Case 1:17-cv-00321-GMS Document 1 Filed 03/24/17 Page 1 of 14 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No.
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`))))))))))
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`ALCON RESEARCH, LTD.,
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`LUPIN LTD. and LUPIN
`PHARMACEUTICALS, INC.,
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`v.
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`Plaintiff,
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`Defendants.
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`COMPLAINT
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`Plaintiff Alcon Research, Ltd. (“Alcon”), by its attorneys, for its Complaint,
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`alleges as follows:
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`1.
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`This is an action for patent infringement under the patent laws of the
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`United States, Title 35, United States Code, and for a declaratory judgment of patent
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`infringement under 28 U.S.C. §§ 2201 and 2202, that arises out of Lupin’s filing of an
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`Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration
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`(“FDA”) seeking approval to manufacture and sell a generic version of PAZEO® ophthalmic
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`solution, a drug product containing olopatadine hydrochloride, a drug product containing
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`olopatadine hydrochloride, prior to the expiration of U.S. Patent No. 9,533,053 (the “’053
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`patent”).
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`2.
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`By letter dated March 15, 2017 (the “Notice Letter”), Lupin notified
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`Alcon that it had submitted to the FDA an ANDA, No. 208896, seeking approval from the FDA
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`to engage in the commercial manufacture, use and/or sale of a generic olopatadine ophthalmic
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`solution (“Lupin’s ANDA Product”) prior to the expiration of the ’053 patent. Upon
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`information and belief, Lupin’s ANDA Product is a drug product that is a generic version of
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`PAZEO®, containing the same or equivalent ingredients in the same or equivalent amounts.
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`PARTIES
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`3.
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`Plaintiff Alcon Research, Ltd. is a corporation organized and existing
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`under the laws of the State of Delaware, having its principal place of business at 6201 South
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`Freeway, Fort Worth, Texas 76134.
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`4.
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`Upon information and belief, defendant Lupin Ltd. is a corporation
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`organized and existing under the laws of India, with a principal place of business at B/4 Laxmi
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`Towers, Bandra-Kurla Complex, Bandra (E), Mumbai 400 051, India. Upon information and
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`belief, Lupin Ltd. is in the business of, among other things, manufacturing and selling generic
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`versions of branded pharmaceutical drugs through various operating subsidiaries, including
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`Lupin Pharmaceuticals, Inc.
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`5.
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`Upon information and belief, defendant Lupin Pharmaceuticals, Inc.
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`(“Lupin Pharmaceuticals”) is a corporation organized and existing under the laws of the State of
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`Delaware, having a principal place of business at Harborplace Tower, 111 South Calvert Street,
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`Baltimore, Maryland 21202. Upon information and belief, Lupin Pharmaceuticals is in the
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`business of, among other things, manufacturing and selling generic versions of branded
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`pharmaceutical products for the U.S. market.
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`6.
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`Upon information and belief, Lupin Pharmaceuticals is a wholly-owned
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`subsidiary of Lupin Ltd.
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`7.
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`Upon information and belief, and consistent with their practice with
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`respect to other generic products, Lupin Ltd. and Lupin Pharmaceuticals acted in concert to
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`prepare and submit ANDA No. 208896.
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`8.
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`Upon information and belief, Lupin Ltd. and Lupin Pharmaceuticals
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`contemplate that, upon approval of ANDA No. 208896, they directly or indirectly manufacture,
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`market, sell, and distribute Lupin’s ANDA Product throughout the United States, including in
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`Delaware. Upon information and belief, Lupin Ltd. and Lupin Pharmaceuticals are agents of
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`each other and/or operate in concert as integrated parts of the same business group, including
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`with respect to Lupin’s ANDA Product, and enter into agreements with each other that are nearer
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`than arm’s length. Upon information and belief, Lupin Pharmaceuticals participated in, assisted,
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`and cooperated with Lupin Ltd. in the acts complained of herein. Lupin Ltd. and Lupin
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`Pharmaceuticals are collectively referred to herein as “Lupin.”
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`9.
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`Upon information and belief, and consistent with their practice with
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`respect to other generic products, following any FDA approval of ANDA No. 208896, Lupin
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`Ltd. and Lupin Pharmaceuticals will act in concert to distribute and sell Lupin’s ANDA Product
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`throughout the United States, including within Delaware.
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`10.
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`Upon information and belief, following any FDA approval of ANDA No.
