Case 1:19-cv-01246-JMS-MJD Document 1 Filed 03/27/19 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`
`
`ELI LILLY AND COMPANY,
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`
`
`
`Plaintiff,
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`v.
`
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`
`
`Defendants.
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`
`
`
`COMPLAINT
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`Civil Action No. 1:19-cv-1246
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`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, that arises out of the filing by defendant Dr. Reddy’s
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`Laboratories, Inc. on behalf of defendant Dr. Reddy’s Laboratories, Ltd. (collectively, “DRL”) of
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`an amendment to New Drug Application (“NDA”) No. 208297 with the U.S. Food and Drug
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`Administration (“FDA”) seeking approval to manufacture and sell a Pemetrexed for Injection
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`1g/vial product (“DRL’s NDA Product”) prior to the expiration of U.S. Patent No. 7,772,209
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`(“the ’209 patent”). DRL notified Lilly that it had submitted this amendment by letter dated
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`February 11, 2019 (the “Notice Letter”). Upon information and belief, DRL’s NDA Product will
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`be marketed as a competing product to ALIMTA®, a chemotherapy agent developed and
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`distributed by Lilly and used for the treatment of various types of cancer.
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`2.
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`In Eli Lilly and Company v. Dr. Reddy’s Laboratories, Ltd. et al., No. 1:16-cv-
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`308-TWP-MPB (S.D. Ind.), this Court concluded—after a two-day bench trial—that the sale of
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`the 100 mg/vial and 500 mg/vial Pemetrexed for Injection products that are the subject of NDA
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`No. 208297 would indirectly infringe the ’209 patent. Specifically, the Court held that the
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`administration of these products according to the labeling proposed by DRL would infringe
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`certain claims of the ’209 patent under the doctrine of equivalents, and that DRL would induce
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`and contribute to that infringement. Accordingly, the Court entered final judgment in favor of
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`Lilly and against DRL, finding that the “filing of NDA No. 208297 infringed at least claims 9,
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`10, 12, 13, 14, 15, 18, 19, 21, and 22 of U.S. Patent No. 7,772,209” and ordering that “the
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`effective date of any approval of any product that is the subject of NDA No. 208297 shall not be
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`earlier than the latest date of expiration of U.S. Patent No. 7,772,209, including any period of
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`pediatric exclusivity.” No. 1:16-cv-308-TWP-MPB, ECF 259 (S.D. Ind. Jul. 27, 2018).
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`3.
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`Upon information and belief, the only difference between DRL’s NDA Product at
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`issue in this case and the 100 mg/vial and 500 mg/vial Pemetrexed for Injection products found
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`to infringe under the doctrine of equivalents, is the quantity of DRL’s product in each vial. In
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`terms of the method of administration claimed in the ’209 patent, the 1g/vial product that is the
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`subject of this action is identical to the 100 mg/vial and 500 mg/vial Pemetrexed for Injection
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`products already adjudicated. Thus, all of the factual and legal questions at issue in this case
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`have already been litigated between the parties and decided in favor of Lilly, and Lilly is entitled
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`to entry of judgment.
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`PARTIES
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`4.
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`Lilly is a corporation organized and existing under the laws of the State of
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`Indiana, having its corporate offices and place of business at Lilly Corporate Center,
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`Indianapolis, Indiana 46285.
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`5.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. is a corporation
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`2
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`organized and existing under the laws of India, having a place of business at 8-2-337, Road
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`No. 3, Banjara Hills, Hyderabad-500034, Telangana, India.
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`6.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. is a corporation
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`organized and existing under the laws of the State of New Jersey, having a place of business at
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`107 College Road East, Princeton, New Jersey 08540. Upon information and belief, Dr. Reddy’s
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`Laboratories, Inc. is in the business of manufacturing, marketing, and selling generic drug
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`products.
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`7.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. is an indirect wholly-
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`owned subsidiary of Dr. Reddy’s Laboratories, Ltd. Upon information and belief, Dr. Reddy’s
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`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. are agents and/or alter-egos of one another,
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`operate in concert as integrated parts of the same business group, and enter or have entered into
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`agreements with each other that are nearer than arm’s length, including with respect to the
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`manufacture, importation, marketing, sale, and distribution of DRL’s NDA Product.
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`JURISDICTION
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`8.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`2201, and 2202.
