DCT

2:17-cv-09105

Sanofi Aventis US LLC v. Mylan NV

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-09105, D.N.J., 10/24/2017
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendants conduct substantial and systematic business in the state, including through a subsidiary, Mylan Specialty, which maintains a "regular and established place of business" in Basking Ridge, New Jersey, and from which Mylan markets prescription drug products.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of a New Drug Application for generic versions of Sanofi's Lantus® and Lantus® SoloSTAR® products infringes eighteen patents related to insulin glargine formulations and pen-type injection devices.
  • Technical Context: The dispute concerns both pharmaceutical formulations for long-acting insulin analogs, a critical therapy for diabetes management, and the mechanical design of pen-type injectors used for their self-administration.
  • Key Procedural History: The complaint notes that on June 5, 2017, Defendant Mylan filed petitions for Inter Partes Review (IPR) with the U.S. Patent and Trademark Office, challenging the validity of U.S. Patent Nos. 7,476,652 and 7,713,930, two of the formulation patents-in-suit. The outcome of these administrative proceedings could affect the scope and validity of claims asserted in this litigation.

Case Timeline

Date Event
2002-06-18 Priority Date for '652 and '930 Patents
2003-03-03 Priority Date for '833, '297, '864, '044, '069, '486, '391, '211, '979, '844, '105, '331, '008, '009, '409, and '189 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
2016-08-09 U.S. Patent No. 9,408,979 Issues
2016-12-27 U.S. Patent No. 9,526,844 Issues
2017-01-03 U.S. Patent No. 9,533,105 Issues
2017-02-07 U.S. Patent No. 9,561,331 Issues
2017-03-28 U.S. Patent Nos. 9,604,008 and 9,604,009 Issue
2017-04-04 U.S. Patent No. 9,610,409 Issues
2017-04-18 U.S. Patent No. 9,623,189 Issues
2017-06-05 Mylan files IPR petitions for '652 and '930 Patents
2017-09-15 Mylan sends Notice Letter regarding NDA No. 210605
2017-09-18 Sanofi receives Mylan's Notice Letter
2017-10-24 Complaint Filed

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

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

The Invention Explained

  • Problem Addressed: The patent describes that insulin preparations, particularly those with an acidic pH like insulin glargine, show decreased stability and an increased tendency to aggregate when subjected to thermal and physicomechanical stress, such as the agitation that occurs during patient handling (Compl. Ex. A, '652 Patent, col. 3:1-9). This aggregation can manifest as turbidity or particle formation, compromising the product's safety and efficacy.
  • The Patented Solution: The invention is a pharmaceutical formulation that aims to solve this stability problem by adding specific surfactants, such as polysorbate 20 or polysorbate 80, to an acidic insulin preparation ('652 Patent, col. 4:40-51; Abstract). This addition is described as greatly increasing the stability of the acidic insulin, making it more robust against aggregation caused by temperature stress and physical agitation ('652 Patent, col. 4:40-45).
  • Technical Importance: This approach provided a method to enhance the shelf-life and in-use stability of an important long-acting insulin analog, facilitating its reliable use in multi-dose formats like vials and pre-filled pens.

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the '652 Patent without specifying which claims (Compl. ¶103). Independent claim 1 is representative.
  • Independent Claim 1:
    • A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin;
    • at least one chemical entity chosen from polysorbate 20 and polysorbate 80;
    • at least one preservative; and
    • water,
    • wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
  • The patent was subject to an Inter Partes Review (IPR2017-01526), and the certificate attached to the patent indicates that claims 1-25 were cancelled as of January 5, 2021 ('652 Patent, p. 11).

