Case 1:17-cv-00399-LPS Document 1 Filed 04/10/17 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BRISTOL-MYERS SQUIBB COMPANY
`AND PFIZER INC.,
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`APOTEX, INC. AND APOTEX CORP.,
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`Plaintiffs,
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`v.
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`Defendants.
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`Civil Action No.____
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`COMPLAINT
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`Plaintiffs Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) (BMS and
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`Pfizer, collectively, “Plaintiffs”), by their attorneys, hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the United
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`States, Title 35, United States Code, against Defendants Apotex, Inc. and Apotex Corp.
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`(collectively “Apotex”). This action relates to Abbreviated New Drug Application (“ANDA”)
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`No. 210091 filed by Apotex with the U.S. Food and Drug Administration (“FDA”).
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`2.
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`In ANDA No. 210091, Apotex seeks approval to market 2.5 mg and 5 mg tablets of
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`apixaban, generic versions of Plaintiffs’ Eliquis® drug product (the “Apotex ANDA product”),
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`prior to expiration of U.S. Patent Nos. 6,413,980 (the “’980 patent”), 6,967,208 (the “’208
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`patent”), and 9,326,945 (the “’945 patent”) (collectively, the “patents-in-suit”).
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`PARTIES
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`3.
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`BMS is a corporation organized and existing under the laws of Delaware, having a
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`place of business at Route 206 and Province Line Road, Princeton, New Jersey 08540.
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`4.
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`Pfizer is a corporation organized and existing under the laws of Delaware, having
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`its principal place of business at 235 East 42nd Street, New York, New York 10017.
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`5.
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`Plaintiffs are engaged in the business of creating, developing, and bringing to
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`market revolutionary pharmaceutical products to help patients prevail against serious diseases,
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`including treatments for thromboembolic disorders. Plaintiffs sell Eliquis® in this judicial district
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`and throughout the United States.
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`6.
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`Upon information and belief, Apotex Inc. is a corporation organized and existing
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`under the laws of Canada, having its principal place of business at 150 Signet Drive, Toronto,
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`Ontario, M9L 1T9, Canada.
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`7.
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`Upon information and belief, Apotex Corp. is a corporation organized and existing
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`under the laws of Delaware, having its principal place of business at 2400 North Commerce
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`Parkway, Suite 400, Weston, Florida, 33326.
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`8.
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`On information and belief, Apotex Inc. and Apotex Corp. have cooperated and
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`assisted in the preparation and filing of ANDA No. 210091 and will be involved in the
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`manufacture, importation, marketing and sale of the Apotex ANDA product in the United States,
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`including in the state of Delaware, if it is approved.
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`JURISDICTION AND VENUE
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`9.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
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`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331,
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`1338(a), 2201, and 2202.
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`10.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and/or 1400(b), and this
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`Court has personal jurisdiction over Apotex. Apotex, through its counsel, by e-mails dated
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`March 21, 2017 and April 6, 2017, agreed that it does not contest jurisdiction or venue in this Court
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`in this matter.
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`PATENTS-IN-SUIT
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`11.
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`On July 2, 2002, the U.S. Patent and Trademark Office duly and legally issued the
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`’980 patent, titled “Nitrogen Containing Heterobicycles as Factor Xa Inhibitors.” A true and
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`correct copy of the ’980 patent is attached hereto as Exhibit A. The claims of the ’980 patent are
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`valid, enforceable, and not expired. BMS is the owner of the ’980 patent and has the right to
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`enforce it.
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`12.
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`On November 22, 2005, the U.S. Patent and Trademark Office duly and legally
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`issued the ’208 patent, titled “Lactam-Containing Compounds and Derivatives thereof as Factor
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`Xa Inhibitors.” A true and correct copy of the ’208 patent is attached hereto as Exhibit B. The
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`claims of the ’208 patent are valid, enforceable, and not expired. BMS is the owner of the ’208
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`patent and has the right to enforce it.
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`13.
