DCT

1:16-cv-00812

Sanofi Aventis US LLC v. Merck Sharp & Dohme Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-00812, D. Del., 09/16/2016
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is registered to do business in Delaware, has a registered agent in the state, and has previously availed itself of the District of Delaware for patent litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of a New Drug Application for a proposed insulin glargine injection pen constitutes an act of infringement of ten patents related to drug delivery devices and insulin formulations.
  • Technical Context: The dispute concerns both the mechanical design of pen-type injectors for self-administration of drugs like insulin and the chemical formulation of the insulin glargine drug product itself.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant Merck’s submission of New Drug Application (NDA) No. 208-722 to the FDA. On August 4, 2016, Merck sent a "Notice of Certification" to Plaintiffs, stating its belief that the ten Patents-in-Suit are invalid, unenforceable, and/or will not be infringed by its proposed product. This lawsuit, filed within 45 days of that notice, triggers a statutory stay of FDA approval for Merck's product.

Case Timeline

Date Event
2002-09-09 Priority Date for ’652 and ’930 Patents
2003-03-03 Priority Date for ’833, ’297, ’864, ’044, ’486, ’069, ’391, ’211 Patents
2009-01-13 U.S. Patent No. 7,476,652 Issues
2010-05-11 U.S. Patent No. 7,713,930 Issues
2011-04-05 U.S. Patent No. 7,918,833 Issues
2013-08-20 U.S. Patent No. 8,512,297 Issues
2013-10-15 U.S. Patent No. 8,556,864 Issues
2013-12-10 U.S. Patent No. 8,603,044 Issues
2014-03-25 U.S. Patent No. 8,679,069 Issues
2015-03-31 U.S. Patent No. 8,992,486 Issues
2015-04-21 U.S. Patent No. 9,011,391 Issues
2016-01-12 U.S. Patent No. 9,233,211 Issues
2016-08-04 Merck sends Notice of Certification to Sanofi
2016-09-16 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,918,833, "Pen-Type Injector," issued April 5, 2011

The Invention Explained

  • Problem Addressed: The patent describes the need for pen-type injectors that are robust, easy to manufacture, and simple for patients without formal medical training, such as diabetics, to operate for self-injection (Compl. ¶11; ’833 Patent, col. 1:5-25).
  • The Patented Solution: The invention is a mechanical drive mechanism for an injector pen. Its core concept involves a specific relationship between a rotatable "dose dial sleeve" (which the user turns to set the dose) and a "drive sleeve" that pushes the piston rod to dispense the drug. The patent claims a configuration where the helical thread on the dose dial sleeve and the helical groove on the drive sleeve have the same "lead," or rate of axial travel per rotation ('833 Patent, col. 1:30-40, Abstract). This design allows the dose dial and drive sleeve to extend out from the housing at the same rate when a dose is dialed ('833 Patent, col. 5:40-45).
  • Technical Importance: This mechanical arrangement aims to provide a reliable and intuitive user experience for setting and delivering a precise dose from a multi-dose cartridge ('833 Patent, col. 1:5-12).

Key Claims at a Glance

The complaint alleges infringement of one or more claims of the ’833 Patent without specifying which claims are asserted (Compl. ¶35, 38). Claim 1 is the first independent claim and is representative of the patented technology.

  • A pen-type injector, comprising:
    • a housing;
    • a piston rod adapted to operate through the housing;
    • a dose dial sleeve located between the housing and the piston rod, having a helical thread of a first lead;
    • a drive sleeve located between the dose dial sleeve and the piston rod, having a helical groove of a second lead;
    • wherein the first lead of the helical thread and the second lead of the helical groove are the same, the sleeves are not mechanically engaged by these features, and the drive sleeve is releasably connected to the dose dial sleeve.

