DCT

3:15-cv-00290

Sanofi Aventis US LLC v. Mylan Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:15-cv-00290, D.N.J., 01/14/2015
  • Venue Allegations: Venue is based on Defendant allegedly conducting business and planning to market, distribute, and sell its generic product in New Jersey through various affiliates and agents, and on Plaintiff Sanofi-Aventis U.S. LLC having its commercial headquarters in the state.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic cabazitaxel injection constitutes an act of infringement of two patents covering the active pharmaceutical ingredient and its crystalline form.
  • Technical Context: The technology is in the field of oncology therapeutics, specifically concerning taxoid-based compounds used in chemotherapy for hormone-refractory metastatic prostate cancer.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant’s December 4, 2014 notice letter, which included a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by its proposed generic product. The complaint also notes pending litigation initiated by Plaintiffs against other generic manufacturers concerning the same patents.

Case Timeline

Date Event
1995-03-27 ’170 Patent Priority Date
1998-12-08 U.S. Patent No. 5,847,170 Issued
2003-09-19 ’907 Patent Priority Date
2007-07-10 U.S. Patent No. 7,241,907 Issued
2010-06-17 FDA Approval of New Drug Application for JEVTANA®
2014-12-04 Defendant’s Paragraph IV Notice Letter Date
2014-12-05 Plaintiffs’ Receipt of Paragraph IV Notice Letter
2015-01-14 Complaint Filing Date

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

U.S. Patent No. 5,847,170 - “Taxoids, Their Preparation And Pharmaceutical Compositions Containing Them”

The Invention Explained

  • Problem Addressed: The patent is directed to new chemical entities and does not explicitly articulate a problem in a background section. However, the context of the invention is the search for novel compounds with anti-cancer properties. (’170 Patent, Abstract).
  • The Patented Solution: The patent discloses a new class of taxoid compounds, their methods of preparation, and pharmaceutical compositions containing them. (’170 Patent, col. 1:7-10). The core of the invention is the chemical structure of these novel compounds, including the specific compound known as cabazitaxel, which is claimed to possess "noteworthy antitumour and antileukaemic properties." (’170 Patent, Abstract).
  • Technical Importance: The invention provided new therapeutic agents in the taxoid class, which had established importance in oncology. The specification notes that the new compounds show activity against tumors resistant to existing drugs like Taxol® or Taxotere®, suggesting an advancement in treating refractory cancers. (’170 Patent, col. 11:58-63).

Key Claims at a Glance

The complaint does not identify specific asserted claims, reserving the right to assert "one or more claims" of the patent-in-suit (Compl. ¶ 34). Claim 1 is an independent claim directed to the compound cabazitaxel itself.

  • Independent Claim 1: A compound identified by the chemical name:
    • 4α-acetoxy-2α-benzoyloxy-5β,20-epoxy-1β-hydroxy-7β,10β-dimethoxy-9-oxo-11-taxen-13α-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate.

U.S. Patent No. 7,241,907 - “Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation”

The Invention Explained

  • Problem Addressed: The patent’s background section is minimal, referencing prior art processes for preparing the active ingredient (cabazitaxel). (’907 Patent, col. 1:21-30). In pharmaceutical development, a common technical problem is obtaining the active pharmaceutical ingredient in a stable, pure, and reproducible solid form suitable for manufacturing and formulation, which the base compound may lack.
  • The Patented Solution: The invention provides a specific crystalline form of cabazitaxel, identified as an acetone solvate. (’907 Patent, Abstract). This solvate is "fully characterized from a chemical viewpoint" and can be obtained by a described process involving crystallization from an acetone and water mixture. (’907 Patent, col. 1:35-42, col. 2:1-5).
  • Technical Importance: The creation of a defined, characterizable crystalline form (a solvate) of a drug substance is a critical step in pharmaceutical manufacturing, as it allows for consistent production, predictable stability, and reliable formulation of the final drug product.

Key Claims at a Glance

The complaint does not identify specific asserted claims, reserving the right to assert "one or more claims" (Compl. ¶ 34). Claim 1 is an independent claim directed to the specific solvate form.

  • Independent Claim 1: A crystalline compound defined as:
    • An acetone solvate of 4-acetoxy-2a-benzoyloxy-5β,20-epoxy-1-hydroxy-7β,10β-dimethoxy-9-oxotax-11-en-13α-yl (2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendant Onco’s proposed generic drug product, cabazitaxel injection [60 mg/1.5 mL] [40 mg/mL], for which it seeks FDA approval via ANDA No. 207381 (Compl. ¶ 9).

