Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 1 of 11 PageID# 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
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`7'- •-
`
`- o :> j i
`
`C
`
`CIVIL ACTION NO
`
`)
`
`) )
`
`) )
`
`) )
`
`) )
`
`)
`
`ELI LILLY AND COMPANY and ICOS
`CORPORATION,
`
`Plaintiffs,
`
`V.
`
`MYLAN PHARMACEUTICALS INC.
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs Eli Lilly and Company ("Lilly") and ICOS Corporation ("ICOS") (collectively
`
`"Plaintiffs") file this Complaint for patent infringement against Mylan Pharmaceuticals Inc.
`
`("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").
`
`NATURE OF THE ACTION
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`1. This is an action for patent infringement arising under the patent laws of the United
`
`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.
`
`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).
`
`ICOS Exhibit 2010
`Mylan v. ICOS
`IPR2017-00323
`
`Page 1 of 11
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`
`7'- •-
`
`- o :> j i
`
`C
`
`CIVIL ACTION NO
`
`)
`
`) )
`
`) )
`
`) )
`
`) )
`
`)
`
`ELI LILLY AND COMPANY and ICOS
`CORPORATION,
`
`Plaintiffs,
`
`V.
`
`MYLAN PHARMACEUTICALS INC.
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs Eli Lilly and Company ("Lilly") and ICOS Corporation ("ICOS") (collectively
`
`"Plaintiffs") file this Complaint for patent infringement against Mylan Pharmaceuticals Inc.
`
`("Mylan" or "Defendant") under 35 U.S.C. § 271(e)(2) for infringement of U.S. Patent No.
`
`6,943,166 ("the '166 patent").
`
`NATURE OF THE ACTION
`
`1. This is an action for patent infringement arising under the patent laws of the United
`
`States, Title 35, United States Code, against Mylan. This action relates to Abbreviated New
`
`Drug Application No. 206956 ("tadalafil ANDA") submitted by Mylan to the U.S. Food and
`
`Drug Administration ("FDA") for approval to market a generic version ofLilly's Cialis®
`
`(tadalafil) tablets ("proposed tadalafil AND A product") prior to the expiration of the ' 166 patent.
`
`Mylan's tadalafil ANDA includes a "Paragraph IV certification" asserting that the ' 166 patent is
`
`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
`
`of Mylan's proposed tadalafil ANDA product, which constitutes an act of infringement under the
`
`United States Patent Laws, Title 35 U.S.C. § 100 et seq., including 35 U.S.C. § 271(e)(2).
`
`ICOS Exhibit 2010
`Mylan v. ICOS
`IPR2017-00323
`
`Page 1 of 11
`
`
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 2 of 11 PageID# 2
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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
`
`its related corporate entities, "is one of the largest generic and specialty pharmaceuticals
`
`companies in the world in terms of revenue," "holds the number two ranking in the U.S. generics
`
`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
`
`set forth herein.
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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
`
`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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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 4 of 11 PageID# 4
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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).
`
`18. As in Acorda, "Mylan has taken the costly, significant step of applying to the FDA
`
`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
`
`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
`
`ANDA product in Virginia, including the Eastern District of Virginia, upon approval of its
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`tadalafil ANDA.
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 5 of 11 PageID# 5
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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
`
`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.
`
`24. Exercising personal jurisdiction over Mylan in this District would not be
`
`unreasonable given Mylan's size, contacts in this District, and the interest in this District of
`
`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
`
`issued the ' 166 patent, entitled "Compositions Comprising Phosphodiesterase Inhibitors for the
`
`Treatment of Sexual Dysfunction." A true and correct copy of the ' 166 patent is attached hereto
`
`as Exhibit A. The claims of the ' 166 patent are valid and enforceable. At the time of its issue,
`
`the ' 166 patent was assigned to Lilly ICOS, LLC and it was subsequently assigned to ICOS
`
`which currently holds title.
`
`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
`
`the treatment of erectile dysfunction. Lilly markets tadalafil tablets in the United States under
`
`the name "Cialis®" in2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths. The ' 166 patent is one
`
`of the patents listed in the FDA publication entitled Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (commonly known as the Orange Book) as covering the approved
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`indications for Cialis®.
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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
`
`set forth herein.
