DCT

1:20-cv-01547

Sanofi Aventis US LLC v. Hong Kong King Friend Industrial Co Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-01547, D. Del., 11/17/2020
  • Venue Allegations: Plaintiff alleges venue is proper in Delaware because Defendant conducts and solicits business in the state and will derive substantial revenue from products used there. The complaint further alleges that by filing its Abbreviated New Drug Application (ANDA) with the intent to sell its product in the district, Defendant committed a tortious act of infringement causing foreseeable harm to Plaintiff Sanofi-Aventis U.S. LLC, a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of the cancer drug JEVTANA® constitutes an act of infringement of two patents covering methods of using cabazitaxel to increase survival in certain prostate cancer patients.
  • Technical Context: The technology concerns a second-line chemotherapeutic regimen for metastatic castration-resistant prostate cancer (mCRPC), a late-stage and aggressive form of the disease that has become resistant to initial hormonal therapies and a first-line taxane-based chemotherapy.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification. This certification asserts that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the proposed generic product. The ’777 patent is a continuation of the ’110 patent.

Case Timeline

Date Event
2009-10-29 Earliest Priority Date for ’110 and ’777 Patents
2010-06-17 FDA Approval of JEVTANA® New Drug Application
2020-03-10 U.S. Patent No. 10,583,110 Issue Date
2020-07-21 U.S. Patent No. 10,716,777 Issue Date
2020-10-22 Defendant’s Paragraph IV Certification Letter
2020-11-17 Complaint Filing Date

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

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

  • Patent Identification: U.S. Patent No. 10,583,110, "Antitumoral Use of Cabazitaxel," issued on March 10, 2020 (Compl. ¶17).

The Invention Explained

  • Problem Addressed: The patent identifies an unmet medical need for a novel therapeutic option for patients with castration-resistant metastatic prostate cancer, particularly for those who have already been treated with a docetaxel-based regimen and whose cancer has become resistant to it (’110 Patent, col. 2:21-29). It notes that prior chemotherapies for this patient population offered primarily palliative effects without a significant improvement in survival time (’110 Patent, col. 1:50-55).
  • The Patented Solution: The invention is a method of treating this specific patient population with the antitumoral agent cabazitaxel, administered in combination with a corticoid (prednisone) and a specific premedication regimen to manage hypersensitivity (’110 Patent, Abstract; col. 3:9-14). The patent presents clinical trial data demonstrating that this method results in a statistically significant increase in overall survival compared to the previous reference treatment (’110 Patent, col. 11:40-48).
  • Technical Importance: The patented method provided a proven, life-extending, second-line therapy for patients with an advanced and difficult-to-treat cancer for whom the standard-of-care taxane had already failed (’110 Patent, col. 11:40-52).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’110 patent (Compl. ¶20). The patent contains one independent claim, Claim 1.
  • Independent Claim 1 requires:
    • A method of increasing survival.
    • Administering cabazitaxel (or a hydrate/solvate) in a three-week cycle.
    • Administering a premedication regimen of dexchlorpheniramine (5 mg), dexamethasone (8 mg), and an H2 antagonist prior to the cabazitaxel.
    • The patient must have castration-resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel.
  • The complaint reserves the right to assert dependent claims at a later time.

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

  • Patent Identification: U.S. Patent No. 10,716,777, "Antitumoral Use of Cabazitaxel," issued on July 21, 2020 (Compl. ¶18).

The Invention Explained

  • Problem Addressed: As a continuation of the ’110 patent, the ’777 patent addresses the same technical problem: the lack of effective, survival-extending treatments for patients with mCRPC whose disease has progressed after docetaxel therapy (’777 Patent, col. 2:21-29).
  • The Patented Solution: The invention is a method of increasing survival by administering cabazitaxel to this patient population. This patent claims a specific dose range of cabazitaxel (20 to 25 mg/m²) in combination with a pre-administered H₂ antagonist (’777 Patent, Claim 1). The patent relies on the same TROPIC clinical study data as the ’110 patent to demonstrate its efficacy in extending patient survival (’777 Patent, Fig. 1; col. 11:40-48).
  • Technical Importance: The claimed method provides specific dosing parameters for a second-line therapy shown to increase survival in a patient population with limited options (’777 Patent, col. 11:40-52).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’777 patent (Compl. ¶42). The patent contains one independent claim, Claim 1.
  • Independent Claim 1 requires:
    • A method of increasing survival.
    • Administering cabazitaxel (or a hydrate/solvate) at a dose of 20 to 25 mg/m².
    • Administering an H₂ antagonist prior to the cabazitaxel.
    • The patient must have castration-resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel.
  • The complaint reserves the right to assert dependent claims at a later time.

