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Eli Lilly & Co. v. Hospira, Inc.

Eli Lilly & Co. v. Hospira, Inc.

United States Court of Appeals for the Federal Circuit

August 9, 2019, Decided

2018-2126, 2018-2127, 2018-2128

Opinion

 [*1323]  Lourie, Circuit Judge.

Hospira Inc. ("Hospira"), Dr. Reddy's Laboratories Ltd., and Dr. Reddy's Laboratories Inc. (collectively, "DRL") appeal from two judgments of the United States District Court for the Southern District of Indiana in two infringement suits brought by Eli Lilly & Company ("Lilly") under the Hatch-Waxman Act, 21 U.S.C. § 355. The district court held in each case that the defendant's submission of a New Drug Application pursuant to 21 U.S.C. § 355(b)(2) infringed U.S. Patent 7,772,209 (the "'209 patent") under 35 U.S.C. § 271(e)(2). See Eli Lilly & Co. v. Hospira, Inc., No. 1:16-cv-03460-TWP-MPB, 2018 U.S. Dist. LEXIS 100550, 2018 WL 3008570 (S.D. Ind. June 15, 2018) ("Hospira Decision"); Eli Lilly & Co. v. Dr. Reddy's Labs., Ltd., 323 F. Supp. 3d 1042 (S.D. Ind. 2018) ("DRL Decision"); see also Eli Lilly & Co. v. Dr. Reddy's  [*1324]  Labs., Ltd., No. 1:16-cv-00308-TWP-MPB, 2017 U.S. Dist. LEXIS 205578, 2017 WL 6387316 (S.D. Ind. Dec. 14, 2017) ("DRL Summary Judgment Decision"). Accordingly, the district court entered orders under 35 U.S.C. § 271(e)(4)(A) prohibiting FDA approval of the products at issue until the expiration of the '209 patent. Eli Lilly & Co. v. Hospira, Inc., No. 1:16-cv-03460-TWP-MPB, 2018 U.S. Dist. LEXIS 100550 (S.D. Ind. June 15, 2018), ECF No. 94; Eli Lilly & Co. v. Dr. Reddy's Labs., Ltd., No. 1:16-cv-00308-TWP-MPB, 2018 U.S. Dist. LEXIS 126714, 2018 WL 3616715 (S.D. Ind. July 27, 2018). We decide these [**3]  appeals together in this combined opinion.1

We reverse the district court's finding of literal infringement in the Hospira Decision as clearly erroneous in light of the court's claim construction of "administration of pemetrexed disodium." Because the district court did not err in its application of the doctrine of equivalents in either decision, we affirm both judgments of infringement. Thus, the Hospira Decision is affirmed-in-part and reversed-in-part, and the DRL Decision is affirmed.

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933 F.3d 1320 *; 2019 U.S. App. LEXIS 23753 **; 2019 U.S.P.Q.2D (BNA) 296249; 2019 WL 3756065

ELI LILLY AND COMPANY, Plaintiff-Appellee v. HOSPIRA, INC., Defendant-Appellant; ELI LILLY AND COMPANY, Plaintiff-Appellee v. DR. REDDY'S LABORATORIES, LTD., DR. REDDY'S LABORATORIES, INC., Defendants-Appellants

Subsequent History: US Supreme Court certiorari denied by Hospira, Inc. v. Eli Lilly & Co., 2020 U.S. LEXIS 3198 (U.S., June 15, 2020)

Prior History:  [**1] Appeals from the United States District Court for the Southern District of Indiana in No. 1:16-cv-03460-TWP-MPB, Judge Tanya Walton Pratt.

Appeal from the United States District Court for the Southern District of Indiana in No. 1:16-cv-00308-TWP-MPB, Judge Tanya Walton Pratt.

Eli Lilly & Co. v. Dr. Reddy's Labs., Ltd., 323 F. Supp. 3d 1042, 2018 U.S. Dist. LEXIS 104653 (S.D. Ind., June 22, 2018)Eli Lilly & Co. v. Hospira, Inc., 2018 U.S. Dist. LEXIS 100550 (S.D. Ind., June 15, 2018)

Disposition: AFFIRMED-IN-PART AND REVERSED-IN-PART IN APPEAL NOS. 2018-2126, 2018-2127.

AFFIRMED IN APPEAL NO. 2018-2128.

CORE TERMS

pemetrexed, disodium, antifolate, ditromethamine, patent, infringement, tangential, salt, district court, doctrine of equivalents, discloses, estoppel, folic acid, administering, literally, compounds, narrowing, acid, summary judgment, disclosure-dedication, tromethamine, dedicated, invention, patentee, toxicity, vitamin, subject matter, cases, prior art, de novo

Civil Procedure, Trials, Bench Trials, Judgments, Summary Judgment, Evidentiary Considerations, Appellate Review, Standards of Review, Appeals, Standards of Review, Clearly Erroneous Review, Patent Law, Infringement Actions, Burdens of Proof, Claim Interpretation, Doctrine of Equivalents, Jurisdiction & Review, De Novo Review, Business & Corporate Compliance, Patent Law, Infringement Actions, Prosecution History Estoppel, Statutory Bars, Public Use Bar