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`28. In a letter dated August 11, 2014 ("the Notice Letter"), Mylan notified ICOS and
`
`Lilly that Mylan had submitted its tadalafil ANDA to FDA under Section 505(j) of the Federal
`
`Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) to obtain approval to engage in the
`
`commercial manufacture, use or sale of its proposed tadalafil ANDA product in 2.5 mg, 10 mg,
`
`and 20 mg strengths.
`
`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
`
`expiration of the ' 166 patent. On information and belief, Mylan intends to engage in the
`
`commercial manufacture, use, and sale of its generic tadalafil tablets after receiving IDA
`
`approval to do so.
`
`30. In the Notice Letter, Mylan notified Lilly that its ANDA contained a Paragraph IV
`
`certification asserting that the ' 166 patent is invalid, unenforceable, and/or will not be infringed
`
`by the conmiercial manufacture, use, and sale of Mylan's proposed tadalafil ANDA product.
`
`31. Pursuant to 21 U.S.C. 355(j)(2)(B)(ii), any notice letter containing a Paragraph IV
`
`certification must contain a "detailed statement of the factual and legal basis of the applicant's
`
`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
`
`its proposed tadalafil ANDA product will infringe claims 1, 2,4,6-9, and 11-12 of the ' 166
`
`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
`
`patient in need thereof comprising orally administering one or more unit dose containing about 1
`
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`Page 6 of 11
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 7 of 11 PageID# 7
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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
`
`orally administered and that it will contain tadalafil as an active ingredient in 2.5 mg, 10 mg, and
`
`20 mg dosage strengths.
`
`34. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
`
`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to treat
`
`"sexual dysfunction in a patient in need thereof comprising orally administering one or more unit
`
`dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day, of
`
`[tadalafil]," consistent with the FDA approved label for Cialis® which states that it isindicated
`
`for the treatment of male erectile dysfunction (ED).
`
`35. On information and belief, Mylan will market its proposed tadalafil ANDA product to
`
`treat "sexual dysfunction in a patient in need thereof comprising orally administering one or
`
`more unit dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day,
`
`of[tadalafil]," consistent with the FDA approved label for Cialis®.
`
`36. Claim 2 of the ' 166 patent recites "[t]he method of claim 1 wherein the sexual
`
`dysfunction is male erectile dysfunction." Exhibit A, col. 15, lines 16-17.
`
`37. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
`
`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to treat
`
`"male erectile dysfunction," consistent with the FDA approved label for Cialis® which states that
`
`it is indicated for the treatment of male erectile dysfunction (ED).
`
`38. On information and belief, Mylan will market its proposed tadalafil ANDA product to
`
`treat male erectile sexual dysfunction, consistent with the FDA approved label for Cialis®.
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 8 of 11 PageID# 8
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`39. Claim 4 recites "[t]he method of claim 1 wherein the unit dose contains about 2 to
`
`about 20 mg of the compound." Exhibit A, col. 15, lines 20-21. In its Notice Letter, Mylan
`
`admits that its proposed tadalafil ANDA product will contain tadalafil as an active ingredient in
`
`2.5 mg, 10 mg, and 20 mg dosage strengths.
`
`40. Claim 6 recites "[t]he method of claim 1 wherein the unit dose contains about 10 mg
`
`of the compound and is administered once per day." Exhibit A, col. 16, lines 5-7.
`
`41. In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product will
`
`contain tadalafil as an active ingredient in a 10 mg dosage strength, among others.
`
`42. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
`
`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to be
`
`"administered once per day," consistent with the FDA approved label for Cialis®. On
`
`information and belief, Mylan will market its proposed tadalafil ANDA product for once daily
`
`use, consistent with the FDA approved label for Cialis®.
`
`43. Claim 7 recites "[t]he method of claim 1 wherein the unit dose is in a form selected
`
`from the group consisting of a Hquid, a tablet, a capsule, and a gelcap." Exhibit A, col. 16, lines
`
`8-9. In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product is a tablet
`
`product.
`
`44. Claim 8 recites "the method of claim 1 wherein the unit dose contains about 2.5 mg
`
`of the compound." Exhibit A, col. 16, lines 11-12. In its Notice Letter, Mylan admits that its
`
`proposed tadalafil ANDA product will contain tadalafil as an active ingredient in a 2.5 mg
`
`dosage strength, among others.
