throbber
Case 1:21-cv-00858-UNA Document 1 Filed 06/15/21 Page 1 of 15 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`PFIZER INC., WARNER-LAMBERT
`COMPANY LLC and PF PRISM IMB B.V.,
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`
`Plaintiffs,
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`COMPLAINT
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`Plaintiffs Pfizer Inc.; Warner-Lambert Company LLC; and PF PRISM IMB B.V.
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`(collectively, “Pfizer”) file this Complaint for patent infringement against MSN Pharmaceuticals
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`Inc. (“MSN Pharmaceuticals”) and MSN Laboratories Private Limited (“MSN Labs”)
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`(collectively, “MSN”), and by their attorneys, hereby 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 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,
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`that arises out of MSN’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) tablets, 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”).
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`2.
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`MSN Pharmaceuticals notified Pfizer by letter dated May 17, 2021 (“MSN’s Notice
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`Letter”) that it had submitted to the FDA ANDA No. 216083 (“MSN’s ANDA”), seeking approval
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`from the FDA to engage in the commercial manufacture, use, and/or sale of generic palbociclib
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`C.A. No. ________________
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`MSN PHARMACEUTICALS INC. and
`MSN LABORATORIES PRIVATE LIMITED,
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`v.
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`Defendants.
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`

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`Case 1:21-cv-00858-UNA Document 1 Filed 06/15/21 Page 2 of 15 PageID #: 2
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`tablets, 75 mg, 100 mg, and 125 mg (“MSN’s ANDA Products”) prior to the expiration of the ’730
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`patent.
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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. 212436 for the
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`manufacture and sale of palbociclib tablets, 75 mg, 100 mg, and 125 mg, which has been approved
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`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
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`235 East 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 MSN Pharmaceuticals is a corporation
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`organized and existing under the laws of the State of Delaware, with a principal place of business
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`at 20 Duke Road, Piscataway, New Jersey 08854.
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`7.
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`Upon information and belief, defendant MSN Labs is a company organized and
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`existing under the laws of the Republic of India, having a place of business at MSN House, C-24,
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`Sanathnagar Industrial Estate, Hyderabad, 500018, Telangana, India.
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`2
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`8.
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`Upon information and belief, MSN Pharmaceuticals is in the business of, among
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`other things, manufacturing and selling generic versions of branded versions of pharmaceutical
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`drugs.
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`9.
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`Upon information and belief, MSN Pharmaceuticals is a wholly owned subsidiary
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`of MSN Labs.
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`10.
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`Upon information and belief, MSN Pharmaceuticals is the designated U.S. agent
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`for MSN Labs in connection with MSN’s ANDA.
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`11.
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`Upon information and belief, MSN Pharmaceuticals and MSN Labs acted in
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`concert to prepare and submit MSN’s ANDA.
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`JURISDICTION AND VENUE
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`12.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`and 2201 and 2202.
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`13. MSN Pharmaceuticals is subject to personal jurisdiction in this Court because,
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`among other things, it has purposefully availed itself of the benefits and protections of Delaware’s
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`laws such that it should reasonably anticipate being haled into court here. Upon information and
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`belief, MSN Pharmaceuticals is organized under the laws of the State of Delaware and is registered
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`to conduct business within the State of Delaware (File No. 5454849). Upon information and belief,
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`MSN Pharmaceuticals maintains in the State of Delaware a registered agent for service of
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`process—United States Corporation Agents, Inc.—with an address at 221 North Broad Street,
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`Suite 3A, Middletown, Delaware 19709. MSN Pharmaceuticals has therefore consented to general
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`jurisdiction in the State of Delaware. Upon information and belief, MSN Pharmaceuticals
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`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the
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`United States, including in the State of Delaware, and therefore transacts business within the State
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`3
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`of Delaware related to Pfizer’s claims, and/or has engaged in systematic and continuous business
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`contacts within the State of Delaware.
