Case 1:17-cv-00408-LPS Document 1 Filed 04/10/17 Page 1 of 8 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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`SIGMAPHARM LABORATORIES, LLC.,
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`Plaintiffs,
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`v.
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`Defendant.
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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 Defendant Sigmapharm Laboratories, LLC.
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`(“Sigmapharm”). This action relates to Abbreviated New Drug Application (“ANDA”)
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`No. 210053 filed by Sigmapharm with the U.S. Food and Drug Administration (“FDA”).
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`2.
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`In ANDA No. 210053, Sigmapharm seeks approval to market 2.5 mg and 5 mg
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`tablets of apixaban, generic versions of Plaintiffs’ Eliquis® drug product (the “Sigmapharm
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`ANDA product”), prior to expiration of U.S. Patent Nos. 6,967,208 (the “’208 patent”) and
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`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, Sigmapharm is a corporation organized and existing
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`under the laws of Pennsylvania, having its principal place of business at 3375 Progress Drive,
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`Bensalem, Pennsylvania 19020.
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`JURISDICTION AND VENUE
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`7.
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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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`8.
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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 Sigmapharm. Sigmapharm, through its counsel, by e-mail
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`dated March 30, 2017, agreed that it does not contest jurisdiction or venue in this Court in this
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`matter.
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`PATENTS-IN-SUIT
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`9.
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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 A. 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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`10.
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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 B. 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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`11.
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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 C.
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`INFRINGEMENT BY SIGMAPHARM
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`12.
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`By letter sent by Federal Express on March 7, 2017, Sigmapharm notified Plaintiffs
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`that Sigmapharm had submitted ANDA No. 210053 to the FDA under Section 505(j) of the
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`Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) (“the Eliquis Notice Letter”).
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`Plaintiffs received the Eliquis Notice Letter no earlier than March 8, 2017.
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`13.
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`The Eliquis Notice Letter states that Sigmapharm seeks approval from the FDA to
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`engage in the commercial manufacture, use, and sale of the Sigmapharm ANDA product before
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`the expiration of the patents-in-suit. Upon information and belief, Sigmapharm intends to –
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`directly or indirectly – engage in the commercial manufacture, use, and sale of the Sigmapharm
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`ANDA product promptly upon receiving FDA approval to do so.
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`14.
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`By filing ANDA No. 210053, Sigmapharm has necessarily represented to the FDA
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`that the Sigmapharm ANDA product has the same active ingredient as Eliquis®, has the same
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`dosage form and strength as Eliquis®, and is bioequivalent to Eliquis®.
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`15.
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`Upon information and belief, Sigmapharm is seeking approval to market the
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`Sigmapharm ANDA product for the same approved indications as Eliquis®.
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`16.
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`In the Eliquis Notice Letter, Sigmapharm states that its ANDA contains a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the patents-in-suit are
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`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
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`of the Sigmapharm ANDA product.
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`17.
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`In the Eliquis Notice Letter, Sigmapharm offered confidential access to portions of
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`its ANDA No. 210053 on terms and conditions set forth in the Eliquis Notice Letter (“the
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`Sigmapharm Offer”). Sigmapharm requested that Plaintiffs accept the Sigmapharm Offer before
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`receiving access to Sigmapharm’s ANDA No. 210053. The Sigmapharm Offer contained
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`unreasonable restrictions well beyond those that would apply under a protective order on who
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`could view the ANDA. For example, the Sigmapharm Offer contained a broad patent prosecution
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`bar, which, among other things, does not have a carve-out for inter-partes reviews or other
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`adversarial proceedings, and a broad restriction barring access by outside counsel who engage in
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`any work before or involving the FDA. The Sigmapharm Offer unreasonably restricted the
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`ability of counsel to seek the opinions of Plaintiffs’ employees and outside experts without written
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`permission from Sigmapharm’s designated counsel; Sigmapharm had broad authority to reject any
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`such request for access to the Sigmapharm ANDA. The restrictions Sigmapharm has placed on
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`access to ANDA No. 210053 contravene 21 U.S.C. § 355(j)(5)(C)(i)(III), which states that an offer
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`of confidential access “shall contain such restrictions as to persons entitled to access, and on the
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`use and disposition of any information accessed, as would apply had a protective order been
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`entered for the purpose of protecting trade secrets and other confidential business information”
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`(emphasis added).
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`18.
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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 ’208 PATENT)
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`19.
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`20.
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`Each of the preceding paragraphs 1 to 18 is incorporated as if fully set forth herein.
