`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`PFIZER INC., WARNER-LAMBERT
`COMPANY LLC and PF PRISM IMB B.V.,
`
`
`Plaintiffs,
`
`COMPLAINT
`
`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 Qilu Pharmaceutical
`
`Co., Ltd. and Qilu Pharma, Inc. (collectively, “Qilu”), and by their attorneys, hereby alleges as
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`follows:
`
`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 Qilu’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”).
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`2.
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`Qilu notified Pfizer by letter dated May 26, 2021 (“Qilu’s Notice Letter”) that it
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`had submitted to the FDA ANDA No. 213093 (“Qilu’s ANDA”), seeking approval from the FDA
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`to engage in the commercial manufacture, use, and/or sale of generic palbociclib capsules, 75 mg,
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`100 mg, and 125 mg (“Qilu’s ANDA Products”) prior to the expiration of the ’730 patent.
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`C.A. No. ________________
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`))))))
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`QILU PHARMACEUTICAL CO., LTD. and
`QILU PHARMA, INC.,
`
`
`v.
`
`Defendants.
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`
`
`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 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.
`
`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)
`
`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 Qilu Pharmaceutical Co., Ltd. is a company
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`organized and existing under the laws of the People’s Republic of China with its principal place
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`of business at No. 243, Gong Ye Bei Road, Jinan, 250100, P.R. China. Upon information and
`
`belief, Qilu Pharmaceutical Co., Ltd. is in the business of, among other things, manufacturing and
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`selling generic versions of branded pharmaceutical drugs through various operating subsidiaries,
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`including Qilu Pharma, Inc.
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`7.
`
`Upon information and belief, defendant Qilu Pharma, Inc. is a corporation
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`organized and existing under the laws of the State of Pennsylvania with its principal place of
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`business at 101 Lindenwood Drive, Suite 225, Malvern, Pennsylvania 19355. Upon information
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`2
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`
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 3 of 15 PageID #: 3
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`
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`and belief, Qilu Pharma, Inc. is in the business of, among other things, manufacturing and selling
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`generic versions of branded pharmaceutical drugs for the U.S. market.
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`8.
`
`Upon information and belief, Qilu Pharma, Inc. is a wholly owned subsidiary of
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`Qilu Pharmaceutical Co., Ltd.
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`9.
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`Upon information and belief, Qilu Pharma, Inc. is the designated U.S. agent for
`
`Qilu Pharmaceutical Co., Ltd. in connection with Qilu’s ANDA.
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`10.
`
`Upon information and belief, Qilu Pharmaceutical Co., Ltd. and Qilu Pharma, Inc.
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`acted in concert to prepare and submit Qilu’s ANDA.
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`JURISDICTION
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`11.
`
`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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`12.
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`Qilu Pharmaceutical Co., Ltd. is subject to personal jurisdiction in Delaware
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`because, among other things, Qilu Pharmaceutical Co., Ltd., itself and through its wholly-owned
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`subsidiary Qilu Pharma, Inc., has purposefully 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, Qilu Pharmaceutical Co., Ltd., itself and through its subsidiary Qilu
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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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`within the State of Delaware, and/or has engaged in systematic and continuous business contacts
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`within the State of Delaware. In addition, Qilu Pharmaceutical Co., Ltd. is subject to personal
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`jurisdiction in Delaware because, upon information and belief, it controls Qilu Pharma, Inc. and
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`therefore the activities of Qilu Pharma, Inc. in this jurisdiction are attributed to Qilu
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`Pharmaceutical Co., Ltd.
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`3
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 4 of 15 PageID #: 4
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`
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`13.
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`Qilu Pharma, Inc. is subject to personal jurisdiction in Delaware because, among
`
`other things, it has purposefully availed itself of the benefits and protections of Delaware’s laws
`
`such that it should reasonably anticipate being haled into court here. Upon information and belief,
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`Qilu Pharma, Inc. develops, manufactures, imports, markets, offers to sell, and/or sells generic
`
`drugs throughout the United States, including in the State of Delaware and therefore transacts
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`business within the State of Delaware related to Pfizer’s claims, and/or has engaged in systematic
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`and continuous business contacts within the State of Delaware.
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`14.
`
`Qilu 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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`15.
`
`Upon information and belief, Qilu, with knowledge of the Hatch-Waxman Act
`
`process, directed Qilu’s Notice Letter to, inter alia, Pfizer Inc., an entity incorporated in Delaware,
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`and alleged in Qilu’s Notice Letter that Pfizer’s ’730 patent is invalid. Upon information and
`
`belief, Qilu knowingly and deliberately challenged Pfizer’s patent rights, and knew when it did so
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`that it was triggering the forty-five day period for Pfizer to bring an action for patent infringement
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`under the Hatch-Waxman Act.
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`16.
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`Because Pfizer Inc. is incorporated in Delaware, Pfizer Inc. suffers injury and
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`consequences from Qilu’s filing of Qilu’s ANDA challenging Pfizer’s patent rights in Delaware.
