Case 1:14-cv-00113-RGA-MPT Document 1 Filed 01/30/14 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _________________
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`))))))))))
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`SANOFI-AVENTIS U.S. LLC and SANOFI-
`AVENTIS DEUTSCHLAND GMBH,
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`Plaintiffs,
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`v.
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`Defendant.
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`ELI LILLY AND COMPANY,
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Sanofi-Aventis U.S. LLC (“Sanofi U.S.”) and Sanofi-Aventis Deutschland
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`GmbH (“Sanofi GmbH”) (collectively, “Plaintiffs” or “Sanofi”), by and through their attorneys,
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`for their complaint against Eli Lilly and Company (“Eli Lilly”), hereby allege as follows:
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`THE PARTIES
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`1.
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`Plaintiff Sanofi U.S. is a Delaware limited liability corporation with its principal
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`place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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`2.
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`Plaintiff Sanofi GmbH is a German corporation, with its principal place of
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`business located at Industriepark Hoechst, Bldg. K607, Frankfurt Am Main, Germany D-65926.
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`3.
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`On information and belief, Defendant Eli Lilly is an Indiana corporation with its
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`principal place of business located at Lilly Corporate Center, Indianapolis, Indiana 46285.
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`4.
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`On information and belief, Eli Lilly conducts business operations in the United
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`States, including in the State of Delaware.
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`JURISDICTION AND VENUE
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`5.
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`This is an action for patent infringement under the Patent Laws of the United
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`States, Title 35, United States Code. This Court has jurisdiction over the subject matter of this
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`action under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`6.
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`This Court has personal jurisdiction over Eli Lilly because, inter alia, Eli Lilly
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`maintains continuous and systematic contacts with this judicial district. Either directly, or
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`through its subsidiaries, agents, and/or affiliates, Eli Lilly has conducted and continues to
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`conduct business in this judicial district, including, upon information and belief, by
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`manufacturing, marketing, and selling drug products throughout the United States and in the
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`District of Delaware. This Court has personal jurisdiction over Eli Lilly for the additional
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`reasons set forth below.
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`7.
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`8.
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`Eli Lilly is registered to do business in the State of Delaware.
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`National Registered Agents, Inc., 160 Greentree Drive, Suite 101, Dover,
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`Delaware 19904 serves as Eli Lilly’s Registered Agent in the State of Delaware.
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`9.
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`Eli Lilly has previously elected to avail itself of the benefits of litigating its patent
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`disputes in the District of Delaware. See, e.g., Eli Lilly & Co. v. Teva Parenteral Medicines,
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`Inc., C.A. No. 08-335-GMS.
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`10.
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`Venue is proper in this court pursuant to 28 U.S.C. §§ 1391(b), (c), and 1400(b).
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`PATENTS-IN-SUIT
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`11.
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`On October 15, 2013, United States Patent No. 8,556,864 (“the ’864 Patent”),
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`entitled “Drive Mechanisms Suitable for Use in Drug Delivery Devices,” was duly and legally
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`issued by the United States Patent and Trademark Office (“PTO”). A true and copy of the ’864
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`Patent is attached as Exhibit A to this Complaint.
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`12.
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`On December 10, 2013, United States Patent No. 8,603,044 (“the ’044 Patent”),
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`entitled “Pen-Type Injector,” was duly and legally issued by the PTO. A true and copy of the
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`’044 Patent is attached as Exhibit B to this Complaint.
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`13.
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`On January 13, 2009, United States Patent No. 7,476,652 (“the ’652 Patent”),
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`entitled “Acidic Insulin Preparations Having Improved Stability,” was duly and legally issued by
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`the PTO. A true and copy of the ’652 Patent is attached as Exhibit C to this Complaint.
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`14.
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`On May 11, 2010, United States Patent No. 7,713,930 (“the ’930 Patent”), entitled
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`“Acidic Insulin Preparations Having Improved Stability,” was duly and legally issued by the
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`PTO. A true and copy of the ’930 Patent is attached as Exhibit D to this Complaint.
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`15.
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`The ’864 Patent, ’044 Patent, ’652 Patent, and ’930 Patent, are collectively
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`referred to herein as the “Patents-in-Suit.” By assignment, Sanofi GmbH owns all right, title,
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`and interest in and to the Patents-in-Suit. Sanofi U.S. is an exclusive licensee of the Patents-in-
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`Suit with exclusive rights, including the rights to sell and offer to sell in the United States the
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`technologies, products, or services claimed by the Patents-in-Suit. Plaintiffs have the right to sue
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`and recover for the infringement of the Patents-in-Suit.