Functionality and Market Context

  • The proposed product is a generic equivalent of Plaintiffs' JEVTANA® drug product (Compl. ¶ 30). The ANDA seeks approval for the same therapeutic use: "in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen" (Compl. ¶ 26). The act of infringement alleged is the filing of the ANDA itself, a statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶¶ 36, 41). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed, element-by-element infringement allegations for either patent-in-suit. The infringement theory is based on the statutory act of infringement defined in 35 U.S.C. § 271(e)(2), where the submission of an ANDA for a drug claimed in a patent is an act of infringement if the purpose is to obtain approval to market the drug before the patent expires (Compl. ¶¶ 36, 41).

The core of the infringement allegation is that the product described in Onco’s ANDA, if commercially manufactured and sold, would infringe the asserted patents. For the ’170 Patent, the allegation is that Onco's proposed product contains the chemical compound cabazitaxel, which is claimed by the patent (Compl. ¶¶ 9, 21, 36). For the ’907 Patent, the allegation is that the active pharmaceutical ingredient in Onco’s proposed product is the specific acetone solvate of cabazitaxel claimed by that patent (Compl. ¶¶ 9, 23, 41).

  • Identified Points of Contention: The complaint states that Onco’s Paragraph IV certification letter asserts that the patents will not be infringed and/or are invalid or unenforceable (Compl. ¶ 29).
    • Scope Questions: For the ’170 Patent, a potential dispute may arise regarding whether the active ingredient in Defendant's product meets all structural and stereochemical requirements defined by the chemical name in the claims. For the ’907 Patent, a central question will be whether the term "acetone solvate" is limited to the specific crystalline form characterized in the patent’s specification or if it can read on other forms containing acetone.
    • Technical Questions: A key factual question for the ’170 Patent will be the chemical analysis of Defendant's active pharmaceutical ingredient to confirm its identity as cabazitaxel. For the ’907 Patent, the primary technical question will be one of polymorphic identity: does the solid-state form of the active ingredient in Defendant's product correspond to the claimed acetone solvate, as would be determined by techniques like powder X-ray diffraction, or is it an amorphous form or a different, non-infringing crystalline polymorph?

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim term disputes. However, based on the subject matter, certain terms may become central to the case.

  • ’170 Patent: As the independent claim recites a specific chemical compound by its IUPAC name, claim construction disputes are less common than in other technology areas. The primary dispute is typically factual—whether the accused product is that precisely defined molecule. Any dispute may center on the purity or stereoisomeric form of the accused compound as compared to that required by the claim.

  • ’907 Patent:

    • The Term: "acetone solvate"
    • Context and Importance: This term is the basis of the ’907 Patent's claim to novelty over the prior art ’170 Patent, which claimed the compound itself. The entire infringement and validity analysis for this patent will depend on the scope of this term and whether Defendant’s product falls within it. Practitioners may focus on this term because demonstrating that a generic product uses a different, non-infringing crystalline form is a common strategy for avoiding infringement of polymorph patents.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language of Claim 1 simply claims "An acetone solvate..." without express limitation to a specific stoichiometry or set of analytical peaks. A party could argue this covers any crystalline form of cabazitaxel that incorporates acetone molecules into its crystal lattice.
      • Evidence for a Narrower Interpretation: The specification provides a specific powder X-ray diffraction diagram (PXRD) in FIG. 1, which serves to characterize the invention (’907 Patent, col. 1:45-47). Further, the detailed description notes a mean acetone content of 7%, which "represents approximately the acetone stoichiometry, which is 6.5%, for a solvate comprising one molecule of acetone" (’907 Patent, col. 2:40-43). This data may be used to argue that the term "acetone solvate" is limited to the specific monosolvate form characterized by the PXRD pattern shown in FIG. 1.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Onco commercially makes, sells, or imports its product, it would induce or contribute to infringement under 35 U.S.C. §§ 271(b) and (c) (Compl. ¶¶ 37, 42). The factual basis for inducement would likely rely on the proposed product labeling that instructs physicians and patients to use the drug for the patented indication.
  • Willful Infringement: While the complaint does not use the word "willful," it alleges that Onco was "aware" of both patents-in-suit at the time it submitted its ANDA (Compl. ¶¶ 36, 41). Plaintiffs also request a declaration that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for an award of attorney fees and is often predicated on conduct akin to willfulness (Compl. ¶¶ 39, 44, Prayer for Relief K).

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

Based on the complaint and the nature of the asserted patents, the litigation may center on the following key questions:

  • A core issue will be one of chemical and physical identity: Can Defendant demonstrate through analytical evidence that the active pharmaceutical ingredient in its proposed generic product is either a different chemical entity than claimed in the ’170 Patent, or, more plausibly, a different physical crystalline form (polymorph) that falls outside the scope of the "acetone solvate" claimed in the ’907 Patent?
  • A second issue will be one of validity: Will Defendant be able to prove, by clear and convincing evidence, that the asserted claims are invalid as anticipated or obvious in light of prior art concerning other taxoid compounds (’170 Patent) or known crystallization techniques (’907 Patent)?