Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 1 of 25 PageID #: 2009
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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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`Defendants.
`
`)
`)
`)
`) C.A. No. 14-1453-LPS
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`APOTEX INC. AND APOTEX CORP.’S ANSWER AND COUNTERCLAIMS
`TO FIRST AMENDED COMPLAINT
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`Defendants Apotex Inc. and Apotex Corp. (collectively “Apotex”) by and through their
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`undersigned counsel, file this Answer and respond to each of the allegations of plaintiffs Meda
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`Pharmaceuticals Inc. and Cipla Ltd. (collectively “Plaintiffs”) as follows:
`
`This is an action for patent infringement under the patent laws of the United
`1.
`States, Title 35, United States Code, against defendants Apotex Inc. and Apotex Corp.
`(collectively, "Apotex"). This action relates to Apotex's submission of Abbreviated New Drug
`Application ("ANDA") No. 207712 to the U.S. Food and Drug Administration ("FDA"). ANDA
`No. 207712 seeks approval to market a 137 mcg strength azelastine hydrochloride and 50 mcg
`strength fluticasone propionate combination nasal spray ("Generic Product")—a generic version
`of Plaintiff Meda's proprietary DYMISTA® drug product— before the expiration of Plaintiff
`Cipla’s U.S. Patent Nos. 8,163,723 (“the ’723 patent”), 8,168,620 (“the ’620 patent”), and
`9,259,428 (“the ’428 patent”), all of which cover the DYMISTA® drug product, and for all of
`which Meda is the exclusive licensee in the United States.
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`ANSWER: Paragraph 1 states legal conclusions to which no answer is required. To the
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`extent an answer is required, Apotex admits that the Complaint purports to relate to an action for
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`patent infringement under the patent laws of the United States, Title 35, United States Code,
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`against Apotex. Apotex admits that Apotex submitted ANDA No. 207712 to the FDA and seeks
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`approval to market a 137 mcg strength azelastine hydrochloride and 50 mcg strength fluticasone
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`propionate combination nasal spray. Apotex lacks knowledge or information sufficient to form a
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`belief as to the truth of whether the ’723 patent, ’620 patent, and ’428 cover the DYMISTA® drug
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 2 of 25 PageID #: 2010
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`product or whether Meda is the exclusive licensee in the United States for all of the patents. To
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`the extent not expressly admitted, Apotex denies the allegations of paragraph 1.
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`Meda is a corporation organized and existing under the laws of Delaware, and
`2.
`having its principal place of business at 265 Davidson Avenue, Suite 300, Somerset, New Jersey
`08873-4120.
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`ANSWER: Apotex admits that publically available documents indicate that Meda is a
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`corporation organized and existing under the laws of Delaware, and having its principal place of
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`business at 265 Davidson Avenue, Suite 300, Somerset, New Jersey 08873-4120. To the extent
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`not expressly admitted, Apotex lacks knowledge or information sufficient to form a belief as to
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`the truth of the allegations of paragraph 2 and therefore denies them.
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`Cipla is a publicly held company organized and existing under the laws of India,
`3.
`and having a registered office at Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg,
`Lower Parel, Mumbai 400 013, Maharashtra, India.
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`ANSWER: Apotex admits that publically available documents indicate that Cipla is a
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`publicly held company organized and existing under the laws of India, and having a registered
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`office at Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai
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`400 013, Maharashtra, India. To the extent not expressly admitted, Apotex lacks knowledge or
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`information sufficient to form a belief as to the truth of the allegations of paragraph 3 and
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`therefore denies them.
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`Upon information and belief, Apotex Inc. is a corporation organized and existing
`4.
`under the laws of Canada, and having its principal place of business at 150 Signet Drive,
`Toronto, Ontario M9L 1T9, Canada.
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`ANSWER: Apotex admits that Apotex Inc. is a corporation organized and existing
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`under the laws of Canada and that it has an office located at 150 Signet Drive, Toronto, Ontario
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`M9L 1T9, Canada. To the extent not expressly admitted, Apotex denies the allegations of
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`paragraph 4.
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 3 of 25 PageID #: 2011
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`Upon information and belief, Apotex Corp. is a corporation organized and
`5.
`existing under the laws of Delaware, and having its principal place of business at 2400 North
`Commerce Parkway, Suite 400, Weston, Florida 33326.
