United States District Court, S.D. Indiana, Indianapolis Division
ENTRY ON PLAINTIFF'S MOTION TO AMEND FINAL
WALTON PRATT, JUDGE
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. For the reasons stated below, the Court
determines that Lilly's Motion to Amend Final Judgment is
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.
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,
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.
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.)
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 ...