Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 1 of 16 PageID #: 1939
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`Plaintiffs,
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`v.
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`APOTEX INC. and APOTEX CORP.,
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`C.A. No. 14-1453-LPS
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`FIRST AMENDED COMPLAINT FOR PATENT INFRINGEMENT
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`Defendants.
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`Plaintiffs Meda Pharmaceuticals Inc. (“Meda”) and Cipla Ltd. (“Cipla”) (collectively,
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`“Plaintiffs”), by their attorneys, hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, against defendants Apotex Inc. and Apotex Corp.
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`(collectively, “Apotex”). This action relates to Apotex’s submission of Abbreviated New Drug
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`Application (“ANDA”) No. 207712 to the U.S. Food and Drug Administration (“FDA”). ANDA
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`No. 207712 seeks approval to market a 137 mcg strength azelastine hydrochloride and 50 mcg
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`strength fluticasone propionate combination nasal spray (“Generic Product”)—a generic version
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`of Plaintiff Meda’s proprietary DYMISTA® drug product—before the expiration of Plaintiff
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`Cipla’s U.S. Patent Nos. 8,163,723 (“the ’723 patent”), 8,168,620 (“the ’620 patent”), and
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`9,259,428 (“the ’428 patent”), all of which cover the DYMISTA® drug product, and for all of
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`which Meda is the exclusive licensee in the United States.
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 2 of 16 PageID #: 1940
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`PARTIES
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`2.
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`Meda is a corporation organized and existing under the laws of Delaware, and
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`having its principal place of business at 265 Davidson Avenue, Suite 300, Somerset, New Jersey
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`08873-4120.
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`3.
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`Cipla is a publicly held company organized and existing under the laws of India,
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`and having a registered office at Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg,
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`Lower Parel, Mumbai 400 013, Maharashtra, India.
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`4.
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`Upon information and belief, Apotex Inc. is a corporation organized and existing
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`under the laws of Canada, and having its principal place of business at 150 Signet Drive,
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`Toronto, Ontario M9L 1T9, Canada.
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`5.
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`Upon information and belief, Apotex Corp. is a corporation organized and
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`existing under the laws of Delaware, and having its principal place of business at 2400 North
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`Commerce Parkway, Suite 400, Weston, Florida 33326.
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`6.
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`Upon information and belief, Apotex Inc. is in the business of manufacturing,
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`marketing and selling generic drug products. As part of its business, upon information and belief,
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`Apotex Inc., directly or through agents (including Apotex Corp.), regularly files ANDAs with
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`the FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
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`and/or importation of generic versions of drug products that are covered by United States
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`patents. Upon information and belief, as part of these ANDAs, Apotex Inc., directly or through
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`agents (including Apotex Corp.), regularly files certifications of the type described in Section
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`505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (“Paragraph IV
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`certification”) to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of generic drug products prior to the expiration of the U.S. patents that cover them.
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 3 of 16 PageID #: 1941
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`Upon information and belief, Apotex Inc.’s ordinary business operations include litigating and
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`filing claims in the courts of the United States, including the United States District Court for the
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`District of Delaware, regarding the infringement, validity, and/or enforceability of United States
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`patents that cover or are alleged to cover generic drug products that are the subject of ANDAs
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`filed by Apotex.
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`7.
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`Upon information and belief, Apotex Inc. manufactures drug products for the
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`purpose of sale within the United States, including in Delaware, by Apotex Corp.
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`8.
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`Upon information and belief, Apotex Corp. is a wholly-owned subsidiary of
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`Apotex Inc. that serves as Apotex Inc.’s United States sales agent and distributor, and sells and
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`offers for sale Apotex Inc.’s drug products throughout the United States, including in Delaware.
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`Upon information and belief, Apotex Inc. derives substantial revenue from services or things
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`used or consumed in the State of Delaware. Apotex Inc. has stated on its website that “Apotex
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`Inc. serves a marketplace of over 115 countries, and is committed to the growth on a global basis
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`through affiliates such as Apotex Corp. in the United States of America.”
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`JURISDICTION AND VENUE
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`9.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 1 et
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`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`10.