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`ANSWER: Apotex admits that Apotex Corp. is a corporation organized and existing
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`under the laws of Delaware and that it has an office located at 2400 North Commerce Parkway,
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`Suite 400, Weston, Florida 33326. To the extent not expressly admitted, Apotex denies the
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`allegations of paragraph 5.
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`Upon information and belief, Apotex Inc. is in the business of manufacturing,
`6.
`marketing and selling generic drug products. As part of its business, upon information and belief,
`Apotex Inc., directly or through agents (including Apotex Corp.), regularly files ANDAs with
`the FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`and/or importation of generic versions of drug products that are covered by United States patents.
`Upon information and belief, as part of these ANDAs, Apotex Inc., directly or through agents
`(including Apotex Corp.), regularly files certifications of the type described in Section
`505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act ("Paragraph IV certification")
`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of generic
`drug products prior to the expiration of the U.S. patents that cover them. Upon information and
`belief, Apotex Inc.'s ordinary business operations include litigating and filing claims in the courts
`of the United States, including the United States District Court for the District of Delaware,
`regarding the infringement, validity, and/or enforceability of United States patents that cover or
`are alleged to cover generic drug products that are the subject of ANDAs filed by Apotex.
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`ANSWER: Apotex admits that Apotex Inc. is in the business of manufacturing,
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`marketing and selling generic drug products. Apotex further admits that as part of its business,
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`Apotex has filed ANDAs with the FDA seeking approval of proposed generic drug products.
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`Apotex further admits that it has filed 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. Apotex further admits it has
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`been involved in litigation regarding claims related to its generic drug products in the courts of
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`the United States, including the United States District Court for the District of Delaware. To the
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`extent not expressly admitted, Apotex denies the allegations of paragraph 6.
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`Upon information and belief, Apotex Inc. manufactures drug products for the
`7.
`purpose of sale within the United States, including in Delaware, by Apotex Corp.
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 4 of 25 PageID #: 2012
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`ANSWER: Apotex admits that Apotex Inc. manufactures drug products. Apotex admits
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`that Apotex Corp. sells drug products within the United States. To the extent not expressly
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`admitted, Apotex denies the allegations of paragraph 7.
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`Upon information and belief, Apotex Corp. is a wholly-owned subsidiary of
`8.
`Apotex Inc. that serves as Apotex Inc.'s United States sales agent and distributor, and sells and
`offers for sale Apotex Inc.'s drug products throughout the United States, including in Delaware.
`Upon information and belief, Apotex Inc. derives substantial revenue from services or things
`used or consumed in the State of Delaware. Apotex Inc. has stated on its website that "Apotex
`Inc. serves a marketplace of over 115 countries, and is committed to the growth on a global basis
`through affiliates such as Apotex Corp. in the United States of America."
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`ANSWER: Apotex admits that Apotex Corp. sells drug products within the United
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`States. The Apotex public website speaks for itself and is the best evidence of its contents. To
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`the extent not expressly admitted, Apotex denies the allegations of paragraph 8.
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`JURISDICTION AND VENUE
`This action arises under the patent laws of the United States, 35 U.S.C. §§ 1 et
`9.
`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§
`1331, 1338(a), 2201, and 2202.
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`ANSWER: Paragraph 9 contains conclusions of law for which no response is required.
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`To the extent a response is required, Apotex admits that paragraph 9 cites the patent laws of the
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`United States generally and that this Court has subject matter jurisdiction.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
`10.
`ANSWER: Paragraph 10 contains conclusions of law for which no response is required.
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`To the extent a response is required, Apotex does not contest venue for purposes of this litigation
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`only.
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`Apotex Corp. is subject to personal jurisdiction in Delaware because, among other
`11.
`things, upon information and belief, Apotex Corp. is a Delaware corporation with a registered
`agent in Delaware (The Corporation Trust Company, Corporation Trust Center, 1209 Orange
`Street, Wilmington, Delaware 19801); it is registered with the Delaware Board of Pharmacy as a
`"Distributor/Manufacturer CSR" and "Pharmacy — Wholesale" pursuant to 24 Del. C. § 2540; it
`is in the business of marketing drug products, which it distributes and sells throughout the United
`States, including in Delaware; it derives substantial revenue from services or things used and/or
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 5 of 25 PageID #: 2013
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`consumed in Delaware; it transacts business with companies located and/or headquartered in
`Delaware; and, upon receiving FDA approval, it intends to offer to sell and sell the Generic
`Product described in ANDA No. 207712 in the United States, including in Delaware.
