Case 1:21-cv-00078-UNA Document 1 Filed 01/26/21 Page 1 of 15 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`PFIZER INC., WARNER-LAMBERT
`COMPANY LLC and PF PRISM IMB B.V.,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`C.A. No. __________________
`
`
`
`
`
`)))))))))))
`
`
`
`
`NATCO PHARMA, INC. and
`NATCO PHARMA, LTD.,
`
`
`Defendants.
`
`
`COMPLAINT
`
`Plaintiffs Pfizer Inc.; Warner-Lambert Company LLC; and PF PRISM IMB B.V.
`
`(collectively, “Pfizer”) file this Complaint for patent infringement against Natco Pharma, Inc. and
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`Natco Pharma, Ltd. (collectively, “Natco”), and by their attorneys, hereby allege as follows:
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`1.
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`This is an action for patent infringement under the patent laws of the United States,
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`Title 35, United States Code, and for a declaratory judgment of patent infringement under
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`28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title 35, United States Code,
`
`that arises out of Natco’s submission of an Abbreviated New Drug Application (“ANDA”) to the
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`U.S. Food and Drug Administration (“FDA”) seeking approval to commercially manufacture, use,
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`offer for sale, sell, and/or import generic versions of IBRANCE® (palbociclib) capsules, 75 mg,
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`100 mg, and 125 mg, prior to the expiration of U.S. Patent No. 10,723,730 (“the ’730 patent”).
`
`2.
`
`Natco Pharma, Ltd. notified Pfizer by letter dated December 15, 2020 (“Natco’s
`
`Notice Letter”) that it had submitted to the FDA ANDA No. 213089 (“Natco’s ANDA”), seeking
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`approval from the FDA to engage in the commercial manufacture, use, and/or sale of generic
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`palbociclib capsules, 75 mg, 100 mg, and 125 mg (“Natco’s ANDA Product”) prior to the
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`expiration of the ’730 patent.
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`

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`Case 1:21-cv-00078-UNA Document 1 Filed 01/26/21 Page 2 of 15 PageID #: 2
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`PARTIES
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`3.
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`Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of the
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`State of Delaware and having a place of business at 235 East 42nd Street, New York, New York
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`10017. Pfizer Inc. is the holder of New Drug Application (“NDA”) No. 207103 for the
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`manufacture and sale of palbociclib capsules, 75 mg, 100 mg, and 125 mg, which has been
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`approved by the FDA.
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`4.
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`Plaintiff Warner-Lambert Company LLC is a limited liability company organized
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`and existing under the laws of the State of Delaware, and having a place of business at 235 East
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`42nd Street, New York, New York 10017.
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`5.
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`Plaintiff PF PRISM IMB B.V. is a private limited company (besloten venootschap)
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`organized under the law of the Netherlands, having its registered seat in Rotterdam, the
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`Netherlands, and having its business address at Rivium Westlaan 142, 2909 LD, Capelle aan den
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`IJessel, the Netherlands.
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`6.
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`Upon information and belief, defendant Natco Pharma, Ltd. is a company organized
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`and existing under the laws of the Republic of India with its principal place of business at Natco
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`House, Road No-2, Banjara Hills, Hyderabad 500034, India. Upon information and belief, Natco
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`Pharma, Ltd. is in the business of, among other things, manufacturing and selling generic versions
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`of branded pharmaceutical products through various operating subsidiaries, including Natco
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`Pharma Inc.
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`7.
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`Upon information and belief, defendant Natco Pharma, Inc. is a corporation
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`organized and existing under the laws of the State of Delaware with its principal place of business
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`at 241 West Roseville Road, Lancaster, PA 17601. Upon information and belief, Natco Pharma,
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`2
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`Inc. is in the business of, among other things, manufacturing and selling generic versions of
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`branded pharmaceutical products for the U.S. market.
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`8.
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`Upon information and belief, Natco Pharma, Inc. is a wholly owned subsidiary of
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`Natco Pharma, Ltd. Natco Pharma, Ltd. and Natco Pharma, Inc. are collectively referred to herein
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`as “Natco.”
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`9.
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`Upon information and belief, Natco Pharma, Ltd. and Natco Pharma, Inc. acted in
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`concert to prepare and submit Natco’s ANDA to the FDA.
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`10.