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`BACKGROUND
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`16.
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`Sanofi U.S. is the holder of approved New Drug Application (“NDA”) No. 21-
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`081 for insulin glargine [rDNA origin] for injection, which is prescribed and sold in the United
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`States under the trademarks Lantus® and Lantus® SoloSTAR®. Currently, there are no generic
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`or follow-on versions of Lantus® or of Lantus® SoloSTAR® approved by the United States
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`Food and Drug Administration (“FDA”) for sale in the United States.
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`17.
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`The publication Approved Drug Products with Therapeutic Equivalence
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`Evaluations (the “Orange Book”) identifies drug products approved on the basis of safety and
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`effectiveness by FDA under the Federal Food, Drug, and Cosmetic Act (“FFDCA”). Sanofi U.S.
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`has listed each of the ’864, ’044, ’652, and ’930 Patents in the Orange Book as covering its
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`Lantus® and/or Lantus® SoloSTAR® products.
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`18.
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`On information and belief, Eli Lilly submitted NDA No. 205-692 to FDA, under
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`21 U.S.C. § 355(b)(2) (§ 505(b)(2) of the FFDCA), seeking FDA’s approval to manufacture
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`commercially and sell its proposed product – an insulin glargine [rDNA origin] for injection in a
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`prefilled insulin delivery device, 100 units/mL (“Proposed Product”), that contains data from
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`bioavailability or bioequivalence studies conducted in connection with Sanofi U.S.’s NDA No.
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`21-081.
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`19.
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`On information and belief, on December 18, 2013, Eli Lilly sent a “Notice of
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`Paragraph IV Certifications” pursuant to § 505(b)(2)(A)(iv), (b)(3) of the FFDCA to Plaintiffs,
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`which discloses that its NDA No. 205-692 contained Paragraph IV certifications for, inter alia,
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`the ’864, ’652, and ’930 Patents. In its letter, Eli Lilly stated that its certification to FDA alleges
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`that, inter alia, the ’864, ’652, and ’930 Patents are invalid, unenforceable, and/or will not be
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`infringed by the commercial manufacture, use, or sale of Eli Lilly’s Proposed Product, before
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`their respective expirations.
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`20.
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`Sanofi U.S. received Eli Lilly’s Notice of Paragraph IV Certifications on
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`December 19, 2013.
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`21.
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`Sanofi GmbH received Eli Lilly’s Notice of Paragraph IV Certifications on
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`December 20, 2013.
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`22.
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`On information and belief, on January 23, 2014, Eli Lilly sent an “Amended
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`Notice of Paragraph IV Certifications” pursuant to § 505(b)(2)(A)(iv), (b)(3) of the FFDCA to
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`Plaintiffs, disclosing that Eli Lilly amended its Paragraph IV certifications contained in NDA
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`No. 205-692 to include the ’044 Patent. In its letter dated January 23, 2014, Eli Lilly stated that
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`its certification to FDA alleges, inter alia, that each of the Patents-in-Suit is invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Eli
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`Lilly’s Proposed Product, before their respective expirations.
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`23.
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`Sanofi U.S. received Eli Lilly’s Amended Notice of Paragraph IV Certifications
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`on January 24, 2014.
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`24.
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`Sanofi GmbH received Eli Lilly’s Amended Notice of Paragraph IV Certifications
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`on or about January 27, 2014.
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`25.
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`Eli Lilly’s Notice of Paragraph IV Certifications dated December 18, 2013, was
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`accompanied by an Offer of Confidential Access.
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`26.
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`Eli Lilly and Sanofi executed an Offer for Confidential Access, entitled “Terms of
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`Confidential Access,” on January 23, 2014.
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`27.
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`On January 25, 2014, Sanofi received approximately 66 pages of Eli Lilly’s
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`505(b)(2) application. Those pages were provided subject to the Terms of Confidential Access.
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`No other portions of the 505(b)(2) application have been provided.
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`28.
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`On information and belief, Eli Lilly’s manufacture, use, sale and/or offer to sell in
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`the United States, and/or importation into the United States, of its Proposed Product would
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`infringe each of the Patents-in-Suit, literally and/or under the Doctrine of Equivalents.
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`29.
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`Plaintiffs have commenced this action within 45 days after receiving Eli Lilly’s
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`Notice of Paragraph IV Certifications, and therefore FDA’s approval of NDA 205-692 is subject
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`to the stay provisions of 21 U.S.C. § 355(c)(3)(C).
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`COUNT I
`(Infringement of U.S. Patent No. 8,556,864)
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`30.