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`ANSWER: Paragraph 11 contains conclusions of law for which no response is required.
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`To the extent that a response is required, solely to conserve the resources of the parties and the
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`Court, Apotex does not contest personal jurisdiction in this judicial district for the limited purpose
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`of this action only. To the extent not expressly admitted, Apotex denies the remaining allegations
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`of paragraph 11.
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`12. Apotex Inc. is subject to personal jurisdiction in Delaware because, among
`other reasons, upon information and belief, Apotex Inc. has had persistent and continuous
`contacts with this judicial district. It is in the business of manufacturing drug products which
`it manufactures, distributes, sells and/or offers to sell, primarily through Apotex Corp.,
`throughout the United States, including in Delaware; it derives substantial revenue from
`services or things used or consumed in the State of Delaware; it transacts business with
`companies located and/or headquartered in Delaware; as part of its ordinary business practice
`of engaging in U.S. patent litigation, it has regularly and routinely litigated ANDA cases
`without contesting jurisdiction in this District, including by availing itself of this forum by
`filing counterclaims; it has, directly or through an agent, filed an ANDA, and/or been actively
`involved in the preparation and submission of an ANDA, for the purpose of seeking approval
`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of the
`Generic Product described in ANDA No. 207712 in the United States, including in Delaware;
`upon receiving FDA approval, it intends to offer to sell and sell, primarily through Apotex
`Corp., a Delaware corporation, the Generic Product described in ANDA No. 207712
`throughout the United States, including in Delaware; and Apotex Corp., acting as Apotex
`Inc.'s agent and/or alter ego, regularly does and solicits business in Delaware and is engaged
`in a persistent, continuous and systematic course of conduct in Delaware in which it
`distributes, sells, and offers to sell Apotex Inc.'s drug products in Delaware and derives
`substantial revenue from services or things used or consumed in the State of Delaware on
`behalf of Apotex Inc.
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`ANSWER: Paragraph 12 contains conclusions of law for which no response is
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`required. To the extent that a response is required, solely to conserve the resources of the
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`parties and the Court, Apotex does not contest personal jurisdiction in this judicial district for
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`the limited purpose of this action only. To the extent not expressly admitted, Apotex denies the
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`remaining allegations of paragraph 12.
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 6 of 25 PageID #: 2014
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`By letter dated October 20, 2014, Apotex sent notice of its ANDA submission and
`13.
`Paragraph IV certification to Meda and Cipla ("the Notice Letter"), affirmatively challenging the
`validity and infringement of the ’723 and ’620 patents. Meda and Cipla's receipt of the Notice
`Letter triggered the 45-day statutory deadline for Meda and Cipla to initiate an infringement
`lawsuit that would invoke the automatic 30-month stay of FDA approval of ANDA No. 207712 in
`accordance with the Hatch-Waxman framework. 35 U.S.C. § 355(j)(5)(B)(iii). Apotex's
`submission of ANDA No. 207712 with Paragraph IV certifications to the ’723 and ’620 patents
`and its act of sending the Notice Letter are tortious acts with real and injurious consequences
`giving rise to this infringement action. And because Meda is a Delaware corporation, these
`injuries and consequences are suffered in Delaware. Apotex, therefore, has purposefully directed
`its activities towards the State of Delaware, where Meda is incorporated. And because defending
`against an infringement lawsuit such as this one is an inherent and expected part of a generic
`ANDA filer's business, Apotex reasonably anticipated being haled into court in Delaware.
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`ANSWER: Paragraph 13 contains conclusions of law for which no response is
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`required. To the extent a response is required, Apotex admits it sent a Notice Letter dated
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`October 20, 2014 to Meda and Cipla. Apotex denies the remaining allegations of paragraph
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`13.
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`Apotex's Notice Letter listed the law firm of Wilson Sonsini Goodrich & Rosati
`14.
`P.C. ("WSGR") as the agent in the United States authorized to accept service of process for
`Apotex Inc. relating to ANDA 207712, which is the subject of the present action. WSGR
`maintains an office in Delaware, at 222 Delaware Avenue, Suite 800, Wilmington, Delaware,
`19801.