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`208896, Lupin Ltd. and Lupin Pharmaceuticals know and intend that Lupin’s ANDA Product
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`will be distributed and sold throughout the United States, including in Delaware.
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`JURISDICTION AND VENUE
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`11.
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`Jurisdiction and venue are proper in this district pursuant to 28 U.S.C.
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`§§ 1331, 1338(a), 1391 and 1400(b), and 2201 and 2202.
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`12.
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`This Court has personal jurisdiction over Lupin Ltd. and Lupin
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`Pharmaceuticals.
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`13.
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`Lupin Ltd. is subject to personal jurisdiction in Delaware because, among
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`other things, Lupin Ltd., itself and through its wholly-owned subsidiary Lupin Pharmaceuticals,
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`has purposefully availed itself of the benefits and protections of Delaware’s laws such that it
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`should reasonably anticipate being haled into court here. Upon information and belief, Lupin
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`Ltd., itself and through its wholly-owned subsidiary Lupin Pharmaceuticals, develops,
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`manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the United
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`States, including in the State of Delaware and therefore transacts business within the State of
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`Delaware related to Plaintiff’s claims, and/or has engaged in systematic and continuous business
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`contacts within the State of Delaware. In addition, Lupin Ltd. is subject to personal jurisdiction
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`in Delaware because, upon information and belief, it controls and dominates Lupin
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`Pharmaceuticals and therefore the activities of Lupin Pharmaceuticals in this jurisdiction are
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`attributed to Lupin Ltd.
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`14.
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`Lupin Pharmaceuticals is subject to personal jurisdiction in Delaware
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`because, among other things, it has purposely availed itself of the benefits and protections of
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`Delaware’s laws such that it should reasonably anticipate being haled into court here. Upon
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`information and belief, Lupin Pharmaceuticals develops, manufactures, imports, markets, offers
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`to sell, and/or sells generic drugs throughout the United States, including in the State of
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`Delaware and therefore transacts business within the State of Delaware related to Plaintiff’s
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`claims, and/or has engaged in systematic and continuous business contacts within the State of
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`Delaware. In addition, upon information and belief, Lupin Pharmaceuticals is qualified to do
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`business in Delaware and has appointed a registered agent for service of process, and therefore
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`has consented to general jurisdiction in Delaware.
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`15.
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`Upon information and belief, Lupin earns substantial revenue from generic
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`pharmaceutical products that are distributed, sold, used and/or consumed in Delaware which are
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`manufactured by Lupin and/or for which Lupin Ltd. or Lupin Pharmaceuticals is the named
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`applicant on approved ANDAs. Upon information and belief, various products for which Lupin
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`Ltd. or Lupin Pharmaceuticals is the named applicant on approved ANDAs are available at retail
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`pharmacies in Delaware.
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`16.
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`Upon information and belief, if ANDA No. 208896 is approved, Lupin
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`will directly or indirectly manufacture, market, and/or sell Lupin’s ANDA Product within the
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`United States, including in Delaware, consistent with Lupin’s practices for the manufacturing,
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`marketing and distribution of other generic pharmaceutical products. Upon information and
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`belief, Lupin regularly does business in Delaware, and its practices with other generic
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`pharmaceutical products have involved placing those products into the stream of commerce for
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`distribution throughout the United States, including in Delaware. Upon information and belief,
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`Lupin’s generic pharmaceutical products are used and/or consumed within and throughout the
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`United States, including in Delaware.
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`17.
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`Upon information and belief, Lupin’s ANDA Product will be prescribed
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`by physicians practicing in Delaware, dispensed by pharmacies located within Delaware, and
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`used by patients in Delaware. Each of these activities would have a substantial effect within
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`Delaware and would constitute infringement of Alcon’s patent in the event that Lupin’s ANDA
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`Product is approved before the ’053 patent expires.
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`18.
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`Lupin has previously used the process contemplated by the Drug Price
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`Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j) (the “Hatch-Waxman
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`Act”), to challenge branded pharmaceutical companies’ patents by filing a certification of the
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`type described in Section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
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`(“FFDCA”), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), serving a notice letter on those companies, and
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`engaging in patent litigation arising from the process contemplated by the Hatch-Waxman Act.
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`19.