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`Plaintiffs repeat and re-allege paragraphs 1-29 above as if fully set forth herein.
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`31.
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`On information and belief, Eli Lilly submitted NDA No. 205-692 to obtain
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`approval under the FFDCA to engage in the commercial manufacture, use, and/or sale of its
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`Proposed Product, which is claimed in the ’864 Patent, before the expiration of the ’864 Patent.
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`On information and belief, Eli Lilly filed NDA No. 205-692 pursuant to § 505(b)(2) of the
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`FFDCA seeking approval to engage in the commercial manufacture, use, and/or sale of the
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`Proposed Product using data from bioavailability or bioequivalence studies conducted in
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`connection with NDA No. 21-081 before the expiration of the ’864 Patent. Eli Lilly’s
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`submission of NDA No. 205-692 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
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`32.
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`On information and belief, Eli Lilly was aware of the ’864 Patent prior to filing
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`NDA No. 205-692. If Eli Lilly’s NDA No. 205-692 is approved, Eli Lilly’s manufacture, use,
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`sale and/or offer to sell in the United States, and/or importation into the United States, of its
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`Proposed Product would infringe the ’864 Patent under 35 U.S.C. § 271(a), (b), and (c), literally
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`and/or under the Doctrine of Equivalents.
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`33.
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`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
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`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
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`will continue unless FDA’s approval of NDA No. 205-692 is stayed, and Eli Lilly is enjoined by
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`the Court from engaging in further infringing acts, pending a date that is not earlier than the
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`expiration of the ’864 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’864
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`Patent are, or become, entitled.
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`COUNT II
`(Infringement of U.S. Patent No. 8,603,044)
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`34.
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`35.
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`Plaintiffs repeat and re-allege paragraphs 1-29 above as if fully set forth herein.
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`On information and belief, Eli Lilly submitted NDA No. 205-692 to obtain
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`approval under the FFDCA to engage in the commercial manufacture, use, and/or sale of its
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`Proposed Product, which is claimed in the ’044 Patent, before the expiration of the ’044 Patent.
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`On information and belief, Eli Lilly filed NDA No. 205-692 pursuant to § 505(b)(2) of the
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`FFDCA seeking approval to engage in the commercial manufacture, use, and/or sale of the
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`Proposed Product using data from bioavailability or bioequivalence studies conducted in
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`connection with NDA No. 21-081 before the expiration of the ’044 Patent. Eli Lilly’s
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`submission of NDA No. 205-692 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
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`36.
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`On information and belief, Eli Lilly is aware of the ’044 Patent. If Eli Lilly’s
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`NDA No. 205-692 is approved, Eli Lilly’s manufacture, use, sale and/or offer to sell in the
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`United States, and/or importation into the United States, of its Proposed Product would infringe
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`the ’044 Patent under 35 U.S.C. § 271(a), (b), and (c), literally and/or under the Doctrine of
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`Equivalents.
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`37.
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`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
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`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
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`will continue unless FDA’s approval of NDA No. 205-692 is stayed, and Eli Lilly is enjoined by
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`the Court from engaging in further infringing acts, pending a date that is not earlier than the
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`expiration of the ’044 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’044
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`Patent are, or become, entitled.
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`COUNT III
`(Infringement of U.S. Patent No. 7,476,652)
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`38.
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`39.
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`Plaintiffs repeat and re-allege paragraphs 1-29 above as if fully set forth herein.
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`On information and belief, Eli Lilly submitted NDA No. 205-692 to obtain
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`approval under the FFDCA to engage in the commercial manufacture, use, and/or sale of its
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`Proposed Product, which is claimed in the ’652 Patent, before the expiration of the ’652 Patent.
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`On information and belief, Eli Lilly filed NDA No. 205-692 pursuant to § 505(b)(2) of the
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`FFDCA seeking approval to engage in the commercial manufacture, use, and/or sale of the
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`Proposed Product using data from bioavailability or bioequivalence studies conducted in
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`connection with NDA No. 21-081 before the expiration of the ’652 Patent. Eli Lilly’s
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`submission of NDA No. 205-692 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
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`40.
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`On information and belief, Eli Lilly was aware of the ’652 Patent prior to filing
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`NDA No. 205-692. If Eli Lilly’s NDA No. 205-692 is approved, Eli Lilly’s manufacture, use,
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`sale and/or offer to sell in the United States, and/or importation into the United States, of its
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`Proposed Product would infringe the ’652 Patent under 35 U.S.C. § 271(a), (b), and (c), literally
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`and/or under the Doctrine of Equivalents.
