Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
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`Civil Action No. 1:16-cv-308
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`ELI LILLY AND COMPANY,
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`v.
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`Plaintiff,
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`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
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`Defendants.
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`COMPLAINT
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`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as
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`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
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`United 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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`a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”)
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`seeking approval to manufacture and sell its Pemetrexed for Injection 100 mg/vial and 500
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`mg/vial products (“DRL’s NDA Products”) 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 to the FDA NDA No. 208297 for
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`DRL’s NDA Products by letter dated December 22, 2015 (“DRL’s Notice Letter” or “Notice
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`Letter”). Upon information and belief, DRL’s NDA Products will be marketed as competing
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`products to ALIMTA®, a chemotherapy agent developed and distributed by Lilly and used for
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`the treatment of various types of cancer.
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`Civil Action No. 1:16-cv-308
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`ELI LILLY AND COMPANY,
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`v.
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`Plaintiff,
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`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
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`Defendants.
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`COMPLAINT
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`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as
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`follows:
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`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the
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`United 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
`
`a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”)
`
`seeking approval to manufacture and sell its Pemetrexed for Injection 100 mg/vial and 500
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`mg/vial products (“DRL’s NDA Products”) prior to the expiration of U.S. Patent No. 7,772,209
`
`(“the ’209 patent”). DRL notified Lilly that it had submitted to the FDA NDA No. 208297 for
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`DRL’s NDA Products by letter dated December 22, 2015 (“DRL’s Notice Letter” or “Notice
`
`Letter”). Upon information and belief, DRL’s NDA Products will be marketed as competing
`
`products to ALIMTA®, a chemotherapy agent developed and distributed by Lilly and used for
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`the treatment of various types of cancer.
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`
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 2 of 10 PageID #: 2
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`PARTIES
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`2.
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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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`3.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. is a
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`corporation organized and existing under the laws of India, having a place of business at 8-2-
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`337, Road No. 3, Banjara Hills, Hyderabad, India 500034.
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`4.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. is a
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`corporation organized and existing under the laws of the State of New Jersey, having a place of
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`business at 107 College Road East, Princeton, New Jersey 08540. Upon information and belief,
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`Dr. Reddy’s Laboratories, Inc. is in the business of manufacturing, marketing, and selling
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`generic drug products.
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`5.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. is a 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 Products.
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`JURISDICTION AND VENUE
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`6.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331,
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`1338(a), 2201, and 2202.
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`7.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`2
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 3 of 10 PageID #: 3
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`8.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. is a generic
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`pharmaceutical company in India engaged in developing, manufacturing, marketing, selling, and
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`distributing a broad range of pharmaceutical products globally. Upon information and belief, a
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`substantial number of these products are marketed throughout the United States, including in the
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`State of Indiana. Upon information and belief, Dr. Reddy’s Laboratories, Ltd. operates its
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`manufacturing, marketing, sales, and distribution infrastructure in the United States through Dr.
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`Reddy’s Laboratories, Inc. as a vertically-integrated company.
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`9.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. performs
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`functions relating to Dr. Reddy’s Laboratories, Ltd., including manufacturing, marketing, and
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`sales. Lee Banks, 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.
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`10.
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`Upon information and belief, Dr. Reddy’s Laboratories, Inc. is engaged in
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`the manufacturing, marketing, and sale of generic pharmaceutical products for the U.S.
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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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`3
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 4 of 10 PageID #: 4
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`Dr. Reddy’s Laboratories, Inc. or its affiliates will distribute DRL’s NDA Products in the United
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`States, including in Indiana, upon approval of NDA No. 208297.
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`11.
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`Upon information and belief, DRL has previously used the process
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`contemplated by the Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 355(b) and the
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`Drug Price Competition Term Restoration Act of 1984, 21. U.S.C. § 355(j) (the “Hatch-Waxman
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`Act”), to challenge branded pharmaceutical companies’ patents by filing a certification of the
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`type described in Section 505(b)(2)(A)(iv) or 505(j)(2)(A)(vii)(IV), serving a notice letter on
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`those companies, and engaging in patent litigation arising from the processes contemplated by
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`those acts. Upon information and belief, as of March 31, 2015, DRL had cumulative filings of
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`735 Drug Master Files and 220 Abbreviated New Drug Applications (“ANDAs”), of which 68
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`were pending approval.