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`9.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. is engaged in
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`developing, manufacturing, marketing, selling, and distributing a broad range of generic
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`pharmaceutical products globally. Upon information and belief, a substantial number of these
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`products are marketed throughout the United States, including in the State of Indiana. Upon
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`information and belief, Dr. Reddy’s Laboratories, Ltd. operates its manufacturing, marketing,
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`sales, and distribution infrastructure in the United States through Dr. Reddy’s Laboratories, Inc.
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`as a vertically-integrated company.
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`10.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. performs functions
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`relating to Dr. Reddy’s Laboratories, Ltd., including manufacturing, marketing, and sales.
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`Anjum Swaroom, Esq., who is listed in DRL’s Notice Letter as the Vice President, Intellectual
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`Property of Dr. Reddy’s Laboratories, Inc., is designated as the agent of Dr. Reddy’s
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`Laboratories, Ltd. for service of process with respect to this litigation. Upon information and
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`belief, Dr. Reddy’s Laboratories, Inc. participated with Dr. Reddy’s Laboratories, Ltd. in the
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`preparation, review, and/or submission of NDA No. 208297 and the amendments thereto.
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`11.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. is engaged in the
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`manufacturing, marketing, and sale of generic pharmaceutical products for the United States
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`prescription drug market on behalf of Dr. Reddy’s Laboratories, Ltd. Upon information and
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`belief, Dr. Reddy’s Laboratories, Ltd. provides Dr. Reddy’s Laboratories, Inc. with products for
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`sale in the United States. Upon information and belief, those products are then marketed, sold,
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`and distributed to oncologists, clinics, and hospitals throughout the United States, including in
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`Indiana, as well as to wholesalers, who sell, with Dr. Reddy’s Laboratories, Ltd.’s knowledge,
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`Dr. Reddy’s Laboratories Ltd.’s products, including in Indiana. Upon information and belief,
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`Dr. Reddy’s Laboratories, Inc. and/or its affiliates will distribute DRL’s NDA Product in the
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`United States, including in Indiana, upon approval of NDA No. 208297 and the amendments
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`thereto.
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`12.
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`Upon information and belief, DRL has availed itself of the legal protections of the
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`State of Indiana by filing claims or counterclaims affirmatively seeking relief in other prior
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`actions in this Court, including Eli Lilly and Company v. Dr. Reddy’s Laboratories, Ltd. et al.,
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`1:16-cv-308-TWP-MPB (S.D. Ind.). In that case DRL affirmatively filed a counterclaim, asking
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`this Court to adjudicate the infringement issues with respect to the same NDA No. 208297 that
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`has now been amended. Thus, upon information and belief, DRL has consented to the
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`jurisdiction of this Court with respect to adjudicating the infringement of DRL’s NDA Product.
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`13.
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`Upon information and belief, DRL regularly does business in Indiana and has
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`engaged in a persistent course of conduct within Indiana by continuously and systematically
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`placing goods into the stream of commerce for distribution throughout the United States,
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`including Indiana, and/or by directly selling pharmaceutical products in Indiana.
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`14.
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`Upon information and belief, DRL has sought approval in its amendment to NDA
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`No. 208297 to distribute DRL’s NDA Product in the United States, including in Indiana (and in
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`this District) and will do so upon approval of the amendment to NDA No. 208297. The filing of
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`NDA No. 208297 and the amendments thereto is therefore tightly tied, in purpose and planned
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`effect, to the deliberate making of sales in Indiana and this District, and reliably indicates that
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`DRL plans to engage in the marketing of DRL’s NDA Product in this State and District.
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`15.
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`Upon information and belief, with knowledge of the processes described in the
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`Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(b) and the Drug Price Competition
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`and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j) (the “Hatch Waxman Act”), DRL
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`directed its Notice Letter to Lilly, an entity incorporated in Indiana, at its corporate headquarters
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`in Indiana, and alleged in the Notice Letter the invalidity, unenforceability, and/or non-
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`infringement of Lilly’s ’209 patent. Upon information and belief, DRL deliberately challenged
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`Lilly’s patent rights, and knew when it did so that it was triggering a forty-five-day period for
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`Lilly to bring an action for patent infringement under the FDCA. Moreover, upon information
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`and belief, DRL knew that other FDCA and/or Hatch-Waxman Act infringement actions relating
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`to the ’209 patent had been brought and litigated in Indiana, including the prior infringement
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`action against DRL with respect to the same NDA.
