`FOR THE EASTERN DISTRICT OF VIRGINIA
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`7'- •-
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`C
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`CIVIL ACTION NO
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`ELI LILLY AND COMPANY and ICOS
`CORPORATION,
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`Plaintiffs,
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`V.
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`MYLAN PHARMACEUTICALS INC.
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`Defendant.
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`COMPLAINT
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`Plaintiffs Eli Lilly and Company ("Lilly") and ICOS Corporation ("ICOS") (collectively
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`"Plaintiffs") file this Complaint for patent infringement against Mylan Pharmaceuticals Inc.
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`("Mylan" or "Defendant") under 35 U.S.C. § 271(e)(2) for infringement of U.S. Patent No.
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`6,943,166 ("the '166 patent").
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`NATURE OF THE ACTION
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`1. 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 Mylan. This action relates to Abbreviated New
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`Drug Application No. 206956 ("tadalafil ANDA") submitted by Mylan to the U.S. Food and
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`Drug Administration ("FDA") for approval to market a generic version ofLilly's Cialis®
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`(tadalafil) tablets ("proposed tadalafil AND A product") prior to the expiration of the ' 166 patent.
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`Mylan's tadalafil ANDA includes a "Paragraph IV certification" asserting that the ' 166 patent is
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`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
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`of Mylan's proposed tadalafil ANDA product, which constitutes an act of infringement under the
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`United States Patent Laws, Title 35 U.S.C. § 100 et seq., including 35 U.S.C. § 271(e)(2).
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`MYLAN - EXHIBIT 1030
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`0001
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`THE PARTIES
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`2. Lilly is an Indiana Corporation that has its corporate offices and principal place of
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`business at Lilly Corporate Center, Indianapolis, Indiana 46285. Lilly is engaged in the business
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`of research, development, manufacture, and sale of pharmaceutical products throughout the
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`world.
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`3.
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`ICOS is a Delaware corporation having its corporate office at Lilly Corporate Center,
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`Indianapolis, Indiana 46825. ICOS is a wholly owned subsidiary of Lilly.
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`4. On information and belief, Mylan is a corporation organized and existing under the
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`laws of the State of West Virginia, having a principal place of business at 781 Chestnut Ridge
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`Rd, Morgantown, West Virginia, 26505.
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`5. On information and belief, Mylan is a pharmaceutical company that formulates,
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`manufactures, packages, and markets generic drug products for distribution in the Eastern
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`District of Virginia and throughout the United States.
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`6. On information and belief, as stated in its 2016 Annual Report, Mylan, together with
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`its related corporate entities, "is one of the largest generic and specialty pharmaceuticals
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`companies in the world in terms of revenue," "holds the number two ranking in the U.S. generics
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`prescription market both in terms of sales and prescriptions dispensed," and supplies
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`"[ajpproximately, one in every 13 prescriptions dispensed in the U.S...."
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`JURISDICTION AND VENUE
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`7. Each of the preceding paragraphs 1 to 6 is re-alleged and re-incorporated as if fully
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`set forth herein.
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`-2-
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`0002
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`8. 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. §§
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`1331,1338(a), 2201, and 2202.
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`9. Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b),
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`10. Mylan is subject to personal jurisdiction in this District due, among other things, to its
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`substantial, systematic, purposeful, and continuous contact in this District.
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`11. Mylan is registered to do business in the Commonwealth of Virginia and has a
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`registered agent for service of process in this Judicial District.
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`12. Since at least 2010, Mylan has maintained an active license with the Virginia
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`Department of Health Professions as a "Non-Resident Wholesale Distributor," which permits
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`Mylan to directly distribute prescription drugs to pharmacies, physicians, and other retail entities
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`throughout the Commonwealth of Virginia. On information and belief, pursuant to its Non-
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`Resident Wholesale Distributer license, Mylan distributes prescription drugs in this District.
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`13. Mylan is a pharmaceutical vendor for the Minnesota Multistate Contracting Alliance
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`for Pharmacy (MMCAP) which sells pharmaceuticals in the Eastern District of Virginia and in a
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`number of states. In 2015,15% of Mylan's net sales were to McKesson Corporation, and 12%
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`of Mylan's sales were to Cardinal Health, Inc.; both are nationwide distributors with facilities in
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`the Eastern District of Virginia.