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`14. MSN Labs is subject to personal jurisdiction in Delaware because, among other
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`things, MSN Labs, itself and through its wholly owned subsidiary MSN Pharmaceuticals, has
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`purposefully availed itself of the benefits and protections of Delaware’s laws such that it should
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`reasonably anticipate being haled into court here. Upon information and belief, MSN Labs, itself
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`and through its wholly owned subsidiary MSN Pharmaceuticals, develops, manufactures, imports,
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`markets, offers to sell, and/or sells generic drugs throughout the United States, including in the
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`State of Delaware, and therefore transacts business within the State of Delaware related to Pfizer’s
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`claims, and/or has engaged in continuous and systematic business contacts with the State of
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`Delaware. In addition, MSN Labs is subject to personal jurisdiction in Delaware because, upon
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`information and belief, it controls MSN Pharmaceuticals, and the activities of MSN
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`Pharmaceuticals in this jurisdiction are therefore attributed to MSN Labs.
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`15. MSN has previously used the process contemplated by the Drug Price Competition
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`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
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`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, MSN, with knowledge of the Hatch-Waxman Act
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`process, directed MSN’s Notice Letter to, inter alia, Pfizer Inc., an entity incorporated in
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`Delaware, and alleged in MSN’s Notice Letter that Pfizer’s ’730 patent is invalid. Upon
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`information and belief, MSN knowingly and deliberately challenged Pfizer’s patent rights, and
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`4
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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 MSN’s filing of MSN’s ANDA challenging Pfizer’s patent rights in Delaware.
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`Upon information and belief, MSN knew that it was deliberately challenging the patent rights of a
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`Delaware entity and seeking to invalidate intellectual property held in Delaware. MSN has been
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`a litigant in connection with other infringement actions under the Hatch-Waxman Act, and
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`reasonably should have anticipated that by sending MSN’s Notice Letter to Pfizer Inc., a Delaware
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`corporation, it would be sued in Delaware for patent infringement.
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`18.
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`Upon information and belief, if MSN’s ANDA is approved, MSN will directly or
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`indirectly manufacture, market, sell, and/or distribute MSN’s ANDA Products within the United
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`States, including in Delaware, consistent with MSN’s practices for the marketing and distribution
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`of other generic pharmaceutical products. Upon information and belief, MSN 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, MSN’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, MSN’s ANDA Products 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 MSN’s ANDA Products are approved before the
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`patent expires.
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`5
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`19.
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`Upon information and belief, MSN 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 MSN and/or for which MSN Pharmaceuticals and/or MSN Labs is the named
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`applicant on approved ANDAs. Upon information and belief, various products for which MSN
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`Pharmaceuticals and/or MSN Labs 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 MSN Pharmaceuticals pursuant to 28 U.S.C.
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`§§ 1391 and 1400(b) because, inter alia, MSN Pharmaceuticals is a corporation organized and
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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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`21.
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`Venue is proper in this district as to MSN Labs pursuant to 28 U.S.C. §§ 1391 and
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`1400(b) because, inter alia, MSN Labs is a company organized and existing under the laws of the
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`Republic of India and is subject to personal jurisdiction in this 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-
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`positive, HER2-negative advanced or metastatic breast cancer.
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`23.
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`Upon information and belief, MSN’s ANDA Products are a generic version of
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`IBRANCE®.
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`24. MSN’s Notice Letter purported to include an “Offer of Confidential Access” to
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`Pfizer to MSN’s ANDA. The offer, however, was subject to various unreasonably restrictive
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`conditions. Rather than engage in protracted negotiations regarding access to MSN’s confidential
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`information prior to filing of a complaint for infringement of the ’730 patent, and in order to better
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`align the schedule in this action with that of other already-pending actions, Pfizer and MSN agreed
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`6
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`through counsel to proceed to file this Complaint and handle the production of MSN’s confidential
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`information in post-filing discovery.
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`25.
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`Plaintiffs are filing this Complaint within forty-five days of receipt of MSN’s
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`Notice Letter.
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`COUNT I – INFRINGEMENT OF THE ’730 PATENT
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`26.
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`Pfizer incorporates each of the preceding paragraphs 1–25 as if fully set forth
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`herein.
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`27.
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`28.
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`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
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`as Exhibit A), was duly and legally issued on July 28, 2020.
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`29.
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`30.
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`Pfizer is the owner and assignee of the ’730 patent.
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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
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`Therapeutic Equivalence Evaluations (commonly known as “the Orange Book”).
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`31.
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`In MSN’s Notice Letter, MSN notified Pfizer of the submission of MSN’s ANDA
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`to the FDA. The purpose of this submission was to obtain approval under the FDCA to engage in
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`the commercial manufacture, use, offer for sale, sale and/or importation of MSN’s ANDA
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`Products prior to the expiration of the ’730 patent.