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`Sigmapharm’s submission of ANDA No. 210053 to obtain approval to engage in
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`the commercial manufacture, use, offer to sell, or sale of the Sigmapharm ANDA product prior to
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`the expiration of the ’208 patent constituted a technical act of infringement of at least one of the
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`claims of the ’208 patent, either literally or under the doctrine of equivalents, including but not
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`limited to claims 8, 13, 26-27, and 55-61, under 35 U.S.C. § 271(e)(2)(A).
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`21.
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`Sigmapharm’s commercial manufacture, use, offer to sell, sale, or importation of
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`the Sigmapharm ANDA product prior to the expiration of the ’208 patent, and its inducement of
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`and/or 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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`22.
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`Sigmapharm’s commercial manufacture, use, offer to sell, sale, or importation of
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`the Sigmapharm ANDA product for the same treatment claimed in the ’208 patent prior to the
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`expiration of the ’208 patent, and its inducement of and/or contribution to such conduct, would
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`further infringe, either literally or under the doctrine of equivalents, at least one of the claims of the
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`’208 patent, including but not limited to claims 55-61, under 35 U.S.C. §§ 271(a), (b) and/or (c).
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`23.
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`Upon FDA approval of Sigmapharm’s ANDA No. 210053, Sigmapharm will
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`infringe, either literally or under the doctrine of equivalents, at least one of the claims of the ’208
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`patent, including but not limited to claims 8, 13, 26-27, and 55-61, by making, using, offering to
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`sell, and selling the Sigmapharm ANDA product in the United States and/or importing said
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`product into the United States, or by actively inducing and contributing to infringement of the ’208
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`patent by others, under 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
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`24.
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`If Sigmapharm’s marketing and sale of the Sigmapharm ANDA product prior to
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`expiration of the ’208 patent and all other relevant exclusivities are not enjoined, BMS will suffer
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`substantial and irreparable harm for which there is no remedy at law.
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`COUNT II
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`(INFRINGEMENT OF THE ’945 PATENT)
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`25.
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`26.
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`Each of the preceding paragraphs 1 to 24 is incorporated as if fully set forth herein.
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`Sigmapharm’s submission of ANDA No. 210053 to obtain approval to engage in
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`the commercial manufacture, use, offer to sell, or sale of the Sigmapharm ANDA product prior to
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`the expiration of the ’945 patent constituted a technical act of infringement of at least one of the
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`claims of the ’945 patent, either literally or under the doctrine of equivalents, including but not
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`limited to 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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`27.
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`Sigmapharm’s commercial manufacture, use, offer to sell, sale, or importation of
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`the Sigmapharm ANDA product prior to the expiration of the ’945 patent, and its inducement of
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`and/or contribution to such conduct, would further infringe at least one of the claims of the ’945
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`patent, either literally or under the doctrine of equivalents, including but not limited to claims 1,
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`9-12, 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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`28.
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`Upon FDA approval of Sigmapharm’s ANDA No. 210053, Sigmapharm will
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`infringe one or more claims of the ’945 patent, either literally or under the doctrine of equivalents,
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`including but not limited to claims 1, 9-12, 20-23, 25, 27, 29, 31, 33, 35, and 37, by making, using,
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`offering to sell, and selling the Sigmapharm ANDA product in the United States and/or importing
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`said product into the United States, or by actively inducing and contributing to infringement of the
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`’945 patent by others, under 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
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`29.
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`If Sigmapharm’s marketing and sale of the Sigmapharm ANDA product prior to
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`expiration of the ’945 patent and all other relevant exclusivities are not enjoined, Plaintiffs will
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`suffer 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 Sigmapharm’s submission of ANDA No. 210053, either
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`literally or under the doctrine of equivalents, and that Sigmapharm’s making, using, offering to
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`sell, or selling in the United States, or importing into the United States the Sigmapharm ANDA
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`product will infringe the claims of the patents-in-suit, either literally or under the doctrine of
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`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. 210053 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 Sigmapharm, its affiliates, subsidiaries,
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`and 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 Sigmapharm ANDA product until after the latest expiration date of the
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`patents-in-suit, including any extensions and/or additional periods of exclusivity to which
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`Plaintiffs are or become 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 Sigmapharm engages in commercial manufacture, use,
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`offers to sell, sale, or importation in or into the United States of the Sigmapharm ANDA product
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`prior to the latest expiration date of the patents-in-suit, including any extensions and/or additional
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`periods of 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
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`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
`202-663-6000
`202-663-6363
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`/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
`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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