`
`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.
`
`DR. REDDY’S LABORATORIES, INC. and DR.
`REDDY’S LABORATORIES, LTD.
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`CIVIL ACTION NO.
`
`COMPLAINT
`
`Plaintiffs Eli Lilly and Company (“Lilly”) and ICOS Corporation (“ICOS”) (collectively
`
`“Plaintiffs”) file this Complaint for patent infringement against Defendants Dr. Reddy’s
`
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively “DRL” 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 DRL. This action relates to Abbreviated New Drug
`
`Application No. 210069 (“tadalafil ANDA”) submitted by DRL to the U.S. Food and Drug
`
` DRL - EXHIBIT 1030
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 2 of 15 PageID: 2
`
`
`
`
`
`Administration (“FDA”) for approval to market a generic version of Lilly’s Cialis® (tadalafil)
`
`tablets (“proposed tadalafil ANDA product”) prior to the expiration of the ’166 patent. DRL’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
`
`DRL’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).
`
`THE PARTIES
`
`2. Lilly is an Indiana Corporation that has its corporate offices and principal place of
`
`business at Lilly Corporate Center, Indianapolis, Indiana 46285. Lilly is engaged in the business
`
`of research, development, manufacture, and sale of pharmaceutical products throughout the
`
`world.
`
`3. ICOS is a Delaware corporation having its corporate office at Lilly Corporate Center,
`
`Indianapolis, Indiana 46825. ICOS is a wholly owned subsidiary of Lilly.
`
`4. Upon information and belief, Dr. Reddy’s Laboratories, Inc. is a corporation
`
`organized under the laws of the State of New Jersey and has its principal place of business at 107
`
`College Road East, Princeton, New Jersey 08540.
`
`5. Upon information and belief, Dr. Reddy’s Laboratories, 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 Dr. Reddy’s Laboratories, Ltd.
`
`6. Upon information and belief, Dr. Reddy’s Laboratories, Inc. is a subsidiary of Dr.
`
`Reddy’s Laboratories, Ltd.
`
`
`
`-2-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 3 of 15 PageID: 3
`
`
`
`
`
`7. Upon information and belief, Dr. Reddy’s Laboratories, Ltd. is an India corporation
`
`and has its principal place of business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500
`
`034, India.
`
`8. Upon information and belief, Dr. Reddy’s Laboratories, Ltd. 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 Dr. Reddy’s Laboratories, Inc.
`
`JURISDICTION AND VENUE
`
`9. Each of the preceding paragraphs 1 to 8 is re-alleged and re-incorporated as if fully
`
`set forth herein.
`
`10. 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. §§
`
`1331, 1338(a), 2201, and 2202.
`
`11. Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
`
`12. On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. collaborate to develop, manufacture, import, market, and distribute, and/or sell
`
`pharmaceutical products, including generic drug products manufactured and sold pursuant to the
`
`tadalafil ANDA, throughout the United States and the State of New Jersey.
`
`13. On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. hold themselves out as a unitary entity for purposes of manufacturing,
`
`marketing, selling, and distributing generic products.
`
`14. On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. work in concert with each other with respect to the regulatory approval,
`
`
`
`-3-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 4 of 15 PageID: 4
`
`
`
`
`
`manufacturing, marketing, sale, and distribution of generic pharmaceutical products in the State
`
`of New Jersey and throughout the United States.
`
`15. On information and belief, Dr. Reddy’s Laboratories, Inc. is the agent of Dr. Reddy’s
`
`Laboratories, Ltd. Upon information and belief, Dr. Reddy’s Laboratories, Inc. is acting as the
`
`agent of Dr. Reddy’s Laboratories, Ltd. with respect to ANDA No. 210069.
`
`16. Dr. Reddy’s Laboratories, Inc. is subject to personal jurisdiction in this District due,
`
`among other things, to its substantial, systematic, purposeful, and continuous contact in this
`
`District.
