`
`
`
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Eli Lilly and Company
`And ICOS Corporation
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`ELI LILLY AND COMPANY and ICOS
`CORPORATION,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`HETERO USA INC., HETERO LABS LIMITED
`UNIT-III, and HETERO LABS LIMITED
`
`
`Defendants.
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`COMPLAINT
`
`
`
`CIVIL ACTION NO.
`
`
`
`
`
`Plaintiffs Eli Lilly and Company (“Lilly”) and ICOS Corporation (“ICOS”) (collectively
`
`“Plaintiffs”) file this Complaint for patent infringement against Defendants Hetero USA Inc.,
`
`Hetero Labs Limited Unit-III, and Hetero Labs Limited (collectively “Hetero” 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 Defendant. This action relates to Abbreviated New
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`Drug Application No. 209908 (“tadalafil ANDA”) submitted by Defendant to the U.S. Food and
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`
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`
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`
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`Drug Administration (“FDA”) for approval to market a generic version of Lilly’s Cialis®
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`(tadalafil) tablets (“proposed tadalafil ANDA product”) prior to the expiration of the ’166 patent.
`
`Defendant’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 Defendant’s proposed tadalafil ANDA product, which constitutes an act of
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`infringement under the United States Patent Laws, Title 35 U.S.C. § 100 et seq., including 35
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`U.S.C. § 271(e)(2).
`
`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
`
`world.
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`3. 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. Upon information and belief, Hetero USA Inc. is a corporation organized under the
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`laws of the State of Delaware and has its principal place of business at 1035 Centennial Ave,
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`Piscataway, New Jersey 08854.
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`5. Upon information and belief, Hetero USA Inc. manufactures and/or distributes
`
`numerous generic drugs for sale and use throughout the United States, including in the State of
`
`New Jersey, and including as an agent of Hetero Labs Limited Unit-III and Hetero Labs Limited.
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`6. Upon information and belief, Hetero USA Inc. is a wholly-owned subsidiary of
`
`Hetero Labs Limited.
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`7. Upon information and belief, Hetero Labs Limited Unit-III is an India corporation
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`and has its principle place of business at 7-2-A2, Hetero Corporate Industrial Estates, Sanath
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`Nagar, Hyderabad – 500 018, A.P. India.
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`8. Upon information and belief, Hetero Labs Limited Unit-III is a division of Hetero
`
`Labs Limited.
`
`9. Upon information and belief, Hetero Labs Limited Unit-III manufactures and/or
`
`distributes numerous generic drugs for sale and use throughout the United States, including in
`
`the State of New Jersey, and including through its agent Hetero USA Inc.
`
`10. Upon information and belief, Hetero Labs Limited is an India corporation and has its
`
`principle place of business at 7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar,
`
`Hyderabad – 500 018, A.P. India.
`
`11. Upon information and belief, Hetero Labs Limited manufactures and/or distributes
`
`numerous generic drugs for sale and use throughout the United States, including in the State of
`
`New Jersey, and including through its agent Hetero USA Inc.
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`JURISDICTION AND VENUE
`
`12. Each of the preceding paragraphs 1 to 11 is re-alleged and re-incorporated as if fully
`
`set forth herein.
`
`13. This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
`
`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.
`
`14. Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
`
`15. On information and belief, Hetero USA Inc., Hetero Labs Limited Unit-III, and
`
`Hetero Labs Limited collaborate to develop, manufacture, import, market, and distribute, and/or
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`sell pharmaceutical products, including generic drug products manufactured and sold pursuant to
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`the tadalafil ANDA, throughout the United States and the State of New Jersey.
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`16. On information and belief, Hetero USA Inc., Hetero Labs Limited Unit-III, and
`
`Hetero Labs Limited hold themselves out as a unitary entity for purposes of manufacturing,
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`marketing, selling, and distributing generic products.
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`17. On information and belief, Hetero USA Inc., Hetero Labs Limited Unit-III, and
`
`Hetero Labs Limited work in concert with each other with respect to the regulatory approval,
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`manufacturing, marketing, sale, and distribution of generic pharmaceutical products in the State
`
`of New Jersey and throughout the United States.
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`18. On information and belief, Hetero USA Inc. is the agent of Hetero Labs Limited Unit-
`
`III and Hetero Labs Limited. Upon information and belief, Hetero USA Inc. is acting as the
`
`agent of Hetero Labs Limited Unit-III and Hetero Labs Limited with respect to ANDA No.
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`209908.
`
`19. Hetero USA Inc. is subject to personal jurisdiction in this District due, among other
`
`things, to its substantial, systematic, purposeful, and continuous contact in this District.