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`14. Mylan solicits customers in the Eastern District of Virginia using its extensive
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`website. Through Mylan's interactive website, customers and potential customers throughout
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`the United States, including in the Eastern District of Virginia can, among other things: (1)
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`search and download prescribing information for Mylan's full product line; (2) request Mylan's
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`Generic Brand Reference Guide which catalogs brand name products with corresponding Mylan
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`-3-
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`0003
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`generic products; (3) submit product return requests; and (4) download patient materials and
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`health information.
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`15. Mylan consented to personal jurisdiction in the Eastern District of Virginia in another
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`action. GD Searle LLC v. Lupin Pharmaceuticals, Inc., 2:13-cv-00121 (E.D. Va. 2014).
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`16. Mylan has also previously availed itself of the benefits of the Eastern District of
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`Virginia Courts by filing suit in this jurisdiction, including, at least, suing Lilly in this court.
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`Mylan Pharmaceuticals Inc. v. Eli Lilly, 3:08-cv-144 (E.D. Va. 2008).
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`17. Mylan is also subject to specific jurisdiction in this District based on the filing of its
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`tadalafil ANDA with a Paragraph IV certification regarding the ' 166 patent. See Acorda
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`Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755 (Fed. Cir. 2016).
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`18. As in Acorda, "Mylan has taken the costly, significant step of applying to the FDA
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`for approval to engage in future activities—^including the marketing of its generic drugs—that
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`will be purposefully directed at," on information and belief, this District and elsewhere. Acorda
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`Therapeutics, 817 F.3d at 759.
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`19. "Mylan's ANDA filings constitute formal acts that reliably indicate plans to engage in
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`marketing of the proposed generic drugs." Acorda Therapeutics, 817 F.3d at 760.
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`20. As in Acorda, on information and belief "Mylan intends to direct sales of its drugs
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`into [Virginia], among other places, once it has the requested PTDA approval to market them."
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`Acorda Therapeutics, 817 F.3d at 758.
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`21. On information and belief, Mylan will engage in marketing of its proposed tadalafil
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`ANDA product in Virginia, including the Eastern District of Virginia, upon approval of its
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`tadalafil ANDA.
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`-4-
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`0004
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`22. Mylan's ANDA filing, including its Paragraph IV certifications regarding the *166
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`patent at issue here, is suit-related, and has a substantial connection with this District because it
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`reliably, non-speculatively predicts activities in this District by Mylan.
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`23. "[T]he minimum-contacts standard is satisfied by the particular actions Mylan has
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`already taken—^its ANDA filing[]—for the purpose of engaging in that injury-causing and
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`allegedly wrongful marketing conduct in" this District. Acorda Therapeutics, 817 F.3d at 760.
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`24. Exercising personal jurisdiction over Mylan in this District would not be
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`unreasonable given Mylan's size, contacts in this District, and the interest in this District of
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`resolving disputes related to products to be sold herein.
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`PATENT-IN-SUIT
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`25. On September 13,2005, the U.S. Patent and Trademark Office duly and legally
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`issued the ' 166 patent, entitled "Compositions Comprising Phosphodiesterase Inhibitors for the
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`Treatment of Sexual Dysfunction." A true and correct copy of the ' 166 patent is attached hereto
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`as Exhibit A. The claims of the ' 166 patent are valid and enforceable. At the time of its issue,
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`the ' 166 patent was assigned to Lilly ICOS, LLC and it was subsequently assigned to ICOS
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`which currently holds title.
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`26. Lilly is the holder of NDA No. 021368 by which FDA granted approval for the
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`marketing and selling of tadalafil tablets in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths for
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`the treatment of erectile dysfunction. Lilly markets tadalafil tablets in the United States under
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`the name "Cialis®" in2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths. The ' 166 patent is one
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`of the patents listed in the FDA publication entitled Approved Drug Products with Therapeutic
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`Equivalence Evaluations (commonly known as the Orange Book) as covering the approved
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`indications for Cialis®.
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`-5-
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`0005
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`INFRINGEMENT BY DEFENDANT
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`27. Each of the preceding paragraphs 1 to 26 is re-alleged and re-incorporated as if fully
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`set forth herein.
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`28. In a letter dated August 11, 2014 ("the Notice Letter"), Mylan notified ICOS and
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`Lilly that Mylan had submitted its tadalafil ANDA to FDA under Section 505(j) of the Federal
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`Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) to obtain approval to engage in the
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`commercial manufacture, use or sale of its proposed tadalafil ANDA product in 2.5 mg, 10 mg,
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`and 20 mg strengths.
