DCT

2:24-cv-07904

Ferring Pharma Inc v. Jiangsu Hansoh Pharmaceutical Group Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07904, D.N.J., 07/19/2024
  • Venue Allegations: Venue is alleged to be proper on the basis that Defendant is a foreign corporation subject to personal jurisdiction in the District of New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's FIRMAGON® (degarelix) product constitutes an act of infringement of four patents related to methods of treating prostate cancer.
  • Technical Context: The technology relates to androgen deprivation therapy for advanced prostate cancer using degarelix, a gonadotrophin-releasing hormone (GnRH) antagonist.
  • Key Procedural History: This Hatch-Waxman action was triggered by Defendant's submission of ANDA No. 217496 and a Paragraph IV Certification challenging the asserted patents, which are listed in the FDA's Orange Book as covering FIRMAGON®. Plaintiff received a Notice Letter regarding the ANDA on September 27, 2022. Two of the asserted patents, U.S. Patent Nos. 11,766,468 and 11,826,397, were issued after Plaintiff’s receipt of Defendant's initial notice.

Case Timeline

Date Event
2008-02-11 Priority Date for ’081 and ’999 Patents
2008-12-24 FDA approves FIRMAGON® (degarelix) NDA
2012-04-27 Priority Date for ’468 and ’397 Patents
2014-09-23 ’081 Patent Issues
2018-01-30 ’999 Patent Issues
2022-09-27 Plaintiff receives Defendant’s Notice Letter for ANDA
2023-09-26 ’468 Patent Issues
2023-11-28 ’397 Patent Issues
2024-07-19 Complaint Filed

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

U.S. Patent No. 8,841,081 - “Method of Treating Metastatic Stage Prostate Cancer”

  • Issued: September 23, 2014

The Invention Explained

  • Problem Addressed: The patent describes the management of advanced prostate cancer, which is dependent on testosterone for growth (Compl. ¶40; ’081 Patent, col. 1:47-52). A standard treatment, androgen deprivation therapy using GnRH agonists, can cause an initial, undesirable "testosterone surge" that may worsen the patient's condition (’081 Patent, col. 2:1-12). While GnRH antagonists like degarelix avoid this surge, there remains a need for treatment methods that can effectively monitor and control the progression of metastatic disease, particularly skeletal metastases which are a major cause of morbidity (Compl. ¶¶39, 43; ’081 Patent, col. 1:28-35).
  • The Patented Solution: The patent claims a method for treating patients specifically with metastatic stage prostate cancer by administering degarelix according to a defined dosing schedule while using the biomarker serum alkaline phosphatase (S-ALP) as a benchmark for treatment (Compl. ¶62). The method involves identifying a patient with metastatic disease, measuring their baseline S-ALP level, and then administering degarelix to reduce that S-ALP level over a sustained duration, indicating control of metastatic activity (’081 Patent, col. 3:16-44, Abstract).
  • Technical Importance: The invention provided a method for treating a specific, high-risk patient population (metastatic prostate cancer) using a specific biomarker (S-ALP) to guide and assess the therapeutic effect of a GnRH antagonist on bone metastases (Compl. ¶¶46, 70-71).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 7, 8, 9, and 10 (’081 Patent, Compl. ¶61).
  • Independent Claim 1 of the ’081 Patent requires:
    • A method of treating metastatic stage prostate cancer in a subject, comprising:
    • identifying a subject with metastatic stage prostate cancer comprising measuring the subject's baseline serum alkaline phosphatase (S-ALP) level; and
    • reducing the subject's S-ALP level with respect to the baseline level by administering an initial dose of degarelix (about 160 to 320 mg) and at least one maintenance dose (about 60 mg to 160 mg) approximately 20 to 36 days after the previous dose, for a treatment duration of 20 to 450 days; and
    • wherein the S-ALP level is reduced for the duration of treatment relative to the initial S-ALP level measured at the start of treatment.

