DCT

3:22-cv-00616

Ferring Pharma Inc v. Jiangsu Hansoh Pharmaceutical Group Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:22-cv-00616, W.D.N.C., 11/10/2022
  • Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation, and under 28 U.S.C. § 1400(b), such a defendant may be sued in any district in which it is subject to personal jurisdiction. The complaint alleges personal jurisdiction exists in the Western District of North Carolina.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs’ prostate cancer drug FIRMAGON® (degarelix) constitutes an act of patent infringement.
  • Technical Context: The technology relates to methods of treating androgen-dependent prostate cancer using gonadotropin-releasing hormone (GnRH) antagonists and methods for manufacturing the active pharmaceutical ingredient, degarelix.
  • Key Procedural History: This is a Hatch-Waxman action filed under 35 U.S.C. § 271(e)(2) and triggered by Defendant's submission of ANDA No. 217496. Plaintiffs state they received Defendant's Paragraph IV Certification Notice Letter on September 27, 2022, and filed the complaint within the statutory 45-day window.

Case Timeline

Date Event
2008-02-11 Priority Date for ’359, ’739, ’870, ’085, ’398 Patents
2008-12-24 FDA approves Plaintiff's FIRMAGON® New Drug Application
2009-04-24 Priority Date for ’938 Patent
2014-09-09 U.S. Patent No. 8,828,938 issues
2016-08-16 U.S. Patent No. 9,415,085 issues
2017-02-28 U.S. Patent No. 9,579,359 issues
2020-06-30 U.S. Patent No. 10,695,398 issues
2020-08-04 U.S. Patent No. 10,729,739 issues
2021-04-13 U.S. Patent No. 10,973,870 issues
2022-09-27 Plaintiff Ferring Pharma receives Defendant's Notice Letter
2022-11-10 Complaint filed

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

U.S. Patent No. 9,579,359 - "Method of Treating Prostate Cancer with GnRH Antagonist"

  • Patent Identification: U.S. Patent No. 9,579,359, "Method of Treating Prostate Cancer with GnRH Antagonist," issued February 28, 2017.

The Invention Explained

  • Problem Addressed: The patent addresses the problem of the "testosterone surge" or "flare reaction" that occurs with traditional gonadotropin-releasing hormone (GnRH) agonist therapies for prostate cancer (U.S. Patent No. 9,579,359, col. 2:9-24). This initial surge in testosterone can temporarily worsen the cancer and its symptoms, a significant clinical drawback.
  • The Patented Solution: The invention is a method of treatment using a GnRH antagonist, specifically degarelix, which avoids the testosterone surge associated with agonists ('359 Patent, col. 2:36-40). The patent claims a specific dosing regimen involving an initial starting dose followed by monthly maintenance doses, which safely and rapidly suppresses testosterone to therapeutic levels without the initial flare ('359 Patent, col. 4:50-56).
  • Technical Importance: This approach provides a method for androgen deprivation that avoids the initial, potentially dangerous, testosterone flare seen with GnRH agonist treatments, thereby offering a safer initiation of therapy for prostate cancer patients.

Key Claims at a Glance

  • The complaint does not specify which claims it asserts, which is permissible under federal pleading standards. Claim 1 is the first independent claim.
  • Claim 1 of the ’359 Patent includes the following essential elements:
    • A method of treating prostate cancer in a subject with a reduced likelihood of causing a testosterone spike or other side effect of a GnRH agonist therapy.
    • Administering an initial dose of about 240 mg of degarelix to the subject.
    • Administering a maintenance dose of about 80 mg of degarelix to the subject once every approximately 28 days thereafter.

U.S. Patent No. 10,729,739 - "Methods of Treating Prostate Cancer with GnRH Antagonist"

  • Patent Identification: U.S. Patent No. 10,729,739, "Methods of Treating Prostate Cancer with GnRH Antagonist," issued August 4, 2020.