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`12.
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`Upon information and belief, DRL has availed itself of the legal
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`protections of the state of Indiana by filing claims or counterclaims affirmatively seeking relief
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`in other prior actions in this Court.
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`13.
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`Upon information and belief, with knowledge of the processes described
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`in the FDCA and the Hatch-Waxman Act, DRL directed its Notice Letter to Lilly, an entity
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`incorporated in Indiana, at its corporate headquarters in Indiana, and alleged in the Notice Letter
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`the invalidity, unenforceability, and/or non-infringement of Lilly’s ’209 patent. Upon
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`information and belief, DRL deliberately challenged Lilly’s patent rights, and knew when it did
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`so that it was triggering a forty-five-day period for Lilly to bring an action for patent
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`infringement under the FDCA. Moreover, upon information and belief, DRL knew that other
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`FDCA and/or Hatch-Waxman Act infringement actions relating to the ’209 patent had been
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`brought and litigated in Indiana.
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`4
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 5 of 10 PageID #: 5
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`14.
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`Because Lilly is incorporated and has its principal place of business in
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`Indiana, the injury and consequences of DRL’s filing of NDA No. 208297, challenging Lilly’s
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`patent rights, are suffered in Indiana. Upon information and belief, DRL knew that it was
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`deliberately challenging the patent rights of an Indiana entity and seeking to challenge
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`intellectual property held in Indiana and that the effects of any successful challenge of the ’209
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`patent would be felt by Lilly in Indiana.
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`15.
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`Upon information and belief, if NDA No. 208297 is approved, DRL will
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`directly or indirectly market and/or sell DRL’s NDA Products within the United States, including
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`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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`16.
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`Upon information and belief, DRL and its affiliates derive substantial
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`revenue from pharmaceutical products that are used and/or consumed within Indiana, and which
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`are manufactured by DRL or its affiliates and/or for which DRL is the named applicant on
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`approved NDAs or ANDAs. Upon information and belief, various products for which DRL, or
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`its affiliates, is the named applicant on approved NDAs and ANDAs are available at pharmacies
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`in Indiana.
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`17.
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`Upon information and belief, if NDA No. 208297 is approved, DRL’s
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`NDA Products, under the direction and control of physicians practicing in Indiana, will be
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`5
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 6 of 10 PageID #: 6
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`administered to patients of Indiana. These activities, as well as DRL’s marketing, selling, and/or
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`distributing of DRL’s NDA Products, would have a substantial effect within Indiana and would
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`constitute infringement of Lilly’s patent in the event that DRL’s NDA Products are approved
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`before the ’209 patent expires.
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`18.
`
`For the reasons described above, among others, this Court may properly
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`exercise personal jurisdiction over Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
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`Inc.
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`19.
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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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`20.
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`ALIMTA® is indicated (in combination with cisplatin) (a) for the
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`treatment of patients with malignant pleural mesothelioma, or (b) for the initial treatment of
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`locally advanced or metastatic nonsquamous non-small cell lung cancer. ALIMTA® also is
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`indicated as a single-agent for the treatment of patients with locally advanced or metastatic
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`nonsquamous non-small cell lung cancer after prior chemotherapy. ALIMTA® also is indicated
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`for maintenance treatment of patients with locally advanced or metastatic nonsquamous non-
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`small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-
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`line chemotherapy.
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`21.
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`Lilly sells ALIMTA® in the United States pursuant to a New Drug
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`Application that has been approved by the FDA.
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`6
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 7 of 10 PageID #: 7
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`22.
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`The ’209 patent, titled “Antifolate Combination Therapies,” was duly and
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`legally issued on August 10, 2010. The ’209 patent is attached as Exhibit A.
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`23.
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`24.
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`Lilly is the assignee of the ’209 patent.
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`An actual case or controversy exists between Lilly and DRL with respect
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`to infringement of the ’209 patent.
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`25.
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`This action is being filed within 45 days of Lilly’s receipt of DRL’s
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`Notice Letter.
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`herein.
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`COUNT
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`(Infringement of U.S. Patent No. 7,772,209)
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`26.
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`Lilly incorporates each of the preceding paragraphs as if fully set forth
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`27.
