Case 1:16-cv-00308-TWP-MPB Document 257 Filed 07/27/18 Page 1 of 5 PageID #: 7548
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
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`) Case No. 1:16-cv-00308-TWP-MPB
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`ELI LILLY AND COMPANY,
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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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`ENTRY ON PLAINTIFF’S MOTION TO AMEND FINAL JUDGMENT
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`This matter is before the Court on Plaintiff Eli Lilly’s (“Lilly”) Motion to Amend Final
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`Judgment. (Filing No. 244.) Also before the Court is Defendants Dr. Reddy’s Laboratories, Ltd.’s
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`and Dr. Reddy’s Laboratories, Inc.’s, (collectively, “Dr. Reddy’s”) Motion for Leave to File
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`Surreply Brief. (Filing No. 250.) Lilly takes no position on Dr. Reddy’s Motion for Leave to File
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`Surreply. (Filing No. 251.) The Court grants Dr. Reddy’s Motion, and has considered its
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`Surreply.1 For the reasons stated below, the Court determines that Lilly’s Motion to Amend Final
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`Judgment is granted.
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`I. BACKGROUND
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`On February 5, 2016, Lilly filed a Hatch-Waxman patent infringement action against Dr.
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`Reddy’s following Dr. Reddy’s submission of a New Drug Application (“NDA”) seeking approval
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`to market a pemetrexed ditromethamine product. (Filing No. 1.) Lilly alleged that Dr. Reddy’s
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`product infringed upon its U.S. Patent No. 7,772,209 (“209 Patent”) on its ALTIMA® cancer
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`1 The Court agrees with Dr. Reddy’s that new arguments were made in Lilly’s Reply Brief, and therefore has
`considered Dr. Reddy’s surreply to address these arguments. A party may seek leave from the court to file a surreply
`to address new matters argued in the reply brief. Heckler & Koch, Inc. v. German Sport Guns GmbH, No. 1:11-CV-
`1108-SEB-TAB, 2013 WL 2406262, at *3 (S.D. Ind. May 31, 2013).
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`Case 1:16-cv-00308-TWP-MPB Document 257 Filed 07/27/18 Page 2 of 5 PageID #: 7549
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`chemotherapy product, which uses pemetrexed disodium. A bench trial was held beginning on
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`February 1, 2018 and concluding on February 2, 2018.
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`On June 22, 2018, the Court entered a Final Judgment in favor of Lilly. (Filing No. 242.)
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`The Court found that Dr. Reddy’s product infringed Lilly’s product under the doctrine of
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`equivalents. The Final Judgment stated that, “Judgment is entered in favor of Plaintiff Eli Lilly &
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`Co. and against Defendant Dr. Reddy’s Inc. and this action is TERMINATED.” Id. On June 27,
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`2018, Lilly filed the pending Motion to Amend Final Judgment (Filing No. 244) requesting an
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`amendment which would provide particular relief as follows:
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`The filing of NDA No. 208297 infringed at least claims 9, 10, 12,
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`13, 14, 15, 18, 19, 21, and 22 of U.S. Patent No. 7,772,209.
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`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.
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`3. JUDGMENT IS ENTERED in favor of Lilly and against Defendants Dr.
`Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
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`Filing No. 244-1. Dr. Reddy’s objects to the Motion.
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`II. DISCUSSION
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`Dr. Reddy’s asserts three bases for denying Lilly’s Motion to Amend Final Judgment: 1)
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`the amendment is unnecessary and would give Lilly an unjustified windfall; 2) the Court is not
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`required to grant the relief sought by Lilly; 3) Lilly’s enumeration of the asserted claims is
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`inaccurate and overbroad. In turn, Lilly responds that the Hatch-Waxman Act requires this Court
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`to amend the Final Judgment in accordance with Lilly’s proposal. Lilly seeks to amend the Final
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`Judgment to order resetting the effective date of approval of Dr. Reddy’s product to a date not
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`earlier than the date of the expiration of the patent which has been infringed (including pediatric
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`exclusivity). (Filing No. 248 at 1.)
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`2
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`Case 1:16-cv-00308-TWP-MPB Document 257 Filed 07/27/18 Page 3 of 5 PageID #: 7550
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`The relevant statute reads:
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`(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 expiration of the patent which has
`been infringed,
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`(4) For an act of infringement described in paragraph (2)—
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`(B) injunctive relief may be granted against an infringer to prevent the
`commercial manufacture, use, offer to sell, or sale within the United States
`or importation into the United States of an approved drug, veterinary
`biological product, or biological product,
`….
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`35 U.S.C. § 271(e)(4) (emphasis added). Relying on SmithKline Beecham Corp. v. Apotex Corp.,
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`247 F. Supp. 2d 1011 (N.D. Ill. 2003), Dr. Reddy’s contends that 35 U.S.C. § 271(e)(4) “permits
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`the Court to order delay of approval sought by Lilly but does not require the Court to do so.”