U.S. Patent No. 9,877,999 - “Methods For Treating Metastatic Stage Prostate Cancer”

  • Issued: January 30, 2018

The Invention Explained

  • Problem Addressed: This patent addresses a similar technical problem as the ’081 Patent but focuses on a more specific patient sub-population: those with metastatic prostate cancer who already present with an S-ALP level above the normal range prior to treatment (Compl. ¶96). This indicates a focus on patients who may already have significant bone metastatic activity at the time of diagnosis (’999 Patent, col. 1:47-51).
  • The Patented Solution: The invention is a method that begins with identifying a patient having both metastatic prostate cancer and a pre-treatment S-ALP level above the normal range (’999 Patent, Abstract). It then specifies a degarelix dosing regimen to reduce the elevated S-ALP level, thereby treating the metastatic disease (Compl. ¶96).
  • Technical Importance: This method refines the therapeutic approach by using a pre-treatment biomarker to select a patient population for whom the claimed degarelix regimen is asserted to be particularly effective (Compl. ¶¶46, 113).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 4, 5, 6, 7, and 8 (’999 Patent, Compl. ¶95).
  • Independent Claim 1 of the ’999 Patent requires:
    • A method for treating a subject with metastatic stage prostate cancer having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment, comprising:
    • identifying a subject with metastatic stage prostate cancer having a S-ALP level above the normal range for S-ALP;
    • reducing the subject's S-ALP level by administering an initial dose of degarelix (about 160 mg to about 320 mg) and at least one maintenance dose (about 60 mg to 160 mg);
    • wherein the at least one maintenance dose is administered approximately 20 to 36 days after the previous dose for a duration of treatment ranging from 20 days to 450 days.

U.S. Patent No. 11,826,397 - “Method of Treating Prostate Cancer with GnRH Antagonist”

  • Issued: November 28, 2023 (Compl. ¶25)
  • Technology Synopsis: The patent addresses the problem that certain androgen deprivation therapies using GnRH agonists may be associated with an increased risk of cardiovascular (CV) events (Compl. ¶¶41-42, 142). The invention is a method of treating prostate cancer in patients who have a pre-existing history of CV events by administering degarelix, which is alleged to diminish the risk of experiencing an additional CV event compared to treatment with a GnRH agonist (Compl. ¶¶47, 133).
  • Asserted Claims: Claims 1-8 and 10 are asserted (Compl. ¶132).
  • Accused Features: The administration of Hansoh's generic degarelix product according to its proposed package insert is alleged to infringe by encouraging healthcare professionals (HCPs) to select and treat prostate cancer patients with a history of CV events, thereby performing the claimed method (Compl. ¶¶134, 140, 150). The complaint points to the absence of a cardiovascular safety warning on the FIRMAGON® label, which is present on GnRH agonist labels, as a factor that instructs this selection (Compl. ¶¶143-144).

U.S. Patent No. 11,766,468 - “Method of Treating Prostate Cancer with GnRH Antagonist”

  • Issued: September 26, 2023 (Compl. ¶22)
  • Technology Synopsis: This patent is directed to the same core technology as the ’397 Patent. It claims a method of treating prostate cancer in a subject with a history of at least one cardiovascular event by administering degarelix (Compl. ¶167). The method is alleged to decrease the patient's likelihood of developing or experiencing an additional cardiovascular event compared to treatment with a GnRH agonist (Compl. ¶¶47, 167).
  • Asserted Claims: Claims 1-8 and 10 are asserted (Compl. ¶166).
  • Accused Features: The infringement allegations are parallel to those for the ’397 Patent, focusing on the administration of Hansoh's product to prostate cancer patients with a CV history in accordance with its proposed package insert (Compl. ¶¶168, 174, 184). The complaint again references the differential product labeling between GnRH antagonists and agonists as encouraging the infringing use (Compl. ¶¶177-178).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Jiangsu Hansoh's generic degarelix for injection product, for which it has filed Abbreviated New Drug Application (ANDA) No. 217496 (Compl. ¶2).