`
`17. On information and belief, Dr. Reddy’s Laboratories, Inc. has its principal place of
`
`business in New Jersey and has a registered agent for service of process in this Judicial District.
`
`18. On information and belief, Dr. Reddy’s Laboratories, Inc., directly or through its
`
`affiliate Dr. Reddy’s Laboratories, Ltd., manufactures, markets, imports, and sells generic drugs
`
`for distribution in New Jersey and throughout the United States. On information and belief, Dr.
`
`Reddy’s Laboratories, Inc. purposefully has conducted and continues to conduct business,
`
`directly or through its affiliate Dr. Reddy’s Laboratories, Ltd., in New Jersey, and this Judicial
`
`District is a destination for Dr. Reddy’s Laboratories, Inc.’s generic products.
`
`19. On information and belief, Dr. Reddy’s Laboratories, Inc. has previously consented to
`
`personal jurisdiction in this District. See, e.g., AstraZeneca AB et al. v. v. Dr. Reddy’s
`
`Laboratories, Ltd. et al., Civ. Action No. 3:15-cv-8267-MLC-TJB (D.N.J.); Helsinn Healthcare
`
`SA, et al. v. Dr. Reddy’s Laboratories, Ltd. et al., Civ. Action No. 3:15-cv-8662-MLC-DEA
`
`(D.N.J.).
`
`20. On information and belief, Dr. Reddy’s Laboratories, Inc. has availed itself of the
`
`jurisdiction of this court by initiating litigation in this district. See, e.g., Dr. Reddy’s
`
`
`
`-4-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 5 of 15 PageID: 5
`
`
`
`
`
`Laboratories, Inc. et al. v. Purdue Pharmaceutical Products LP et al., Civ. Action No. 2:14-cv-
`
`3230-JLL-JAD (D.N.J.).
`
`21. Dr. Reddy’s Laboratories, Ltd. 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, Dr. Reddy’s Laboratories, Ltd., directly or through its agent
`
`Dr. Reddy’s Laboratories, Inc., manufactures, markets, imports, and sells generic drugs for
`
`distribution in New Jersey and throughout the United States. On information and belief, Dr.
`
`Reddy’s Laboratories, Ltd. purposefully has conducted and continues to conduct business,
`
`directly or through its agent Dr. Reddy’s Laboratories, Inc., in New Jersey, and this Judicial
`
`District is a destination for Dr. Reddy’s Laboratories, Ltd.’s generic products.
`
`22. On information and belief, Dr. Reddy’s Laboratories, Ltd. has previously consented
`
`to personal jurisdiction in this District. See, e.g., AstraZeneca AB et al. v. v. Dr. Reddy’s
`
`Laboratories, Ltd. et al., Civ. Action No. 3:15-cv-8267-MLC-TJB (D.N.J.); Helsinn Healthcare
`
`SA, et al. v. Dr. Reddy’s Laboratories, Ltd. et al., Civ. Action No. 3:15-cv-8662-MLC-DEA
`
`(D.N.J.).
`
`23. On information and belief, Dr. Reddy’s Laboratories, Ltd. has availed itself of the
`
`jurisdiction of this court by initiating litigation in this district. See, e.g., Dr. Reddy’s
`
`Laboratories, Inc. et al. v. Purdue Pharmaceutical Products LP et al., Civ. Action No. 2:14-cv-
`
`3230-JLL-JAD (D.N.J.).
`
`24. DRL is subject to specific jurisdiction in this District based on the filing of its
`
`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).
`
`
`
`-5-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 6 of 15 PageID: 6
`
`
`
`
`
`25. As in Acorda, DRL “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 will
`
`be purposefully directed at,” on information and belief, this District and elsewhere. Acorda
`
`Therapeutics, 817 F.3d at 759.
`
`26. DRL’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.
`
`27. As in Acorda, on information and belief DRL “intends to direct sales of its drugs into
`
`[New Jersey], among other places, once it has the requested FDA approval to market them.”
`
`Acorda Therapeutics, 817 F.3d at 758.
