Case 1:14-cv-00113-RGA-MPT Document 278-1 Filed 09/25/15 Page 1 of 8 PageID #: 9336
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-113-RGA-MPT
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`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`PRETRIAL ORDER EXHIBIT 1:
`SANOFI AND ELI LILLY’S JOINT STATEMENT OF ADMITTED FACTS
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`Case 1:14-cv-00113-RGA-MPT Document 278-1 Filed 09/25/15 Page 2 of 8 PageID #: 9337
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`I.
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`TABLE OF CONTENTS
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`I.
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`II.
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`Page
`The Parties ......................................................................................................................... 2
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`The Patents-In-Suit ............................................................................................................ 2
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`A.
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`B.
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`The Asserted Formulation Patents (ʼ652 and ʼ930 Patents) .................................. 3
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`The Asserted Device Patents (’864, ’044, and ’069 Patents) ................................ 3
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`a.
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`b.
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`The ’044 and ’069 Patents ......................................................................... 3
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`The ’864 Patent .......................................................................................... 4
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`III.
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`New Drug Applications (“NDAs”) .................................................................................... 4
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`A.
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`B.
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`Sanofi’s NDA......................................................................................................... 4
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`Lilly’s NDA ........................................................................................................... 5
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`a.
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`b.
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`Lilly’s Proposed Insulin Glargine Product ................................................ 6
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`Lilly’s
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` ............................................................................ 6
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`IV.
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`Certain References and Prior Art ....................................................................................... 6
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`A.
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`Asserted Device Patents ......................................................................................... 7
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`a.
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`b.
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`c.
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`The ’044 Patent .......................................................................................... 7
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`The ’069 Patent .......................................................................................... 7
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`The ’864 Patent .......................................................................................... 7
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`I.
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`THE PARTIES
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`1.
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`Plaintiffs and Counterclaim Defendants in this lawsuit are Sanofi-Aventis U.S.
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`LLC and Sanofi-Aventis Deutschland GmbH. Sanofi-Aventis U.S. LLC and Sanofi-Aventis
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`Deutschland GmbH, as well as their predecessors-in-interest, are referred to herein as “Sanofi.”
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`2.
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`Sanofi U.S. is a Delaware limited liability corporation with its principal place of
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`business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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`3.
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`Sanofi GmbH is a German corporation, with its principal place of business
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`located at Industriepark Hoechst, Bldg. K607, Frankfurt Am Main, Germany D-65926.
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`4.
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`Defendant and Counterclaim Plaintiff Eli Lilly and Company (“Lilly”) is an
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`Indiana corporation with its principal place of business located at Lilly Corporate Center,
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`Indianapolis, Indiana 46285. Lilly conducts business operations in the United States, including
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`in the State of Delaware.
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`II.
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`THE PATENTS-IN-SUIT
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`5.
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`Sanofi asserts that Lilly infringes certain claims of five United States patents in
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`this litigation (collectively, “Patents-in-Suit”), which are U.S. Patent No. 7,476,652 (“the ’652
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`Patent”), U.S. Patent No. 7,713,930 (“the ’930 Patent”), U.S. Patent No. 8,556,864 (“the ’864
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`Patent”), , U.S. Patent No.8,603,044 (“the ’044 Patent”), and , U.S. Patent No. 8,679,069 (“the
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`’069 Patent”) The Asserted Claims of the Patents-in-Suit are as follows: Claims 7, 10, 20 and 24
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`of the ’652 Patent; claims 7 and 17 of the ’930 Patent; claim 2 of the ’864 Patent; claims 1, 5, 7
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`and 10 of the ’044 Patent; and claim 1 of the ’069 Patent.
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`6.
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`Lilly asserts, among other things, that the Asserted Claims of the Patents-in-Suit
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`are not infringed and invalid, and further that the Asserted Devices Patents are unenforceable due
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`to prosecution laches.
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`A.
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`7.
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`The ʼ652 and ʼ930 Patents
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`Each of the ’652 and ’930 Patents names Anette Brunner-Schwarz and Norbert
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`Lill as inventors.
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`8.
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`On January 13, 2009, U.S. Patent Application No. 11/089,777 issued as the ʼ652
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`Patent.
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`Patent.
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`9.
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`On May 11, 2010, U.S. Patent Application No. 12/328,208 issued as the ʼ930
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`10.
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`Both the ’652 Patent and the ’930 Patent claim ultimate priority to U.S.
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`Provisional application 60/409,338 (filed June 13, 2003) and German Patent Application No.
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`10/227,232 (filed June 18, 2002).
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`B.
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`11.
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`The’864, ’044, and ’069 Patents
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`Each of the ’864, ’044, and ’069 Patents names Robert Veasey, Robert Perkins,
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`and David Plumptre as inventors.
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`a.
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`The ’044 and ’069 Patents
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`12.
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`On March 25, 2014, U.S. Patent Application No. 12/944,544 issued as the ’069
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`Patent.
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`13.
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`The ’069 Patent claims ultimate priority to GB Patent Application No. 0304822.0,
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`filed March 3, 2003.
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`14.
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`On December 10, 2013, U.S Patent Application No. 13/909,649 issued as the ’044
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`Patent.
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`15.
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`The ’044 Patent claims ultimate priority to GB Patent Application No. 0304822.0,
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`filed March 3, 2003.
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`b.
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`The ’864 Patent
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`16.
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`On October 15, 2013, U.S. Patent Application No. 13/075,212 issued as the ’864
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`Patent.
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`17.
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`The ’864 Patent claims ultimate priority to GB Patent Application No. 0304822.0,
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`filed March 3, 2003.
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`III. New Drug Applications (“NDAs”)
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`A.
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`Sanofi’s NDA
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`18.