Functionality and Market Context

  • The accused product is a generic version of Ferring's FIRMAGON®, an injectable GnRH antagonist indicated for the treatment of patients with advanced prostate cancer (Compl. ¶¶2, 52). As a generic, it is intended to be bioequivalent to FIRMAGON® and is expected to be sold with a substantially similar package insert providing dosing and administration instructions (Compl. ¶¶51, 75). The recommended dosing regimen includes a 240 mg starting dose followed by 80 mg maintenance doses every 28 days, administered via subcutaneous injection by a healthcare professional (Compl. ¶¶53-54). The complaint includes a table from the FIRMAGON® package insert detailing this specific dosing information (Compl. ¶53). The product is intended to compete with FIRMAGON® in the U.S. market upon receiving FDA approval (Compl. ¶¶31-32).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,841,081 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating metastatic stage prostate cancer in a subject... HCPs will administer Hansoh's ANDA Product to treat patients with metastatic prostate cancer, a subset of the product's approved indication for advanced prostate cancer. ¶69 col. 3:16-17
identifying a subject with metastatic stage prostate cancer comprising measuring the subject's baseline serum alkaline phosphatase (S-ALP) level HCPs treating patients with metastatic prostate cancer will measure baseline S-ALP as part of their routine diagnostic and monitoring practice. ¶¶70, 72 col. 3:45-50
reducing the subject's S-ALP level...by administering an initial dose of degarelix ranging from about 160 to about 320 mg...and administering at least one maintenance dose...ranging from about 60 mg to about 160 mg...administered approximately 20 days to 36 days, after the previous dose... HCPs following Hansoh's package insert will administer an initial 240 mg dose and subsequent 80 mg maintenance doses every 28 days, which falls within the claimed ranges. ¶¶73, 74 col. 3:28-39
further, wherein the S-ALP level is reduced for the duration of treatment relative to the initial S-ALP level... Clinical study data for FIRMAGON®, to which Hansoh's product is deemed bioequivalent, allegedly demonstrates this reduction in S-ALP levels in metastatic prostate cancer patients for the specified duration. ¶75 col. 4:1-5

Identified Points of Contention

  • Scope Questions: A central question may be whether the affirmative claim step "identifying a subject... comprising measuring the subject's baseline... S-ALP level" is met by an HCP who measures S-ALP as part of routine clinical practice. The dispute may focus on whether the patent requires a specific diagnostic purpose linked to the S-ALP measurement beyond general patient workup.
  • Technical Questions: The infringement theory relies on the outcome that S-ALP levels "will be reduced" (Compl. ¶75). A point of contention may be what evidence is required to show that the instructions on Hansoh's package insert will necessarily result in this claimed therapeutic outcome for patients with metastatic stage prostate cancer.

U.S. Patent No. 9,877,999 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating a subject with metastatic stage prostate cancer having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment... HCPs will use Hansoh's product to treat patients with metastatic prostate cancer, a population known to often present with elevated S-ALP. ¶¶103, 113 col. 3:13-17
identifying a subject with metastatic stage prostate cancer having a S-ALP level above the normal range for S-ALP As part of routine diagnosis and monitoring for metastatic prostate cancer, HCPs will measure S-ALP and thereby identify patients with levels above the normal range. ¶¶104, 106 col. 4:21-23
reducing the subject's S-ALP level by administering an initial dose of degarelix...and administering at least one maintenance dose of degarelix... HCPs will administer the 240 mg initial dose and 80 mg maintenance doses as instructed by the proposed package insert, which are within the claimed dose ranges. ¶¶107, 108 col. 4:29-38

Identified Points of Contention

  • Scope Questions: Similar to the ’081 Patent, a key issue will be whether the "identifying" step requires more than an HCP's observation of an elevated S-ALP level during routine bloodwork. The dispute may concern whether the package insert instructs or encourages HCPs to specifically select patients for treatment because their S-ALP is elevated.
  • Technical Questions: What evidence does the complaint provide that HCPs will identify patients based on having an S-ALP level "above a normal range" as a specific criterion for initiating degarelix treatment, as required by the claim, versus simply treating the patient's underlying metastatic cancer? (Compl. ¶106).