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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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`Apotex Corp. is subject to personal jurisdiction in Delaware because, among other
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`things, upon information and belief, Apotex Corp. is a Delaware corporation with a registered
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`agent in Delaware (The Corporation Trust Company, Corporation Trust Center, 1209 Orange
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`Street, Wilmington, Delaware 19801); it is registered with the Delaware Board of Pharmacy as a
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 4 of 16 PageID #: 1942
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`“Distributor/Manufacturer CSR” and “Pharmacy – Wholesale” pursuant to 24 Del. C. § 2540; it
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`is in the business of marketing drug products, which it distributes and sells throughout the United
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`States, including in Delaware; it derives substantial revenue from services or things used and/or
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`consumed in Delaware; it transacts business with companies located and/or headquartered in
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`Delaware; and, upon receiving FDA approval, it intends to offer to sell and sell the Generic
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`Product described in ANDA No. 207712 in the United States, including in Delaware.
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`12.
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`Apotex Inc. is subject to personal jurisdiction in Delaware because, among other
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`reasons, upon information and belief, Apotex Inc. has had persistent and continuous contacts
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`with this judicial district. It is in the business of manufacturing drug products which it
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`manufactures, distributes, sells and/or offers to sell, primarily through Apotex Corp., throughout
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`the United States, including in Delaware; it derives substantial revenue from services or things
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`used or consumed in the State of Delaware; it transacts business with companies located and/or
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`headquartered in Delaware; as part of its ordinary business practice of engaging in U.S. patent
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`litigation, it has regularly and routinely litigated ANDA cases without contesting jurisdiction in
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`this District, including by availing itself of this forum by filing counterclaims; it has, directly or
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`through an agent, filed an ANDA, and/or been actively involved in the preparation and
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`submission of an ANDA, for the purpose of seeking approval to engage in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of the Generic Product described in
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`ANDA No. 207712 in the United States, including in Delaware; upon receiving FDA approval, it
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`intends to offer to sell and sell, primarily through Apotex Corp., a Delaware corporation, the
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`Generic Product described in ANDA No. 207712 throughout the United States, including in
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`Delaware; and Apotex Corp., acting as Apotex Inc.’s agent and/or alter ego, regularly does and
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`solicits business in Delaware and is engaged in a persistent, continuous and systematic course of
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 5 of 16 PageID #: 1943
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`conduct in Delaware in which it distributes, sells, and offers to sell Apotex Inc.’s drug products
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`in Delaware and derives substantial revenue from services or things used or consumed in the
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`State of Delaware on behalf of Apotex Inc.
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`13.
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`By letter dated October 20, 2014, Apotex sent notice of its ANDA submission and
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`Paragraph IV certification to Meda and Cipla (“the Notice Letter”), affirmatively challenging the
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`validity and infringement of the ’723 and ’620 patents. Meda and Cipla’s receipt of the Notice
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`Letter triggered the 45-day statutory deadline for Meda and Cipla to initiate an infringement
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`lawsuit that would invoke the automatic 30-month stay of FDA approval of ANDA No. 207712
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`in accordance with the Hatch-Waxman framework. 35 U.S.C. § 355(j)(5)(B)(iii). Apotex’s
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`submission of ANDA No. 207712 with Paragraph IV certifications to the ’723 and ’620 patents
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`and its act of sending the Notice Letter are tortious acts with real and injurious consequences
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`giving rise to this infringement action. And because Meda is a Delaware corporation, these
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`injuries and consequences are suffered in Delaware. Apotex, therefore, has purposefully directed
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`its activities towards the State of Delaware, where Meda is incorporated. And because defending
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`against an infringement lawsuit such as this one is an inherent and expected part of a generic
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`ANDA filer’s business, Apotex reasonably anticipated being haled into court in Delaware.
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`14.
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`Apotex’s Notice Letter listed the law firm of Wilson Sonsini Goodrich & Rosati
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`P.C. (“WSGR”) as the agent in the United States authorized to accept service of process for
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`Apotex Inc. relating to ANDA 207712, which is the subject of the present action. WSGR
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`maintains an office in Delaware, at 222 Delaware Avenue, Suite 800, Wilmington, Delaware,
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`19801.