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`ANSWER: Apotex admits that Wilson Sonsini Goodrich & Rosati P.C. is authorized
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`to accept service of process related to ANDA No. 207712. Apotex admits that WSGR
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`maintains an office in Delaware, at 222 Delaware Avenue, Suite 800, Wilmington, Delaware,
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`19801. To the extent not expressly admitted, Apotex denies the allegations of paragraph 14.
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`Upon information and belief, Apotex Corp. and Apotex Inc. have on multiple
`15.
`occasions consented to personal jurisdiction in patent infringement actions in this District,
`including in Aventis Pharma S.A. and Sanofi-Aventis U.S., LLC v. Apotex Inc. and Apotex Corp.,
`No. 08-cv-00496-GMS (D. Del.); The Proctor & Gamble Company and Hoffmann-La Roche,
`Inc. v. Apotex, Inc. and Apotex Corp., No. 09-cv-00143-LPS (D. Del.); Pronova Biopharma
`Norge AS v. Apotex Corp. and Apotex Inc., No. 09-00304-SLR-MPT (D. Del.); Daiichi Sankyo
`Co., Ltd. and Daiichi Sankyo, Inc. v. Apotex Inc. and Apotex Corp., No. 09-cv-00470 (D. Del.);
`Warner Chilcott Company, LLC and Hoffman-La Roche, Inc. v. Apotex Inc. and Apotex Corp.,
`No. 10-cv-01111-LPS (D. Del.); Pfizer Inc. et al. v. Apotex, Inc. and Apotex Corp., No. 11-cv-
`606-GMS (D. Del.); Senju Pharmaceutical Co., Ltd. et al. v. Apotex Inc. and Apotex Corp., 12-
`cv-0159-SLR; Pfizer Inc. et al. v. Apotex Inc. and Apotex Corp., No. 12-cv-00809-SLR (D. Del.);
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 7 of 25 PageID #: 2015
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`Bristol-Myers Squibb Co. v. Apotex Inc. and Apotex Corp., No. 14-00351-RGA (D. Del.); and
`most recently when they answered a complaint for infringement and asserted counterclaims on
`September 12, 2014 in Aptalis Pharmatech, Inc. and Ivax International GMBH v. Apotex Inc.
`and Apotex Corp., No. 14-cv-01038-DED (D. Del.).
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`ANSWER: Paragraph 15 contains conclusions of law for which no response is
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`required. To the extent that a response is required, solely to conserve the resources of the
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`parties and the Court, Apotex does not contest personal jurisdiction in this judicial district for
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`the limited purpose of this action only. To the extent not expressly admitted, Apotex denies the
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`remaining allegations of paragraph 15.
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`Upon information and belief, Apotex Inc. and Apotex Corp. have availed
`16.
`themselves of the legal protections of the State of Delaware by filing claims or counterclaims
`affirmatively seeking relief in other prior actions in this Court, including in Aventis-Pharma S.A.
`and Sanofi-Aventis U.S., LLC v. Apotex Inc. and Apotex Corp., No. 08-cv-00496-GMS (D. Del.);
`The Procter & Gamble Company and Hoffmann-La Roche, Inc. v. Apotex Inc. and Apotex Corp.,
`No. 09-cv-00143-LPS (D. Del.); Pronova Biopharma Norge AS v. Apotex Corp. and Apotex Inc.,
`No. 09-00304-SLR-MPT (D. Del.); Daiichi Sankyo Co., Ltd. and Daiichi Sankyo, Inc. v. Apotex
`Inc. and Apotex Corp., No. 09-cv-00470 (D. Del.); Warner Chilcott Company, LLC and
`Hoffman-La Roche, Inc. v. Apotex Inc. and Apotex Corp., No. 10-cv-01111-LPS (D. Del.); Pfizer
`Inc. et al. v. Apotex, Inc. and Apotex Corp., No. 11-cv-606-GMS (D. Del.); Senju
`Pharmaceutical Co., Ltd. et al. v. Apotex Inc. and Apotex Corp., 12-cv-0159-SLR; Pfizer Inc. et al.
`v. Apotex Inc. and Apotex Corp., No. 12-cv-00809-SLR (D. Del.); Bristol-Myers Squibb Co.
`v. Apotex Inc. and Apotex Corp., No. 14-00351-RGA (D. Del.); and most recently, on September
`12, 2014 in Aptalis Pharmatech, Inc. and Ivax International GmbH v. Apotex Inc. and Apotex
`Corp., No. 14-cv-01038-DED (D. Del.).
