ELI LILLY AND COMPANY v. HOSPIRA, INC.

Filing 65

ORDER approving 64 STIPULATION. The 30-month stay on Hospira's solution product is terminated subject to the terms and conditions of the parties' stipulation. Signed by Judge Sarah Evans Barker on 12/3/2010. (PGS)

UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA INDIANAPOLIS DIVISION ELI LILLY AND COMPANY, Plaintiff, v. HOSPIRA, INC. Defendant. ) ) ) ) ) ) ) ) )

Case No.: 1:10-CV-00346-SEB-DML

STIPULATION AND [PROPOSED] ORDER Plaintiff Eli Lilly & Co. (Lilly), by and through its undersigned counsel of record, and Defendant Hospira, Inc. (Hospira), by and through its undersigned counsel of record, hereby stipulate, subject to Court approval, to entry of the following order: 1. This action was filed by Lilly on March 23, 2010, alleging that Hospira's solution

product described in New Drug Application No. 200-795, seeking marketing approval from the Food and Drug Administration pursuant to 21 U.S.C. § 355(b), would infringe U.S. Patent Nos. 4,808,614 ("the `614 patent") and 5,464,826 ("the `826 patent"). Based on Lilly's timely filing of the action, an automatic 30-month stay of FDA approval of Hospira's solution product is presently in effect pursuant to 21 U.S.C. § 355(j)(5)(B)(iii). 2. 3. On November 15, 2010, the '614 patent expired. On November 12, 2010, the Federal Circuit issued its mandate in Sun Pharma-

ceuticals Industries, Ltd. v. Eli Lilly & Co., Appeal No. 2010-1105, affirming the district court's summary judgment of invalidity of the '826 patent. Lilly intends to file a petition for writ of certiorari to the United States Supreme Court seeking review of the Federal Circuit's decision.

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Lilly is entering this stipulation to avoid any potentially unnecessary interference

with the marketing of otherwise approvable gemcitabine products, without acquiescing in the propriety of the Sun judgment or its applicability as collateral estoppel, and without effect on any matters that remain pending in or controlled by Eli Lilly & Co. v. Sicor Pharmaceuticals, Inc., No. 06-cv-238 (S.D. Ind.). 5. Upon the Court's signature below, the 30-month stay on Hospira's solution prod-

uct is hereby terminated. The FDA may thus grant final approval to Hospira's solution product when it would otherwise, due to the existence of the stay, only tentatively approve such product. 6. Nothing in this stipulation or order shall prevent Lilly from seeking to have the

stay reinstated should its petition for certiorari be granted before the FDA approves Hospira's solution product. 7. Nothing in this stipulation or order, or Lilly's acquiescence in its entry, shall con-

stitute a waiver of any claim for damages or preliminary or permanent injunctive relief to which Lilly may otherwise be entitled, and may not be used by Hospira to argue that any such relief should be reduced or is inappropriate. SO STIPULATED. December 3, 2010 Respectfully submitted,

s/ Sally Franklin Zweig Sally Franklin Zweig (Atty. No. 11367-49) KATZ & KORIN, PC The Emelie Building 334 North Senate Avenue Indianapolis, IN 46204-1708 Telephone: [phone] Facsimile: 317-464-1111 E-Mail: [e-mail] 2

James F. Hurst Gail J. Standish Peter Perkowski WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, IL 60601-9703 & 333 South Grand Avenue Los Angeles, CA 90071-1543 Telephone: [phone] Facsimile: 312-558-5700 E-Mail: [e-mail] [e-mail] [e-mail] Counsel to Defendant Hospira, Inc. December 3, 2010 Respectfully submitted, s/ Jan M. Carroll________________________ Jan M. Carroll (Atty. No. 4187-49) BARNES & THORNBURG LLP 11 South Meridian Street Indianapolis, IN 46204 [phone] Fax: [phone] Email: [e-mail] Charles Edmund Lipsey FINNEGAN HENDERSON FARABOW GARRETT & DUNNER LLP 11955 Freedom Drive Reston, VA 20190 [phone] Fax: [phone] Email: [e-mail] Counsel to Plaintiff Eli Lilly and Company

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IT IS SO ORDERED. ENTERED this _____ day of __________, 2010.

Date: 12/03/2010

__________________________________ _______________________________ Sarah Evans Barker, U.S. District Judge SARAH EVANS BARKER, JUDGE Southern District of Indiana United States District Court Southern District of Indiana

Distribution:

Jan M. Carroll (Lilly) Barnes & Thornburg LLP Charles E. Lipsey (Lilly) Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Robert D. Bajefsky (Lilly) Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Robert F. Shaffer (Lilly) Finnegan, Henderson, Farabow, Garrett & Dunner, LLP James F. Hurst (Mayne/Hospira) Winston & Strawn LLP Gail J. Standish (Mayne/Hospira) Winston & Strawn LLP Peter E. Perkowski (Mayne/Hospira) Winston & Strawn LLP Sally Franklin Zweig (Mayne/Hospira) Katz & Korin, PC

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