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`15.
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`Upon information and belief, Apotex Corp. and Apotex Inc. have on multiple
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`occasions consented to personal jurisdiction in patent infringement actions in this District,
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 6 of 16 PageID #: 1944
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`including in Aventis Pharma S.A. and Sanofi-Aventis U.S., LLC v. Apotex Inc. and Apotex Corp.,
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`No. 08-cv-00496-GMS (D. Del.); The Proctor & Gamble Company and Hoffmann-La Roche,
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`Inc. v. Apotex, Inc. and Apotex Corp., No. 09-cv-00143-LPS (D. Del.); Pronova Biopharma
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`Norge AS v. Apotex Corp. and Apotex Inc., No. 09-00304-SLR-MPT (D. Del.); Daiichi Sankyo
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`Co., Ltd. and Daiichi Sankyo, Inc. v. Apotex Inc. and Apotex Corp., No. 09-cv-00470 (D. Del.);
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`Warner Chilcott Company, LLC and Hoffman-La Roche, Inc. v. Apotex Inc. and Apotex Corp.,
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`No. 10-cv-01111-LPS (D. Del.); Pfizer Inc. et al. v. Apotex, Inc. and Apotex Corp., No. 11-cv-
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`606-GMS (D. Del.); Senju Pharmaceutical Co., Ltd. et al. v. Apotex Inc. and Apotex Corp., 12-
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`cv-0159-SLR; Pfizer Inc. et al. v. Apotex Inc. and Apotex Corp., No. 12-cv-00809-SLR (D.
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`Del.); Bristol-Myers Squibb Co. v. Apotex Inc. and Apotex Corp., No. 14-00351-RGA (D. Del.);
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`and most recently when they answered a complaint for infringement and asserted counterclaims
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`on September 12, 2014 in Aptalis Pharmatech, Inc. and Ivax International GMBH v. Apotex Inc.
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`and Apotex Corp., No. 14-cv-01038-DED (D. Del.).
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`16.
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`Upon information and belief, Apotex Inc. and Apotex Corp. have availed
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`themselves of the legal protections of the State of Delaware by filing claims or counterclaims
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`affirmatively seeking relief in other prior actions in this Court, including in Aventis-Pharma S.A.
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`and Sanofi-Aventis U.S., LLC v. Apotex Inc. and Apotex Corp., No. 08-cv-00496-GMS (D. Del.);
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`The Procter & Gamble Company and Hoffmann-La Roche, Inc. v. Apotex Inc. and Apotex Corp.,
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`No. 09-cv-00143-LPS (D. Del.); Pronova Biopharma Norge AS v. Apotex Corp. and Apotex Inc.,
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`No. 09-00304-SLR-MPT (D. Del.); Daiichi Sankyo Co., Ltd. and Daiichi Sankyo, Inc. v. Apotex
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`Inc. and Apotex Corp., No. 09-cv-00470 (D. Del.); Warner Chilcott Company, LLC and
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`Hoffman-La Roche, Inc. v. Apotex Inc. and Apotex Corp., No. 10-cv-01111-LPS (D. Del.); Pfizer
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`Inc. et al. v. Apotex, Inc. and Apotex Corp., No. 11-cv-606-GMS (D. Del.); Senju
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 7 of 16 PageID #: 1945
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`Pharmaceutical Co., Ltd. et al. v. Apotex Inc. and Apotex Corp., 12-cv-0159-SLR; Pfizer Inc. et
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`al. v. Apotex Inc. and Apotex Corp., No. 12-cv-00809-SLR (D. Del.); Bristol-Myers Squibb Co.
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`v. Apotex Inc. and Apotex Corp., No. 14-00351-RGA (D. Del.); and most recently, on September
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`12, 2014 in Aptalis Pharmatech, Inc. and Ivax International GmbH v. Apotex Inc. and Apotex
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`Corp., No. 14-cv-01038-DED (D. Del.).
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`REGULATORY REQUIREMENTS FOR
`APPROVAL OF NEW AND GENERIC DRUGS
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`17.
