DCT

1:20-cv-00804

Sanofi Aventis US LLC v. Apotex Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00804, D. Del., 07/31/2020
  • Venue Allegations: The complaint alleges that venue is proper for each Defendant, asserting that by regularly conducting business in Delaware and by participating in prior pharmaceutical patent litigation in the district, including filing counterclaims, the Defendants have consented to jurisdiction and venue.
  • Core Dispute: Plaintiff alleges that Defendants' submission of Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) to the FDA seeking approval to market generic versions of JEVTANA® constitutes an act of infringement of two patents covering methods of using cabazitaxel to treat prostate cancer.
  • Technical Context: The technology concerns a second-line chemotherapy regimen for patients with metastatic castration-resistant prostate cancer, a late-stage and difficult-to-treat form of the disease.
  • Key Procedural History: The complaint details extensive prior litigation between the same parties over parent patents to those now in suit (the '170 and ’592 patents). In that prior litigation, a district court found claims of the '170 patent to be infringed and not invalid, a finding of nonobviousness that was affirmed by the U.S. Court of Appeals for the Federal Circuit. The ’110 and ’777 patents-in-suit are continuations of the same family and, according to the complaint, claim methods that are patentably distinct from those previously litigated.

Case Timeline

Date Event
2009-10-29 Earliest Priority Date for ’110 and ’777 Patents
2010-06-17 FDA approves NDA for JEVTANA® KIT
2014-11-03 Earliest notice letter date mentioned from a Defendant (Fresenius) regarding prior litigation
2017-09-18 Prior litigation bench trial begins
2020-03-10 U.S. Patent No. 10,583,110 Issues
2020-06-12 Original Complaint Filed
2020-07-21 U.S. Patent No. 10,716,777 Issues
2020-07-31 First Amended Complaint Filed

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

U.S. Patent No. 10,583,110 - “Antitumoral Use of Cabazitaxel”

The Invention Explained

  • Problem Addressed: The patent addresses the need for a new therapeutic option for patients with advanced prostate cancer, particularly metastatic castration-resistant prostate cancer, for whom treatment with a docetaxel-based regimen has already failed due to disease progression (’110 Patent, col. 2:21-29). This represents an unmet medical need for a second-line therapy in a patient population with limited options (’110 Patent, col. 2:21-29).
  • The Patented Solution: The invention is a method of using the taxane drug cabazitaxel in combination with a corticosteroid (prednisone or prednisolone) and a specific pre-medication regimen to treat this patient population (’110 Patent, Abstract; col. 6:45-56). The patent describes the results of a clinical trial (TROPIC) where this method demonstrated a statistically significant increase in overall survival compared to the previous standard-of-care, mitoxantrone (’110 Patent, col. 12:40-48).
  • Technical Importance: The invention provided a clinically proven method to extend the lives of patients with an advanced and aggressive form of prostate cancer after first-line chemotherapy had failed (’110 Patent, col. 2:21-29).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of one or more claims. Independent claim 1 is representative.
  • Essential elements of Independent Claim 1:
    • 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.

U.S. Patent No. 10,716,777 - “Antitumoral Use of Cabazitaxel”

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the '110 patent, the '777 patent addresses the same technical problem: the lack of effective second-line treatments for patients with metastatic castration-resistant prostate cancer whose disease has progressed after docetaxel therapy (’777 Patent, col. 2:20-28).
  • The Patented Solution: The invention is a method of increasing patient survival by administering cabazitaxel at a specific dose range (20 to 25 mg/m²) in combination with a pre-administered H₂ antagonist to the specific patient population that has failed docetaxel treatment (’777 Patent, col. 3:21-25; col. 8:34-36). The patent is supported by the same TROPIC clinical trial data showing a survival benefit (’777 Patent, col. 12:39-47).
  • Technical Importance: The invention provides a defined, life-extending therapeutic regimen for patients with late-stage prostate cancer who have exhausted first-line chemotherapy options (’777 Patent, col. 2:20-28).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of one or more claims. Independent claim 1 is representative.
  • Essential elements of Independent Claim 1:
    • A method of increasing survival comprising administering to a patient in need thereof:
    • A dose of 20 to 25 mg/m² of cabazitaxel, or a hydrate or solvate thereof;
    • In combination with an H₂ antagonist, wherein the H₂ antagonist is administered to the patient prior to administering the dose of cabazitaxel;
    • Wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the proposed generic cabazitaxel injection products for which each Defendant has submitted an ANDA or a B2 NDA to the FDA (Compl. ¶1, ¶6, ¶22, ¶43, ¶59, ¶78, ¶93).

Functionality and Market Context

  • The Defendants' products are generic versions of Sanofi's JEVTANA® KIT, a chemotherapy drug for intravenous infusion (Compl. ¶1). The act of infringement alleged is the submission of the ANDA/NDA seeking FDA approval to market these generic products before the expiration of the patents-in-suit (Compl. ¶128, ¶151).
  • The infringement theory is one of inducement. The complaint alleges that the proposed labeling for the Defendants' products will be "substantially identical" to the FDA-approved label for JEVTANA® (Compl. ¶130, ¶153). This label allegedly instructs and encourages physicians to perform the patented methods, including administering the drug to the specified patient population, for the purpose of increasing survival, and using the claimed dosage and premedication regimens (Compl. ¶131-133, ¶154-156).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