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`On May 3, 2016, the U.S. Patent and Trademark Office duly and legally issued the
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`’945 patent, titled “Apixaban Formulations.” A true and correct copy of the ’945 patent is
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`attached hereto as Exhibit C. The claims of the ’945 patent are valid, enforceable, and not
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`expired. Plaintiffs are the joint owners of the ’945 patent and have the right to enforce it.
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`14.
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`BMS is the holder of New Drug Application (“NDA”) No. 202155, by which the
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`FDA granted approval for the marketing and sale of 2.5 mg and 5 mg strength apixaban tablets.
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`Plaintiffs market apixaban tablets in the United States, under the trade name “Eliquis®.” The
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`FDA’s official publication of approved drugs (the “Orange Book”) includes Eliquis® together with
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`the patents-in-suit. Eliquis® is a factor Xa inhibitor indicated: (1) to reduce the risk of stroke and
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`systemic embolism in patients with nonvalvular atrial fibrillation; (2) for the prophylaxis of deep
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`vein thrombosis (“DVT”), which may lead to pulmonary embolism (“PE”), in patients who have
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`undergone hip or knee replacement surgery; and (3) for the treatment of DVT and PE, and for the
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`reduction in the risk of recurrent DVT and PE following initial therapy. A copy of the complete
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`prescribing information for Eliquis® approved in NDA No. 202155 is attached as Exhibit D.
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`INFRINGEMENT BY APOTEX
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`15.
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`In a letter dated March 13, 2017, Apotex notified Plaintiffs that Apotex had
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`submitted ANDA No. 210091 to the FDA under Section 505(j) of the Federal Food, Drug, and
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`Cosmetic Act (21 U.S.C. § 355(j)) (“the Eliquis Notice Letter”). Plaintiffs received the Eliquis
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`Notice Letter no earlier than March 13, 2017.
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`16.
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`The Eliquis Notice Letter states that Apotex seeks approval from the FDA to
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`engage in the commercial manufacture, use, and sale of the Apotex ANDA product before the
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`expiration of the patents-in-suit. Upon information and belief, Apotex intends to – directly or
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`indirectly – engage in the commercial manufacture, use, and sale of the Apotex ANDA product
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`promptly upon receiving FDA approval to do so.
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`17.
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`By filing ANDA No. 210091, Apotex has necessarily represented to the FDA that
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`the Apotex ANDA product has the same active ingredient as Eliquis®, has the same dosage form
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`and strength as Eliquis®, and is bioequivalent to Eliquis®.
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`18.
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`Upon information and belief, Apotex is seeking approval to market the Apotex
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`ANDA product for the same approved indications as Eliquis®.
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`19.
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`In the Eliquis Notice Letter, Apotex states that its ANDA contains a certification
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the patents-in-suit are invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of the
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`Apotex ANDA product.
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`20.
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`In the Eliquis Notice Letter, Apotex offered confidential access to portions of its
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`ANDA No. 210091 on terms and conditions set forth in the Eliquis Notice Letter (“the Apotex
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`Offer”). Apotex requested that Plaintiffs accept the Apotex Offer before receiving access to
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`Apotex’s ANDA No. 210091. The Apotex Offer contained unreasonable restrictions well beyond
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`those that would apply under a protective order on who could view the ANDA. For example, the
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`Apotex Offer contained a broad patent prosecution bar, which, among other things, does not have
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`a carve-out for inter-partes reviews or other adversarial proceedings. The Apotex Offer
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`unreasonably restricted the ability of counsel to seek the opinions of Plaintiffs’ employees and
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`outside experts. The restrictions Apotex has placed on access to ANDA No. 210091 contravene
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`21 U.S.C. § 355(j)(5)(C)(i)(III), which states that an offer of confidential access “shall contain
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`such restrictions as to persons entitled to access, and on the use and disposition of any information
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`accessed, as would apply had a protective order been entered for the purpose of protecting trade
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`secrets and other confidential business information” (emphasis added).
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`21.
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`This Complaint is being filed before the expiration of forty-five days from the date
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`Plaintiffs received the Eliquis Notice Letter.
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`COUNT I
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`(INFRINGEMENT OF THE ’980 PATENT)
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`22.