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`The Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C. § 301 et seq.,
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`as amended by the Hatch-Waxman Amendments, sets forth the rules FDA follows when
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`considering whether to approve the marketing of pharmaceutical drugs.
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`18. With the passage of the Hatch-Waxman Act in 1984, the FFDCA provisions with
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`respect to the generic drug approval process were amended in several aspects. One provision
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`requires innovator drug companies to submit patent information to FDA “with respect to which a
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`claim of patent infringement could reasonably be asserted if a person not licensed by the owner
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`engaged in the manufacture, use, or sale of the drug.” 21 U.S.C. § 355(b)(1). FDA publishes the
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`submitted patent information in a publication entitled “Approved Drug Products with
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`Therapeutic Equivalence Evaluations” (commonly referred to as the “Orange Book”).
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`19.
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`The Hatch-Waxman Act further amended the FFDCA to permit generic drug
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`companies to gain approval of generic copies of innovator drugs (also called “reference drugs”)
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`by referencing studies performed by the innovator, without having to expend the same
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`considerable investment in time and resources. Thus, generic drug companies are permitted to
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`file what is referred to as an ANDA under 21 U.S.C. § 355(j). When filing an ANDA, generic
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`drug companies are required to review the patent information that FDA lists in the Orange Book
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 8 of 16 PageID #: 1946
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`for the reference drug and make a statutory certification (commonly called “patent certification”)
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`with respect to the same.
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`20.
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`One such certification is the Paragraph IV certification, where the generic drug
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`company seeks FDA approval to market its generic drug products prior to patent expiration by
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`stating in its ANDA that the Orange Book-listed patents are purportedly “invalid or will not be
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`infringed…” 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`PATENTS-IN-SUIT
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`21.
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`On April 24, 2012, the U.S. Patent and Trademark Office duly and legally issued
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`U.S. Patent No. 8,163,723, titled “Combination of Azelastine and Steroids.” The Orange Book
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`presently shows that the ’723 patent’s term ends on August 29, 2023. A true and correct copy of
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`the ’723 patent is attached hereto as Exhibit A.
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`22.
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`On May 1, 2012, the U.S. Patent and Trademark Office duly and legally issued
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`U.S. Patent No. 8,168,620, also titled “Combination of Azelastine and Steroids.” The Orange
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`Book shows that the ’620 patent’s term ends on February 24, 2026. A true and correct copy of
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`the ’620 patent is attached hereto as Exhibit B.
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`23.
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`On February 16, 2016, the U.S. Patent and Trademark Office duly and legally
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`issued U.S. Patent No. 9,259,428, titled “Combination of Azelastine and Fluticasone for Nasal
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`Administration.” The ’428 patent’s term ends on June 13, 2023. A true and correct copy of
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`the ’428 patent is attached hereto as Exhibit C.
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`24.
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`25.
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`Plaintiff Cipla is the owner of the ’723, ’620, and ’428 patents.
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`Plaintiff Meda is the exclusive licensee of the ’723, ’620, and ’428 patents in the
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`United States, pursuant to an exclusive license agreement between Meda and Cipla, of the right
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`to make, use, and sell certain pharmaceutical preparations containing azelastine hydrochloride
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 9 of 16 PageID #: 1947
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`and fluticasone propionate to treat seasonal allergic rhinitis. Pursuant to that exclusive license,
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`Meda currently markets an azelastine hydrochloride and fluticasone propionate combination
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`nasal spray in the United States under the trademark DYMISTA®. The DYMISTA® product and
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`the conditions of use for which DYMISTA® is approved fall within the claims of the ’723, ’620,
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`and ’428 patents.
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`26.
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`As exclusive licensee, Meda has the right to enforce the ’723, ’620, and the ’428
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`patents.
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`MEDA’S APPROVED DRUG PRODUCT: DYMISTA®
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`27. Meda holds NDA No. 202236, which covers the DYMISTA® (137 mcg azelastine
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`hydrochloride and 50 mcg fluticasone propionate) nasal spray. The FDA approved NDA No.