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`32.
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`In MSN’s Notice Letter, MSN also notified Pfizer that, as part of its ANDA, MSN
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`had filed a certification of the type described in Section 505(j)(2)(B)(iv) of the FDCA, 21 U.S.C.
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`§ 355(j)(2)(B)(iv), with respect to the ’730 patent. Upon information and belief, MSN submitted
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`its ANDA to the FDA containing certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`7
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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 MSN’s ANDA Products.
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`33.
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`Upon information and belief, MSN’s ANDA Products and the use of MSN’s
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`ANDA Products are covered by one or more claims of the ’730 patent, either literally or under the
`
`doctrine of equivalents.
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`34.
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`As an example, claim 1 of the ’730 patent recites:
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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
`primary particle size distribution characterized by a D90 value of
`from about 30 µm to about 65 µm.
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`35.
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`Upon information and belief, MSN’s ANDA Products infringe claim 1 of the ’730
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`patent, literally or under the doctrine of equivalents.
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`36.
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`As an example, Claim 7 of the ’730 patent recites:
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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.
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`37.
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`Upon information and belief, MSN’s ANDA Products infringe claim 7 of the ’730
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`patent, literally or under the doctrine of equivalents.
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`38.
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`As an example, Claim 15 of the ’730 patent recites:
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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 30 µm.
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`8
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`39.
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`Upon information and belief, MSN’s ANDA Products infringe claim 15 of the ’730
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`patent, literally or under the doctrine of equivalents.
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`40. MSN’s submission of MSN’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 MSN’s
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`ANDA Products before the expiration of the ’730 patent was an act of infringement of the ’730
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`patent under 35 U.S.C. § 271(e)(2)(A).
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`41.
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`Upon information and belief, MSN will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of MSN’s ANDA Products immediately and
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`imminently upon approval of its ANDA.
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`42.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of MSN’s ANDA Products would infringe one or more claims of the ’730 patent,
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`either literally or under the doctrine of equivalents.
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`43.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of MSN’s ANDA Products in accordance with, and as directed by, their proposed
`
`product labeling would infringe one or more claims of the ’730 patent.
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`44.
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`Upon information and belief, MSN plans and intends to, and will, actively induce
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`infringement of the ’730 patent when MSN’s ANDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon approval. MSN’s activities will be done with
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`knowledge of the ’730 patent and specific intent to infringe that patent.
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`45.
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`Upon information and belief, MSN knows that MSN’s ANDA Products and their
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`proposed labeling are especially made or adapted for use in infringing the ’730 patent, that MSN’s
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`ANDA Products are not staple articles or commodities of commerce, and that MSN’s ANDA
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`Products and their proposed labeling are not suitable for substantial noninfringing use. Upon
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`9
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`information and belief, MSN plans and intends to, and will, contribute to infringement of the ’730
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`patent immediately and imminently upon approval of MSN’s ANDA.
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`46.
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`Notwithstanding MSN’s knowledge of the claims of the ’730 patent, MSN has
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`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import MSN’s
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`ANDA Products with their product labeling following FDA approval of MSN’s ANDA prior to
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`the expiration of the ’730 patent.
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`47.
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`The foregoing actions by MSN 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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`48.
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`Upon information and belief, MSN has acted with full knowledge of the ’730 patent
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`and without a reasonable basis for believing that it would not be liable for infringement of the ’730
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`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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`49.
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`Pfizer will be substantially and irreparably harmed by infringement of the ’730
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`patent.
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`50.
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`Unless MSN 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
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`51.
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`Pfizer incorporates each of the preceding paragraphs 1–50 as if fully set forth
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`herein.
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`52.
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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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`10
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`hand and MSN on the other regarding MSN’s infringement, active inducement of infringement,
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`and contribution to the infringement by others of the ’730 patent, and/or the validity of the ’730
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`patent.
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`53.
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`In MSN’s Notice Letter, MSN notified Pfizer of the submission of MSN’s ANDA
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`to the FDA. The purpose of this submission was to obtain approval under the FDCA to engage in
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`the commercial manufacture, use, offer for sale, sale and/or importation of MSN’s ANDA
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`Products prior to the expiration of the ’730 patent.