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

The Invention Explained

  • Problem Addressed: Similar to the '652 Patent, this patent addresses the problem of physical and thermal instability in acidic insulin preparations, which can lead to aggregation and particle formation during storage and patient use ('930 Patent, col. 3:1-9).
  • The Patented Solution: The invention claims a pharmaceutical formulation for the insulin analog Gly(A21), Arg(B31), Arg(B32)-human insulin that includes a surfactant selected from esters and ethers of polyhydric alcohols ('930 Patent, col. 11:46-51). This formulation is designed to have a pH in the acidic range and is intended to improve stability against aggregation ('930 Patent, col. 4:45-49).
  • Technical Importance: This technology provides another formulation strategy to ensure the stability and reliability of long-acting insulin glargine for diabetic patients.

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the '930 Patent without specification (Compl. ¶107). Independent claim 1 is representative.
  • Independent Claim 1:
    • A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin;
    • at least one chemical entity chosen from esters and ethers of polyhydric alcohols;
    • at least one preservative; and
    • water,
    • wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
  • This patent was also subject to an Inter Partes Review (IPR2017-01528), and the certificate attached to the patent indicates that claims 1-20 were cancelled as of January 5, 2021 ('930 Patent, p. 12).

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

  • Technology Synopsis: This patent addresses the mechanical design of pen-type injectors used for self-administering medication from a multi-dose cartridge. The invention relates to a drive mechanism involving a dose dial sleeve and a drive sleeve that operate with helical threads of the same lead, which is intended to provide a robust and easy-to-use device for patients to set and deliver a dose ('833 Patent, col. 1:5-12; Abstract).
  • Asserted Claims: The complaint does not specify claims (Compl. ¶111).
  • Accused Features: The "Proposed Prefilled Pen Product" is accused of infringement (Compl. ¶110).

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

  • Technology Synopsis: This patent, related to the '833 patent, also covers the mechanical design of a pen-type injector. The claims focus on a "dispensed dose indicator mechanism" that includes a nut which travels along a threaded drive sleeve to provide an indication of the doses dispensed from the cartridge, serving as a means to track the remaining medication ('297 Patent, Abstract; col. 2:1-4).
  • Asserted Claims: The complaint does not specify claims (Compl. ¶115).
  • Accused Features: The "Proposed Prefilled Pen Product" is accused of infringement (Compl. ¶114).

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 clutch that couples and de-couples a dose dial sleeve and a drive sleeve. When coupled, both can rotate to set a dose; when de-coupled to dispense a dose, the drive sleeve is prevented from rotating but moves axially to transfer force, a design intended to provide an intuitive and reliable user experience ('864 Patent, Abstract).
  • Asserted Claims: The complaint does not specify claims (Compl. ¶119).
  • Accused Features: The "Proposed Prefilled Pen Product" is accused of infringement (Compl. ¶118).

III. The Accused Instrumentality

Product Identification

The accused products are Mylan's proposed generic drug products identified in its New Drug Application (NDA) No. 210605 (Compl. ¶1, 88). These include a "Proposed Vial Product" and a "Proposed Prefilled Pen Product" (Compl. ¶88).

Functionality and Market Context

The accused products are proposed copies of Sanofi's Lantus® (vial) and Lantus® SoloSTAR® (prefilled pen) products (Compl. ¶1). They contain insulin glargine [rDNA origin] at a concentration of 100 u/mL for subcutaneous injection to treat diabetes (Compl. ¶88). The complaint alleges that these products, if approved, would be follow-on versions of Sanofi's branded products and that no non-licensed generic versions are currently on the market in the United States (Compl. ¶85). The complaint alleges that Mylan's filing seeks approval to commercially manufacture, use, and sell these products before the expiration of the patents-in-suit (Compl. ¶1).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-chart analysis. The infringement allegations are pleaded at a high level, asserting that Mylan's filing of NDA No. 210605 constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) and that the future manufacture, use, or sale of the Proposed Products would infringe one or more claims of each patent-in-suit, literally or under the doctrine of equivalents (Compl. ¶¶ 102-103, 106-107). No probative visual evidence provided in complaint.

