DCT

1:20-cv-00803

Sanofi Aventis US LLC v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00803, D. Del., 06/12/2020
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendant’s regular and substantial business in Delaware, including the marketing and sale of pharmaceutical products, and Defendant's consent to jurisdiction by participating in prior patent litigation in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of applications to the FDA for approval to market generic versions of the cancer drug JEVTANA® constitutes an act of infringement of a patent covering a specific method of using the drug to increase patient survival.
  • Technical Context: The case involves pharmaceutical treatment methods for metastatic castration-resistant prostate cancer, a field where extending patient survival after initial therapies have failed is a significant clinical challenge and commercial objective.
  • Key Procedural History: The parties have a significant litigation history. In a prior case involving the same drug, a court found that Accord infringed Sanofi’s U.S. Patent No. 5,847,170, but that a related patent, U.S. Patent No. 8,927,592, was invalid. The complaint for the current '110 patent asserts that its claims are patentably distinct from those of the invalidated '592 patent, specifically by adding limitations requiring an intentional purpose of prolonging survival and a specific premedication regimen.

Case Timeline

Date Event
2009-10-29 Earliest Priority Date for U.S. Patent No. 10,583,110
2010-06-17 FDA approves Sanofi's JEVTANA® (NDA No. 201023)
2014-11-24 Accord sends notice letter regarding prior litigation patents ('170, '592)
2015-03-11 Accord sends second notice letter regarding prior litigation patents
2017-09-29 Conclusion of bench trial in prior litigation between the parties
2020-03-10 U.S. Patent No. 10,583,110 Issues
2020-05-22 Accord sends notice letter regarding the '110 Patent
2020-06-12 Complaint Filed

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

  • Patent Identification: U.S. Patent No. 10,583,110, "Novel Antitumoral Use of Cabazitaxel", issued March 10, 2020.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of treating patients with advanced, metastatic prostate cancer who have already been treated with a docetaxel-based chemotherapy regimen and whose cancer is resistant to hormonal therapy ('110 Patent, col. 2:22-29). For this patient population, treatment options are limited, and there is an "unmet medical need" for a therapy that can extend survival ('110 Patent, col. 2:26-29).
  • The Patented Solution: The invention is a specific therapeutic method. It involves administering the anti-cancer drug cabazitaxel in combination with a corticosteroid (prednisone) and a specific pre-treatment regimen of an antihistamine, another corticosteroid, and an H2 antagonist ('110 Patent, cl. 1). This complete regimen is administered to the specific patient population (metastatic, castration-resistant, previously treated with docetaxel) to increase their overall survival ('110 Patent, Abstract; col. 6:38-44). The patent's clinical trial data, presented in Figure 1, purports to show a statistically significant increase in overall survival for patients receiving the cabazitaxel regimen compared to a different chemotherapy ('110 Patent, Fig. 1; col. 12:46-55).
  • Technical Importance: The method provided a second-line chemotherapy option that demonstrated a survival benefit for patients whose prostate cancer had progressed after first-line docetaxel treatment, a critical endpoint in oncology drug development ('110 Patent, col. 2:22-29).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the '110 patent, with the allegations mapping to independent claim 1 (Compl. ¶32, 38).
  • The essential elements of independent claim 1 are:
    • A method of increasing survival comprising administering to a patient in need thereof
    • (1) cabazitaxel, or a hydrate of solvate thereof, as a new cycle every three weeks and
    • (2) dexchlorpheniramine administered at a dose of 5 mg, dexamethasone administered at a dose of 8 mg, and an H2 antagonist, each administered prior to the administration of said cabazitaxel,
    • wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel.
  • The complaint implicitly reserves the right to assert other claims by alleging infringement of "one or more claims" (Compl. ¶32).

III. The Accused Instrumentality

Product Identification

  • Accord’s Proposed ANDA Product (Cabazitaxel Injection, 60 mg/1.5 mL) and Proposed B2 NDA Product (Cabazitaxel Injection, 20 mg/mL, 3 mL), which are generic versions of Plaintiff's JEVTANA® KIT (Compl. ¶6, 8).

Functionality and Market Context

  • The infringement alleged is statutory infringement under 35 U.S.C. § 271(e)(2), which arises from the act of filing an Abbreviated New Drug Application (ANDA) or 505(b)(2) New Drug Application (B2 NDA) seeking FDA approval to market a generic drug prior to the expiration of a patent covering that drug (Compl. ¶1). The complaint alleges that the proposed labeling for Accord's products will be "substantially identical" to the label for Sanofi's JEVTANA® (Compl. ¶34, 45). This label allegedly instructs and encourages physicians to administer the drug in a manner that directly infringes the method claimed in the '110 patent, including the specific patient population, dosing, and premedication regimen (Compl. ¶35-37). The complaint notes that the FDA has granted tentative approval for Accord's applications (Compl. ¶10).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The core of the infringement allegation is that Accord’s proposed product label will induce physicians to practice the patented method.