U.S. Patent No. 8,512,297, "Pen-Type Injector," issued August 20, 2013

The Invention Explained

  • Problem Addressed: This patent addresses the same general problem as the ’833 Patent: the need for robust and easy-to-use pen-type injectors for self-administration of medication (Compl. ¶12; ’297 Patent, col. 1:15-24).
  • The Patented Solution: The invention described is a "dispensed dose indicator mechanism" for an injector pen. It features a nut that is fixed rotationally with respect to the injector housing but is free to move axially along a threaded drive sleeve. As the drive sleeve rotates during dose delivery, the nut travels along its thread. The axial position of this nut serves as a mechanical memory, indicating the total amount of drug that has been dispensed from the cartridge ('297 Patent, col. 5:47-54, Abstract). This mechanism can be used to prevent the user from dialing a dose larger than the amount of medication remaining in the cartridge.
  • Technical Importance: This mechanism provides a clear, mechanical method for tracking the remaining volume in a multi-dose cartridge, enhancing safety by preventing users from attempting to dial a dose that cannot be fully delivered ('297 Patent, col. 6:1-15).

Key Claims at a Glance

The complaint alleges infringement of one or more claims of the ’297 Patent without specifying which claims are asserted (Compl. ¶35, 42). Claim 1 is the first independent claim and is representative of the patented technology.

  • A dispensed dose indicator mechanism for a pen-type injector, comprising:
    • a housing having an internal surface with one or more splines;
    • a drive sleeve configured to move axially and rotationally relative to the housing's internal surface, the drive sleeve having a threaded outer surface; and
    • a nut engaged with the thread, where the nut is rotationally fixed to the housing and is axially displaceable along the thread when the drive sleeve is rotated.

U.S. Patent No. 8,556,864, "Drive Mechanisms Suitable for Use in Drug Delivery Devices," issued October 15, 2013

  • Technology Synopsis: This patent describes a drive mechanism for a drug delivery device featuring a housing, a dose dial sleeve, a drive sleeve, and a clutch. The claimed mechanism operates in two states: a coupled state where the dose dial and drive sleeves rotate together to set a dose, and a de-coupled state where the dose dial sleeve's rotation is blocked, allowing axial movement of the drive sleeve to dispense the dose (Compl. ¶13; ’864 Patent, col. 2:5-29). This clutch-based system is designed to provide an intuitive interface for dose setting, correction, and delivery.
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 46).
  • Accused Features: The complaint accuses Merck’s proposed prefilled insulin delivery device of infringing one or more claims (Compl. ¶24, 46).

U.S. Patent No. 8,603,044, "Pen-Type Injector," issued December 10, 2013

  • Technology Synopsis: This patent claims a housing assembly for a pen-type injector. The invention focuses on the interaction between a main housing, a dose dial sleeve with a helical groove, a non-rotatable piston rod, a drive sleeve, and a tubular clutch ('044 Patent, Abstract). The configuration is intended to provide a reliable and user-friendly dose-setting and injection experience.
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 54).
  • Accused Features: The complaint accuses Merck’s proposed prefilled insulin delivery device of infringing one or more claims (Compl. ¶24, 54).

U.S. Patent No. 8,992,486, "Pen-Type Injector," issued March 31, 2015

  • Technology Synopsis: This patent is directed to a housing for a dispensing apparatus. The claims describe a combination of a main housing, a dose dial sleeve, a dose knob, a non-rotatable piston rod, a driver, and a tubular clutch. The dose dial sleeve is described as extending circumferentially around at least a portion of the clutch ('486 Patent, Abstract).
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 50).
  • Accused Features: The complaint accuses Merck’s proposed prefilled insulin delivery device of infringing one or more claims (Compl. ¶24, 50).

U.S. Patent No. 8,679,069, "Pen-Type Injector," issued March 25, 2014

  • Technology Synopsis: This patent claims a housing part for a medication dispensing apparatus. The claimed structure includes a main housing, a dose dial sleeve with a helical groove, a dose dial grip, a non-rotatable piston rod, a drive sleeve, and a tubular clutch. The invention focuses on the specific arrangement and interaction of these components to facilitate dose setting and delivery ('069 Patent, col. 6:51-64).
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 58).
  • Accused Features: The complaint accuses Merck’s proposed prefilled insulin delivery device of infringing one or more claims (Compl. ¶24, 58).