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`23.
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`Each of the preceding paragraphs 1 to 21 is incorporated as if fully set forth herein.
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`Apotex’s submission of ANDA No. 210091 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of the Apotex ANDA product prior to the
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`expiration of the ’980 patent constituted a technical act of infringement of at least one of the claims
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`of the ’980 patent, either literally or under the doctrine of equivalents, including but not limited to
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`claims 5-8, 10, and 16, under 35 U.S.C. § 271(e)(2)(A).
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`24.
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`Apotex’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Apotex ANDA product prior to the expiration of the ’980 patent, and its inducement of and/or
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`contribution to such conduct, would further infringe, either literally or under the doctrine of
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`equivalents, at least one of the claims of the ’980 patent, including but not limited to claims 5-8,
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`10, and 16, under 35 U.S.C. §§ 271(a), (b) and/or (c).
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`25.
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`Upon FDA approval of Apotex’s ANDA No. 210091, Apotex will infringe, either
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`literally or under the doctrine of equivalents, at least one of the claims of the ’980 patent, including
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`but not limited to claims 5-8, 10, and 16, by making, using, offering to sell, and selling the Apotex
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`ANDA product in the United States and/or importing said product into the United States, or by
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`actively inducing and contributing to infringement of the ’980 patent by others, under 35 U.S.C.
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`§ 271(a)-(c), unless enjoined by the Court.
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`26.
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`If Apotex’s marketing and sale of the Apotex ANDA product prior to expiration of
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`the ’980 patent and all other relevant exclusivities are not enjoined, BMS will suffer substantial
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`and irreparable harm for which there is no remedy at law.
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`COUNT II
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`(INFRINGEMENT OF THE ’208 PATENT)
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`27.
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`28.
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`Each of the preceding paragraphs 1 to 26 is incorporated as if fully set forth herein.
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`Apotex’s submission of ANDA No. 210091 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of the Apotex ANDA product prior to the
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`expiration of the ’208 patent constituted a technical act of infringement of at least one of the claims
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`of the ’208 patent, either literally or under the doctrine of equivalents, including but not limited to
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`claims 8, 13, 26-27, and 55-61, under 35 U.S.C. § 271(e)(2)(A).
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`29.
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`Apotex’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Apotex ANDA product prior to the expiration of the ’208 patent, and its inducement of and/or
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`contribution to such conduct, would further infringe, either literally or under the doctrine of
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`equivalents, at least one of the claims of the ’208 patent, including but not limited to claims 8, 13,
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`and 26-27, under 35 U.S.C. §§ 271(a), (b) and/or (c).
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`30.
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`Apotex’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Apotex ANDA product for the same treatment claimed in the ’208 patent prior to the expiration of
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`the ’208 patent, and its inducement of and/or contribution to such conduct, would further infringe,
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`either literally or under the doctrine of equivalents, at least one of the claims of the ’208 patent,
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`including but not limited to claims 55-61, under 35 U.S.C. §§ 271(a), (b) and/or (c).
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`31.
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`Upon FDA approval of Apotex’s ANDA No. 210091, Apotex will infringe, either
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`literally or under the doctrine of equivalents, at least one of the claims of the ’208 patent, including
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`but not limited to claims 8, 13, 26-27, and 55-61, by making, using, offering to sell, and selling the
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`Apotex ANDA product in the United States and/or importing said product into the United States,
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`or by actively inducing and contributing to infringement of the ’208 patent by others, under 35
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`U.S.C. § 271(a)-(c), unless enjoined by the Court.
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`32.
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`If Apotex’s marketing and sale of the Apotex ANDA product prior to expiration of
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`the ’208 patent and all other relevant exclusivities are not enjoined, BMS will suffer substantial
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`and irreparable harm for which there is no remedy at law.
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`COUNT III
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`(INFRINGEMENT OF THE ’945 PATENT)
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`33.
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`34.
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`Each of the preceding paragraphs 1 to 32 is incorporated as if fully set forth herein.