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`41.
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`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
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`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
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`will continue unless FDA’s approval of NDA No. 205-692 is stayed, and Eli Lilly is enjoined by
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`the Court from engaging in further infringing acts, pending a date that is not earlier than the
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`expiration of the ’652 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’652
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`Patent are, or become, entitled.
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`COUNT IV
`(Infringement of U.S. Patent No. 7,713,930)
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`42.
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`43.
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`Plaintiffs repeat and re-allege paragraphs 1-29 above as if fully set forth herein.
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`On information and belief, Eli Lilly submitted NDA No. 205-692 to obtain
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`approval under the FFDCA to engage in the commercial manufacture, use, and/or sale of its
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`Proposed Product, which is claimed in the ’930 Patent, before the expiration of the ’930 Patent.
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`On information and belief, Eli Lilly filed NDA No. 205-692 pursuant to § 505(b)(2) of the
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`FFDCA seeking approval to engage in the commercial manufacture, use, and/or sale of the
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`Proposed Product using data from bioavailability or bioequivalence studies conducted in
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`connection with NDA No. 21-081 before the expiration of the ’930 Patent. Eli Lilly’s
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`submission of NDA No. 205-692 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
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`44.
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`On information and belief, Eli Lilly was aware of the ’930 Patent prior to filing
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`NDA No. 205-692. If Eli Lilly’s NDA No. 205-692 is approved, Eli Lilly’s manufacture, use,
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`sale and/or offer to sell in the United States, and/or importation into the United States, of its
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`Proposed Product would infringe the ’930 Patent under 35 U.S.C. § 271(a), (b), and (c), literally
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`and/or under the Doctrine of Equivalents.
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`45.
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`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
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`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
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`continue unless FDA’s approval of NDA No. 205-692 is stayed, and Eli Lilly is enjoined by the
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`Court from engaging in further infringing acts, pending a date that is not earlier than the
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`expiration of the ’930 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’930
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`Patent are, or become, entitled.
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`REQUESTED RELIEF
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`Plaintiffs respectfully seek the following relief:
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`a)
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`The entry of judgment declaring that Eli Lilly has infringed each of the Patents-
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`in-Suit;
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`b)
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`The entry of a permanent injunction, enjoining Eli Lilly, its officers, agents,
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`attorneys, and employees, and those acting in active concert with them, from infringing any of
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`the Patents-in-Suit, from engaging in any commercial manufacture, use, offer to sell, or sale
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`within the United States, or importation into the United States, of the insulin glargine [rDNA
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`origin] injection in a prefilled insulin delivery device, 100 units/mL as claimed by the Patents-in-
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`Suit for the full terms thereof (and any additional period of exclusivity to which Plaintiffs and/or
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`the Patents-in-Suit are, or become, entitled), and from inducing or contributing to such activities;
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`c)
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`The entry of an order, pursuant to 35 U.S.C. § 271(e)(4)(A), declaring that the
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`effective date of any approval of NDA No. 205-692 shall be a date that is not earlier than the last
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`date of expiration of any of the Patents-in-Suit, or any later date of exclusivity to which Plaintiffs
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`and/or the Patents-in-Suit are, or become, entitled;
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`d)
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`The entry of an order declaring that this is an exceptional case and awarding
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`Sanofi its costs, expenses, and reasonable attorney fees under 35 U.S.C. § 285 and all other
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`applicable statutes, rules, and common law;
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`e)
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`f)
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`The taxation of all allowable costs against Eli Lilly;
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`The award to Plaintiffs of any other relief that the Court deems just and proper
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`under the circumstances.
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`Of Counsel:
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`Mark A. Perry
`GIBSON, DUNN & CRUTCHER LLP
`1050 Connecticut Avenue, N.W.
`Washington, D.C. 20036
`(202)887-3667
`
`Joseph Evall
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, New York 10166
`(212) 351-2490
`
`Tracey Davies
`GIBSON, DUNN & CRUTCHER LLP
`2100 McKinney Avenue, Suite 1100
`Dallas, Texas 75201
`(214) 698-3335
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`Dated: January 30, 2014
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`ASHBY & GEDDES
`
`/s/ Steven J. Balick
`____________________________
`Steven J. Balick (#2114)
`Tiffany Geyer Lydon (#3950)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, Delaware 19899
`(302) 654-188
`sbalick@ashby-geddes.com
`tlydon@ashby-geddes.com
`amayo@ashby-geddes.com
`
`Attorneys for Plaintiffs Sanofi-Aventis U.S.
`LLC and Sanofi-Aventis Deutschland GmbH
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