U.S. Patent No. 9,011,391, "Pen-Type Injector," issued April 21, 2015

  • Technology Synopsis: This patent describes a method for determining the final dose of a medicament in a pen-type injector. The method involves providing a housing with a drive sleeve and a nut, where the nut's axial position along the drive sleeve is indicative of dispensed doses. The mechanism is configured to engage the nut with the drive sleeve's flange when the final dose is reached, preventing further operation ('391 Patent, col. 8:8-26).
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 62).
  • Accused Features: The complaint accuses Merck’s proposed prefilled insulin delivery device of infringing one or more claims (Compl. ¶24, 62).

U.S. Patent No. 9,233,211, "Relating to a Pen-Type Injector," issued January 12, 2016

  • Technology Synopsis: This patent is directed to a drive mechanism for a pen-type injector that includes a nut threadedly engaged with a drive sleeve between two flanges. The nut is keyed to the housing to prevent rotation, and its axial movement along the drive sleeve tracks the dispensed dose. This mechanism provides a mechanical means of tracking the remaining drug volume ('211 Patent, col. 7:1-9).
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 66).
  • Accused Features: The complaint accuses Merck’s proposed prefilled insulin delivery device of infringing one or more claims (Compl. ¶24, 66).

U.S. Patent No. 7,476,652, "Acidic Insulin Preparations Having Improved Stability," issued January 13, 2009

  • Technology Synopsis: This patent addresses the problem of insulin aggregation and instability, particularly in acidic solutions which are prone to particle formation under thermal and mechanical stress ('652 Patent, col. 3:1-7). The invention claims a pharmaceutical formulation of an insulin analog (insulin glargine) in an acidic solution (pH 1-6.8) that is stabilized by the addition of a surfactant, such as polysorbate 20 or polysorbate 80 ('652 Patent, Abstract, col. 11:1-9).
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 70).
  • Accused Features: The complaint accuses Merck’s proposed insulin glargine product, which is an acidic formulation for injection, of infringing one or more claims (Compl. ¶24, 70).

U.S. Patent No. 7,713,930, "Acidic Insulin Preparations Having Improved Stability," issued May 11, 2010

  • Technology Synopsis: This patent, related to the ’652 patent, also addresses the instability of acidic insulin preparations ('930 Patent, col. 3:1-7). The invention is a pharmaceutical formulation of insulin glargine in an acidic solution (pH 1-6.8) that includes a surfactant selected from esters and ethers of polyhydric alcohols ('930 Patent, Abstract, col. 11:43-56). This addition of a surfactant is intended to prevent particle formation and improve the product's shelf life and in-use stability.
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶35, 74).
  • Accused Features: The complaint accuses Merck’s proposed insulin glargine product, an acidic formulation for injection, of infringing one or more claims (Compl. ¶24, 74).

III. The Accused Instrumentality

Product Identification

  • The accused product is Merck's "Proposed Product" for which it submitted New Drug Application No. 208-722 to the FDA (Compl. ¶24).

Functionality and Market Context

  • The complaint identifies the accused product as an "insulin glargine [rDNA origin] for subcutaneous injection in a prefilled insulin delivery device, 100 units/mL" (Compl. ¶24). The product is intended as a follow-on or generic version of Sanofi's Lantus® and Lantus® SoloSTAR® products (Compl. ¶22).
  • The complaint does not provide specific technical details regarding the functionality of the accused delivery device. It explicitly states that Plaintiffs lack such information and intend to use discovery to confirm their infringement allegations (Compl. ¶31). The infringement allegations are based on the act of filing the NDA for a product that, upon information and belief, will infringe when commercially manufactured and sold (Compl. ¶35, 37).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain element-by-element infringement allegations or claim charts. Instead, it asserts on "information and belief" that Merck's proposed product, if approved and marketed, would infringe one or more claims of each of the ten Patents-in-Suit, both literally and under the doctrine of equivalents (Compl. ¶35, 38, 42, etc.). The act of infringement alleged is Merck's submission of NDA No. 208-722 under 35 U.S.C. § 271(e)(2)(A), which constitutes a technical act of infringement for the purpose of creating federal jurisdiction (Compl. ¶37).