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`Apotex’s submission of ANDA No. 210091 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of the Apotex ANDA product prior to the
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`expiration of the ’945 patent constituted a technical act of infringement of at least one of the claims
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`of the ’945 patent, either literally or under the doctrine of equivalents, including but not limited to
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`claims 1, 9-12, 20-23, 25, 27, 29, 31, 33, 35, and 37, under 35 U.S.C. § 271(e)(2)(A).
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`35.
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`Apotex’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Apotex ANDA product prior to the expiration of the ’945 patent, and its inducement of and/or
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`contribution to such conduct, would further infringe at least one of the claims of the ’945 patent,
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`either literally or under the doctrine of equivalents, including but not limited to claims 1, 9-12,
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`20-23, 25, 27, 29, 31, 33, 35, and 37, under 35 U.S.C. §§ 271(a), (b) and/or (c).
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`36.
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`Upon FDA approval of Apotex’s ANDA No. 210091, Apotex will infringe one or
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`more claims of the ’945 patent, either literally or under the doctrine of equivalents, including but
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`not limited to claims 1, 9-12, 20-23, 25, 27, 29, 31, 33, 35, and 37, by making, using, offering to
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`sell, and selling the Apotex ANDA product in the United States and/or importing said product into
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`the United States, or by actively inducing and contributing to infringement of the ’945 patent by
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`others, under 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
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`37.
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`If Apotex’s marketing and sale of the Apotex ANDA product prior to expiration of
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`the ’945 patent and all other relevant exclusivities are not enjoined, Plaintiffs will suffer
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`substantial and irreparable harm for which there is no remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs pray that this Court grant the following relief:
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`1.
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`A judgment that the claims of the patents-in-suit are not invalid, are not
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`unenforceable, and are infringed by Apotex’s submission of ANDA No. 210091, either literally or
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`under the doctrine of equivalents, and that Apotex’s making, using, offering to sell, or selling in
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`the United States, or importing into the United States the Apotex ANDA product will infringe the
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`claims of the patents-in-suit, either literally or under the doctrine of equivalents.
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`2.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
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`date of any approval of ANDA No. 210091 shall be a date which is not earlier than the latest
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`expiration date of the patents-in-suit, including any extensions and/or additional periods of
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`exclusivity to which Plaintiffs are or become entitled.
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`3.
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`An order permanently enjoining Apotex, its affiliates, subsidiaries, and
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`each of its officers, agents, servants and employees and those acting in privity or concert with
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`them, from making, using, offering to sell, or selling in the United States, or importing into the
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`United States the Apotex ANDA product until after the latest expiration date of the patents-in-suit,
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`including any extensions and/or additional periods of exclusivity to which Plaintiffs are or become
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`entitled.
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`4.
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`Damages or other monetary relief, including costs, fees, pre- and
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`post-judgment interest, to Plaintiffs if Apotex engages in commercial manufacture, use, offers to
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`sell, sale, or importation in or into the United States of the Apotex ANDA product prior to the
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`latest expiration date of the patents-in-suit, including any extensions and/or additional periods of
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`exclusivity to which Plaintiffs are or become entitled.
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`5.
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`Such further and other relief as this Court deems proper and just, including
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`any appropriate relief under 35 U.S.C. § 285.
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`Dated: April 10, 2017
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`Of Counsel:
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`Respectfully submitted,
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`FARNAN, LLP
`
`Amy K. Wigmore
`Gregory H. Lantier
`Tracey C. Allen
`Heather M. Petruzzi
`Jeffrey T. Hantson
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Ave, NW
`Washington, DC 20006
`
`/s/ Michael J. Farnan
`Joseph J. Farnan, Jr. (Bar No. 100245)
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 N. Market Str., 12th Floor
`Wilmington, DE 19801
`Tel: (302) 777-0300
`Fax: (302) 777-0301
`
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`Case 1:17-cv-00399-LPS Document 1 Filed 04/10/17 Page 10 of 10 PageID #: 10
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`202-663-6000
`202-663-6363
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`farnan@farnanlaw.com
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
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`Counsel for Plaintiffs Bristol-Myers Squibb
`Company and Pfizer Inc.
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