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`(Filing No. 247 at 2) (emphasis in original). Moreover, Dr. Reddy’s asserts that because it has
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`already agreed not to launch its product commercially until the expiration of the ‘209 Patent or a
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`successful appeal, the Court need not grant Lilly any further relief. Lilly responds that the statutory
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`language including the word “shall” requires that the Court reset the effective date of any approval,
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`which is sufficient to resolve this case. The Court agrees. Although by the terms of the statute,
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`injunctive relief is a discretionary remedy, resetting the effective date of approval is mandatory.
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`The Federal Circuit has addressed this issue. “Accordingly, upon a finding of patent infringement
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`under § 271(e)(2), the district court must order remedies in accordance with § 271(e)(4).” Vanda
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`Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1138 (Fed. Cir. 2018). Lilly notes
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`that the policy justification for this procedure is due to the fact that the Food and Drug
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`Administration (the “FDA”) is not a party to Hatch-Waxman patent litigation. Congress vested
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`district courts with the role of ordering the FDA, as a non-party, to take action in compliance with
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`the order when a proposed product is found to infringe. (Filing No. 248 at 6.) Because resetting
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`3
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`Case 1:16-cv-00308-TWP-MPB Document 257 Filed 07/27/18 Page 4 of 5 PageID #: 7551
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`the effective date for approval is not a discretionary decision, the Court need not address Dr.
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`Reddy’s argument that the amendment is unnecessary and gives Lilly a windfall based on
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`bureaucratic delay at the FDA.
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`Next, Dr. Reddy’s argues that Lilly’s enumeration of the asserted claims is inaccurate and
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`overbroad because it includes additional claims that were not asserted against Dr. Reddy’s by
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`reciting the words “at least” before the enumerated claims. (Filing No. 247 at 3.) Lilly does not
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`object to striking the words “at least” before the enumerated claims, but notes that dependent
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`claims necessarily would also be found to have been infringed based on the interconnected
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`relationships of the claims, regardless if the claims were not asserted at trial. The Court declines
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`to strike the words “at least” from the amendment in an effort for consistency to parallel other
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`judgments this Court has entered. Case No. 1:12-cv-00086-TWP-MPB, ECF 87 (Accord), ECF
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`98 (Apotex); Case No. 1:16-cv-00469-TWP-MPB, ECF 28 (Biocon); Case No. 1:14-cv-00104-
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`TWP-MPB, ECF 45 (Glenmark); Case No. 1:16-cv-03460-TWP-MPB, ECF 94 (Hospira); Case
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`No. 1:13-cv-01469-TWP-DKL, ECF 57 (Sun).
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`III. CONCLUSION
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`For the reasons stated above, the Court GRANTS Lilly’s Motion to Amend Final Judgment
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`(Filing No. 244) and accepts Lilly’s proposed order (Filing No. 244-1). An amended entry of
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`final judgment will follow in a separate order. The Court grants Dr. Reddy’s Motion (Filing No.
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`250), and has considered its Surreply.
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`SO ORDERED.
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`Date: 7/27/2018
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`4
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`Case 1:16-cv-00308-TWP-MPB Document 257 Filed 07/27/18 Page 5 of 5 PageID #: 7552
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`DISTRIBUTION:
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`Anne N. DePrez
`BARNES & THORNBURG LLP
`(Indianapolis)
`adeprez@btlaw.com
`
`Jan M. Carroll
`BARNES & THORNBURG, LLP
`(Indianapolis)
`jan.carroll@btlaw.com
`
`Rory O’Bryan
`HARRISON & MOBERLY (Indianapolis)
`robryan@harrisonmoberly.com
`
`Stephen E. Arthur
`HARRISON & MOBERLY (Indianapolis)
`sarthur@harrisonmoberly.com
`
`Charles A. Weiss
`HOLLAND & KNIGHT LLP
`charles.weiss@hklaw.com
`
`Jeffery B. Arnold
`HOLLAND & KNIGHT LLP
`jeffery.arnold@hklaw.com
`
`Merri C Moken
`HOLLAND & KNIGHT LLP
`merri.moken@hklaw.com
`
`Eric H. Yecies
`HOLLANDS & KNIGHT LLP
`eric.yecies@hklaw.com
`
`Adam L. Perlman
`WILLIAMS & CONNOLLY LLP
`aperlman@wc.com
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`
`
`Alec T. Swafford
`WILLIAMS & CONNOLLY LLP
`aswafford@wc.com
`
`Bruce Roger Genderson
`WILLIAMS & CONNOLLY LLP
`bgenderson@wc.com
`
`Christopher T Berg
`WILLIAMS & CONNOLLY LLP
`cberg@wc.com
`
`Galina I. Fomenkova
`WILLIAMS & CONNOLLY LLP
`gfomenkova@wc.com
`
`David M. Krinsky
`WILLIAMS & CONNOLLY, LLP
`dkrinsky@wc.com
`
`Dov P. Grossman
`WILLIAMS & CONNOLLY, LLP
`dgrossman@wc.com
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`Andrew Lemens
`WILLIAMS & CONNOLLY LLP
`alemens@wc.com
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`James P. Leeds
`ELI LILLY AND COMPANY
`jleeds@lilly.com
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`Charles E. Oswald, IV
`HARRISON & MOBERLY
`coswald@harrisonmoberly.com
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`5
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