V. Key Claim Terms for Construction

The Term: "identifying a subject"

  • (Appears in Claim 1 of both the ’081 and ’999 Patents)
  • Context and Importance: This term is critical because it defines the active step a practitioner must take to begin the claimed method. Infringement will depend on whether an HCP's routine diagnostic procedures (e.g., ordering a blood panel that includes S-ALP) upon diagnosing metastatic prostate cancer satisfy this claim element, and whether Hansoh's package insert induces that action.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specifications of both patents frame the invention in the context of treating a known patient population ("metastatic stage prostate cancer"). A party could argue that any act of diagnosing this condition and reviewing relevant biomarkers like S-ALP, which is standard practice, falls within the plain meaning of "identifying." (’081 Patent, col. 3:16-17).
    • Evidence for a Narrower Interpretation: The specifications also contain language such as "selecting the subject for treatment if the subject's baseline S-ALP level is 150 IU/L or greater," which suggests a conditional, deliberate selection process based on the biomarker, not just a passive measurement. (’081 Patent, col. 3:49-51). Practitioners may focus on this term because it implies a potential "mental step" requirement that can be difficult to prove in an inducement context.

The Term: "reducing the subject's S-ALP level"

  • (Appears in Claim 1 of both the ’081 and ’999 Patents)
  • Context and Importance: This term defines the therapeutic outcome of the method. The dispute will likely center on whether Hansoh's package insert—which instructs on how to administer the drug—can be said to cause this result, especially since biological outcomes can vary between patients.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patents' detailed descriptions and figures present clinical trial data showing that administration of degarelix at the specified doses leads to a reduction in S-ALP. A party may argue that this establishes a direct causal link between the administration step and the reduction outcome, making the outcome an inherent result of following the instructions. (’081 Patent, col. 7:1-67, FIGS. 1-4).
    • Evidence for a Narrower Interpretation: A party could argue that "reducing" is a biological result, not an action directly instructed by a package insert. The specification describes the S-ALP reduction as an observed effect in a clinical study population, which may not be guaranteed for every individual patient who receives the drug according to the label's instructions. (’081 Patent, col. 7:5-8).

VI. Other Allegations

Indirect Infringement

  • The complaint is predicated on a theory of induced infringement under 35 U.S.C. § 271(b). It alleges that Hansoh, with knowledge of the patents-in-suit, will actively and intentionally encourage HCPs to perform the patented methods by marketing its ANDA Product with a package insert that instructs its administration for the treatment of advanced prostate cancer (Compl. ¶¶77, 88, 115, 126, 152, 160, 185, 193). Knowledge is alleged based on Hansoh's filing of a Paragraph IV certification and its receipt of notice regarding the patents' listing in the Orange Book (Compl. ¶¶33-34, 154, 187).

Willful Infringement

  • The complaint does not contain an explicit count for willful infringement. However, it requests that the case be found "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶91, 129, 163, 196). The factual basis for this appears to be Hansoh's alleged knowledge of the patents through its Paragraph IV certification prior to the infringing act of filing the ANDA.

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

  • A core issue will be one of inducement: can Plaintiff prove that Defendant's proposed product label encourages or instructs HCPs to perform every step of the claimed methods, particularly the affirmative steps of "identifying" patients based on specific biomarkers (S-ALP) or a pre-existing condition (history of CV events)? The court will likely examine whether the label's instructions for a general patient population are specific enough to induce infringement of method claims tailored to patient sub-populations.
  • A second key question will be one of claim scope versus clinical reality: does the act of an HCP measuring a common biomarker like S-ALP as part of a routine diagnostic workup for metastatic cancer satisfy the "identifying" and "measuring" limitations of the claims? The case may turn on whether these claim elements require a specific intent to use the biomarker as a basis for selecting the claimed therapy, or if infringement occurs as an inevitable consequence of standard medical practice when using the accused product.