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`202236 on May 1, 2012, allowing Meda to market DYMISTA® throughout the United States for
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`the treatment of seasonal allergic rhinitis (“SAR”).
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`28.
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`The FDA lists the ’723 and ’620 patents in the Orange Book in connection with
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`NDA No. 202236 because each individually claims the drug composition or methods for using
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`the approved drug product. 21 U.S.C. § 355(b)(1). The ’428 patent will be added to the Orange
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`Book in connection with NDA No. 202236 within 30 days of issuance. 21 U.S.C. § 314.53(d)(3).
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`APOTEX’S ANDA
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`29.
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`By Notice Letter dated October 20, 2014, Apotex notified Meda and Cipla that it
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`had submitted ANDA No. 207712 and a Paragraph IV certification under Section 505(j) of the
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`Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) for a Generic Product purportedly
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`bioequivalent to Meda’s DYMISTA® product.
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 10 of 16 PageID #: 1948
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`30.
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`The Notice Letter states that Apotex seeks approval from the FDA to engage in
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`the commercial manufacture, use, and sale of the Generic Product before the expiration of
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`the ’723 and ’620 patents.
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`31.
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`By filing ANDA No. 207712, Apotex has necessarily represented to the FDA that
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`its Generic Product has the same active ingredients as Meda’s DYMISTA®, and is bioequivalent
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`to DYMISTA®.
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`32.
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`The product and the conditions of use for which Apotex seeks approval in ANDA
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`No. 207712 fall within one or more of the claims of the ’723, ’620, and ’428 patents. If
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`approved, the importation, manufacture, sale, offer for sale and/or use of Apotex’s Generic
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`Product would infringe one or more claims of the ’723, ’620, and ’428 patents.
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`33.
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`In its Notice Letter, Apotex states that ANDA No. 207712 contains a “Paragraph
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`IV certification” asserting that the ’723 and ’620 patents are invalid, unenforceable, and/or will
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`not be infringed by the commercial manufacture, use, and sale of Apotex’s Generic Product.
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`However, Apotex’s Notice Letter fails to disclose non-infringement positions for claims 1-4, 7,
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`8, 10-18, and 20-28 of the ’723 patent and claims 1-13, 15-18, 21, 22, 24-26, 28-31, 33, and 35-
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`47 of the ’620 patent.
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`34.
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`The original Complaint was initially filed on December 2, 2014, within 45 days
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`from the date Meda and Cipla received the Notice Letter. 35 U.S.C. § 355(j)(5)(B)(iii).
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`35.
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`Upon review of ANDA No. 207712, Meda and Cipla allege that Apotex’s Generic
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`Product as described in ANDA No. 207712 would infringe one or more claims of the ’428
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`patent.
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`COUNT I: INFRINGEMENT OF THE ’723 PATENT
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`36. Meda and Cipla reallege paragraphs 1 to 35 above as if fully set forth herein.
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 11 of 16 PageID #: 1949
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`37.
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`Apotex’s submission of ANDA No. 207712 infringes one or more claims of
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`the ’723 patent under 35 U.S.C. § 271(e)(2)(A).
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`38.
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`Upon information and belief, if the FDA approves Apotex’s ANDA No. 207712,
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`Apotex will further infringe one or more claims of the ’723 patent by making, using, offering to
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`sell, and selling its Generic Product in the United States and/or importing such sprays into the
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`United States, and by actively inducing and contributing to infringement by others, in violation
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`of 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
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`39.
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`If Apotex’s marketing and sale of its Generic Product before the expiration of
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`the ’723 patent is not enjoined, Meda and Cipla will suffer substantial and irreparable harm for
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`which there is no adequate remedy at law.
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`COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’723
`PATENT
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`40. Meda and Cipla reallege paragraphs 1 to 39 above as if fully set forth herein.
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`41.
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`These claims also arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201
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`and 2202.
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`42.
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`There is an actual case and controversy between Meda and Cipla on the one side,
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`and Apotex on the other, creating a justiciable case and controversy for which this Court may
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`grant declaratory relief consistent with Article III of the United States Constitution.
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`43.