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`Upon information and belief, Natco Pharma, Ltd. and Natco Pharma, Inc. know and
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`intend that upon approval of Natco’s ANDA, Natco Pharma, Ltd. will manufacture Natco’s ANDA
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`Product and Natco Pharma, Inc. will directly or indirectly market, sell, and distribute Natco’s
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`ANDA Product throughout the United States, including in Delaware. Upon information and belief,
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`Natco Pharma, Ltd. and Natco Pharma, Inc. are agents of each other and/or operate in concert as
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`integrated parts of the same business group, including with respect to Natco’s ANDA Product, and
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`enter into agreements with each other that are nearer than arm’s length. Upon information and
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`belief, Natco Pharma, Inc. participated in, assisted, and cooperated with Natco Pharma, Ltd. in the
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`acts complained of herein.
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`11.
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`Upon information and belief, following any FDA approval of Natco’s ANDA,
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`Natco Pharma, Ltd. and Natco Pharma, Inc. will act in concert to distribute and sell Natco’s ANDA
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`Product throughout the United States, including within Delaware.
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`3
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`JURISDICTION
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`12.
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`Jurisdiction is proper in this Court pursuant to 28 U.S.C. §§ 1331, 1338(a), and
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`2201 and 2202.
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`13.
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`Natco Pharma, Ltd. is subject to personal jurisdiction in Delaware because, among
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`other things, Natco Pharma, Ltd., itself and through its wholly-owned subsidiary Natco Pharma,
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`Inc., has purposely 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, Natco
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`Pharma, Ltd., itself and through its subsidiary Natco Pharma, Inc., develops, manufactures,
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`imports, markets, offers to sell, and/or sells generic drugs throughout the United States, including
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`in the State of Delaware and therefore transacts business within the State of Delaware related to
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`Pfizer’s claims, and/or has engaged in systematic and continuous business contacts within the State
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`of Delaware. In addition, Natco Pharma, Ltd. is subject to personal jurisdiction in Delaware
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`because, upon information and belief, it controls Natco Pharma, Inc. and therefore the activities of
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`Natco Pharma, Inc. in this jurisdiction are attributed to Natco Pharma, Ltd.
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`14.
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`Natco Pharma, Inc. is subject to personal jurisdiction in Delaware because, among
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`other things, it has purposely availed itself of the benefits and protections of Delaware’s laws such
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`that it should reasonably anticipate being haled into court here. Natco Pharma, Inc. is a corporation
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`organized and existing under the laws of the State of Delaware, is qualified to do business in
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`Delaware, and has appointed a registered agent for service of process in Delaware. It therefore
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`has consented to general jurisdiction in Delaware. In addition, upon information and belief, Natco
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`Pharma, Inc. develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs
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`throughout the United States, including in the State of Delaware, and therefore transacts business
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`4
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`within the State of Delaware related to Pfizer’s claims, and/or has engaged in systematic and
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`continuous business contacts within the State of Delaware.
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`15.
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`Natco has previously used the process contemplated by the Drug Price Competition
`
`and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j) (the “Hatch-Waxman Act”), to
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`challenge branded pharmaceutical companies’ patents by filing a certification of the type described
`
`in Section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (“FDCA”),
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`21 U.S.C. § 355(j)(2)(A)(vii)(IV), serving a notice letter on those companies, and engaging in
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`patent litigation arising from the process contemplated by the Hatch-Waxman Act.
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`16.
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`Upon information and belief, Natco, with knowledge of the Hatch-Waxman Act
`
`process, directed Natco’s Notice Letter to, inter alia, Pfizer Inc., an entity incorporated in
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`Delaware, and alleged in Natco’s Notice Letter that Pfizer’s ’730 patent is invalid. Upon
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`information and belief, Natco knowingly and deliberately challenged Pfizer’s patent rights, and
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`knew when it did so that it was triggering the forty-five day period for Pfizer to bring an action for
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`patent infringement under the Hatch-Waxman Act.
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`17.
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`Because Pfizer Inc. is incorporated in Delaware, Pfizer Inc. suffers injury and
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`consequences from Natco’s filing of Natco’s ANDA challenging Pfizer’s patent rights in
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`Delaware. Upon information and belief, Natco knew that it was deliberately challenging the patent
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`rights of a Delaware entity and seeking to invalidate intellectual property held in Delaware. Natco
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`has been a litigant in connection with other infringement actions under the Hatch-Waxman Act,
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`and reasonably should have anticipated that by sending Natco’s Notice Letter to Pfizer Inc., a
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`Delaware corporation, it would be sued in Delaware for patent infringement.