`
`20. On information and belief, Hetero USA Inc. has its principal place of business in New
`
`Jersey and has a registered agent for service of process in this Judicial District.
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`21. On information and belief, Hetero USA Inc., directly or through its affiliates Hetero
`
`Labs Limited Unit-III and Hetero Labs Limited, manufactures, markets, imports, and sells
`
`generic drugs for distribution in New Jersey and throughout the United States. On information
`
`and belief, Hetero USA Inc. purposefully has conducted and continues to conduct business,
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`directly or through its affiliates Hetero Labs Limited Unit-III and Hetero Labs Limited, in New
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`Jersey, and this Judicial District is a destination for Hetero USA Inc.’s generic products.
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`22. On information and belief, Hetero USA Inc. has previously consented to personal
`
`jurisdiction in this District. See, e.g., BTG Int’l Ltd. v. Actavis Labs. Fl, Inc. et al., Civ. Action
`
`No. 2:15-cv-5909-KM-JBC (D.N.J.); Otsuka Pharmaceutical Co., Ltd. v. Hetero Drugs Limited
`
`et al., Civ. Action No. 1:15-cv-0161-JBS-KMW (D.N.J.).
`
`23. On information and belief, Hetero USA Inc. has availed itself of the jurisdiction of
`
`this court by initiating litigation in this district. See, e.g., Symed Labs Limited et al. v. Amneal
`
`Pharmaceuticals LLC, Civ. Action No. 2:15-cv-8307-MCA-MAH (D.N.J.).
`
`24. Hetero Labs Limited Unit-III is subject to personal jurisdiction in this District due,
`
`among other things, to its substantial, systematic, purposeful, and continuous contact in this
`
`District. On information and belief, Hetero Labs Limited Unit-III, directly or through its
`
`affiliates Hetero USA Inc. and Hetero Labs Limited, manufactures, markets, imports, and sells
`
`generic drugs for distribution in New Jersey and throughout the United States. On information
`
`and belief, Hetero Labs Limited Unit-III purposefully has conducted and continues to conduct
`
`business, directly or through its affiliates Hetero USA Inc. and Hetero Labs Limited, in New
`
`Jersey, and this Judicial District is a destination for Hetero Labs Limited Unit-III’s generic
`
`products.
`
`25. On information and belief, Hetero Labs Limited Unit-III has previously consented to
`
`personal jurisdiction in this District. See, e.g., Takeda GmbH et al. v. Hetero USA Inc. et al.,
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`Civ. Action No. 3:16-cv-1280-FLW-DEA (D.N.J.); Janssen Products, LP et al. v. Hetero Labs,
`
`Ltd. et al., Civ. Action No. 2:13-cv-01444-WHW-SCM (D.N.J.).
`
`26. Hetero Labs Limited is subject to personal jurisdiction in this District due, among
`
`other things, to its substantial, systematic, purposeful, and continuous contact in this District. On
`
`information and belief, Hetero Labs Limited, directly or through its affiliates Hetero USA Inc.
`
`
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`-5-
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`and Hetero Labs Limited Unit-III, manufactures, markets, imports, and sells generic drugs for
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`distribution in New Jersey and throughout the United States. On information and belief, Hetero
`
`Labs Limited purposefully has conducted and continues to conduct business, directly or through
`
`its affiliates Hetero USA Inc. and Hetero Labs Limited Unit-III, in New Jersey, and this Judicial
`
`District is a destination for Hetero Labs Limited’s generic products.
`
`27. On information and belief, Hetero Labs Limited has previously consented to personal
`
`jurisdiction in this District. See, e.g., Takeda GmbH et al. v. Hetero USA Inc. et al., Civ. Action
`
`No. 3:16-cv-1280-FLW-DEA (D.N.J.); Janssen Products, LP et al. v. Hetero Labs, Ltd. et al.,
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`Civ. Action No. 2:13-cv-01444-WHW-SCM (D.N.J.).
`
`28. Hetero is 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
`
`Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755 (Fed. Cir. 2016).
`
`29. As in Acorda, Hetero “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.
`
`30. Hetero’s “ANDA filings constitute formal acts that reliably indicate plans to engage
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`in marketing of the proposed generic drugs.” Acorda Therapeutics, 817 F.3d at 760.
`
`31. As in Acorda, on information and belief Hetero “intends to direct sales of its drugs
`
`into [New Jersey], among other places, once it has the requested FDA approval to market them.”
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`Acorda Therapeutics, 817 F.3d at 758.
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`32. On information and belief, Hetero will engage in marketing of its proposed tadalafil
`
`ANDA product in New Jersey, upon approval of its tadalafil ANDA.
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`33. Hetero’s ANDA filing, including its Paragraph IV certifications regarding the ’166
`
`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 Hetero.