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`Apotex has made, and will continue to make, substantial preparations in the
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`United States, including Delaware, to manufacture, sell, offer to sell and/or import the Generic
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`Products.
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`44.
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`Apotex’s actions indicate a refusal to change the course of its action in the face of
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`acts by Meda and Cipla.
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`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 12 of 16 PageID #: 1950
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`45.
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`Any commercial manufacture, use, offer for sale, sale and/or importation of the
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`Generic Products prior to patent expiry will constitute direct and/or contributory and/or active
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`inducement of the ’723 patent.
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`46.
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`Unless Apotex is enjoined from infringing, inducing infringement and
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`contributing to the infringement of, the ’723 patent, Meda and Cipla will suffer substantial and
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`irreparable harm for which there is no adequate remedy at law.
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`COUNT III: INFRINGEMENT OF THE ’620 PATENT
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`47. Meda and Cipla reallege paragraphs 1 to 46 above as if fully set forth herein.
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`48.
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`Apotex’s submission of ANDA No. 207712 infringes one or more claims of
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`the ’620 patent under 35 U.S.C. § 271(e)(2)(A).
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`49.
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`Upon information and belief, if the FDA approves Apotex’s ANDA No. 207712,
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`Apotex will further infringe one or more claims of the ’620 patent by making, using, offering to
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`sell, and selling its Generic Product in the United States and/or importing such sprays into the
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`United States, and by actively inducing and contributing to infringement by others, in violation
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`of 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
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`50.
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`If Apotex’s marketing and sale of its Generic Product before the expiration of
`
`the ’620 patent is not enjoined, Meda and Cipla will suffer substantial and irreparable harm for
`
`which there is no adequate remedy at law.
`
`COUNT IV: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’620
`PATENT
`
`51. Meda and Cipla reallege paragraphs 1 to 50 above as if fully set forth herein.
`
`52.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`{01092866;v1 }
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`
`

`
`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 13 of 16 PageID #: 1951
`
`
`
`53.
`
`There is an actual case and controversy between Meda and Cipla on the one side,
`
`and Apotex on the other, creating a justiciable case and controversy for which this Court may
`
`grant declaratory relief consistent with Article III of the United States Constitution.
`
`54.
`
`Apotex has made, and will continue to make, substantial preparations in the
`
`United States, including Delaware, to manufacture, sell, offer to sell and/or import the Generic
`
`Products.
`
`55.
`
`Apotex’s actions indicate a refusal to change the course of its action in the face of
`
`acts by Meda and Cipla.
`
`56.
`
`Any commercial manufacture, use, offer for sale, sale and/or importation of the
`
`Generic Products prior to patent expiry will constitute direct and/or contributory and/or active
`
`inducement of the ’620 patent.
`
`57.
`
`Unless Apotex is enjoined from infringing, inducing infringement and
`
`contributing to the infringement of, the ’620 patent, Meda and Cipla will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT V: INFRINGEMENT OF THE ’428 PATENT
`
`58. Meda and Cipla reallege paragraphs 1 to 57 above as if fully set forth herein.
`
`59.
`
`Apotex’s submission of ANDA No. 207712 infringes one or more claims of
`
`the ’428 patent under 35 U.S.C. § 271(e)(2)(A).
`
`60.
`
`Upon information and belief, if the FDA approves Apotex’s ANDA No. 207712,
`
`Apotex will further infringe one or more claims of the ’428 patent by making, using, offering to
`
`sell, and selling its Generic Product in the United States and/or importing such sprays into the
`
`United States, and by actively inducing and contributing to infringement by others, in violation
`
`of 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
`
`{01092866;v1 }
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`- 13 -
`
`

`
`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 14 of 16 PageID #: 1952
`
`
`
`61.
`
`If Apotex’s marketing and sale of its Generic Product before the expiration of
`
`the ’428 patent is not enjoined, Meda and Cipla will suffer substantial and irreparable harm for
`
`which there is no adequate remedy at law.
`
`COUNT VI: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’428
`PATENT
`
`62. Meda and Cipla reallege paragraphs 1 to 61 above as if fully set forth herein.