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`16.
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`Because Lilly is incorporated and has its principal place of business in Indiana,
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`the injury and consequences of DRL’s filing of NDA No. 208297 and the amendments thereto,
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`challenging Lilly’s patent rights, are suffered in Indiana. Upon information and belief, DRL
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`knew that it was deliberately challenging the patent rights of an Indiana entity and seeking to
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`challenge intellectual property held in Indiana and that the effects of any successful challenge of
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`the ’209 patent would be felt by Lilly in Indiana.
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`17.
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`Upon information and belief, if the amendment to NDA No. 208297 is approved,
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`DRL will directly or indirectly market and/or sell DRL’s NDA Product within the United States,
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`including in Indiana, consistent with DRL’s practices for the marketing and distribution of other
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`pharmaceutical products on its own or through its affiliates. Upon information and belief, DRL
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`and/or its affiliates regularly do business in Indiana, and their practices with other
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`pharmaceutical products have involved the distribution of DRL products, directly or indirectly,
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`throughout the United States, including in Indiana. Upon information and belief, DRL’s
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`pharmaceutical products are used and/or consumed within and throughout the United States,
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`including Indiana.
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`18.
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`Upon information and belief, DRL and its affiliates derive substantial revenue
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`from pharmaceutical products that are used and/or consumed within Indiana, and which are
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`manufactured by DRL or its affiliates and/or for which DRL is the named applicant on approved
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`NDAs or Abbreviated New Drug Applications (“ANDAs”). Upon information and belief,
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`various products for which DRL, or its affiliates, is the named applicant on approved NDAs and
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`ANDAs are available at pharmacies in Indiana.
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`19.
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`Upon information and belief, if NDA No. 208297 is approved, DRL’s NDA
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`Product, under the direction and control of physicians practicing in Indiana, will be administered
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`to patients of Indiana. These activities, as well as DRL’s marketing, selling, and/or distributing
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`of DRL’s NDA Product, would have a substantial effect within Indiana and would constitute
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`infringement of Lilly’s patent in the event that DRL’s NDA Product is approved before the ’209
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`patent expires.
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`20.
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`For the reasons described above, among others, the filing of the amendment to
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`NDA No. 208297 was suit-related conduct with a substantial connection to Indiana and this
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`District, the exercise of personal jurisdiction over DRL does not offend traditional notions of fair
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`play and substantial justice, and this Court may properly exercise personal jurisdiction over Dr.
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`Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
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`21.
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`Alternatively, if the exercise of personal jurisdiction over Dr. Reddy’s
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`Laboratories Ltd. in this Court is not held to be proper, then, upon information and belief, Dr.
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`Reddy’s Laboratories, Ltd. is not subject to jurisdiction in any state’s courts of general
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`jurisdiction, and there is therefore personal jurisdiction over Dr. Reddy’s Laboratories, Ltd. in
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`this Court pursuant to Fed. R. Civ. P. 4(k)(2).
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`BACKGROUND
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`22.
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`ALIMTA® is indicated (in combination with cisplatin) (a) for the treatment of
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`patients with malignant pleural mesothelioma, or (b) for the initial treatment of locally advanced
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`or metastatic non-squamous non-small cell lung cancer (“NSCLC”). ALIMTA® is also indicated
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`as a single-agent for the treatment of patients with locally advanced or metastatic non-squamous
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`NSCLC after prior chemotherapy. ALIMTA® is also indicated for maintenance treatment of
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`patients with locally advanced or metastatic non-squamous NSCLC whose disease has not
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`progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA® is also
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`approved for the initial treatment of patients with metastatic non-squamous NSCLC, with no
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`EGFR or ALK genomic tumor aberrations in combination with pembrolizumab and platinum
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`chemotherapy.
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`23.
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`Lilly sells ALIMTA® in the United States pursuant to an NDA that has been
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`approved by the FDA.
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`24.
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`The ’209 patent, titled “Antifolate Combination Therapies,” was duly and legally
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`issued on August 10, 2010. The validity of the ’209 patent was upheld by the Federal Circuit in
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`Eli Lilly and Company v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017). The
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`’209 patent is attached as Exhibit A hereto.