`
`54.
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`In MSN’s Notice Letter, MSN also notified Pfizer that, as part of its ANDA, MSN
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`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, MSN 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
`
`manufacture, use, offer for sale, sale, and/or importation of MSN’s ANDA Products.
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`55.
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`Upon information and belief, MSN’s ANDA Products and the use of MSN’s
`
`ANDA Products are covered by one or more claims of the ’730 patent.
`
`56.
`
`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.
`
`57.
`
`Upon information and belief, MSN’s ANDA Products infringe claim 1 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`58.
`
`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-
`
`11
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`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.
`
`59.
`
`Upon information and belief, MSN’s ANDA Products infringe claim 7 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`60.
`
`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.
`
`61.
`
`Upon information and belief, MSN’s ANDA Products infringe claim 15 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`62.
`
`Upon information and belief, MSN will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of MSN’s ANDA Products immediately and
`
`imminently upon approval of its ANDA.
`
`63.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of MSN’s ANDA Products would infringe one or more claims of the ’730 patent.
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`64.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of MSN’s ANDA Products in accordance with, and as directed by, their proposed
`
`labeling would infringe one or more claims of the ’730 patent.
`
`65.
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`Upon information and belief, MSN plans and intends to, and will, actively induce
`
`infringement of the ’730 patent when MSN’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval. MSN’s activities will be done with
`
`knowledge of the ’730 patent and specific intent to infringe that patent.
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`66.
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`Upon information and belief, MSN knows that MSN’s ANDA Products and their
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`proposed labeling are especially made or adapted for use in infringing the ’730 patent, that MSN’s
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`ANDA Products are not staple articles or commodities of commerce, and that MSN’s ANDA
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`Products and their proposed labeling are not suitable for substantial noninfringing use. Upon
`
`information and belief, MSN plans and intends to, and will, contribute to infringement of the ’730
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`patent immediately and imminently upon approval of MSN’s ANDA.
`
`67.
`
`Notwithstanding MSN’s knowledge of the claims of the ’730 patent, MSN has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import MSN’s
`
`ANDA Products with their proposed labeling following FDA approval of MSN’s ANDA prior to
`
`the expiration of the ’730 patent.
`
`68.
`
`The foregoing actions by MSN 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.
`
`69.
`
`Upon information and belief, MSN 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
`
`infringement by others of the ’730 patent.
`
`70.
`
`Pfizer will be substantially and irreparably damaged by infringement of the
`
`’730 patent.
`
`71.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale
`
`and/or importation of MSN’s ANDA Products with their proposed labeling, or any other MSN
`
`drug product that is covered by or whose use is covered by the ’730 patent, will infringe, induce
`
`13
`
`

`

`Case 1:21-cv-00858-UNA Document 1 Filed 06/15/21 Page 14 of 15 PageID #: 14
`
`
`
`infringement of, and contribute to the infringement by others of the ’730 patent, and that the claims
`
`of the ’730 patent are not invalid.
`
`PRAYER FOR RELIEF
`
`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
`
`MSN’s submission to the FDA of MSN’s ANDA;
`
`(b)
`
`A judgment ordering that the effective date of any FDA approval of commercial
`
`manufacture, use, or sale of MSN’s ANDA Products, or any other drug product that
`
`infringes or the use of which infringes the ’730 patent, be not earlier than the
`
`expiration date of the ’730 patent, inclusive of any extension(s) and additional
`
`period(s) of exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining MSN, and all persons acting in
`
`concert with MSN, from the commercial manufacture, use, sale, offer for sale, or
`
`importation into the United States of MSN’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 MSN’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;
`
`14
`
`

`

`Case 1:21-cv-00858-UNA Document 1 Filed 06/15/21 Page 15 of 15 PageID #: 15
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’ fees
`
`pursuant to 35 U.S.C. § 285;
`
`Costs and expenses in this action; and
`
`Such further and other relief as this Court may deem just and proper.
`
`(f)
`
`(g)
`
`
`
`
`
`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@morrisnichols.com
`mdellinger@morrisnichols.com
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`
`David I. Berl
`Christopher J. Mandernach
`Seth R. Bowers
`Michael Xun Liu
`Kevin Hoagland-Hanson
`Andrew Hoffman
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`June 15, 2021
`
`
`
`15
`
`

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