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`29. The Notice Letter states that Mylan is seeking approval from FDA to engage in the
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`conmiercial manufacture, use, and sale of its proposed tadalafil ANDA product before the
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`expiration of the ' 166 patent. On information and belief, Mylan intends to engage in the
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`commercial manufacture, use, and sale of its generic tadalafil tablets after receiving IDA
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`approval to do so.
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`30. In the Notice Letter, Mylan notified Lilly that its ANDA contained a Paragraph IV
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`certification asserting that the ' 166 patent is invalid, unenforceable, and/or will not be infringed
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`by the conmiercial manufacture, use, and sale of Mylan's proposed tadalafil ANDA product.
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`31. Pursuant to 21 U.S.C. 355(j)(2)(B)(ii), any notice letter containing a Paragraph IV
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`certification must contain a "detailed statement of the factual and legal basis of the applicant's
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`opinion that the patent is not valid, is unenforceable, or will not be infringed." In Defendant's
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`Notice Letter, Mylan does not deny that the commercial manufacture, use, offer to sell, or sale of
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`its proposed tadalafil ANDA product will infringe claims 1, 2,4,6-9, and 11-12 of the ' 166
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`patent, if the claims are found valid.
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`32. Claim 1 of the ' 166 patent recites "a method of treating sexual dysfunction in a
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`patient in need thereof comprising orally administering one or more unit dose containing about 1
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`-6-
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`0006
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`to about 20 mg, up to a maximum total dose of 20 mg per day, of a compound having the
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`structure [that is tadalafil]." Exhibit A, cols. 14-15, line 65-line 15.
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`33. In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product will be
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`orally administered and that it will contain tadalafil as an active ingredient in 2.5 mg, 10 mg, and
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`20 mg dosage strengths.
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`34. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
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`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to treat
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`"sexual dysfunction in a patient in need thereof comprising orally administering one or more unit
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`dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day, of
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`[tadalafil]," consistent with the FDA approved label for Cialis® which states that it isindicated
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`for the treatment of male erectile dysfunction (ED).
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`35. On information and belief, Mylan will market its proposed tadalafil ANDA product to
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`treat "sexual dysfunction in a patient in need thereof comprising orally administering one or
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`more unit dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day,
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`of[tadalafil]," consistent with the FDA approved label for Cialis®.
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`36. Claim 2 of the ' 166 patent recites "[t]he method of claim 1 wherein the sexual
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`dysfunction is male erectile dysfunction." Exhibit A, col. 15, lines 16-17.
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`37. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
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`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to treat
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`"male erectile dysfunction," consistent with the FDA approved label for Cialis® which states that
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`it is indicated for the treatment of male erectile dysfunction (ED).
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`38. On information and belief, Mylan will market its proposed tadalafil ANDA product to
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`treat male erectile sexual dysfunction, consistent with the FDA approved label for Cialis®.
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`-7-
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`0007
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`39. Claim 4 recites "[t]he method of claim 1 wherein the unit dose contains about 2 to
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`about 20 mg of the compound." Exhibit A, col. 15, lines 20-21. In its Notice Letter, Mylan
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`admits that its proposed tadalafil ANDA product will contain tadalafil as an active ingredient in
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`2.5 mg, 10 mg, and 20 mg dosage strengths.
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`40. Claim 6 recites "[t]he method of claim 1 wherein the unit dose contains about 10 mg
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`of the compound and is administered once per day." Exhibit A, col. 16, lines 5-7.
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`41. In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product will
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`contain tadalafil as an active ingredient in a 10 mg dosage strength, among others.
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`42. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
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`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to be
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`"administered once per day," consistent with the FDA approved label for Cialis®. On
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`information and belief, Mylan will market its proposed tadalafil ANDA product for once daily
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`use, consistent with the FDA approved label for Cialis®.
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`43. Claim 7 recites "[t]he method of claim 1 wherein the unit dose is in a form selected
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`from the group consisting of a Hquid, a tablet, a capsule, and a gelcap." Exhibit A, col. 16, lines
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`8-9. In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product is a tablet
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`product.
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`44. Claim 8 recites "the method of claim 1 wherein the unit dose contains about 2.5 mg
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`of the compound." Exhibit A, col. 16, lines 11-12. In its Notice Letter, Mylan admits that its
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`proposed tadalafil ANDA product will contain tadalafil as an active ingredient in a 2.5 mg
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`dosage strength, among others.
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`45. Claim 9 recites "[t]he method of claim 8 wherein the unit dose is administered once
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`per day." Exhibit A, col. 16, lines 13-14.