`
`45. Claim 9 recites "[t]he method of claim 8 wherein the unit dose is administered once
`
`per day." Exhibit A, col. 16, lines 13-14.
`
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`Page 8 of 11
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 9 of 11 PageID# 9
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`46. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
`
`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be marketed to be
`
`"administered once per day," consistent with the FDA approved label for Cialis®. On
`
`information and belief, Mylan will market its proposed tadalafil ANDA product for once daily
`
`use, consistent with the FDA approved label for Cialis®.
`
`47. Claim 11 recites "[t]he method of claim 1 wherein the compound is administered as a
`
`free drug." Exhibit A, col 16, 15-16.
`
`48. In its Notice Letter, Mylan does not provide any alleged "factual and legal basis" (21
`
`U.S.C. 355(j)(2)(B)(ii)) that its proposed tadalafil ANDA product will not be "administered as a
`
`free drug." On information and belief, Mylan's proposed tadalafil ANDA product will contain
`
`tadalafil as a free drug.
`
`49. Claim 12 recites "[t]he method of claim 1 wherein the unit dose contains about 20 mg
`
`of the compound." In its Notice Letter, Mylan admits that its proposed tadalafil ANDA product
`
`will contain tadalafil as an active ingredient in a 20 mg dosage strength, among others.
`
`COUNT I: INFRINGEMENT OF THE '166 PATENT
`UNDER 35 U.S.C. § 271(e)(2)(A)
`
`50. Each of the preceding paragraphs 1 to 49 is re-alleged and re-incorporated as if fully
`
`set forth herein.
`
`51. Defendant's submission of its tadalafil ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer to sell, or sale of its proposed tadalafil ANDA product prior
`
`to the expiration of the ' 166 patent constituted an act of infringement under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`52. On information and belief, upon FDA approval of Defendant's tadalafil ANDA,
`
`Defendant will infringe at least one claim of the ' 166 patent by making, using, offering to sell.
`
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`Page 9 of 11
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 10 of 11 PageID# 10
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`and selling its proposed tadalafil ANDA product in the United States and/or importing such
`
`tablets into the United States in violation of 35 U.S.C. §§ 271(a), 271(b), and/or 271(c) unless
`
`enjoined by the Court.
`
`53. If Defendant's marketing and sale of its proposed tadalafil ANDA product prior to
`
`expiration of the ' 166 patent is not enjoined. Plaintiffs will suffer substantial and irreparable
`
`harm for which there is no remedy at law.
`
`PRAYER FOR RELIEF
`
`Wherefore, Plaintiffs demand judgment against Defendant and respectfully request that
`
`this Court grant the following relief:
`
`A.
`
`A judgment that the claims of the ' 166 patent are not invalid, not unenforceable,
`
`and are infringed by Defendant's submission of its tadalafil ANDA, and that Defendant's
`
`making, using, offering to sell, or selling in the United States, or importing into the United States
`
`Defendant's proposed tadalafil ANDA product will infringe the ' 166 patent.
`
`B.
`
`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any approval of Defendant's tadalafil ANDA shall be a date which is not earlier than the latest
`
`expiration date of the '166 patent, including any extensions and/or additional periods of
`
`exclusivity to which Plaintiffs are or become entitled.
`
`C.
`
`An order permanently enjoining Defendant, its affiliates, subsidiaries, and each of
`
`its officers, agents, servants and employees, and those acting in privity or concert with them,
`
`from making, using, offering to sell, or selling in the United States, or importinginto the United
`
`States, Defendant's proposed tadalafil ANDA product until after the latest expiration date of the
`
`' 166 patent, including any extensions and/or additional periods of exclusivity to which Plaintiffs
`
`are or become entitled.
`
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`Case 1:16-cv-01122-LO-TCB Document 1 Filed 09/02/16 Page 11 of 11 PageID# 11
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`D.
`
`Such further and other relief as this Court deems proper and just, including any
`
`appropriate relief under 35 U.S.C. § 285.
`
`Dated: September 2,2016
`
`Respectfully submitted.
`
`/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
`
`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
`
`Attorneys for Plaintiffs Eli Lilly and Company and
`ICOS Corporation
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`-11-
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`Page 11 of 11
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