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`18.
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`Upon information and belief, if Natco’s ANDA is approved, Natco will directly or
`
`indirectly manufacture, market, sell, and/or distribute Natco’s ANDA Product within the United
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`5
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`States, including in Delaware, consistent with Natco’s practices for the marketing and distribution
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`of other generic pharmaceutical products. Upon information and belief, Natco regularly does
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`business in Delaware, and its practices with other generic pharmaceutical products have involved
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`placing those products into the stream of commerce for distribution throughout the United States,
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`including in Delaware. Upon information and belief, Natco’s generic pharmaceutical products are
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`used and/or consumed within and throughout the United States, including in Delaware. Upon
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`information and belief, Natco’s ANDA Product will be prescribed by physicians practicing in
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`Delaware, dispensed by pharmacies located within Delaware, and used by patients in Delaware.
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`Each of these activities would have a substantial effect within Delaware and would constitute
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`infringement of Pfizer’s patent in the event that Natco’s ANDA Product is approved before the
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`patent expires.
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`19.
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`Upon information and belief, Natco derives substantial revenue from generic
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`pharmaceutical products that are used and/or consumed within Delaware, and which are
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`manufactured by Natco and/or for which Natco Pharma, Inc. or Natco Pharma, Ltd. is the named
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`applicant on approved ANDAs. Upon information and belief, various products for which Natco
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`Pharma, Ltd. or Natco Pharma, Inc. is the named applicant on approved ANDAs are available at
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`retail pharmacies in Delaware.
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`20.
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`Venue is proper in this district as to Natco Pharma, Ltd. pursuant to 28 U.S.C.
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`§§ 1391 and 1400(b) because, inter alia, Natco Pharma, Ltd. is a corporation organized and
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`existing under the laws of the Republic of India and is subject to personal jurisdiction in this
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`judicial district.
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`21.
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`Venue is proper in this district as to Natco Pharma, Inc. pursuant to 28 U.S.C.
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`§§ 1391 and 1400(b) because, inter alia, Natco Pharma, Inc. is a corporation organized and
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`6
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`existing under the laws of the State of Delaware and is subject to personal jurisdiction in this
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`judicial district.
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`FACTUAL BACKGROUND
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`22.
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`IBRANCE®, which contains palbociclib, is approved for the treatment of HR-
`
`positive, HER2-negative advanced or metastatic breast cancer.
`
`23.
`
`Upon information and belief, Natco’s ANDA Product is a generic version of
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`IBRANCE®.
`
`24.
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`Natco’s Notice Letter purported to include an “Offer of Confidential Access” to
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`Pfizer to Natco’s ANDA. The offer, however, was subject to various unreasonably restrictive
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`conditions.
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`25.
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`On January 8, 2021, counsel for Plaintiffs sent a letter to counsel for Natco
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`attempting to negotiate access to Natco’s internal documents, data and/or samples relevant to
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`infringement based on reasonable confidentiality terms. Counsel for Natco did not respond to
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`Plaintiffs’ letter.
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`26.
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`Plaintiffs are filing this Complaint within forty-five days of receipt of Natco’s
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`Notice Letter.
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`COUNT I – INFRINGEMENT OF THE ’730 PATENT
`
`27.
`
`Pfizer incorporates each of the preceding paragraphs 1–26 as if fully set forth
`
`herein.
`
`28.
`
`29.
`
`The inventors of the ’730 patent are Brian Patrick Chekal and Nathan D. Ide.
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`The ’730 patent, entitled “Solid Forms of a Selective Cdk4/6 Inhibitor” (attached
`
`as Exhibit A), was duly and legally issued on July 28, 2020.
`
`30.
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`Pfizer is the owner and assignee of the ’730 patent.
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`7
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`31.
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`IBRANCE® is covered by one or more claims of the ’730 patent, which has been
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`listed in connection with IBRANCE® in the FDA’s publication Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (commonly known as “the Orange Book”).
`
`32.
`
`In Natco’s Notice Letter, Natco notified Pfizer of the submission of Natco’s ANDA
`
`to the FDA. The purpose of this submission was to obtain approval under the FDCA to engage in
`
`the commercial manufacture, use, offer for sale, sale and/or importation of Natco’s ANDA Product
`
`prior to the expiration of the ’730 patent.