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`25.
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`Lilly is the assignee of the ’209 patent.
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`26.
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`An actual case or controversy exists between Lilly and DRL with respect to
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`infringement of the ’209 patent.
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`27.
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`Lilly received DRL’s Notice Letter on February 12, 2019. This action is being
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`filed within 45 days of Lilly’s receipt of DRL’s Notice Letter.
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`28.
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`Both the ’209 patent and NDA No. 208297 were previously the subject of
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`litigation between Lilly and DRL. DRL notified Lilly that it had filed NDA No. 208297 by letter
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`dated December 22, 2015, and Lilly filed suit against DRL on February 5, 2016, alleging that the
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`filing of DRL’s NDA infringed the ’209 patent. See No. 1:16-cv-308-TWP-MPB, ECF 1 (S.D.
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`Ind. Feb. 5, 2016). DRL could have challenged the validity of the ’209 patent as a counterclaim
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`or affirmative defense to Lilly’s claim of patent infringement, but did not do so. See No. 1:16-
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`cv-308-TWP-MPB, ECF 17 (S.D. Ind. Mar. 7, 2016). DRL is thus barred by the doctrines of res
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`judicata and/or collateral estoppel from challenging the validity of any claim of the ’209 patent
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`that was adjudicated in the prior litigation. After a two-day bench trial, this Court found that by
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`filing NDA No. 208297, DRL indirectly infringed certain claims of the ’209 patent and entered
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`8
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`final judgment in favor of Lilly on July 27, 2018. Under the doctrines of res judicata and/or
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`collateral estoppel, DRL is further barred from contesting infringement under any theory that
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`was adjudicated in the prior litigation between Lilly and DRL involving NDA No. 208297 and
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`the ’209 patent.
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`COUNT I
`(Infringement of U.S. Patent No. 7,772,209)
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`29.
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`Lilly incorporates each of the preceding paragraphs as if fully set forth herein.
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`30.
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`Upon information and belief, the administration of DRL’s NDA Product, which
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`contains pemetrexed ditromethamine, is equivalent to the administration of pemetrexed
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`disodium.
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`31.
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`As this Court has found, pemetrexed ditromethamine and pemetrexed disodium
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`both dissociate in the aqueous solutions that are to be infused into patients, and consequently
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`patients receiving DRL’s NDA Product will receive exactly the same active pemetrexed moiety
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`as those receiving pemetrexed disodium. Thus, administering DRL’s NDA Product and
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`administering pemetrexed disodium are insubstantially different from one another.
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`32.
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`Upon information and belief, the proposed labeling for DRL’s NDA Product
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`involves administration of folic acid and vitamins B12.
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`33.
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`Upon information and belief, the use of DRL’s NDA Product in accordance with
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`and as directed by DRL’s proposed labeling for that product will infringe claims 1–22 of the
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`’209 patent under the doctrine of equivalents.
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`34.
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`In addition, upon information and belief, the administration of DRL’s NDA
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`Product will at least under certain circumstances be performed together with the administration
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`of saline solution, thus constituting administration of pemetrexed disodium, and in consequence,
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`the administration of DRL’s NDA Product as directed by DRL’s proposed labeling will literally
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`infringe claims 1–22 of the ’209 patent.
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`35.
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`Upon information and belief, DRL filed as part of its amendment to NDA
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`No. 208297 a certification of the type described in Section 505(b)(2)(A)(iv) of the FDCA, 21
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`U.S.C. § 355(b)(2)(A)(iv), asserting that the claims of the ’209 patent are invalid, unenforceable,
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`and/or not infringed by the manufacture, use, offer for sale, or sale of DRL’s NDA Product.
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`36.
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`The purpose of filing the amendment to NDA No. 208297 was to obtain approval
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`under the FDCA to engage in the commercial manufacture, use, offer for sale, and/or sale of
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`DRL’s NDA Product prior to the expiration of the ’209 patent.
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`37.
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`DRL’s submission of the amendment to NDA No. 208297 for the purpose of
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`obtaining approval to engage in the commercial manufacture, use, offer for sale, and/or sale of
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`DRL’s NDA Product prior to the expiration of the ’209 patent is an act of infringement of the
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`’209 patent under 35 U.S.C. § 271(e)(2)(A).