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`Sanofi holds the approved new drug application (“NDA”) No. 21-081 for Lantus®
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`(insulin glargine [rDNA origin] for injection) products, including Lantus® supplied in 10 mL
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`vials and in 3 mL cartridges for use with Lantus®OptiClik® and Lantus® SoloSTAR®.
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`19.
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`Sanofi submitted its original NDA 21-081 to the United States Food and Drug
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`Administration (“FDA”) on April 9, 1999.
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`20.
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`The Lantus® label approved by the FDA on April 20, 2000 states: “LANTUS is
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`indicated for once-daily subcutaneous administration at bedtime in the treatment of adult and
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`pediatric patients with type l diabetes mellitus or adult patients with type 2 diabetes mellitus who
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`require basal (long-acting) insulin for the control of hyperglycemia.”
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`21.
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`The active ingredient in Lantus® is insulin glargine.
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`22.
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`Insulin glargine’s long-acting effect for 24 hours with no pronounced peak as a
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`basal insulin has been one of the primary clinical benefits for patients treated with Lantus®.
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`23.
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`As approved by the FDA on April 20, 2000 and originally marketed in the United
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`States in May 2001, each milliliter of the Lantus® formulation consisted of: 100 IU (3.6378 mg)
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`insulin glargine, 0.0626 mg zinc chloride (corresponding to 30 mcg zinc), 2.7 mg m-cresol, 20
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`mg glycerol 85%, and water for injection.1 As approved by the FDA on April 20, 2000 and
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`originally marketed in the United States in May 2001, the Lantus® formulation had a pH of
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`approximately 4.
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`24.
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`On May 21, 2001, Lantus® was launched in the United States in 10 mL vials with
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`the formulation approved by the FDA on April 20, 2000.
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`25.
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`On November 15, 2004, Sanofi filed a supplemental NDA seeking approval for a
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`Lantus® product that includes 20 parts-per-million (“ppm”) of polysorbate 20 as a stabilizing
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`agent.
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`26.
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`On April 21, 2006, Sanofi filed supplement S-024 to its NDA 21-081 seeking
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`approval to sell the Lantus® formulation approved by the FDA on April 20, 2000 in the
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`SoloSTAR® disposable insulin injection device.
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`27.
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`On April 25, 2007, the FDA approved Lantus® SoloSTAR®.
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`28.
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`Sanofi launched Lantus® SoloSTAR® in the United States on July 30, 2007.
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`B.
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`Lilly’s NDA
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`29.
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`Lilly submitted NDA No. 205-692 to the FDA under Section 505(b)(2) of the
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`Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(b)(2), seeking the FDA’s
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`approval to sell a 3 mL cartridge of its proposed product—an insulin glargine [rDNA origin] for
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`injection, 100 units/mL (“Lilly’s Proposed Insulin Glargine Product”) – in a prefilled insulin
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`delivery device
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`. NDA No. 205-692
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` 1 There are 1,000 micrograms (mcg or µg) in 1 milligram (mg).
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`30.
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`Lilly’s NDA contained certifications pursuant to § 505(b)(a)(A)(iv) and (b)(3) of
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`the Federal Food, Drug, and Cosmetic Act (collectively, “Paragraph IV Certifications”) for the
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`ʼ652, ʼ930, and ’864 Patents.
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`31.
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`On or about January 23, 2014, Lilly sent Sanofi an “Amended Notice of
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`Paragraph IV Certifications,” disclosing that Lilly amended its Paragraph IV Certifications in
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`NDA No. 205-692 to include the ’044 Patent.
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`32.
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`On or about May 14, 2014, Lilly sent Sanofi a “Notice of Paragraph IV
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`Certification Regarding NDA No. 012081 with Respect to U.S. Patent No. 8,679,069,”
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`disclosing that Lilly amended its Paragraph IV Certifications contained in NDA No. 205-692 to
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`include the ’069 Patent.
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`33.
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`205-692.
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`, the FDA granted tentative approval for Lilly’s NDA No.
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`a.
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`Lilly’s Proposed Insulin Glargine Product
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`34.
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`The primary amino acid sequence of the insulin glargine in Lilly’s Proposed
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`Insulin Glargine Product, as described in NDA No. 205-692 that received tentative FDA
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`approval, is the same as that of the insulin glargine in Lantus, approved by FDA in April 2000.
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`b.
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`Lilly’s
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`35.
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`36.
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`IV. Certain References and Prior Art
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`Case 1:14-cv-00113-RGA-MPT Document 278-1 Filed 09/25/15 Page 8 of 8 PageID #: 9343
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`
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`A.
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`Asserted Device Patents
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`a.
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`The ’044 Patent
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`37. WO 99/38554 to Steenfeldt-Jensen (the “Steenfeldt-Jensen ’554 patent
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`publication”) contains the same specification as U.S. Pat. No. 6,004,297 (the “Steenfeldt-Jensen
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`’297 patent”). The Steenfeldt-Jensen ’554 patent publication is listed on page 2 of the ’044
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`Patent.
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`Patent.
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`Patent.
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`38.
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`U.S. Pat. No. 7,241,278 (the “Møller patent”) is listed on page 2 of the ’044
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`39.
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`U.S. Pat. No. 6,221,046 (the “Burroughs patent”) is listed on page 2 of the ’044
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`b.
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`The ’069 Patent
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`40.
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`The Steenfeldt-Jensen ’554 patent publication, the Møller patent, and the
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`Burroughs patent, are listed on page 2 of the ’069 Patent.
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`c.
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`The ’864 Patent
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`41.
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`The Steenfeldt-Jensen ’297 patent, the Møller patent, and the Burroughs patent
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`are listed on page 2 of the ’864 Patent.
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