`
`33.
`
`In Natco’s Notice Letter, Natco also notified Pfizer that, as part of its ANDA, Natco
`
`had filed a certification of the type described in Section 505(j)(2)(B)(iv) of the FDCA, 21 U.S.C.
`
`§ 355(j)(2)(B)(iv), with respect to the ’730 patent. Upon information and belief, Natco submitted
`
`its ANDA to the FDA containing certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`asserting that the ’730 patent is invalid, unenforceable, and/or will not be infringed by the
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`manufacture, use, offer for sale, sale, and/or importation of Natco’s ANDA Product.
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`34.
`
`Upon information and belief, Natco’s ANDA Product and the use of Natco’s
`
`ANDA Product are covered by one or more claims of the ’730 patent, either literally or under the
`
`doctrine of equivalents.
`
`35.
`
`As an example, claim 1 of the ’730 patent recites:
`
`A crystalline free base of 6-acetyl-8-cyclopentyl-5-methyl-2-(5-
`piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-
`one, having a powder X-ray diffraction pattern comprising peaks at
`diffraction angles (2θ) of 8.0±0.2, 10.1±0.2 and 11.5±0.2 and a
`primary particle size distribution characterized by a D90 value of
`from about 30 µm to about 65 µm.
`
`36.
`
`Upon information and belief, Natco’s ANDA Product infringes claim 1 of the ’730
`
`patent, literally or under the doctrine of equivalents.
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`37.
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`As an example, Claim 7 of the ’730 patent recites:
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`8
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`A crystalline free base of 6-acetyl-8-cyclopentyl-5-methyl-2-(5-
`piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-
`one, having a powder X-ray diffraction pattern comprising peaks at
`diffraction angles (2θ) of 8.0±0.2, 10.1±0.2 and 11.5±0.2 and a
`volume mean diameter characterized by a D[4,3] value of from
`about 15 µm to about 40 µm.
`
`38.
`
`Upon information and belief, Natco’s ANDA Product infringes claim 7 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`39.
`
`As an example, Claim 15 of the ’730 patent recites:
`
`A crystalline free base of 6-acetyl-8-cyclopentyl-5-methyl-2-(5-
`piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-
`one, having a powder X-ray diffraction pattern comprising peaks at
`diffraction angles (2θ) of 8.0±0.2, 10.1±0.2 and 11.5±0.2 and a
`volume mean diameter characterized by a D[4,3] value of from
`about 15 µm to about 30 µm.
`
`40.
`
`Upon information and belief, Natco’s ANDA Product infringes claim 15 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`41.
`
`Natco’s submission of Natco’s ANDA for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Natco’s
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`ANDA Product before the expiration of the ’730 patent was an act of infringement of the ’730
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`42.
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`Upon information and belief, Natco will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Natco’s ANDA Product immediately and
`
`imminently upon approval of its ANDA.
`
`43.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Natco’s ANDA Product would infringe one or more claims of the ’730 patent, either
`
`literally or under the doctrine of equivalents.
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`9
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`44.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Natco’s ANDA Product in accordance with, and as directed by, its proposed product
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`labeling would infringe one or more claims of the ’730 patent.
`
`45.
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`Upon information and belief, Natco plans and intends to, and will, actively induce
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`infringement of the ’730 patent when Natco’s ANDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon approval. Natco’s activities will be done with
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`knowledge of the ’730 patent and specific intent to infringe that patent.
`
`46.
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`Upon information and belief, Natco knows that Natco’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’730 patent, that Natco’s
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`ANDA Product is not a staple article or commodity of commerce, and that Natco’s ANDA Product
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`and its proposed labeling are not suitable for substantial noninfringing use. Upon information and
`
`belief, Natco plans and intends to, and will, contribute to infringement of the ’730 patent
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`immediately and imminently upon approval of Natco’s ANDA.
`
`47.
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`Notwithstanding Natco’s knowledge of the claims of the ’730 patent, Natco has
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`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Natco’s
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`ANDA Product with its product labeling following FDA approval of Natco’s ANDA prior to the
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`expiration of the ’730 patent.
`
`48.
