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Eli Lilly And Co. v. Dr. Reddy's Laboratories, Ltd.

United States District Court, S.D. Indiana, Indianapolis Division

July 27, 2018

ELI LILLY AND COMPANY, Plaintiff,
v.
DR. REDDY'S LABORATORIES, LTD., and DR. REDDY'S LABORATORIES, INC., Defendants.

          ENTRY ON PLAINTIFF'S MOTION TO AMEND FINAL JUDGMENT

          TANYA WALTON PRATT, JUDGE

         This matter is before the Court on Plaintiff Eli Lilly's (“Lilly”) Motion to Amend Final Judgment. (Filing No. 244.) Also before the Court is Defendants Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Laboratories, Inc.'s, (collectively, “Dr. Reddy's”) Motion for Leave to File Surreply Brief. (Filing No. 250.) Lilly takes no position on Dr. Reddy's Motion for Leave to File Surreply. (Filing No. 251.) The Court grants Dr. Reddy's Motion, and has considered its Surreply.[1] For the reasons stated below, the Court determines that Lilly's Motion to Amend Final Judgment is granted.

         I. BACKGROUND

         On February 5, 2016, Lilly filed a Hatch-Waxman patent infringement action against Dr. Reddy's following Dr. Reddy's submission of a New Drug Application (“NDA”) seeking approval to market a pemetrexed ditromethamine product. (Filing No. 1.) Lilly alleged that Dr. Reddy's product infringed upon its U.S. Patent No. 7, 772, 209 (“209 Patent”) on its ALTIMA® cancer chemotherapy product, which uses pemetrexed disodium. A bench trial was held beginning on February 1, 2018 and concluding on February 2, 2018.

         On June 22, 2018, the Court entered a Final Judgment in favor of Lilly. (Filing No. 242.) The Court found that Dr. Reddy's product infringed Lilly's product under the doctrine of equivalents. The Final Judgment stated that, “Judgment is entered in favor of Plaintiff Eli Lilly & Co. and against Defendant Dr. Reddy's Inc. and this action is TERMINATED.” Id. On June 27, 2018, Lilly filed the pending Motion to Amend Final Judgment (Filing No. 244) requesting an amendment which would provide particular relief as follows:

1. The filing of NDA No. 208297 infringed at least claims 9, 10, 12, 13, 14, 15, 18, 19, 21, and 22 of U.S. Patent No. 7, 772, 209.
2. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of any product that is the subject of NDA No. 208297 shall be not earlier than the latest date of expiration of U.S. Patent No. 7, 772, 209, including any period of pediatric exclusivity.
3. JUDGMENT IS ENTERED in favor of Lilly and against Defendants Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc.

Filing No. 244-1. Dr. Reddy's objects to the Motion.

         II. DISCUSSION

         Dr. Reddy's asserts three bases for denying Lilly's Motion to Amend Final Judgment: 1) the amendment is unnecessary and would give Lilly an unjustified windfall; 2) the Court is not required to grant the relief sought by Lilly; 3) Lilly's enumeration of the asserted claims is inaccurate and overbroad. In turn, Lilly responds that the Hatch-Waxman Act requires this Court to amend the Final Judgment in accordance with Lilly's proposal. Lilly seeks to amend the Final Judgment to order resetting the effective date of approval of Dr. Reddy's product to a date not earlier than the date of the expiration of the patent which has been infringed (including pediatric exclusivity). (Filing No. 248 at 1.)

         The relevant statute reads:

(4) For an act of infringement described in paragraph (2)-
(A) the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the ...

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