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`Upon information and belief, Lupin, with knowledge of the Hatch-
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`Waxman Act process, directed the Notice Letter to, inter alia, Alcon Research, Ltd., an entity
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`incorporated in Delaware, and alleged in the Notice Letter that Alcon’s patent is invalid. Upon
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`information and belief, Lupin knowingly and deliberately challenged Alcon’s patent rights, and
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`knew when it did so that it was triggering a forty-five day period for Alcon to bring an action for
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`patent infringement under the Hatch-Waxman Act. Moreover, upon information and belief,
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`Lupin knew that another Hatch-Waxman Act infringement action relating to the same patent has
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`been brought in Delaware.
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`20.
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`Because Alcon Research, Ltd. is a corporation incorporated in Delaware,
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`Alcon suffers injury and consequences from Lupin’s filing of ANDA No. 208896, challenging
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`Alcon’s patent rights, in Delaware. Upon information and belief, Lupin knew that it was
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`deliberately challenging the patent rights of a Delaware entity and seeking to invalidate
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`intellectual property held in Delaware. Lupin has been a litigant in connection with other
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`infringement actions under the Hatch-Waxman Act, and reasonably should have anticipated that
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`by sending the Notice Letter to Alcon, a Delaware corporation, that it would be sued in Delaware
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`for patent infringement.
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`21.
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`In addition, this Court has personal jurisdiction over Lupin because Lupin
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`Ltd. and/or Lupin Pharmaceuticals regularly engage in patent litigation concerning FDA-
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`approved branded drug products in this District, do not contest personal jurisdiction in this
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`district, and have purposefully availed themselves of the rights and benefits of this Court by
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`asserting claims and/or counterclaims in this Court. See, e.g., Alcon Research, Ltd. v. Lupin Ltd.,
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`et al., 15-cv-1159; Vanda Pharmaceuticals Inc. v. Lupin Ltd., et al., 15-cv-01073; Unimed
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`Pharmaceuticals, et al., v. Lupin Atlantics Holdings SA, et al., 15-cv-00904; iCeutica Pty Ltd. v.
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`6
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`Lupin Ltd., et al., 14-cv-01515; Forest Labs., LLC v. Lupin Ltd., et al., 14-cv-01058; VIIV
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`Healthcare UK Ltd. v. Lupin Ltd., et al., No. 14-cv-00369; Teijin Ltd. v. Lupin Ltd., et al., 14-cv-
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`00184.
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`forth herein.
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`COUNT I
`(Infringement Of The ’053 Patent)
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`Alcon incorporates each of the preceding paragraphs 1–21 as if fully set
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`22.
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`23.
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`The ’053 patent, entitled “High Concentration Olopatadine Ophthalmic
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`Composition” (Exhibit A hereto), was duly and legally issued on January 3, 2017, to Alcon
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`Research, Ltd., as assignee of Daniel A. Gamache, Laman Alani, Malay Ghosh, Francisco Javier
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`Galan, Nuria Carreras Perdiguer, and Onkar N. Singh.
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`24.
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`The ’053 patent claims, inter alia, an aqueous ophthalmic solution for
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`treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v%
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`olopatadine dissolved in the solution; PEG having a molecular weight of 200 to 800;
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`polyvinylpyrrolidone; a cyclodextrin selected from the group consisting of SAE-β-cyclodextrin,
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`hydroxypropyl-β-cyclodextrin, and hydroxypropyl-γ-cyclodextrin; and water.
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`25.
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`The ’053 patent also claims, inter alia, an aqueous ophthalmic solution for
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`treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v%
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`olopatadine dissolved in the solution; PEG having a molecular weight of 200 to 800;
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`polyvinylpyrrolidone; a cyclodextrin selected from the group consisting of hydroxypropyl-β-
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`cyclodextrin and hydroxypropyl-γ-cyclodextrin; benzalkonium chloride; hydroxypropylmethyl
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`cellulose; and water.
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`26.
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`Alcon owns the ’053 patent.
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`27.
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`Alcon will be substantially and irreparably damaged by infringement of
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`the ’053 patent.
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`28.
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`PAZEO®, and the use of PAZEO®, are covered by one or more claims of
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`the ’053 patent, and the ’053 patent has been listed in connection with that drug product in the
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`FDA’s Orange Book.
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`29.
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`In its Notice Letter, Lupin notified Plaintiff that it had submitted to the
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`FDA ANDA No. 208896. The purpose of the submission of the ANDA was to obtain approval
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`under the FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or
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`importation of Lupin’s ANDA Product prior to the expiration of the ’053 patent.
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`30.