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`-8-
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`0008
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`46. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
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`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to be
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`"administered once per day," consistent with the FDA approved label for Cialis®. On
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`information and belief, Mylan will market its proposed tadalafil ANDA product for once daily
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`use, consistent with the FDA approved label for Cialis®.
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`47. Claim 11 recites "[t]he method of claim 1 wherein the compound is administered as a
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`free drug." Exhibit A, col 16, 15-16.
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`48. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
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`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be "administered as a
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`free drug." On information and belief, Mylan's proposed tadalafil ANDA product will contain
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`tadalafil as a free drug.
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`49. Claim 12 recites "[t]he method of claim 1 wherein the unit dose contains about 20 mg
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`of the compound." In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product
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`will contain tadalafil as an active ingredient in a 20 mg dosage strength, among others.
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`COUNT I: INFRINGEMENT OF THE '166 PATENT
`UNDER 35 U.S.C. § 271(e)(2)(A)
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`50. Each of the preceding paragraphs 1 to 49 is re-alleged and re-incorporated as if fully
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`set forth herein.
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`51. Defendant's submission of its tadalafil ANDA to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of its proposed tadalafil ANDA product prior
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`to the expiration of the ' 166 patent constituted an act of infringement under 35 U.S.C.
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`§ 271(e)(2)(A).
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`52. On information and belief, upon FDA approval of Defendant's tadalafil ANDA,
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`Defendant will infringe at least one claim of the ' 166 patent by making, using, offering to sell.
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`-9-
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`0009
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`and selling its proposed tadalafil ANDA product in the United States and/or importing such
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`tablets into the United States in violation of 35 U.S.C. §§ 271(a), 271(b), and/or 271(c) unless
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`enjoined by the Court.
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`53. If Defendant's marketing and sale of its proposed tadalafil ANDA product prior to
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`expiration of the ' 166 patent is not enjoined. Plaintiffs will suffer substantial and irreparable
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`harm for which there is no remedy at law.
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`PRAYER FOR RELIEF
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`Wherefore, Plaintiffs demand judgment against Defendant and respectfully request that
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`this Court grant the following relief:
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`A.
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`A judgment that the claims of the ' 166 patent are not invalid, not unenforceable,
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`and are infringed by Defendant's submission of its tadalafil ANDA, and that Defendant's
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`making, using, offering to sell, or selling in the United States, or importing into the United States
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`Defendant's proposed tadalafil ANDA product will infringe the ' 166 patent.
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`B.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any approval of Defendant's tadalafil ANDA shall be a date which is not earlier than the latest
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`expiration date of the '166 patent, including any extensions and/or additional periods of
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`exclusivity to which Plaintiffs are or become entitled.
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`C.
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`An order permanently enjoining Defendant, its affiliates, subsidiaries, and each of
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`its officers, agents, servants and employees, and those acting in privity or concert with them,
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`from making, using, offering to sell, or selling in the United States, or importinginto the United
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`States, Defendant's proposed tadalafil ANDA product until after the latest expiration date of the
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`' 166 patent, including any extensions and/or additional periods of exclusivity to which Plaintiffs
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`are or become entitled.
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`-10-
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`0010
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`D.
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`Such further and other relief as this Court deems proper and just, including any
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`appropriate relief under 35 U.S.C. § 285.
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`Dated: September 2,2016
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`Respectfully submitted.
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`/s/ Laura Masurovskv
`Laura Masurovsky (VA Bar # 32379)
`laura.masurovsky@finnegan.com
`Mark J. Feldstein {pro hac vice to be filed)
`mark.feldstein@finnegan.com
`John M. Williamson {pro hac vice to be filed)
`john.Williamson @fmnegan.com
`Danielle A. Duszczyszjni {pro hac vice to be filed)
`danielle.duszczysz)ni @finnegan.com
`Yieyie Yang (VA Bar # 88134)
`yieyie.yang@finnegan.com
`Emily R. Gabranski {pro hac vice to be filed)
`emily.gabranski @finnegan.com
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`Phone: (202) 408-4000
`Fax: (202) 408-4400
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`Charles E. Lipsey (VA Bar # 17251)
`Charles.lipsey@fmnegan.com
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Two Freedom Square
`11955 Freedom Drive
`Reston, Virginia 20190-5675
`Phone: (571) 203-2700
`Fax: (202) 408-4400
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`Attorneys for Plaintiffs Eli Lilly and Company and
`ICOS Corporation
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`-11-
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`0011