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`38.
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`Upon information and belief, DRL intends to engage in the manufacture, use,
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`offer for sale, sale, marketing, distribution, and/or importation of DRL’s NDA Product and the
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`proposed labeling therefor immediately and imminently upon the approval of NDA No. 208297
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`and any amendments thereto, i.e., prior to the expiration of the ’209 patent.
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`39.
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`Upon information and belief, DRL has knowledge of the claims of the ’209
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`patent. Notwithstanding this knowledge, DRL continues to assert its intent to engage in the
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`manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of DRL’s NDA
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`Product and the proposed labeling therefor immediately and imminently upon the approval of
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`NDA No. 208297 and any amendments thereto.
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`40.
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`Upon information and belief, DRL plans and intends to, and will, actively induce
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`infringement of the ’209 patent when NDA No. 208297 and any amendments thereto are
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`approved, and plans and intends to, and will, do so immediately and imminently upon approval.
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`41.
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`Upon information and belief, DRL knows that DRL’s NDA Product is especially
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`made or adapted for use in infringing the ’209 patent, and that DRL’s NDA Product is not
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`suitable for substantial noninfringing use. Upon information and belief, DRL plans and intends
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`to, and will, contribute to infringement of the ’209 patent immediately and imminently upon
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`approval of NDA No. 208297 and any amendments thereto.
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`42.
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`The foregoing actions by DRL constitute and/or will constitute infringement of
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`the ’209 patent, active inducement of infringement of the ’209 patent, and contribution to the
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`infringement by others of the ’209 patent.
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`43.
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`Unless DRL is enjoined from infringing the ’209 patent, actively inducing
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`infringement of the ’209 patent, and contributing to the infringement by others of the ’209
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`patent, Lilly will suffer irreparable injury. Lilly has no adequate remedy at law.
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`
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`WHEREFORE, Lilly requests the following relief:
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`(a)
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`A judgment that DRL has infringed the ’209 patent and/or will infringe, actively
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`induce infringement of, and/or contribute to infringement by others of the ’209 patent;
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`(b)
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`A judgment ordering that the effective date of any FDA approval for DRL to
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`make, use, offer for sale, sell, market, distribute, or import DRL’s NDA Product, or any product
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`the use of which infringes the ’209 patent, be not earlier than the expiration date of the ’209
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`patent, inclusive of any extension(s) and additional period(s) of exclusivity;
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`(c)
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`A preliminary and permanent injunction enjoining DRL, and all persons acting in
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`concert with DRL, from making, using, selling, offering for sale, marketing, distributing, or
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`importing DRL’s NDA Product, or any product the use of which infringes the ’209 patent, or
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`inducing or contributing to any of the foregoing, prior to the expiration date of the ’209 patent,
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`inclusive of any extension(s) and additional period(s) of exclusivity;
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`(d)
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`A judgment declaring that making, using, selling, offering for sale, marketing,
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`distributing, or importing of DRL’s NDA Product, or any product the use of which infringes the
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`’209 patent, prior to the expiration date of the ’209 patent, infringes, will infringe, will actively
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`induce infringement of, and/or will contribute to the infringement by others of the ’209 patent;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’ fees
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`pursuant to 35 U.S.C. § 285;
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`(f)
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`An award of Lilly’s costs and expenses in this action; and
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`(g)
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`Such further and other relief as this Court may deem just and proper.
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`12
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`Case 1:19-cv-01246-JMS-MJD Document 1 Filed 03/27/19 Page 13 of 13 PageID #: 13
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`Dated: March 27, 2019
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`Respectfully submitted,
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`
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`
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`
`
`/s/Deborah Pollack-Milgate
`Deborah Pollack-Milgate, No. 22475-49
`BARNES & THORNBURG LLP
`11 South Meridian Street
`Indianapolis, IN 46204
`(317) 236-1313
`dpollackmilgate@btlaw.com
`
`Adam L. Perlman
`Dov P. Grossman
`David M. Krinsky
`Galina I. Fomenkova
`Andrew P. Lemens
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`aperlman@wc.com
`dgrossman@wc.com
`dkrinsky@wc.com
`gfomenkova@wc.com
`alemens@wc.com
`
`Attorneys for Plaintiff Eli Lilly and Company
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`13
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