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`In the Notice Letter, Lupin also notified Plaintiff that, as part of its
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`ANDA, it had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the
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`FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to, inter alia, the ’053 patent. Upon
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`information and belief, Lupin submitted ANDA No. 208896 to the FDA containing a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’053 patent is
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`invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, sale,
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`and/or importation of Lupin’s ANDA Product.
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`31.
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`Lupin’s ANDA Product and the use of Lupin’s ANDA Product are
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`covered by one or more claims of the ’053 patent, including at least claim 1 and claim 8.
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`32.
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`In the Notice Letter, Lupin did not contest the infringement of claims 1–6,
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`and 8–12 of the ’053 patent.
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`33.
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`34.
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`Lupin has knowledge of the ’053 patent.
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`Lupin’s submission of ANDA No. 208896 for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
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`8
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`Lupin’s ANDA Product before the expiration of the ’053 patent was an act of infringement of
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`that patent under 35 U.S.C. § 271(e)(2)(A).
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`35.
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`Upon information and belief, Lupin will engage in the manufacture, use,
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`offer for sale, sale, marketing, distribution, and/or importation of Lupin’s ANDA Product
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`immediately and imminently upon approval of ANDA No. 208896.
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`36.
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`The manufacture, use, sale, offer for sale, or importation of Lupin’s
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`ANDA Product would infringe one or more claims of the ’053 patent, including at least Claim 1
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`and Claim 8.
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`37.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Lupin’s ANDA Product in accordance with, and as directed by Lupin’s proposed
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`product labeling would infringe one or more claims of the ’053 patent, including at least Claim 1
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`and Claim 8.
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`38.
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`Upon information and belief, Lupin plans and intends to, and will, actively
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`induce infringement of the ’053 patent when its ANDA is approved, and plans and intends to,
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`and will, do so immediately and imminently upon approval.
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`39.
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`Notwithstanding Lupin’s knowledge of the claims of the ’053 patent,
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`Lupin has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or
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`import Lupin’s ANDA Product with its product labeling following upon FDA approval of
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`ANDA No. 208896 prior to the expiration of the ’053 patent.
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`40.
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`The foregoing actions by Lupin constitute and/or will constitute
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`infringement, and active inducement of infringement, of the ’053 patent.
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`9
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`41.
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`Upon information and belief, Lupin has acted with full knowledge of the
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`’053 patent and without a reasonable basis for believing that it would not be liable for
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`infringement of the ’053 patent and/or active inducement of infringement of the ’053 patent.
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`42.
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`Unless Lupin is enjoined from infringing the ’053 patent and actively
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`inducing infringement of the ’053 patent, Alcon will suffer irreparable injury. Alcon has no
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`adequate remedy at law.
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`COUNT II
`(Declaratory Judgment Of Infringement Of The ’053 Patent)
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`43.
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`Alcon incorporates each of the preceding paragraphs 1–42 as if fully set
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`forth herein.
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`44.
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`The Court may declare the rights and legal relations of the parties pursuant
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`to 28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Alcon on
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`the one hand and Lupin on the other regarding Lupin’s infringement, and active inducement of
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`infringement, of the ’053 patent.
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`45.
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`The ’053 patent claims, inter alia, an aqueous ophthalmic solution for
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`treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v%
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`olopatadine dissolved in the solution; PEG having a molecular weight of 200 to 800;
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`polyvinylpyrrolidone; a cyclodextrin selected from the group consisting of SAE-β-cyclodextrin,
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`hydroxypropyl-β-cyclodextrin, and hydroxypropyl-γ-cyclodextrin; and water.
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`46.
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`The ’053 patent also claims, inter alia, an aqueous ophthalmic solution for
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`treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v%
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`olopatadine dissolved in the solution; PEG having a molecular weight of 200 to 800;
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`polyvinylpyrrolidone; a cyclodextrin selected from the group consisting of hydroxypropyl-β-
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`10
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`cyclodextrin and hydroxypropyl-γ-cyclodextrin; benzalkonium chloride; hydroxypropylmethyl
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`cellulose; and water.
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`47.
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`In the Notice Letter, Lupin notified Plaintiff that it had submitted ANDA
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`No. 208896 to the FDA. The purpose of the ANDA was to obtain approval under the FDCA to
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`engage in the commercial manufacture, use, offer for sale, sale and/or importation of Lupin’s
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`ANDA Product prior to the expiration of the ’053 patent.
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`48.