III. The Accused Instrumentality

Product Identification

  • Defendant HKF’s Proposed ANDA Product is a Cabazitaxel Injection, 60 mg/1.5 mL, intended as a generic version of Plaintiff's JEVTANA® KIT (Compl. ¶¶ 1, 6).

Functionality and Market Context

  • The product is a drug for intravenous infusion. The act of infringement alleged in an ANDA case is the submission of the ANDA itself to the FDA for the purpose of marketing a generic drug prior to patent expiration (Compl. ¶20, citing 35 U.S.C. § 271(e)(2)). The complaint alleges that HKF’s infringement will be completed upon approval, when use of the generic product in accordance with its label will directly infringe, and HKF’s sale of the product with such a label will induce infringement (Compl. ¶¶ 22, 26-27). The core of the infringement allegation is that the proposed label for HKF’s product will be "substantially identical" to the label for JEVTANA®, thereby instructing and encouraging physicians to perform the patented methods (Compl. ¶22).

IV. Analysis of Infringement Allegations

The complaint alleges that the instructions on the JEVTANA® label, which HKF's proposed label will allegedly mirror, map directly onto the elements of the asserted patents' claims. The complaint references the JEVTANA® label (attached as Exhibit C, which was not provided for this analysis) as the primary evidence for its infringement contentions. The clinical data showing increased survival, which is foundational to the patents' claims, is visualized in Figure 1 of the patents. This Kaplan-Meier plot from the TROPIC study shows a clear separation in overall survival curves between the cabazitaxel (CBZ) arm and the mitoxantrone (MTX) arm, graphically representing the claimed "increasing survival" (’110 Patent, Fig. 1).

10,583,110 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality - Complaint Citation Patent Citation
A method of increasing survival... The accused product's label allegedly describes the TROPIC clinical study, which showed cabazitaxel prolongs overall survival, and encourages its use for that purpose. - ¶23 col. 11:40-48
...administering to a patient... (1) cabazitaxel... as a new cycle every three weeks... The label allegedly recommends administration of cabazitaxel as a one-hour intravenous infusion every three weeks. - ¶24 col. 5:20-25
...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 label allegedly instructs physicians to premedicate at least 30 minutes prior to the cabazitaxel dose with specific medications matching the claim, including an antihistamine (dexchlorpheniramine 5 mg), a corticosteroid (dexamethasone 8 mg), and an H2 antagonist. ¶25 col. 6:45-56
...wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel. The label's approved indication is allegedly for the "treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen." - ¶23 col. 2:21-29

10,716,777 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality - Complaint Citation Patent Citation
A method of increasing survival... The accused product's label allegedly describes clinical data showing cabazitaxel prolongs overall survival and encourages its use for that purpose. - ¶45 col. 11:40-48
...administering to a patient... a dose of 20 to 25 mg/m² of cabazitaxel... The label allegedly recommends a dose of 20 mg/m² and notes that a 25 mg/m² dose can be used, both of which fall within the claimed range. - ¶46 col. 3:15-17
...in combination with an H₂ antagonist, wherein the H₂ antagonist is administered to the patient prior to administering the dose of cabazitaxel... The label allegedly instructs premedication with an H2 antagonist (e.g., ranitidine 50 mg) at least 30 minutes before each dose of cabazitaxel. - ¶47 col. 6:45-56
...and wherein said patient has castration resistant metastatic prostate cancer that has progressed during or after treatment with docetaxel. The label's approved indication is allegedly for the "treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen." - ¶45 col. 2:21-29
  • Identified Points of Contention:
    • Scope Questions: In an ANDA case, infringement analysis often hinges on whether the generic's label will necessarily lead to infringement. A potential question, though not raised in the complaint, is whether the defendant could "carve out" the patented method from its label. Here, the patented method appears to be the primary, if not only, approved use, which raises the question of whether such a carve-out would be legally or commercially feasible.
    • Technical Questions: Since the infringement allegation is based on copying a label, the primary factual questions will relate to validity (e.g., obviousness, written description), which the Defendant asserted in its Paragraph IV letter (Compl. ¶7). The complaint itself presents the infringement case as a direct mapping of the JEVTANA® label onto the claims, suggesting few anticipated technical disputes on the infringement front.