`
`34. “[T]he minimum-contacts standard is satisfied by the particular actions [Hetero] 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.
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`35. Exercising personal jurisdiction over Hetero in this District would not be
`
`unreasonable given Hetero’s contacts in this District, and the interest in this District of resolving
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`disputes related to products to be sold herein.
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`PATENT-IN-SUIT
`
`36. 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,
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`the ’166 patent was assigned to Lilly ICOS, LLC and it was subsequently assigned to ICOS
`
`which currently holds title.
`
`37. 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®” in 2.5 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
`
`indications for Cialis®.
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`INFRINGEMENT BY DEFENDANT
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`38. Each of the preceding paragraphs 1 to 37 is re-alleged and re-incorporated as if fully
`
`set forth herein.
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`39. In a letter dated February 8, 2017 (“the Notice Letter”), Defendant notified Plaintiffs
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`that Defendant 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, 5 mg, 10
`
`mg, and 20 mg strengths.
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`40. This Complaint is being filed before the expiration of forty-five days from the date
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`Lilly received the Notice Letter.
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`41. The Notice Letter states that Defendant is seeking approval from FDA to engage in
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`the commercial 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, Defendant intends to engage in the
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`commercial manufacture, use, and sale of its generic tadalafil tablets after receiving FDA
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`approval to do so.
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`42. In the Notice Letter, Defendant notified Plaintiffs that its ANDA contained a
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`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 Defendant’s proposed tadalafil
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`ANDA product.
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`43. 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, Defendant does not deny that the commercial manufacture, use, offer to sell, or
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`-8-
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`sale of its proposed tadalafil ANDA product will induce infringement of claims 1-2, 4, 5 and 7-
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`12 of the ’166 patent, if these claims are found valid.
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`44. 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
`
`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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`45. In its Notice Letter, Defendant admits that its proposed tadalafil ANDA product will
`
`be a tablet and that it will contain tadalafil as an active ingredient in 2.5 mg, 5 mg, 10 mg, and 20
`
`mg dosage strengths.
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`46. In its Notice Letter, Defendant does not provide any alleged “factual and legal basis”
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`(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 is indicated
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`for the treatment of male erectile dysfunction (ED).
`
`47. On information and belief, Defendant will market its proposed tadalafil ANDA
`
`product to treat “sexual dysfunction in a patient in need thereof comprising orally administering
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`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®.
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`48. 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.
`
`49. In its Notice Letter, Defendant 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
`
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`-9-
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`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).
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`50. On information and belief, Defendant 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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`51. 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, Defendant
`
`admits that its proposed tadalafil ANDA product will contain tadalafil as an active ingredient in
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`2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths.
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`52. Claim 5 recites “[t]he method of claim 1 wherein the unit dose contains about 5 mg of
`
`the compound. Exhibit A, col. 16, lines 3-4. In its Notice Letter, Defendant admits that its
`
`proposed tadalafil ANDA product will contain tadalafil as an active ingredient in a 5 mg dosage
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`strength, among others.
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`53. 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 liquid, a tablet, a capsule, and a gelcap.” Exhibit A, col. 16, lines
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`8-9. In its Notice Letter, Defendant admits that its proposed tadalafil ANDA product is a tablet
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`product.
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`54. 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, Defendant admits that its
`
`proposed tadalafil ANDA product will contain tadalafil as an active ingredient in a 2.5 mg
`
`dosage strength, among others.
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`55. 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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`56. In its Notice Letter, Defendant does not provide any alleged “factual and legal basis”
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`(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, Defendant will market its proposed tadalafil ANDA product for once
`
`daily use, consistent with the FDA approved label for Cialis®.
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`57. Claim 10 recites “[t]he method of claim 5 wherein the unit dose is administered once
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`per day.” Exhibit A, col. 16, lines 13-14.
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`58. In its Notice Letter, Defendant does not provide any alleged “factual and legal basis”
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`(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, Defendant will market its proposed tadalafil ANDA product for once
`
`daily use, consistent with the FDA approved label for Cialis®.
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`59. 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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`60. In its Notice Letter, Defendant 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, Defendant’s proposed tadalafil ANDA product will
`
`contain tadalafil as a free drug.
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`61. 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, Defendant admits that its proposed tadalafil ANDA
`
`product 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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`62. Each of the preceding paragraphs 1 to 61 is re-alleged and re-incorporated as if fully
`
`set forth herein.
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`63. 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).
`
`64. 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,
`
`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.
`
`65. 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
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`harm for which there is no remedy at law.
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`PRAYER FOR RELIEF
`
`Wherefore, Plaintiffs demand judgment against Defendant and respectfully request that
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`this Court grant the following relief:
`
`A.