10,583,110 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing survival... The proposed label allegedly describes clinical study results showing that cabazitaxel was shown to prolong overall survival, thereby encouraging its administration for that purpose. ¶131 col. 12:40-48
...administering to a patient in need thereof (1) cabazitaxel... as a new cycle every three weeks... The proposed label allegedly recommends administration of cabazitaxel as an intravenous infusion every three weeks. ¶132 col. 10:52-64
...and (2) dexchlorpheniramine... dexamethasone... and an H2 antagonist, each administered prior to the administration of said cabazitaxel... The proposed label allegedly instructs physicians to premedicate with an intravenous antihistamine, corticosteroid, and H2 antagonist at least 30 minutes prior to each dose. ¶133 col. 7:1-7
...wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel. The proposed label allegedly states that the indication is for the "treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen." ¶131 col. 10:49-52

10,716,777 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing survival... The proposed label allegedly describes clinical study results showing that cabazitaxel was shown to prolong overall survival, thereby encouraging its administration for that purpose. ¶154 col. 12:39-47
...administering to a patient in need thereof a dose of 20 to 25 mg/m² of cabazitaxel... The proposed label allegedly recommends a dose of 20 mg/m² and states that a 25 mg/m² dose "can be used in select patients." ¶155 col. 3:21-25
...in combination with an H₂ antagonist, wherein the H₂ antagonist is administered to the patient prior to administering the dose of cabazitaxel... The proposed label allegedly instructs physicians to premedicate with an intravenous H₂ antagonist at least 30 minutes prior to each dose. ¶156 col. 8:34-36
...and wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel. The proposed label allegedly states that the indication is for the "treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen." ¶154 col. 10:49-51

Identified Points of Contention

  • Scope Questions: The preamble of the asserted claims recites a "method of increasing survival." A potential point of contention may be whether a product label that describes clinical trial results demonstrating a survival benefit is sufficient to meet the legal standard for inducing infringement of this claim element, which requires an affirmative act to encourage infringement.
  • Technical Questions: Since infringement is based on the contents of Defendants' proposed labels, a central evidentiary question will be whether the final, FDA-approved labels for the generic products will, in fact, contain instructions that track each element of the asserted claims. The complaint alleges this on "information and belief," which is standard for this stage of litigation but remains a matter for future proof (Compl. ¶130, ¶153).

V. Key Claim Terms for Construction

  • The Term: "increasing survival"

    • Context and Importance: This term, appearing in the preamble of the independent claims of both patents, defines the purpose and outcome of the claimed method. Its construction is critical because it goes to the intent required for inducement. Practitioners may focus on whether this preamble is a positive limitation of the claim that requires proof that the generic label encourages administration for this specific purpose, not just for general "treatment."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The '110 Patent specification consistently frames the entire invention around the survival benefit observed in the TROPIC clinical trial. The "Summary" section states the invention relates to cabazitaxel for treating prostate cancer, and the Detailed Description links the method to the clinical trial where "patients receiving cabazitaxel demonstrated statistically significant longer overall survival (OS)" (’110 Patent, col. 2:46-48; col. 12:40-48). This may support an interpretation where performing the claimed steps inherently constitutes a method of increasing survival.
      • Evidence for a Narrower Interpretation: The claim is written as a "method of increasing survival," not a "method of treating cancer." This phrasing could be argued to require a specific, articulable goal of survival extension, beyond just palliation or tumor response. However, the specification does not appear to provide a definition of "increasing survival" that is distinct from the clinical trial results.

  • The Term: "H₂ antagonist"

    • Context and Importance: This is a required element of the premedication regimen in the asserted claims of both patents. Its definition determines the scope of chemical compounds that satisfy this limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim uses the general class name "H₂ antagonist," suggesting the claim is not limited to any specific drug within that class. The specification also refers to the class generally, stating that examples of premedication drugs include "histamine H₂ antagonists" (’110 Patent, col. 8:35-36). This suggests the term should be given its plain and ordinary meaning covering all drugs within that well-known therapeutic class.
      • Evidence for a Narrower Interpretation: The complaint, in describing the JEVTANA label, identifies a specific example: "ranitidine 50 mg or equivalent H2 antagonist" (Compl. ¶133). While this is extrinsic to the patent, a party could argue that the term should be understood in the context of specific examples known at the time, though the patent's use of the broader class name may counter this argument.

VI. Other Allegations

  • Indirect Infringement: The complaint's theory is entirely centered on induced infringement under 35 U.S.C. § 271(b). It is alleged that each Defendant will have actual knowledge of the patents and will actively induce infringement by marketing its generic product with a label that instructs and encourages physicians and healthcare providers to perform all steps of the claimed methods (Compl. ¶135, ¶146, ¶158, ¶169). The specific instructions on the proposed label are alleged to be the affirmative act of inducement.

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

  • A core issue will be one of inducement and intent: Does a generic drug label that describes clinical trial data showing a survival benefit, and provides instructions for administration consistent with that trial, constitute sufficient evidence to prove active inducement of a "method of increasing survival" as claimed in the patents?
  • A second key question will involve patentable distinction: The complaint asserts that the claims of the '110 and '777 patents are "materially different and patentably distinct" from the claims of a parent patent previously litigated by the same parties (Compl. ¶123, ¶125). A central issue for the court will be to determine whether the specific limitations added to the new claims—such as the complete premedication cocktail or the specific dosage ranges—are sufficient to render the claims nonobvious over the prior art that was asserted in the previous litigation.