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`In the Notice Letter, Lupin also notified Plaintiff that, as part of its
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`ANDA, Lupin had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of
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`the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`49.
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`Upon information and belief, Lupin will engage in the manufacture, use,
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`offer for sale, sale, marketing, distribution, and/or importation of Lupin’s ANDA Product
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`immediately and imminently upon approval of ANDA No. 208896.
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`50.
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`Lupin’s ANDA Product and use of Lupin’s ANDA Product is covered by
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`one or more claims of the ’053 patent, including at least claim 1 and claim 8.
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`51.
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`The manufacture, use, sale, offer for sale, or importation of Lupin’s
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`ANDA Product would infringe one or more claims of the ’053 patent, including at least Claim 1
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`and Claim 8.
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`52.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Lupin’s ANDA Product in accordance with, and as directed by, Lupin’s proposed
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`product labeling would infringe one or more claims of the ’053 patent, including at least Claim 1
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`and Claim 8.
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`11
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`53.
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`Upon information and belief, Lupin plans and intends to, and will, actively
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`induce infringement of the ’053 patent when its ANDA is approved, and plans and intends to,
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`and will, do so immediately and imminently upon approval.
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`54.
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`Notwithstanding Lupin’s knowledge of the claims of the ’053 patent,
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`Lupin has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or
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`import Lupin’s ANDA Product with its product labeling following FDA approval of ANDA No.
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`208896 prior to the expiration of the ’053 patent.
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`55.
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`The foregoing actions by Lupin will constitute infringement of, and active
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`inducement of infringement of, the ’053 patent.
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`56.
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`Upon information and belief, Lupin has acted with full knowledge of the
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`’053 patent and without a reasonable basis for believing that it would not be liable for
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`infringement of the ’053 patent and/or active inducement of infringement of the ’053 patent.
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`57.
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`Unless Lupin is enjoined from infringing, and inducing infringement of,
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`the ’053 patent, Alcon will suffer irreparable injury. Alcon has no adequate remedy at law.
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`58.
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`The Court should declare that the commercial manufacture, use, sale, offer
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`for sale or importation of Lupin’s ANDA Product, or any other drug product which is covered by
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`or whose use is covered by United States Patent No. 9,533,053, will infringe, and induce the
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`infringement of, that patent.
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`WHEREFORE, Plaintiff requests the following relief:
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`(a)
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`A judgment that United States Patent No. 9,533,053 has been infringed
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`under 35 U.S.C. § 271(e)(2) by Lupin’s submission to the FDA of its ANDA No. 208896;
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`(b)
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`A judgment providing that the effective date of any FDA approval of
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`commercial manufacture, use, or sale of Lupin’s ANDA Product, or any other drug product that
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`infringes or the use of which infringes United States Patent No. 9,533,053 be not earlier than the
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`latest of the expiration dates of that patent, inclusive of any extension(s) and additional period(s)
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`of exclusivity;
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`(c)
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`A preliminary and permanent injunction enjoining Lupin, and all persons
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`acting in concert with Lupin, from the commercial manufacture, use, sale, offer for sale, or
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`importation into the United States of Lupin’s ANDA Product, or any other drug product covered
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`by or whose use is covered by United States Patent No. 9,533,053, prior to the expiration of
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`United States Patent No. 9,533,053, inclusive of any extension(s) and additional period(s) of
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`exclusivity;
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`(d)
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`A judgment declaring that the commercial manufacture, use, sale, offer for
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`sale or importation of Lupin’s ANDA Product, or any other drug product which is covered by or
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`whose use is covered by United States Patent No. 9,533,053, prior to the expiration of United
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`States Patent No. 9,533,053, will infringe, induce the infringement of, and contribute to the
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`infringement by others of, that patent;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’
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`fees pursuant to 35 U.S.C. § 285;
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`(f)
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`(g)
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`Costs and expenses in this action;
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`Such further and other relief as this Court may deem just and proper.
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`Case 1:17-cv-00321-GMS Document 1 Filed 03/24/17 Page 14 of 14 PageID #: 14
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Jack B. Blumenfeld
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`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street, 18th Floor
`P.O. Box 1347
`Wilmington, DE 19899-1347
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
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`Attorneys for Plaintiff Alcon Research, Ltd.
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`OF COUNSEL:
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`Adam L. Perlman
`Thomas H.L. Selby
`Christopher J. Mandernach
`Joelle P. Justus
`Christopher A. Suarez
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
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`March 24, 2017
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`14
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