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`Upon information and belief, Qilu 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. Qilu has been a
`
`4
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`
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 5 of 15 PageID #: 5
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`
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`litigant in connection with other infringement actions under the Hatch-Waxman Act, and
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`reasonably should have anticipated that by sending Qilu’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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`17.
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`Upon information and belief, if Qilu’s ANDA is approved, Qilu will directly or
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`indirectly manufacture, market, sell, and/or distribute Qilu’s ANDA Products within the United
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`States, including in Delaware, consistent with Qilu’s practices for the marketing and distribution
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`of other generic pharmaceutical products. Upon information and belief, Qilu 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, Qilu’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, Qilu’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 Qilu’s ANDA Products are approved before the
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`patent expires.
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`18.
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`Upon information and belief, Qilu 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 Qilu and/or for which Qilu Pharmaceutical Co., Ltd. and/or Qilu Pharma, Inc. is
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`the named applicant on approved ANDAs. Upon information and belief, various products for
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`which Qilu Pharmaceuticals Co., Ltd. and/or Qilu Pharma, Inc. is the named applicant on approved
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`ANDAs are available at retail pharmacies in Delaware.
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`5
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 6 of 15 PageID #: 6
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`
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`FACTUAL BACKGROUND
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`19.
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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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`20.
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`Upon information and belief, Qilu’s ANDA Products are a generic version of
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`IBRANCE®.
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`21.
`
`Qilu’s Notice Letter purported to include an “Offer of Confidential Access” to
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`Pfizer to Qilu’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 Qilu’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 Qilu agreed
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`through counsel to proceed to file this Complaint and handle the production of Qilu’s confidential
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`information in post-filing discovery.
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`22.
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`Plaintiffs are filing this Complaint within forty-five days of receipt of Qilu’s Notice
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`Letter.
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`COUNT I – INFRINGEMENT OF THE ’730 PATENT
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`23.
`
`Pfizer incorporates each of the preceding paragraphs 1–22 as if fully set forth
`
`herein.
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`24.
`
`25.
`
`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.
`
`26.
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`Pfizer is the owner and assignee of the ’730 patent.
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`6
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 7 of 15 PageID #: 7
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`27.
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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”).
`
`28.
`
`In Qilu’s Notice Letter, Qilu notified Pfizer of the submission of Qilu’s ANDA 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 Qilu’s ANDA Products
`
`prior to the expiration of the ’730 patent.
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`29.
`
`In Qilu’s Notice Letter, Qilu also notified Pfizer that, as part of its ANDA, Qilu 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, Qilu 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 Qilu’s ANDA Products.
`
`30.
`
`Upon information and belief, Qilu’s ANDA Products and the use of Qilu’s 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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`31.
`
`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.
`
`32.
`
`Upon information and belief, Qilu’s ANDA Products infringe claim 1 of the ’730
`
`patent, literally or under the doctrine of equivalents.
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`33.
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`As an example, Claim 7 of the ’730 patent recites:
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`7
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 8 of 15 PageID #: 8
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`
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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.
`
`34.
`
`Upon information and belief, Qilu’s ANDA Products infringe claim 7 of the ’730
`
`patent, literally or under the doctrine of equivalents.
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`35.
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`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.
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`36.
`
`Upon information and belief, Qilu’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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`37.
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`Qilu’s submission of Qilu’s ANDA for the purpose of obtaining approval to engage
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`in the commercial manufacture, use, offer for sale, sale, and/or importation of Qilu’s ANDA
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`Products before the expiration of the ’730 patent was an act of infringement of the ’730 patent
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`under 35 U.S.C. § 271(e)(2)(A).
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`38.
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`Upon information and belief, Qilu will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Qilu’s ANDA Products immediately and
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`imminently upon approval of its ANDA.
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`39.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Qilu’s ANDA Products would infringe one or more claims of the ’730 patent, either
`
`literally or under the doctrine of equivalents.
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`8
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 9 of 15 PageID #: 9
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`40.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Qilu’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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`41.
`
`Upon information and belief, Qilu plans and intends to, and will, actively induce
`
`infringement of the ’730 patent when Qilu’s ANDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon approval. Qilu’s activities will be done with
`
`knowledge of the ’730 patent and specific intent to infringe that patent.
`
`42.
`
`Upon information and belief, Qilu knows that Qilu’s ANDA Products and their
`
`proposed labeling are especially made or adapted for use in infringing the ’730 patent, that Qilu’s
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`ANDA Products are not staple articles or commodities of commerce, and that Qilu’s ANDA
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`Products and their proposed labeling are not suitable for substantial noninfringing use. Upon
`
`information and belief, Qilu plans and intends to, and will, contribute to infringement of the ’730
`
`patent immediately and imminently upon approval of Qilu’s ANDA.
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`43.
`
`Notwithstanding Qilu’s knowledge of the claims of the ’730 patent, Qilu has
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`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Qilu’s
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`ANDA Products with their product labeling following FDA approval of Qilu’s ANDA prior to the
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`expiration of the ’730 patent.
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`44.
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`The foregoing actions by Qilu 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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`45.
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`Upon information and belief, Qilu 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
`
`9
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 10 of 15 PageID #: 10
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`
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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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`46.
`
`Pfizer will be substantially and irreparably harmed by infringement of the ’730
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`patent.
