and
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`methods of enhancing compliance with the oral contraception regimen.
`
`16. Minastrin® 24 Fe and its use in accordance with the FDA-approved labeling
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`are covered by the claims of the ’050 Patent. The ’050 Patent is listed in FDA’s Approved
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`Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for
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`Minastrin® 24 Fe.
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 4 of 9)
`
`
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`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 5 of 21
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`17.
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`Upon information and belief, Lupin Ltd. and Lupin Pharmaceuticals, through
`
`their affiliate, agent, and alter-ego Lupin Atlantis, submitted ANDA No. 206287 to FDA
`
`seeking approval to engage in the commercial manufacture, use, offer for sale, and sale of
`
`a generic version of Minastrin® 24 Fe before the expiration of the ’050 Patent. Defendants’
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`manufacture, use, offer for sale, or sale in the United States, or importation into the
`
`United States, of such product would infringe the claims of the ’050 Patent under 35
`
`U.S.C. § 271(a), (b), and/or (c).
`
`18.
`
`Defendants’ manufacture, use, offer for sale, or sale in the United States, or
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`importation into the United States, of the generic Minastrin® 24 Fe product for which
`
`approval is sought in ANDA No. 206287 would actively induce and contribute to
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`infringement of the ’050 Patent, and Defendants would be liable under 35 U.S.C. § 271(b)
`
`and/or (c).
`
`19.
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`As part of their ANDA filing, Lupin Ltd. and Lupin Pharmaceuticals, through
`
`their affiliate, agent, and alter-ego Lupin Atlantis, have purportedly provided written
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`certification (“Paragraph IV certification”) to FDA that the claims of the ’050 Patent are
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`invalid and/or will not be infringed by the manufacture, use, or sale of Defendants’ generic
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`version of Minastrin® 24 Fe.
`
`20.
`
`By letter dated April 24, 2014, Defendants’ counsel gave written notice of the
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`certification of invalidity and/or noninfringement of the ’050 Patent, alleging that the
`
`claims of the ’050 Patent are invalid due to obviousness, indefiniteness, and lack of
`
`enablement, and that claims 18, 36, and 54 are not infringed by Defendants’ generic
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 5 of 9)
`
`
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`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 6 of 21
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`Minastrin® 24 Fe product. The letter additionally informed Warner Chilcott that
`
`Defendants seek to engage in the commercial manufacture, use, and sale of a product
`
`bioequivalent to Minastrin® 24 Fe prior to the expiration of the ’050 Patent.
`
`21.
`
`Lupin Atlantis has infringed the ’050 Patent under 35 U.S.C. § 271(e)(2)(A)
`
`by virtue of submitting ANDA No. 206287 with a Paragraph IV certification and seeking
`
`FDA approval of ANDA No. 206287 prior to the expiration of the ’050 Patent. Moreover, if
`
`Lupin Atlantis commercially manufactures, uses, offers for sale, or sells in the United
`
`States, or imports into the United States, Defendants’ generic version of Minastrin® 24 Fe,
`
`it would further infringe the ’050 Patent under 35 U.S.C. § 271(a), (b), and/or (c). Upon
`
`approval of ANDA No. 206287, Lupin Atlantis will actively induce and/or contribute to
`
`infringement of the ’050 Patent under 35 U.S.C. § 271(b) and/or (c).
`
`22.
`
`Lupin Pharmaceuticals and Lupin Ltd. are jointly and severally liable for any
`
`infringement of the ’05O Patent by virtue of submitting ANDA No. 206287 through their
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`agent, affiliate, and alter-ego Lupin Atlantis. Upon information and belief, Lupin
`
`Pharmaceuticals and Lupin Ltd. contributed to, aided, abetted, and/or induced the
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`submission of ANDA No. 206287 and its Paragraph IV certification to FDA. Additionally,
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`upon information and belief, Lupin Pharmaceuticals will market and/or distribute
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`Defendants’ generic version of Minastrin® 24 Fe if ANDA No. 206287 is approved by FDA.
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`23.
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`Lupin Pharmaceuticals and Lupin Ltd.’s participation in, contribution to,
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`aiding, abetting, and/or inducement of the submission of ANDA No. 206287 and its
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`Paragraph IV certification to FDA constitute infringement of the ’050 Patent under 35
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 6 of 9)
`
`
`
`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 7 of 21
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`U.S.C. § 271(e)(2)(A). Moreover, if Lupin Pharmaceuticals and/or Lupin Ltd. commercially
`
`manufacture, use, offer for sale, or sell within the United States, or import into the United
`
`States, Defendants’ generic version of Minastrin® 24 Fe, they would further infringe the
`
`’050 Patent under 35 U.S.C. § 271(a), (b), and/or (c). Upon approval ofANDA No. 206287,
`
`Lupin Pharmaceuticals and Lupin Ltd. will actively induce and/or contribute to
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`infringement of the ’050 Patent under § 271(b) and/or (c).
`
`24.
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`This case is an exceptional one, and Warner Chilcott is entitled to an award
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`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
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`25. Warner Chilcott will be irreparably harmed if Defendants are not enjoined
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`from infringing or actively inducing or contributing to infringement of the ’050 Patent.
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`Warner Chilcott does not have an adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Warner Chilcott respectfully requests the following relief:
`
`A.
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`A judgment that Defendants have infringed one or more claims of the ’050
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`Patent by submitting ANDA No. 206287;
`
`B.
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`A permanent injunction restraining and enjoining Defendants, their officers,
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`agents, servants, employees, parents, subsidiaries, divisions, affiliates, and those persons
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`in active concert or participation with any of them, from making, using, selling, offering to
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`sell, or importing any product that infringes the ’050 Patent, including the product
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`described in ANDA No. 206287;
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 7 of 9)
`
`
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`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 8 of 21
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`C.
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`A judgment declaring that making, using, selling, offering to sell, or
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`importing the product described in ANDA No. 206287, or inducing or contributing to such
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`conduct, would constitute infringement of the ’050 Patent by Defendants pursuant to 35
`
`U.S.C. § 271(a), (b), and/or (c);
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`D.
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`An order that the effective date of any approval of Defendants’ ANDA be a
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`date that is not earlier than the expiration of the ’050 Patent or any later expiration of
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`exclusivity to which Warner Chilcott is or becomes entitled;
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`E.
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`A finding that this is an exceptional case, and an award of attorneys’ fees in
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`this action pursuant to 35 U.S.C. § 285;
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`F.
`
`G.
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`Costs and expenses in this action; and
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`Such other and further relief as the Court may deem just and proper.
`
`7
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 8 of 9)
`
`
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`Case 1:14—cv—O1827—RWT Document 1 Filed 06/06/14 Page 9 of 21
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`Dated: June 6, 2014
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`Respectfully submitted,
`
`/s/ Beniamin C. Block
`
`George F. Pappas (D. Md. Bar No. 15339)
`Jeffrey B. Elikan (D. Md. Bar No. 26179)
`Benjamin C. Block (D. Md. Bar No. 15811)
`Eric R. Sonnenschein
`
`Erica N. Andersen
`
`Sumon S. Dantiki
`
`Jeremy D. Cobb
`COVINGTON & BURLING LLP
`
`1201 Pennsylvania Avenue, NW
`Washington, DC 20004
`Tel. (202) 662-6000
`Fax. (202)662-6291
`bb10ck@c0V.c0m
`
`Janssen Ex. 2037
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 9 of 9)
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