`
`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
`
`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
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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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`
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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.
`
`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 importing into 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.
`
`D.
`
`An order that the effective date of any FDA approval of Defendant’s generic
`
`proposed tadalafil ANDA product shall be no earlier than thirty months from the date of the
`
`Notice Letter, in accordance with 21 U.S.C. § 355(j)(5)(B)(iii).
`
`E.
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`Such further and other relief as this Court deems proper and just, including any
`
`appropriate relief under 35 U.S.C. § 285.
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`-13-
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` Respectfully submitted,
`
`
`By: s/John E. Flaherty
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Eli Lilly and Company
`And ICOS Corporation
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`Dated: March 24, 2017
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`Of Counsel:
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`Mark J. Feldstein
`John M. Williamson
`Krista Bianco
`Danielle A. Duszczyszyn
`Glen C. Cheng (NJ Bar No. 031282011)
`Yieyie Yang
`Emily R. Gabranski
`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
`FINNEGAN, HENDERSON,
`FARABOW,
` GARRETT & DUNNER, LLP
`Two Freedom Square
`11955 Freedom Drive
`Reston, Virginia 20190-5675
`Phone: (571) 203-2700
`Fax: (202) 408-4400
`
`Counsel for Plaintiffs Eli Lilly and Company
`and ICOS Corporation
`
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`-14-
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`Case 2:17-cv-01951-KM-MAH Document 1 Filed 03/24/17 Page 15 of 16 PageID: 15
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
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`Pursuant to Local Civil Rule 11.2, I hereby certify that the matter in controversy is
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`related to the subject matter of the following actions that have been consolidated under the lead
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`case Eli Lilly and Company, et al., v. Actavis Laboratories UT, Inc., 1:16-cv-01119-AJT-MSN
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`(E.D. Va.):
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`1. Eli Lilly and Company, et al. v. Watson Laboratories, Inc.,
`Pre-consolidated Docket No. 1:16-cv-1119-AJT-MSN
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`2. Eli Lilly and Company, et al. v. Alembic Pharmaceuticals Ltd. and Alembic
`Pharmaceuticals, Inc., Pre-consolidated Docket No. 1:16-cv-1120-AJT-MSN
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`3. Eli Lilly and Company, et al. v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA,
`Inc., Pre-consolidated Docket No. 1:16-cv-1121-AJT-MSN
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`4. Eli Lilly and Company, et al. v. Mylan Pharmaceuticals Inc.,
`Pre-consolidated Docket No. 1:16-cv-1122-AJT-MSN
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`5. Eli Lilly and Company, et al. v. Sun Pharma Global FZE and Sun Pharmaceutical
`Industries, Ltd., Pre-consolidated Docket No. 1:16-cv-1168-AJT-MSN
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`6. Eli Lilly and Company, et al. v. Teva Pharmaceuticals USA Inc.,
`Pre-consolidated Docket No. 1:16-cv-1169-AJT-MSN
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`7. Eli Lilly and Company, et al. v. Zydus Pharmaceuticals (USA) Inc.,
`Pre-consolidated Docket No. 1:16-cv-1170-AJT-MSN
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`8. Eli Lilly and Company, et al. v. Cipla Limited and Cipla USA, Inc.,
`Pre-consolidated Docket No. 1:16-cv-1208-AJT-MSN
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`9. Eli Lilly and Company, et al. v. Accord Healthcare, Inc.,
`Pre-consolidated Docket No. 1:16-cv-1352-AJT-MSN
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`10. Eli Lilly and Company, et al. v. Ajanta Pharma Ltd. and Ajanta Pharma USA Inc.,
`Pre-consolidated Docket No. 1:17-cv-00020-AJT-MSN
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`-15-
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`Case 2:17-cv-01951-KM-MAH Document 1 Filed 03/24/17 Page 16 of 16 PageID: 16
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` Respectfully submitted,
`
`
`By: s/John E. Flaherty
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Eli Lilly and Company
`And ICOS Corporation
`
`Dated: March 24, 2017
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`
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`
`
`Of Counsel:
`
`Mark J. Feldstein
`John M. Williamson
`Krista Bianco
`Danielle A. Duszczyszyn
`Glen C. Cheng (NJ Bar No. 031282011)
`Yieyie Yang
`Emily R. Gabranski
`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
`FINNEGAN, HENDERSON,
`FARABOW,
` GARRETT & DUNNER, LLP
`Two Freedom Square
`11955 Freedom Drive
`Reston, Virginia 20190-5675
`Phone: (571) 203-2700
`Fax: (202) 408-4400
`
`Counsel for Plaintiffs Eli Lilly and Company
`and ICOS Corporation
`
`
`
`
`-16-
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`