`
`63.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`64.
`
`There is an actual case and controversy between Meda and Cipla on the one side,
`
`and Apotex on the other, creating a justiciable case and controversy for which this Court may
`
`grant declaratory relief consistent with Article III of the United States Constitution.
`
`65.
`
`Apotex has made, and will continue to make, substantial preparations in the
`
`United States, including Delaware, to manufacture, sell, offer to sell and/or import the Generic
`
`Products.
`
`66.
`
`Apotex’s actions indicate a refusal to change the course of its action in the face of
`
`acts by Meda and Cipla.
`
`67.
`
`Any commercial manufacture, use, offer for sale, sale and/or importation of the
`
`Generic Products prior to patent expiry will constitute direct and/or contributory and/or active
`
`inducement of the ’428 patent.
`
`68.
`
`Unless Apotex is enjoined from infringing, inducing infringement and
`
`contributing to the infringement of, the ’428 patent, Meda and Cipla will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`{01092866;v1 }
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`
`

`
`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 15 of 16 PageID #: 1953
`
`
`
`REQUEST FOR RELIEF
`
`WHEREFORE, Meda and Cipla respectfully request that this Court grant the following
`
`relief:
`
`A.
`
`A judgment that Apotex has infringed valid and enforceable claims of
`
`the ’723, ’620, and ’428 patents under 35 U.S.C. § 271(e)(2)(A);
`
`B.
`
`A judgment and order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the
`
`effective date of any FDA approval of ANDA No. 207712 not be earlier than the latest of the
`
`expiration dates of the ’723, ’620, and ’428 patents, inclusive of any extension(s) and additional
`
`period(s) of exclusivity;
`
`C.
`
`A judgment declaring that Apotex’s manufacture, use, sale, offer for sale, or
`
`importation into the United States of the Generic Product for which approval is sought in ANDA
`
`No. 207712 would constitute infringement of the ’723, ’620, and ’428 patents, or would induce
`
`or contribute to such infringement, pursuant to 35 U.S.C. § 271(a), (b), and/or (c);
`
`D.
`
`A permanent injunction enjoining Apotex and its officers, agents, servants, and
`
`employees, and those persons in active concert or participation with any of them, from making,
`
`using, selling, or offering to sell in the United States, or importing into the United States, the
`
`Generic Product for which approval is sought in ANDA No. 207712, or any generic azelastine
`
`hydrochloride and fluticasone propionate combination nasal spray product that infringes or
`
`induces or contributes to the infringement of the ’723, ’620, and ’428 patents, until expiration of
`
`those patents;
`
`E.
`
`A declaration under 28 U.S.C. § 2201 that if Apotex, their officers, agents,
`
`servants, employees, licensees, representatives, and attorneys, and all other persons acting or
`
`attempting to act in active concert or participation with them or acting on their behalf, engage in
`
`{01092866;v1 }
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`- 15 -
`
`

`
`Case 1:14-cv-01453-LPS Document 90 Filed 02/26/16 Page 16 of 16 PageID #: 1954
`
`
`
`the commercial manufacture, use, offer for sale, sale and/or importation of the Generic Products
`
`prior to patent expiry, it will constitute an act of direct and/or indirect infringement of
`
`the ’723, ’620, and ’428 patents;
`
`F.
`
`A finding that this is an exceptional case, and an award of attorneys’ fees in this
`
`action pursuant to 35 U.S.C. § 285;
`
`G.
`
`H.
`
`An award of costs and expenses in this action; and
`
`Such further and other relief as this Court determines to be just and proper.
`
`ASHBY & GEDDES
`
`/s/ Andrew C. Mayo
`_________________________________
`Steven J. Balick (#2114)
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`500 Delaware Ave., 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`jday@ashby-geddes.com
`amayo@ashby-geddes.com
`
`Attorneys for Plaintiffs
`Meda Pharmaceuticals Inc. and Cipla Ltd.
`
`
`
`Of Counsel:
`
`H. Keeto Sabharwal
`Uma N. Everett
`Dennies Varughese
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
`
`Dated: February 26, 2016
`
`
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