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`47.
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`Unless Qilu 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 1–47 as if fully set forth
`
`48.
`
`herein.
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`49.
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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 Qilu on the other regarding Qilu’s infringement, active inducement of infringement, and
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`contribution to the infringement by others of the ’730 patent, and/or the validity of the ’730 patent.
`
`50.
`
`In Qilu’s Notice Letter, Qilu notified Pfizer of the submission of Qilu’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 Qilu’s ANDA Products
`
`prior to the expiration of the ’730 patent.
`
`51.
`
`In Qilu’s Notice Letter, Qilu also notified Pfizer that, as part of its ANDA, Qilu 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, Qilu submitted
`
`its ANDA to the FDA containing certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`10
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 11 of 15 PageID #: 11
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`
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`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 Qilu’s ANDA Products.
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`52.
`
`Upon information and belief, Qilu’s ANDA Products and the use of Qilu’s ANDA
`
`Products are covered by one or more claims of the ’730 patent.
`
`53.
`
`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.
`
`54.
`
`Upon information and belief, Qilu’s ANDA Products infringe claim 1 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`55.
`
`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.
`
`56.
`
`Upon information and belief, Qilu’s ANDA Products infringe claim 7 of the ’730
`
`patent, literally or under the doctrine of equivalents.
`
`57.
`
`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.
`
`58.
`
`Upon information and belief, Qilu’s ANDA Products infringe claim 15 of the ’730
`
`patent, literally or under the doctrine of equivalents.
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`11
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 12 of 15 PageID #: 12
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`59.
`
`Upon information and belief, Qilu will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Qilu’s ANDA Products immediately and
`
`imminently upon approval of its ANDA.
`
`60.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Qilu’s ANDA Products would infringe one or more claims of the ’730 patent.
`
`61.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Qilu’s ANDA Products in accordance with, and as directed by, their proposed
`
`labeling would infringe one or more claims of the ’730 patent.
`
`62.
`
`Upon information and belief, Qilu plans and intends to, and will, actively induce
`
`infringement of the ’730 patent when Qilu’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval. Qilu’s activities will be done with
`
`knowledge of the ’730 patent and specific intent to infringe that patent.
`
`63.
`
`Upon information and belief, Qilu knows that Qilu’s ANDA Products and their
`
`proposed labeling are especially made or adapted for use in infringing the ’730 patent, that Qilu’s
`
`ANDA Products are not staple articles or commodities of commerce, and that Qilu’s ANDA
`
`Products and their proposed labeling are not suitable for substantial noninfringing use. Upon
`
`information and belief, Qilu plans and intends to, and will, contribute to infringement of the ’730
`
`patent immediately and imminently upon approval of Qilu’s ANDA.
`
`64.
`
`Notwithstanding Qilu’s knowledge of the claims of the ’730 patent, Qilu has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Qilu’s
`
`ANDA Products with their proposed labeling following FDA approval of Qilu’s ANDA prior to
`
`the expiration of the ’730 patent.
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`12
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 13 of 15 PageID #: 13
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`65.
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`The foregoing actions by Qilu 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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`66.
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`Upon information and belief, Qilu 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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`67.
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`Pfizer will be substantially and irreparably damaged by infringement of the ’730
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`patent.
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`68.
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`The Court should declare that the commercial manufacture, use, sale, offer for sale
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`and/or importation of Qilu’s ANDA Products with their proposed labeling, or any other Qilu drug
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`product that is covered by or whose use is covered by the ’730 patent, will infringe, induce
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`infringement of, and contribute to the infringement by others of the ’730 patent, and that the claims
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`of the ’730 patent are not invalid.
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`PRAYER FOR RELIEF
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`WHEREFORE, Pfizer requests the following relief:
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`(a)
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`A judgment that the ’730 patent has been infringed under 35 U.S.C. § 271(e)(2) by
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`Qilu’s submission to the FDA of Qilu’s ANDA;
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`(b)
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`A judgment ordering that the effective date of any FDA approval of commercial
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`manufacture, use, or sale of Qilu’s ANDA Products, or any other drug product that
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`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
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`period(s) of exclusivity;
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`13
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 14 of 15 PageID #: 14
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`(c)
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`A preliminary and permanent injunction enjoining Qilu, and all persons acting in
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`concert with Qilu, from the commercial manufacture, use, sale, offer for sale, or
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`importation into the United States of Qilu’s ANDA Products, or any other drug
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`product covered by or whose use is covered by the ’730 patent, prior to the
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`expiration of that patent, inclusive of any extension(s) and additional period(s) of
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`exclusivity;
`
`(d)
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`A judgment declaring that the commercial manufacture, use, sale, offer for sale or
`
`importation of Qilu’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
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`others of, said patent;
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`(e)
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`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)
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`(g)
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`
`
`
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`14
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`
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`Case 1:21-cv-00929-UNA Document 1 Filed 06/29/21 Page 15 of 15 PageID #: 15
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`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 29, 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@morrisnichols.com
`mdellinger@morrisnichols.com
`
`Attorneys for Plaintiffs
`
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`15
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`