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`ANSWER: Paragraph 16 contains conclusions of law for which no response is
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`required. To the extent that a response is required, solely to conserve the resources of the
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`parties and the Court, Apotex does not contest personal jurisdiction in this judicial district for
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`the limited purpose of this action only. To the extent not expressly admitted, Apotex denies the
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`remaining allegations of paragraph 16.
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`REGULATORY REQUIREMENTS FOR
`APPROVAL OF NEW AND GENERIC DRUGS
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`The Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. § 301 et seq.,
`17.
`as amended by the Hatch-Waxman Amendments, sets forth the rules FDA follows when
`considering whether to approve the marketing of pharmaceutical drugs.
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 8 of 25 PageID #: 2016
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`ANSWER: Paragraph 17 contains conclusions of law for which no response is
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`required. To the extent that a response is required, Apotex denies the allegations of paragraph
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`17.
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`18. With the passage of the Hatch-Waxman Act in 1984, the FFDCA provisions with
`respect to the generic drug approval process were amended in several aspects. One provision
`requires innovator drug companies to submit patent information to FDA "with respect to which a
`claim of patent infringement could reasonably be asserted if a person not licensed by the owner
`engaged in the manufacture, use, or sale of the drug." 21 U.S.C. § 355(b)(1). FDA publishes the
`submitted patent information in a publication entitled "Approved Drug Products with
`Therapeutic Equivalence Evaluations" (commonly referred to as the "Orange Book").
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`ANSWER: Paragraph 18 contains conclusions of law for which no response is
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`required. To the extent that a response is required, Apotex denies the allegations of paragraph
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`18.
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`19. The Hatch-Waxman Act further amended the FFDCA to permit generic drug
`companies to gain approval of generic copies of innovator drugs (also called "reference drugs") by
`referencing studies performed by the innovator, without having to expend the same considerable
`investment in time and resources. Thus, generic drug companies are permitted to file what is
`referred to as an ANDA under 21 U.S.C. § 355(j). When filing an ANDA, generic drug companies
`are required to review the patent information that FDA lists in the Orange Book for the reference
`drug and make a statutory certification (commonly called "patent certification") with respect to the
`same.
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`ANSWER: Paragraph 19 contains conclusions of law for which no response is
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`required. To the extent that a response is required, Apotex denies the allegations of paragraph
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`19.
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`20. One such certification is the Paragraph IV certification, where the generic drug
`company seeks FDA approval to market its generic drug products prior to patent expiration by
`stating in its ANDA that the Orange Book-listed patents are purportedly "invalid or will not be
`infringed..." 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`ANSWER: Paragraph 20 contains conclusions of law for which no response is
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`required. To the extent that a response is required, Apotex denies the allegations of paragraph
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`20.
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 9 of 25 PageID #: 2017
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`PATENTS-IN-SUIT
`On April 24, 2012, the U.S. Patent and Trademark Office duly and legally issued
`21.
`U.S. Patent No. 8,163,723, titled "Combination of Azelastine and Steroids." The Orange Book
`presently shows that the ’723 patent's term ends on August 29, 2023. A true and correct copy of
`the ’723 patent is attached hereto as Exhibit A.
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`ANSWER: Apotex admits that the face of the ’723 patent indicates the title is
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`“Combination of Azelastine and Steroids” and that its issuance occurred on April 24, 2012.
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`Apotex further admits that Exhibit A purports to be a copy of the ’723 patent. The public
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`documents referenced in paragraph 21 speak for themselves and are the best evidence of their
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`contents. Apotex denies that the ’723 patent was duly and legally issued. To the extent not
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`expressly admitted, Apotex denies the allegations of paragraph 21.
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`On May 1, 2012, the U.S. Patent and Trademark Office duly and legally issued
`22.
`U.S. Patent No. 8,168,620, also titled "Combination of Azelastine and Steroids." The Orange
`Book shows that the ’620 patent's term ends on February 24, 2026. A true and correct copy of
`the ’620 patent is attached hereto as Exhibit B.
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`ANSWER: Apotex admits that the face of the ’620 patent indicates the title is
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`“Combination of Azelastine and Steroids” and that its issuance occurred on May 1, 2012.
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`Apotex further admits that Exhibit B purports to be a copy of the ’620 patent. The public
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`documents referenced in paragraph 22 speak for themselves and are the best evidence of their
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`contents. Apotex denies that the ’620 patent was duly and legally issued. To the extent not
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`expressly admitted, Apotex denies the allegations of paragraph 22.
