Eli Lilly & Co. v. Dr. Reddy's Labs., Ltd.

• Decision Date: 27 July 2018
• Docket Number: Case No. 1:16-cv-00308-TWP-MPB
• Parties: ELI LILLY AND COMPANY, Plaintiff, v. DR. REDDY'S LABORATORIES, LTD., and DR. REDDY'S LABORATORIES, INC., Defendants.
• Court: U.S. District Court — Southern District of Indiana

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

Case No. 1:16-cv-00308-TWP-MPB

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA INDIANAPOLIS DIVISION

July 27, 2018

ENTRY ON PLAINTIFF'S MOTION TO AMEND FINAL JUDGMENT

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® cancerchemotherapy 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 expiration of the patent which has been infringed,

(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,

....

35 U.S.C. § 271(e)(4) (emphasis added). Relying on SmithKline Beecham Corp. v. Apotex Corp., 247 F. Supp. 2d 1011 (N.D. Ill. 2003), Dr. Reddy's contends that 35 U.S.C. § 271(e)(4) "permits the Court to order delay of approval sought by Lilly but does not require the Court to do so." (Filing No. 247 at 2) (emphasis in original). Moreover, Dr. Reddy's asserts that because it has already agreed not to launch its product commercially until the expiration of the '209 Patent or a successful appeal, the Court need not grant Lilly any further relief. Lilly responds that the statutory language including the word "shall" requires that the Court reset the effective date of any approval, which is sufficient to resolve this case. The Court agrees. Although by the terms of the statute, injunctive relief is a discretionary remedy, resetting the effective date of approval is mandatory. The Federal Circuit has addressed this issue. "Accordingly, upon a finding of patent infringement under § 271(e)(2), the district court must order remedies in accordance with § 271(e)(4)." Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1138 (Fed. Cir. 2018). Lilly notes that the policy justification for this procedure is due to the fact that the Food and Drug Administration (the "FDA") is not a party to Hatch-Waxman patent litigation. Congress vested district courts with the role of ordering the FDA, as a non-party, to take action in compliance with the order when a proposed product is found to infringe. (Filing No. 248 at 6.) Because resettingthe effective date for approval is not a discretionary decision, the Court need not address Dr. Reddy's argument that the amendment is unnecessary and gives Lilly a windfall based on bureaucratic delay at the FDA.

Next, Dr. Reddy's argues that Lilly's enumeration of the asserted claims is inaccurate and overbroad because it includes additional claims that were not asserted against Dr. Reddy's by reciting the words "at least" before the enumerated claims. (Filing No. 247 at 3.) Lilly does not object to striking the words "at least" before the enumerated claims, but notes that dependent claims necessarily would also be found to have been infringed based on the interconnected relationships of the claims, regardless if the claims were not asserted at trial. The Court declines to strike the words "at least" from the amendment in an effort for consistency to parallel other judgments this Court has entered. Case No. 1:12-cv-00086-TWP-MPB, ECF 87 (Accord), ECF 98 (Apotex); Case No. 1:16-cv-00469-TWP-MPB, ECF 28 (Biocon); Case No. 1:14-cv-00104-TWP-MPB, ECF 45 (Glenmark); Case No. 1:16-cv-03460-TWP-MPB, ECF 94 (Hospira); Case No. 1:13-cv-01469-TWP-DKL, ECF 57 (Sun).

III. CONCLUSION

For the reasons stated above, the Court GRANTS Lilly's Motion to Amend Final Judgment (Filing No. 244) and accepts Lilly's proposed order (Filing No. 244-1). An amended entry of final judgment will follow in a separate order. The Court grants Dr. Reddy's Motion (Filing No. 250), and has considered its Surreply.

SO ORDERED.

Date: 7/27/2018

/s/_________

TANYA WALTON PRATT, JUDGE

United States District Court

Southern District of Indiana

DISTRIBUTION:

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

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

Andrew Lemens

WILLIAMS & CONNOLLY LLP

alemens@wc.com

James P. Leeds

ELI LILLY AND COMPANY

jleeds@lilly.com

Charles E. Oswald, IV

HARRISON & MOBERLY

coswald@harrisonmoberly.com

1. The Court...