V. Key Claim Terms for Construction

  • The Term: "increasing survival" (’110 Patent, Claim 1; ’777 Patent, Claim 1)

    • Context and Importance: This preamble term defines the objective of the method and is likely a limiting element of the claim. Its construction is critical because if it is construed narrowly to require a specific, statistically significant survival benefit, a defendant could attempt to argue its label does not induce infringement for that specific purpose, even if it instructs the same administrative steps for "treatment."
    • Evidence for a Broader Interpretation: The patents also refer to the invention more generally as being for "antitumoral use" or for the "treatment of prostate cancer," which may support an interpretation where any administration for treatment that happens to increase survival meets the limitation (’110 Patent, col. 2:61-63).
    • Evidence for a Narrower Interpretation: The specification heavily emphasizes the clinical trial results showing a statistically significant survival benefit over the prior art, contrasting it with earlier treatments that had "no effect on the survival time" (’110 Patent, col. 1:50-51, col. 11:40-48). This may support a narrower construction requiring an instruction to achieve a demonstrated, non-palliative survival extension.

  • The Term: "patient... that has progressed during or after treatment with docetaxel" (’110 Patent, Claim 1; ’777 Patent, Claim 1)

    • Context and Importance: This phrase defines the specific patient population to be treated. Its construction is central to both infringement and validity. Practitioners may focus on this term because the non-obviousness of the invention could depend on the criticality of selecting this particular sub-population for treatment with cabazitaxel.
    • Evidence for a Broader Interpretation: The specification sometimes uses broader phrases like "patients who are not catered for by a taxane-based treatment" (’110 Patent, Abstract), which could be argued to encompass a wider group than the claim language specifies.
    • Evidence for a Narrower Interpretation: The claim language "during or after" is highly specific. The patent's own clinical data tables distinguish between patients whose cancer progressed "while on" docetaxel versus "after" docetaxel, suggesting these are recognized, discrete clinical scenarios that the inventors specifically contemplated and addressed (’110 Patent, Table 2). This could support a narrow construction that requires the patient to fit one of these specific progression profiles.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement against HKF (Compl. ¶¶ 27-28, 49-50). The factual basis alleged is that HKF, with actual knowledge of the patents (evidenced by its own Paragraph IV letter), intends to market its generic product with a label that will instruct and encourage medical professionals to perform the steps of the patented methods (Compl. ¶22).
  • Willful Infringement: The complaint does not contain a separate count for willfulness. However, it alleges that HKF has "actual knowledge" of the patents-in-suit and seeks a declaration that the case is "exceptional" under 35 U.S.C. § 285, which would entitle Plaintiffs to an award of attorney fees (Compl. ¶27, p. 15, ¶J). The basis for this allegation is HKF’s pre-suit knowledge of the patents, as demonstrated by its October 22, 2020 letter to Plaintiffs (Compl. ¶7).

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

  1. Validity in View of the Prior Art: The central issue will likely be one of validity. Can the defendant prove by clear and convincing evidence that the claimed methods of treatment were obvious? The court will need to determine whether a person of ordinary skill in the art in 2009 would have had a reasonable expectation of success in using cabazitaxel with the claimed premedication regimen to increase survival specifically in the docetaxel-resistant mCRPC patient population.
  2. Scope of Label-Based Inducement: A key question for infringement will be whether the FDA-approved label for the defendant's generic product will inevitably instruct infringement. The case will examine whether the directions for use on the proposed label encourage, recommend, or promote the performance of every step of the patented methods, thereby establishing the intent required for induced infringement.
  3. Definitional Scope of the Patient Population: The outcome may depend on how the court construes the term defining the patient as one whose cancer has "progressed during or after treatment with docetaxel." The interpretation of this phrase will be critical for determining the scope of the claims and assessing both infringement by the accused label and the patents' validity over prior art treatments for advanced prostate cancer.