The Invention Explained

  • Problem Addressed: Beyond the testosterone flare associated with GnRH agonists, the broader field of androgen deprivation therapy has raised concerns about other adverse effects, including musculoskeletal and connective tissue disorders ('739 Patent, col. 4:45-56, col. 29:45-54).
  • The Patented Solution: This patent claims a method of treating locally advanced prostate cancer by choosing and administering a specific dosing regimen of degarelix. The claimed method is purported to decrease the likelihood of the patient developing a musculoskeletal or connective tissue disorder compared to treatment with a GnRH agonist like leuprolide ('739 Patent, col. 4:45-56, col. 30:29-44). The invention focuses on the differentiated safety profile of degarelix relative to older agonist therapies.
  • Technical Importance: This invention seeks to establish a safety advantage for degarelix over GnRH agonists regarding specific side effects, which could be a key factor in a physician's choice of therapy.

Key Claims at a Glance

  • The complaint does not specify which claims it asserts. Claim 1 is the first independent claim.
  • Claim 1 of the ’739 Patent includes the following essential elements:
    • A method of treating locally advanced prostate cancer in a subject.
    • Choosing a dosing regimen of degarelix over GnRH agonist treatment to decrease the likelihood of developing a musculoskeletal disorder or a connective tissue disorder.
    • Administering an initial dose of 160-320 mg of degarelix.
    • Administering a maintenance dose of 60-160 mg of degarelix once every 20-36 days thereafter.

U.S. Patent No. 10,973,870 - "Methods of Treating Prostate Cancer with GnRH Antagonist"

  • Patent Identification: U.S. Patent No. 10,973,870, "Methods of Treating Prostate Cancer with GnRH Antagonist," issued April 13, 2021.
  • Technology Synopsis: This patent is directed to methods of treating prostate cancer with degarelix that reduce the likelihood of specific adverse events, namely urinary or renal system disorders, compared to treatment with GnRH agonists (U.S. Patent No. 10,973,870, col. 4:56-65). It claims a specific dosing regimen to achieve this improved safety profile.
  • Asserted Claims: The complaint does not specify claims. Claim 1 is an independent method claim.
  • Accused Features: The accused features are the dosing and administration instructions that will be included in the Defendant's proposed product labeling for its generic degarelix product (Compl. ¶75, 77).

U.S. Patent No. 9,415,085 - "Method of Treating Prostate Cancer with GnRH Antagonist"

  • Patent Identification: U.S. Patent No. 9,415,085, "Method of Treating Prostate Cancer with GnRH Antagonist," issued August 16, 2016.
  • Technology Synopsis: This patent claims methods of treating prostate cancer in a subject who has a history of at least one cardiovascular event. The method involves administering degarelix to decrease the likelihood of the subject experiencing an additional cardiovascular event compared to treatment with a GnRH agonist (U.S. Patent No. 9,415,085, col. 56:11-25).
  • Asserted Claims: The complaint does not specify claims. Claim 1 is an independent method claim.
  • Accused Features: The accused features are the dosing and administration instructions that will be included in the Defendant's proposed product labeling for its generic degarelix product (Compl. ¶84, 86).

U.S. Patent No. 10,695,398 - "Method of Treating Prostate Cancer with GnRH Antagonist"

  • Patent Identification: U.S. Patent No. 10,695,398, "Method of Treating Prostate Cancer with GnRH Antagonist," issued June 30, 2020.
  • Technology Synopsis: This patent, similar to the ’085 patent, is directed to a method of treating a prostate cancer subject who has a history of at least one cardiovascular event. The claimed administration of degarelix allegedly diminishes the risk of the subject developing or experiencing an additional cardiovascular event compared to treatment with a GnRH agonist (U.S. Patent No. 10,695,398, col. 55:56-col. 56:20).
  • Asserted Claims: The complaint does not specify claims. Claim 1 is an independent method claim.
  • Accused Features: The accused features are the dosing and administration instructions that will be included in the Defendant's proposed product labeling for its generic degarelix product (Compl. ¶93, 95).