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`On February 16, 2016, the U.S. Patent and Trademark Office duly and legally
`23.
`issued U.S. Patent No. 9,259,428, titled “Combination of Azelastine and Fluticasone for Nasal
`Administration.” The ’428 patent’s term ends on June 13, 2023. A true and correct copy of the
`’428 patent is attached hereto as Exhibit C.
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`ANSWER: Apotex admits that the face of the ’428 patent indicates the title is
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`“Combination of Azelastine and Fluticasone for Nasal Administration” and that its issuance
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`occurred on February 16, 2016. Apotex further admits that Exhibit C purports to be a copy of
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`the ’428 patent. The public documents referenced in paragraph 23 speak for themselves and
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 10 of 25 PageID #: 2018
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`are the best evidence of their contents. Apotex denies that the ’428 patent was duly and
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`legally issued. To the extent not expressly admitted, Apotex denies the allegations of
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`paragraph 23.
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`Plaintiff Cipla is the owner of the ’723, ’620, and ’428 patents.
`24.
`ANSWER: Apotex admits that Plaintiff Cipla is listed in publically available
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`documents as the owner of the ’723, ’620, and ’428 patents. To the extent not expressly
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`admitted, Apotex lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations of paragraph 24 and therefore denies them.
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`Plaintiff Meda is the exclusive licensee of the ’723, ’620, and ’428 patents in the
`25.
`United States, pursuant to an exclusive license agreement between Meda and Cipla, of the right to
`make, use, and sell certain pharmaceutical preparations containing azelastine hydrochloride and
`fluticasone propionate to treat seasonal allergic rhinitis. Pursuant to that exclusive license, Meda
`currently markets an azelastine hydrochloride and fluticasone propionate combination nasal spray
`in the United States under the trademark DYMISTA®. The DYMISTA® product and the
`conditions of use for which DYMISTA® is approved fall within the claims of the ’723, ’620, and
`’428 patents.
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`ANSWER: Apotex lacks knowledge or information sufficient to form a belief as to
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`the truth of the allegations of paragraph 25 and therefore denies them.
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`As exclusive licensee, Meda has the right to enforce the ’723, ’620, and the ’428
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`26.
`patents.
`ANSWER: Apotex lacks knowledge or information sufficient to form a belief as to
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`the truth of the allegations of paragraph 26 and therefore denies them.
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`MEDA'S APPROVED DRUG PRODUCT: DYMISTA®
`27. Meda holds NDA No. 202236, which covers the DYMISTA® (137 mcg azelastine
`hydrochloride and 50 mcg fluticasone propionate) nasal spray. The FDA approved NDA No.
`202236 on May 1, 2012, allowing Meda to market DYMISTA® throughout the United States for
`the treatment of seasonal allergic rhinitis ("SAR").
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`ANSWER: Apotex admits that Meda is listed in publically available documents as the
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`holder of NDA No. 202236 for 137 mcg azelastine hydrochloride and 50 mcg fluticasone
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`propionate nasal spray, which is sold under the name DYMISTA® and that FDA approved
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`NDA No. 202236, allowing Meda to market DYMISTA® throughout the United States for the
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`treatment of seasonal allergic rhinitis ("SAR"). Apotex lacks knowledge or information
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`sufficient to form a belief as to the truth of the remaining allegations of paragraph 27 and
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`therefore denies them.
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`28. The FDA lists the ’723 and ’620 patents in the Orange Book in connection with
`NDA No. 202236 because each individually claims the drug composition or methods for using
`the approved drug product. 21 U.S.C. § 355(b)(1). The ’428 patent will be added to the Orange
`Book in connection with NDA No. 202236 within 30 days of issuance. 21 U.S.C. § 314.53(d)(3).
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`ANSWER: Paragraph 28 contains conclusions of law for which no response is
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`required. The public documents referenced in paragraph 28 speak for themselves and are the
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`best evidence of their contents. To the extent that a response is required, Apotex denies the
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`allegations of paragraph 28.
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`APOTEX'S ANDA
`By Notice Letter dated October 20, 2014, Apotex notified Meda and Cipla that it
`29.
`had submitted ANDA No. 207712 and a Paragraph IV certification under Section 505(j) of the
`Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) for a Generic Product purportedly
`bioequivalent to Meda's DYMISTA® product.