`
`28. On information and belief, DRL will engage in marketing of its proposed tadalafil
`
`ANDA product in New Jersey, upon approval of its tadalafil ANDA.
`
`29. DRL’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
`
`reliably, non-speculatively predicts activities in this District by DRL.
`
`30. “[T]he minimum-contacts standard is satisfied by the particular actions [DRL] has
`
`already taken—its ANDA filing[]—for the purpose of engaging in that injury-causing and
`
`allegedly wrongful marketing conduct in” this District. Acorda Therapeutics, 817 F.3d at 760.
`
`31. Exercising personal jurisdiction over DRL in this District would not be unreasonable
`
`given DRL’s contacts in this District, and the interest in this District of resolving disputes related
`
`to products to be sold herein.
`
`PATENT-IN-SUIT
`
`32. 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
`
`
`
`-6-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 7 of 15 PageID: 7
`
`
`
`
`
`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.
`
`33. Lilly is the holder of NDA No. 021368 by which FDA granted approval for the
`
`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®.
`
`INFRINGEMENT BY DEFENDANT
`
`34. Each of the preceding paragraphs 1 to 33 is re-alleged and re-incorporated as if fully
`
`set forth herein.
`
`35. In a letter dated February 28, 2017 (“the Notice Letter”), DRL notified ICOS and
`
`Lilly that DRL 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, 5 mg, 10
`
`mg, and 20 mg strengths.
`
`36. This Complaint is being filed before the expiration of forty-five days from the date
`
`Lilly received the Notice Letter.
`
`37. The Notice Letter states that DRL is seeking approval from FDA to engage in the
`
`commercial manufacture, use, and sale of its proposed tadalafil ANDA product before the
`
`
`
`-7-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 8 of 15 PageID: 8
`
`
`
`
`
`expiration of the ’166 patent. On information and belief, DRL intends to engage in the
`
`commercial manufacture, use, and sale of its generic tadalafil tablets after receiving FDA
`
`approval to do so.
`
`38. In the Notice Letter, DRL 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 commercial manufacture, use, and sale of DRL’s proposed tadalafil ANDA product.
`
`39. 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
`
`Notice Letter, DRL does not deny that the commercial manufacture, use, offer to sell, or sale of
`
`its proposed tadalafil ANDA product will induce infringement of claims 1-2, 4-12, if these
`
`claims are found valid.
`
`40. 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
`
`to about 20 mg, up to a maximum total dose of 20 mg per day, of a compound having the
`
`structure [that is tadalafil].” Exhibit A, cols. 14-15, line 65-line 15.
`
`41. In its Notice Letter, DRL admits that its proposed tadalafil ANDA product will be a
`
`tablet for oral administration and that it will contain tadalafil as an active ingredient in 2.5 mg, 5
`
`mg, 10 mg, and 20 mg dosage strengths.
`
`42. In its Notice Letter, DRL 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
`
`
`
`-8-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 9 of 15 PageID: 9
`
`
`
`
`
`[tadalafil],” consistent with the FDA approved label for Cialis® which states that it is indicated
`
`for the treatment of male erectile dysfunction (ED).
`
`43. On information and belief, DRL 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®.
`
`44. 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. In its Notice Letter,
`
`DRL admits that its proposed tadalafil ANDA product will be marketed to treat erectile
`
`dysfunction.
`
`45. 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, DRL
`
`admits that its proposed tadalafil ANDA product will contain tadalafil as an active ingredient in
`
`2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths.
`
`46. 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, DRL admits that its proposed
`
`tadalafil ANDA product will contain tadalafil as an active ingredient in a 5 mg dosage strength,
`
`among others.
`
`47. Claim 7 recites “[t]he method of claim 1 wherein the unit dose is in a form selected
`
`from the group consisting of a liquid, a tablet, a capsule, and a gelcap.” Exhibit A, col. 16, lines
`
`8-9. In its Notice Letter, DRL admits that its proposed tadalafil ANDA product is a tablet
`
`product.