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`The foregoing actions by Natco constitute and/or will constitute infringement of the
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`’730 patent; active inducement of infringement of the ’730 patent; and contribution to the
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`infringement by others of the ’730 patent.
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`49.
`
`Upon information and belief, Natco has acted with full knowledge of the ’730
`
`patent and without a reasonable basis for believing that it would not be liable for infringement of
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`the ’730 patent; active inducement of infringement of the ’730 patent; and/or contribution to the
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`infringement by others of the ’730 patent.
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`50.
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`Pfizer will be substantially and irreparably harmed by infringement of the ’730
`
`patent.
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`51.
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`Unless Natco is enjoined from infringing the ’730 patent, actively inducing
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`infringement of the ’730 patent, and contributing to the infringement by others of the ’730 patent,
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`Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
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`COUNT II – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’730 PATENT
`
`Pfizer incorporates each of the preceding paragraphs 1–51 as if fully set forth
`
`52.
`
`herein.
`
`53.
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`The Court may declare the rights and legal relations of the parties pursuant to
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`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Pfizer on one
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`hand and Natco on the other regarding Natco’s infringement, active inducement of infringement,
`
`and contribution to the infringement by others of the ’730 patent, and/or the validity of the ’730
`
`patent.
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`54.
`
`In Natco’s Notice Letter, Natco notified Pfizer of the submission of Natco’s ANDA
`
`to the FDA. The purpose of this submission was to obtain approval under the FDCA to engage in
`
`the commercial manufacture, use, offer for sale, sale and/or importation of Natco’s ANDA Product
`
`prior to the expiration of the ’730 patent.
`
`55.
`
`In Natco’s Notice Letter, Natco also notified Pfizer that, as part of its ANDA, Natco
`
`had filed certifications of the type described in Section 505(j)(2)(B)(iv) of the FDCA, 21 U.S.C.
`
`§ 355(j)(2)(B)(iv), with respect to the ’730 patent. Upon information and belief, Natco submitted
`
`its ANDA to the FDA containing certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`asserting that the ’730 patent is invalid, unenforceable, and/or will not be infringed by the
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`manufacture, use, offer for sale, sale, and/or importation of Natco’s ANDA Product.
`
`56.
`
`Upon information and belief, Natco’s ANDA Product and the use of Natco’s
`
`ANDA Product are covered by one or more claims of the ’730 patent.
`
`57.
`
`As an example, claim 1 of the ’730 patent recites:
`
`A crystalline free base of 6-acetyl-8-cyclopentyl-5-methyl-2-(5-
`piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-
`one, having a powder X-ray diffraction pattern comprising peaks at
`diffraction angles (2θ) of 8.0±0.2, 10.1±0.2 and 11.5±0.2 and a
`primary particle size distribution characterized by a D90 value of
`from about 30 µm to about 65 µm.
`
`58.
`
`Upon information and belief, Natco’s ANDA Product infringes claim 1 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`59.
`
`As an example, Claim 7 of the ’730 patent recites:
`
`A crystalline free base of 6-acetyl-8-cyclopentyl-5-methyl-2-(5-
`piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-
`one, having a powder X-ray diffraction pattern comprising peaks at
`diffraction angles (2θ) of 8.0±0.2, 10.1±0.2 and 11.5±0.2 and a
`volume mean diameter characterized by a D[4,3] value of from
`about 15 µm to about 40 µm.
`
`60.
`
`Upon information and belief, Natco’s ANDA Product infringes claim 7 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`61.
`
`As an example, Claim 15 of the ’730 patent recites:
`
`A crystalline free base of 6-acetyl-8-cyclopentyl-5-methyl-2-(5-
`piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-
`one, having a powder X-ray diffraction pattern comprising peaks at
`diffraction angles (2θ) of 8.0±0.2, 10.1±0.2 and 11.5±0.2 and a
`volume mean diameter characterized by a D[4,3] value of from
`about 15 µm to about 30 µm.
`
`62.
`
`Upon information and belief, Natco’s ANDA Product infringes claim 15 of the ’730
`
`patent, literally or under the doctrine of equivalents.
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`63.
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`Upon information and belief, Natco will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Natco’s ANDA Product immediately and
`
`imminently upon approval of its ANDA.
`
`64.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Natco’s ANDA Product would infringe one or more claims of the ’730 patent.
`
`65.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Natco’s ANDA Product in accordance with, and as directed by, its proposed
`
`labeling would infringe one or more claims of the ’730 patent.