`
`Upon information and belief, DRL’s NDA Products contain pemetrexed
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`disodium or its equivalent.
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`28.
`
`Upon information and belief, the proposed labeling for DRL’s NDA
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`Products involves administration of folic acid and vitamins B12.
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`29.
`
`Upon information and belief, the use of DRL’s NDA Products in
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`accordance with and as directed by DRL’s proposed labeling for those products will infringe
`
`claims 1-22 of the ’209 patent, either literally or under the doctrine of equivalents.
`
`30.
`
`Upon information and belief, DRL filed as part of NDA No. 208297 a
`
`certification of the type described in Section 505(b)(2)(A)(iv) of the FDCA, 21 U.S.C. §
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`355(b)(2)(A)(iv), asserting that the claims of the ’209 patent are invalid, unenforceable, and/or
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`not infringed by the manufacture, use, offer for sale, or sale of DRL’s NDA Products.
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`7
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 8 of 10 PageID #: 8
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`31.
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`The purpose of NDA No. 208297 was to obtain approval under the FDCA
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`to engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s NDA
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`Products prior to the expiration of the ’209 patent.
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`32.
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`DRL’s submission of NDA No. 208297 for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s
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`NDA Products prior to the expiration of the ’209 patent is an act of infringement of the ’209
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`patent under 35 U.S.C. § 271(e)(2)(A).
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`33.
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`Upon information and belief, DRL intends to engage in the manufacture,
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`use, offer for sale, sale, marketing, distribution, and/or importation of DRL’s NDA Products and
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`the proposed labeling therefor immediately and imminently upon approval of NDA No. 208297,
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`i.e., prior to the expiration of the ’209 patent.
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`34.
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`Upon information and belief, DRL has knowledge of the claims of the
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`’209 patent. Notwithstanding this knowledge, DRL has continued to assert its intent to engage in
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`the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of DRL’s
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`NDA Products and the proposed labeling therefor immediately and imminently upon approval of
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`NDA No. 208297.
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`35.
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`Upon information and belief, DRL plans and intends to, and will, actively
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`induce infringement of the ’209 patent when its NDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon approval.
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`36.
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`Upon information and belief, DRL knows that DRL’s NDA Products are
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`especially made or adapted for use in infringing the ’209 patent, and that DRL’s NDA Products
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`are not suitable for substantial noninfringing use. Upon information and belief, DRL plans and
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`8
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 9 of 10 PageID #: 9
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`intends to, and will, contribute to infringement of the ’209 patent immediately and imminently
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`upon approval of NDA No. 208297.
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`37.
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`The foregoing actions by DRL constitute and/or will constitute
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`infringement of the ’209 patent, active inducement of infringement of the ’209 patent, and
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`contribution to the infringement by others of the ’209 patent.
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`38.
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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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`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,
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`actively 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
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`to make, use, offer for sale, sell, market, distribute, or import DRL’s NDA Products, or any
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`product the use of which infringes the ’209 patent, be not earlier than the expiration date of the
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`’209 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
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`acting in concert with DRL, from making, using, selling, offering for sale, marketing,
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`distributing, or importing DRL’s NDA Products, or any product the use of which infringes the
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`’209 patent, or the inducement of or contribution to any of the foregoing, prior to the expiration
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`date of the ’209 patent, 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,
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`marketing, distributing, or importing of DRL’s NDA Products, or any product the use of which
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`infringes the ’209 patent, prior to the expiration date of the ’209 patent, infringes, will infringe,
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`9
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`Case 1:16-cv-00308-TWP-DKL Document 1 Filed 02/05/16 Page 10 of 10 PageID #: 10
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`will actively induce infringement of, and/or will contribute to the infringement by other of the
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`’209 patent;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’
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`fees pursuant to 35 U.S.C. § 285;
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`(f)
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`(g)
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`An award of Lilly’s costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`Dated: February 5, 2016
`
`/s/ Jan M. Carroll
`Jan M. Carroll, No. 4187-49
`BARNES & THORNBURG LLP
`11 South Meridian Street
`Indianapolis, IN 46204
`(317) 236-1313
`jan.carroll@btlaw.com
`Attorney for Plaintiff
`Eli Lilly and Company
`
`DMS 3664612v1
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`10
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