For the formulation patents ('652 and '930), the core of the infringement allegation is that Mylan's proposed insulin glargine products are "acidic insulin preparations" that necessarily fall within the scope of the claims covering stable formulations containing specific surfactants (Compl. ¶¶ 102-103, 106-107). For the sixteen device patents, the allegation is that Mylan's "Proposed Prefilled Pen Product" contains the mechanical components and drive mechanisms covered by the asserted claims (e.g., Compl. ¶¶ 110-111).

Identified Points of Contention

  • Formulation Questions: The primary dispute for the '652 and '930 patents will likely concern the specific composition of Mylan's proposed formulation. Key questions may include: Does Mylan's formulation contain a claimed surfactant (e.g., polysorbate 20 or 80)? Does its product maintain a pH within the claimed "acidic range" throughout its shelf life? What evidence exists that Mylan's excipients are equivalent to those claimed?
  • Device Questions: For the numerous pen injector patents, the analysis will turn on a detailed comparison of the mechanical structures in Mylan's proposed pen device against the specific claim limitations. Questions will arise regarding whether Mylan's device contains, for example, a "drive sleeve" and "dose dial sleeve" that operate with the same "lead" as required by claim 1 of the '833 patent, or a "dispensed dose indicator mechanism" as claimed in the '297 patent.

V. Key Claim Terms for Construction

U.S. Patent Nos. 7,476,652 & 7,713,930

  • The Term: "pharmaceutical formulation... having a pH in the acidic range from 1 to 6.8" (appearing in claim 1 of both patents)
  • Context and Importance: The definition of this term is central to the scope of the formulation patents. Practitioners may focus on this term because the infringement analysis will depend on whether Mylan's proposed product, as defined in its NDA, possesses a formulation that meets this limitation. The stability of insulin glargine is highly dependent on its pH.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the claim itself recites a broad range of "1 to 6.8," which could be argued to cover any formulation falling anywhere within that range ('652 Patent, col. 11:11-12).
    • Evidence for a Narrower Interpretation: The specification repeatedly emphasizes a "very particularly" preferred pH range of 3.5-4.5 ('652 Patent, col. 5:15-17). A defendant may argue that the invention is properly centered on this narrower range, where the stability benefits are most pronounced, potentially limiting the scope of the claim.

VI. Other Allegations

Indirect Infringement

For each asserted patent, the complaint alleges that Mylan was aware of the patent prior to filing its NDA and that if the NDA is approved, Mylan's actions will induce and/or contribute to infringement by others (e.g., patients and physicians) (Compl. ¶¶ 103, 107, 111). This allegation is based on Mylan’s submission of a Paragraph IV certification, which is a statement that the patents are invalid, unenforceable, or will not be infringed, and which by its nature demonstrates knowledge of the patents.

Willful Infringement

The complaint does not explicitly use the word "willful." However, the Prayer for Relief requests an order declaring the case "exceptional" and awarding attorney fees under 35 U.S.C. § 285 (Compl. p. 66(f)). Such a finding is often predicated on allegations of willful or egregious conduct. The basis for this would be the allegation that Mylan acted with "full knowledge" of the patents and their claims "and without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶¶ 178, 185).

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

  • A core issue will be one of claim validity and scope: Given that all asserted claims of the two lead formulation patents ('652 and '930) were subsequently cancelled in Inter Partes Review proceedings, a primary question is what claims, if any, from the remaining sixteen device patents are valid and sufficiently broad to cover Mylan's proposed pen injector.
  • A key evidentiary question will be one of formulation and mechanical equivalence: Assuming any claims survive validity challenges, the case will turn on technical comparisons. For the formulation patents, does the specific combination of excipients and pH in Mylan's product fall within the literal scope of, or is it equivalent to, the claimed formulations? For the device patents, does the mechanical design of Mylan's pen injector incorporate the specific structural and functional elements recited in the claims, or are there material differences in its mechanism of operation?