`
`
`
`-9-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 10 of 15 PageID: 10
`
`
`
`
`
`48. 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, DRL admits that its
`
`proposed tadalafil ANDA product will contain tadalafil as an active ingredient in a 2.5 mg
`
`dosage strength, among others.
`
`49. 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.
`
`50. In its Notice Letter, DRL 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, DRL will market its proposed tadalafil ANDA product for once daily use,
`
`consistent with the FDA approved label for Cialis®.
`
`51. Claim 10 recites “[t]he method of claim 5 wherein the unit dose is administered once
`
`per day.” Exhibit A, col. 16, lines 13-14.
`
`52. In its Notice Letter, DRL 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, DRL will market its proposed tadalafil ANDA product for once daily use,
`
`consistent with the FDA approved label for Cialis®.
`
`53. Claim 11 recites “[t]he method of claim 1 wherein the compound is administered as a
`
`free drug.” Exhibit A, col 16, 15-16.
`
`54. In its Notice Letter, DRL 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
`
`
`
`-10-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 11 of 15 PageID: 11
`
`
`
`
`
`free drug.” On information and belief, DRL’s proposed tadalafil ANDA product will contain
`
`tadalafil as a free drug.
`
`55. Claim 12 recites “[t]he method of claim 1 wherein the unit dose contains about 20 mg
`
`of the compound.” In its Notice Letter, DRL 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)
`
`56. Each of the preceding paragraphs 1 to 55 is re-alleged and re-incorporated as if fully
`
`set forth herein.
`
`57. 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).
`
`58. 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.
`
`59. 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:
`
`
`
`-11-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 12 of 15 PageID: 12
`
`
`
`
`
`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 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.
`
`Such further and other relief as this Court deems proper and just, including any
`
`appropriate relief under 35 U.S.C. § 285.
`
`
`
`
`
`
`
`-12-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 13 of 15 PageID: 13
`
`
`
`
`
` 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: April 13, 2017
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`-13-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 14 of 15 PageID: 14
`
`
`
`
`
`
`
`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`Pursuant to Local Civil Rule 11.2, I hereby certify that the matter in controversy is
`
`related to the subject matter in Eli Lilly and Company, et al. v. Hetero USA Inc., et al., Civil
`
`Action No. 2:17-cv-01951-KM-MAH (D.N.J.), and in the following actions that have been
`
`consolidated under the lead case Eli Lilly and Company, et al., v. Actavis Laboratories UT, Inc.,
`
`1:16-cv-01119-AJT-MSN (E.D. Va.):
`
`1. Eli Lilly and Company, et al. v. Watson Laboratories, Inc.,
`Pre-consolidated Docket No. 1:16-cv-1119-AJT-MSN
`
`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
`
`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
`
`4. Eli Lilly and Company, et al. v. Mylan Pharmaceuticals Inc.,
`Pre-consolidated Docket No. 1:16-cv-1122-AJT-MSN
`
`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
`
`6. Eli Lilly and Company, et al. v. Teva Pharmaceuticals USA Inc.,
`Pre-consolidated Docket No. 1:16-cv-1169-AJT-MSN
`
`7. Eli Lilly and Company, et al. v. Zydus Pharmaceuticals (USA) Inc.,
`Pre-consolidated Docket No. 1:16-cv-1170-AJT-MSN
`
`8. Eli Lilly and Company, et al. v. Cipla Limited and Cipla USA, Inc.,
`Pre-consolidated Docket No. 1:16-cv-1208-AJT-MSN
`
`9. Eli Lilly and Company, et al. v. Accord Healthcare, Inc.,
`Pre-consolidated Docket No. 1:16-cv-1352-AJT-MSN
`
`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
`
`
`
`
`-14-
`
`
`
`Case 2:17-cv-02541-KM-MAH Document 1 Filed 04/13/17 Page 15 of 15 PageID: 15
`
`
`
`
`
` 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: April 13, 2017
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`-15-
`
`