'110 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing survival... The proposed product label, by describing the pivotal TROPIC clinical study, allegedly instructs physicians that the drug increases overall survival and encourages its administration for that purpose. ¶35, 46 col. 12:46-55
...administering to a patient in need thereof (1) cabazitaxel, or a hydrate of solvate thereof, as a new cycle every three weeks... The proposed products are cabazitaxel injections, and the proposed label allegedly instructs administration as a one-hour intravenous infusion every three weeks at specified doses (e.g., 15, 20, or 25 mg/m²). ¶36, 47 col. 10:54-57
...and (2) dexchlorpheniramine administered at a dose of 5 mg, dexamethasone administered at a dose of 8 mg, and an H2 antagonist, each administered prior to the administration of said cabazitaxel... The proposed label allegedly instructs physicians to premedicate patients at least 30 minutes prior to each dose with an intravenous antihistamine, corticosteroid, and H2 antagonist. ¶37, 48 col. 6:46-56
...wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel. The proposed label's indication is for the "treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen." ¶35, 46 col. 2:25-29
  • Identified Points of Contention:
    • Scope Questions: The claim recites "a method of increasing survival." A central question will be whether this preamble is a limiting element that requires proof of a physician's specific intent to "increase survival," and if so, whether a product label describing clinical trial survival data is sufficient to prove inducement of that intent.
    • Technical Questions: The dispute does not appear to center on a technical mismatch in the chemical compound or administration steps. Instead, the key question is evidentiary: will Accord's final, FDA-approved label be "substantially identical" to the JEVTANA® label as alleged, and will its instructions be interpreted as encouraging infringement of every element of the patented method? (Compl. ¶34, 45).

V. Key Claim Terms for Construction

  • The Term: "increasing survival"
  • Context and Importance: This phrase, appearing in the preamble of claim 1, defines the purpose and outcome of the method. Its construction is critical for determining the scope of the claim and the standard for proving infringement. Practitioners may focus on this term because method claims with "intent" or "purpose" elements can present high evidentiary hurdles for a patentee.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification is replete with data from the TROPIC clinical trial, which had overall survival as a primary endpoint ('110 Patent, Table 1; Fig. 1). A party could argue that performing the steps of the method inherently "increases survival" as demonstrated by the patent's own data, making the preamble a statement of the invention's intended, and actual, result rather than a separate intent element.
    • Evidence for a Narrower Interpretation: A party could argue that because the preamble states a purpose, a physician must perform the claimed steps with the specific goal of increasing survival for infringement to occur. The body of the claim details the physical administration steps, suggesting the preamble imposes a separate, mental-step requirement that might be difficult to prove is induced by a product label alone.

VI. Other Allegations

  • Indirect Infringement: The complaint is founded on allegations of induced infringement. It alleges that Accord, by seeking approval for a product with a specific label, intends for physicians to use the product in accordance with that label, which will cause them to directly infringe the '110 patent (Compl. ¶39-40, 61-62). The complaint alleges Accord has "actual knowledge" of the patent, a prerequisite for inducement (Compl. ¶39, 61).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Accord has actual knowledge of the '110 patent and seeks a declaration that the case is "exceptional" under 35 U.S.C. § 285, which allows for the award of attorney fees (Compl. ¶39, 74.J). The basis for this is the direct notification provided by Sanofi and the extensive prior litigation between the parties over the same drug product, which may be used to argue that Accord's conduct was not merely negligent (Compl. ¶11-17).

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

  • A core issue will be one of induced infringement: Can Sanofi prove that Accord's proposed drug label will actively encourage and instruct physicians to perform the complete patented method, including the mental step of intending to "increase survival"? The case may turn on whether describing clinical trial outcomes on a label is legally sufficient to induce infringement of a method claim with a purpose-based preamble.
  • A second key question will concern claim validity in context: Given that a related patent ('592) was previously found invalid, will the "new" limitations in the '110 patent—specifically the premedication regimen and the "increasing survival" purpose—be sufficient to survive an obviousness challenge? The court will have to decide if these elements, added to a known drug for a known patient population, represent a patentable, non-obvious invention.
  • Finally, an overarching question relates to the impact of prior litigation: How will the established history of litigation between these two parties over the same technology and drug product shape the current dispute? This history establishes clear knowledge on Accord's part and may influence the court's view of the parties' litigation positions and conduct, particularly regarding the request for a finding that the case is "exceptional."