U.S. Patent No. 8,828,938 - "Method for the Manufacture of Degarelix"

  • Patent Identification: U.S. Patent No. 8,828,938, "Method for the Manufacture of Degarelix," issued September 9, 2014.
  • Technology Synopsis: This patent addresses problems with prior art methods for synthesizing degarelix, which allegedly used reagents that were toxic to humans and the environment (Compl. ¶104). The invention provides a method for manufacturing pharmaceutically pure degarelix using solid-phase synthesis with an Fmoc protecting group, which is asserted to be safer and capable of producing a purer final product ('938 Patent, col. 3:45-54).
  • Asserted Claims: The complaint does not specify claims. Claim 1 is an independent method claim.
  • Accused Features: Plaintiffs allege that Defendant's degarelix is synthesized according to the methods of the ’938 patent, reasoning that other commercially viable methods to produce sufficiently pure degarelix are not available (Compl. ¶107, 109).

III. The Accused Instrumentality

Product Identification

  • Defendant's generic version of FIRMAGON® (degarelix for injection), which is the subject of ANDA No. 217496 (Compl. ¶2).

Functionality and Market Context

  • The accused product is a GnRH antagonist intended for the treatment of patients with advanced prostate cancer (Compl. ¶38, 48). The complaint alleges that the Defendant's ANDA product, upon approval, will be sold with a package insert that is "substantially similar to the package insert for FIRMAGON® in all material respects" (Compl. ¶53). This insert allegedly will instruct healthcare professionals to administer the drug using a specific dosing regimen, including a 240 mg starting dose and an 80 mg maintenance dose every 28 days (Compl. ¶49). The complaint includes a table from the FIRMAGON® package insert detailing these recommended dosages (Compl. ¶49).

IV. Analysis of Infringement Allegations

The complaint alleges that Defendant’s submission of its ANDA constitutes a technical act of infringement under 35 U.S.C. § 271(e)(2)(A) and that commercialization post-approval will induce infringement under § 271(b). The core of the infringement allegation for the method-of-use patents is that Defendant’s proposed product label will instruct medical professionals and patients to perform the patented methods.

’359 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating prostate cancer in a subject with a reduced likelihood of causing a testosterone spike or other side effect of a gonadotrophin releasing hormone (GnRH) agonist therapy The Defendant's ANDA Product is indicated for the treatment of advanced prostate cancer, and as a GnRH antagonist, it does not cause the testosterone spike associated with GnRH agonists. ¶48, 53 col. 4:45-56
administering an initial dose of about 240 mg of degarelix to the subject The proposed product label for Defendant's ANDA Product will instruct the administration of a 240 mg starting dose. ¶49 col. 4:50-51
and administering a maintenance dose of about 80 mg of degarelix to the subject once every approximately 28 days thereafter The proposed product label for Defendant's ANDA Product will instruct the administration of an 80 mg maintenance dose every 28 days. ¶49 col. 4:51-53

’739 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating locally advanced prostate cancer in a subject, comprising The Defendant's ANDA Product is indicated for the treatment of advanced prostate cancer. ¶48, 53 col. 4:45-49
choosing a dosing regimen of degarelix over gonadotrophin releasing hormone (GnRH) agonist treatment to decrease the likelihood of developing a musculoskeletal disorder or a connective tissue disorder The proposed label and marketing materials for the ANDA product will allegedly highlight the safety profile of degarelix, thereby instructing or encouraging physicians to choose it over GnRH agonists to reduce the likelihood of such side effects. ¶53, 67, 69 col. 29:45-54
administering the dosing regimen of degarelix of an initial dose of 160-320 mg of degarelix to the subject The proposed label will instruct a 240 mg starting dose, which falls within the claimed range. ¶49 col. 4:50-51
and a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter The proposed label will instruct an 80 mg maintenance dose every 28 days, which falls within the claimed ranges. ¶49 col. 4:51-53

Identified Points of Contention

  • Evidentiary Question ('938 Patent): A central question for the '938 manufacturing patent will be evidentiary. The complaint alleges infringement based on the theory that no other commercially viable methods exist to produce the required purity of degarelix (Compl. ¶107-110). A potential point of contention will be whether Plaintiffs can prove, likely after discovery, that Defendant actually uses the patented solid-phase synthesis process.
  • Scope Questions (Method-of-Use Patents): For patents claiming a comparative benefit (e.g., the '739 patent's "decrease the likelihood of developing a musculoskeletal disorder... compared to... agonist treatment"), a key legal and factual question will be what evidence is required to show that the use of Defendant's generic product satisfies this limitation. The dispute may turn on whether the inherent properties of degarelix are sufficient or if specific clinical data for the generic product is needed.