  • Identified Points of Contention:
    • Technical Questions (Device Patents): As the complaint lacks technical detail on the accused device, a primary point of contention will be factual. A central question, pending discovery, is whether the mechanical design of Merck's device incorporates the specific drive mechanisms, clutch systems, and dose indicator features recited in the independent claims of the asserted device patents (e.g., the '833 and '297 Patents).
    • Technical Questions (Formulation Patents): For the '652 and '930 Patents, the key technical question will be whether Merck's insulin glargine formulation includes a stabilizing surfactant as claimed. The complaint alleges infringement on information and belief, suggesting this will be a subject of discovery into the product's exact composition.

V. Key Claim Terms for Construction

The complaint does not identify any claim terms for construction. Based on the representative claims of the lead patents, the following terms may become central to the dispute.

  • ’833 Patent, Claim 1:

    • The Term: "drive sleeve being releasably connected to the dose dial sleeve"
    • Context and Importance: The nature of this "releasable connection" is the core of the claimed dose setting and delivery mechanism. Practitioners may focus on this term because its definition will determine whether a wide range of mechanical interfaces (e.g., different types of clutches) fall within the scope of the claim, or if it is limited to the specific clutch shown in the patent's embodiments.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself does not specify a particular mechanism for the connection, which may support an interpretation covering any means of releasably connecting the two sleeves for the stated purpose.
      • Evidence for a Narrower Interpretation: The specification describes the connection as being implemented via a "clutch means" with specific dog teeth ('833 Patent, col. 2:52-54; Fig. 8). A defendant may argue that the claim should be limited to this disclosed embodiment or its equivalents.

  • ’652 Patent, Claim 1:

    • The Term: "a pH in the acidic range from 1 to 6.8"
    • Context and Importance: This term defines the chemical environment of the claimed formulation. Its construction will be critical because insulin glargine's solubility and stability are highly pH-dependent. The scope of "acidic range" will determine whether products operating at the edge of this range (e.g., near neutral pH) are covered.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim provides an explicit numerical range, which generally defines its own scope.
      • Evidence for a Narrower Interpretation: The specification repeatedly emphasizes a "particularly preferably" pH range of 3.5-4.5 ('652 Patent, col. 4:16-18). A defendant might argue that the true invention is limited to this narrower, more effective range, although overcoming the explicit claim language would present a significant challenge.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges infringement under 35 U.S.C. § 271(b) and (c), covering induced and contributory infringement (Compl. ¶38, 42, etc.). The complaint does not plead specific facts to support these allegations beyond the general assertion that Merck's activities will cause infringement if its product is approved.
  • Willful Infringement: For each patent, the complaint alleges that "Merck was aware of the [asserted] Patent prior to filing NDA No. 208-722" (e.g., Compl. ¶38, 42). This allegation of pre-suit knowledge forms the basis for a potential claim of willful infringement. The prayer for relief also seeks a declaration that this is an exceptional case under 35 U.S.C. § 285 (Compl. p. 18).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central evidentiary question will be one of technical overlap: once the design of Merck's proposed device and the composition of its formulation are revealed in discovery, will they be found to practice the specific mechanical arrangements and chemical compositions required by the asserted claims, or is there a fundamental mismatch?
  • A key legal issue, raised by Merck’s Paragraph IV certification, will be one of patent validity: will the ten asserted patents withstand Merck’s challenges that they are invalid and/or unenforceable, as alleged in its Notice of Certification (Compl. ¶25)?
  • A foundational issue for the formulation patents will be one of chemical composition: does Merck's proposed insulin glargine product contain a surfactant for stability, as claimed in the '652 and '930 patents, or does it achieve stability through an alternative, non-infringing method?