`
`66.
`
`Upon information and belief, Natco plans and intends to, and will, actively induce
`
`infringement of the ’730 patent when Natco’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval. Natco’s activities will be done with
`
`knowledge of the ’730 patent and specific intent to infringe that patent.
`
`67.
`
`Upon information and belief, Natco knows that Natco’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’730 patent, that Natco’s
`
`ANDA Product is not a staple article or commodity of commerce, and that Natco’s ANDA Product
`
`and its proposed labeling are not suitable for substantial noninfringing use. Upon information and
`
`belief, Natco plans and intends to, and will, contribute to infringement of the ’730 patent
`
`immediately and imminently upon approval of Natco’s ANDA.
`
`68.
`
`Notwithstanding Natco’s knowledge of the claims of the ’730 patent, Natco has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Natco’s
`
`ANDA Product with its product labeling following FDA approval of Natco’s ANDA prior to the
`
`expiration of the ’730 patent.
`
`13
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`

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`Case 1:21-cv-00078-UNA Document 1 Filed 01/26/21 Page 14 of 15 PageID #: 14
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`69.
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`The foregoing actions by Natco constitute and/or will constitute infringement of the
`
`’730 patent; active inducement of infringement of the ’730 patent; and contribution to the
`
`infringement by others of the ’730 patent.
`
`70.
`
`Upon information and belief, Natco has acted with full knowledge of the ’730
`
`patent and without a reasonable basis for believing that it would not be liable for infringement of
`
`the ’730 patent; active inducement of infringement of the ’730 patent; and/or contribution to the
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`infringement by others of the ’730 patent.
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`71.
`
`Pfizer will be substantially and irreparably damaged by infringement of the
`
`’730 patent.
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`72.
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`The Court should declare that the commercial manufacture, use, sale, offer for sale
`
`and/or importation of Natco’s ANDA Product with its proposed labeling, or any other Natco drug
`
`product that is covered by or whose use is covered by the ’730 patent, will infringe, induce
`
`infringement of, and contribute to the infringement by others of the ’730 patent, and that the claims
`
`of the ’730 patent are not invalid.
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`PRAYER FOR RELIEF
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`WHEREFORE, Pfizer requests the following relief:
`
`(a)
`
`A judgment that the ’730 patent has been infringed under 35 U.S.C. § 271(e)(2) by
`
`Natco’s submission to the FDA of Natco’s ANDA;
`
`(b)
`
`A judgment ordering that the effective date of any FDA approval of commercial
`
`manufacture, use, or sale of Natco’s ANDA Product, or any other drug product that
`
`infringes or the use of which infringes the ’730 patent, be not earlier than the
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`expiration date of the ’730 patent, inclusive of any extension(s) and additional
`
`period(s) of exclusivity;
`
`14
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`

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`Case 1:21-cv-00078-UNA Document 1 Filed 01/26/21 Page 15 of 15 PageID #: 15
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`(c)
`
`A preliminary and permanent injunction enjoining Natco, and all persons acting in
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`concert with Natco, from the commercial manufacture, use, sale, offer for sale, or
`
`importation into the United States of Natco’s ANDA Products, or any other drug
`
`product covered by or whose use is covered by the ’730 patent, prior to the
`
`expiration of that patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity;
`
`(d)
`
`A judgment declaring that the commercial manufacture, use, sale, offer for sale or
`
`importation of Natco’s ANDA Products, or any other drug product which is covered
`
`by or whose use is covered by the ’730 patent, prior to the expiration of that patent,
`
`will infringe, induce the infringement of, and contribute to the infringement by
`
`others of, said patent;
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’ fees
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`pursuant to 35 U.S.C. § 285;
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`Costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
`
`(f)
`
`(g)
`
`
`
`
`OF COUNSEL:
`
`David I. Berl
`Christopher J. Mandernach
`Seth R. Bowers
`Michael Xun Liu
`Kevin Hoagland-Hanson
`Andrew L. Hoffman
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`January 26, 2021
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Megan E. Dellinger
`_________________________________
`Jack B. Blumenfeld (#1014)
`Megan E. Dellinger (#5739)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`(302) 658-9200
`jblumenfeld@mnat.com
`mdellinger@mnat.com
`
`Attorneys for Plaintiffs
`
`
`15
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`