V. Key Claim Terms for Construction

The Term: "about" (e.g., "about 240 mg," "about 80 mg")

  • Context and Importance: This term appears in the dosage limitations of the '359 patent and other asserted patents. The scope of "about" will be critical to the infringement analysis. Defendant may argue that its product, while bioequivalent, delivers a dosage that falls outside a reasonable construction of "about," thereby avoiding literal infringement. Practitioners may focus on this term because even small variations in dosage could be argued to place the accused product outside the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification uses the claimed 240 mg/80 mg regimen as a specific embodiment of a broader inventive concept, which could support a construction that encompasses values reasonably close to the stated amounts that achieve the same function ('359 Patent, col. 4:50-56).
    • Evidence for a Narrower Interpretation: The patent repeatedly and specifically recites the 240 mg starting dose and 80 mg maintenance dose as the effective amounts determined in clinical trials ('359 Patent, Table 1). A defendant could argue this ties the term "about" very closely to these specific, clinically-validated figures.

The Term: "choosing a dosing regimen... to decrease the likelihood of developing a musculoskeletal disorder"

  • Context and Importance: This is a key preamble/method step in Claim 1 of the '739 patent. The infringement analysis depends on whether this step is met by a physician prescribing degarelix instead of a GnRH agonist. The dispute will likely focus on whether this claim limitation requires a specific mental step or intent on the part of the physician, and what evidence from the product's label or marketing would be sufficient to induce a physician to perform this "choosing" step for the claimed reason.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification extensively compares the adverse event profiles of degarelix and leuprolide (a GnRH agonist), including for musculoskeletal disorders ('739 Patent, col. 29-30, Table 6). Plaintiffs may argue this context implies that the mere act of prescribing degarelix instead of an agonist inherently constitutes "choosing" for this purpose.
    • Evidence for a Narrower Interpretation: A defendant may argue that this is a limiting method step that requires a physician to have the specific intent of reducing musculoskeletal risk, and that a generic label merely reciting clinical trial data would not be sufficient to induce this specific choice.

VI. Other Allegations

Indirect Infringement

  • The complaint's primary allegation for the method-of-use patents is induced infringement under 35 U.S.C. § 271(b). It is alleged that Defendant, with knowledge of the patents, will induce infringement by marketing its ANDA Product with an FDA-approved label that instructs physicians and patients to administer the drug in accordance with the patented methods (Compl. ¶58-60).

Willful Infringement

  • The complaint does not explicitly use the word "willful," but it alleges that Defendant has knowledge of the patents-in-suit as of the receipt of the Paragraph IV notice letter (Compl. ¶61, 70, 79, 88, 97). It also requests an award of attorneys' fees under 35 U.S.C. § 285, alleging the case is "exceptional" (Compl. ¶64).

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

  • A central issue will be one of process verification: For the ’938 patent, can Plaintiffs substantiate their allegation that Defendant must be using the patented manufacturing process? This question will likely depend heavily on evidence obtained during discovery, as the complaint's current theory rests on the elimination of other known commercial alternatives.
  • A key question of infringement for comparative claims will arise for patents like the ’739 and ’085 patents. The case will likely explore what is required to prove infringement of claims that recite a benefit—such as a "decreased likelihood" of an adverse event—"compared to" an alternative therapy. The dispute will focus on whether the inherent properties of the active ingredient suffice, or if the claim requires specific evidence tied to the marketing and clinical profile of the accused generic product itself.
  • The case will also turn on a foundational Hatch-Waxman question: Does the content of Defendant's proposed product label, which Plaintiffs allege will be substantially similar to the innovator's label, provide sufficient instruction to healthcare providers and patients to directly infringe the asserted method-of-use claims upon the product's launch?