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`ANSWER: Apotex admits that Apotex sent Meda and Cipla a letter dated October 20,
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`2014 indicating it had submitted ANDA No. 207712 with a Paragraph IV certification. To
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`the extent not expressly admitted, Apotex denies the allegations of paragraph 29.
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`The Notice Letter states that Apotex seeks approval from the FDA to engage in
`30.
`the commercial manufacture, use, and sale of the Generic Product before the expiration of the
`’723 and ’620 patents.
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`ANSWER: Apotex admits the allegations of paragraph 30.
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`By filing ANDA No. 207712, Apotex has necessarily represented to the FDA that
`31.
`its Generic Product has the same active ingredients as Meda's DYMISTA, and is bioequivalent
`to DYMISTA®.
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`ANSWER: Paragraph 31 contains conclusions of law for which no response is
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`required. To the extent that a response is required, on information and belief, Apotex admits
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`that Apotex’s ANDA product contains the same active ingredients as Meda’s DYMISTA. To
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`Case 1:14-cv-01453-LPS Document 93 Filed 03/09/16 Page 12 of 25 PageID #: 2020
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`the extent not expressly admitted, Apotex denies the remaining allegations of paragraph 31.
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`The product and the conditions of use for which Apotex seeks approval in ANDA
`32.
`No. 207712 fall within one or more of the claims of the ’723, ’620, and ’428 patents. If
`approved, the importation, manufacture, sale, offer for sale and/or use of Apotex's Generic
`Product would infringe one or more claims of the ’723, ’620, and ’428 patents.
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`ANSWER: Apotex denies the allegations of paragraph 32.
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`In its Notice Letter, Apotex states that ANDA No. 207712 contains a "Paragraph
`33.
`IV certification" asserting that the ’723 and ’620 patents are invalid, unenforceable, and/or will
`not be infringed by the commercial manufacture, use, and sale of Apotex's Generic Product.
`However, Apotex's Notice Letter fails to disclose non-infringement positions for claims 1-4, 7, 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- 47
`of the ’620 patent.
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`ANSWER: The Notice Letter referenced in paragraph 33 speaks for itself and is the
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`best evidence of its contents. To the extent a response is required, Apotex denies that the
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`product that is the subject of ANDA No. 207712 would infringe one or more valid or
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`enforceable claims of the ’723 and ’620 patents. To the extent not expressly admitted, Apotex
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`denies the remaining allegations of paragraph 33.
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`The original Complaint was initially filed on December 2, 2014, within 45
`34.
`days from the date Meda and Cipla received the Notice Letter. 35 U.S.C.
`§ 355(j)(5)(B)(iii)..
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`ANSWER: Apotex lacks knowledge or information sufficient to form a belief as to
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`the truth of the allegations of paragraph 34 and therefore denies them.
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`Upon review of ANDA No. 207712, Meda and Cipla allege that Apotex’s Generic
`35.
`Product as described in ANDA No. 207712 would infringe one or more claims of the ’428 patent.
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`ANSWER: Apotex denies the allegations of paragraph 35.
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`COUNT I: INFRINGEMENT OF THE ’723 PATENT
`Meda and Cipla reallege paragraphs 1 to 35 above as if fully set forth herein.
`36.
`ANSWER: Apotex restates its answers to Paragraphs 1-35 as if fully set forth herein.
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`To the extent any further answer is required, Apotex denies the allegations of paragraph 36.
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`Apotex's submission of ANDA No. 207712 infringes one or more claims of the
`37.
`'723 patent under 35 U.S.C. § 271(e)(2)(A).
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`ANSWER: Apotex denies the allegations of paragraph 37.
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`Upon information and belief, if the FDA approves Apotex's ANDA No. 207712,
`38.
`Apotex will further infringe one or more claims of the '723 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.
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`ANSWER: Apotex denies the allegations of paragraph 38.
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`If Apotex's marketing and sale of its Generic Product before the expiration of the
`39.
`'723 patent is not enjoined, Meda and Cipla will suffer substantial and irreparable harm for
`which there is no adequate remedy at law.
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`ANSWER: Apotex denies the allegations of paragraph 39.
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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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`ANSWER: Apotex restates its answers to Paragraphs 1-39 as if fully set forth herein.
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`To the extent any further answer is required, Apotex denies the