DCT

4:24-cv-00303

Murray Poole Enterprises Ltd v. Cigna Group

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:24-cv-00303, E.D. Tex., 04/08/2024
  • Venue Allegations: Venue is based on Defendants conducting substantial business in the district, including through Defendant Cigna Healthcare of Texas, Inc., which is headquartered in Plano, Texas.
  • Core Dispute: Plaintiff alleges that Defendants induce infringement of five patents covering methods of treating cardiovascular disease with low-dose colchicine by implementing insurance formulary policies that require or financially incentivize doctors to prescribe a generic 0.6 mg colchicine product off-label for this indication.
  • Technical Context: The technology involves repurposing colchicine, a well-known anti-inflammatory drug, at specific low doses for the secondary prevention of major cardiovascular events in patients with atherosclerotic disease.
  • Key Procedural History: Plaintiff alleges it sent a letter to Defendant on January 4, 2024, identifying the patents-in-suit and asserting that Defendant’s formulary policies induced infringement. The complaint alleges that Defendant continued its policies after receiving this notice.

Case Timeline

Date Event
2012-11-02 Earliest Patent Priority Date for all Patents-in-Suit
2019-02-19 U.S. Patent No. 10,206,891 Issues
2019-04-23 U.S. Patent No. 10,265,281 Issues
2021-06-08 U.S. Patent Nos. 11,026,899, 11,026,900, and 11,026,901 Issue
2024-01-01 Alleged effective date of Cigna’s Formulary requiring trial of 0.6 mg colchicine
2024-01-04 Plaintiff sends letter to Cigna identifying patents and alleging inducement
2024-03-01 Alleged effective date for Cigna removing LODOCO® from covered drug list
2024-04-08 Complaint Filed

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

U.S. Patent No. 10,206,891 - "Method of Treating Cardiovascular Events Using Colchicine Concurrently with an Antiplatelet Agent", Issued February 19, 2019

The Invention Explained

  • Problem Addressed: The patent's background describes that even with standard treatments like anti-platelet and statin therapy, patients with atherosclerotic vascular disease continue to be at risk for cardiovascular events, possibly because these therapies fail to target certain inflammatory pathways implicated in the disease (’891 Patent, col. 2:34-38).
  • The Patented Solution: The invention claims a method for treating or reducing the risk of specific cardiovascular events (acute coronary syndrome, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke) by administering colchicine to a patient at risk (’891 Patent, Claim 1). The proposed mechanism is that colchicine’s anti-inflammatory properties inhibit neutrophil activity, which in turn reduces plaque instability and the likelihood of plaque rupture that leads to clinical events (’891 Patent, col. 10:10-16).
  • Technical Importance: This method provides a therapeutic approach that targets inflammation-driven plaque instability, a mechanism distinct from the pathways targeted by standard anti-platelet or cholesterol-lowering therapies (’891 Patent, col. 2:34-38).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶21).
  • Essential elements of Claim 1:
    • A method of treating and/or reducing the risk of a cardiovascular event in a subject.
    • The method comprises administering colchicine (or a salt thereof) to a subject at risk of or who has had a cardiovascular event.
    • The cardiovascular event is specified as being acute coronary syndrome, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke.
  • The complaint reserves the right to assert dependent claims 2-5 (Compl. ¶42).

U.S. Patent No. 10,265,281 - "Treatment or Prevention of Cardiovascular Events via the Administration of a Colchicine Derivative", Issued April 23, 2019

The Invention Explained

  • Problem Addressed: The patent addresses the need for a long-term treatment to reduce cardiovascular events in patients with clinically stable atherosclerotic vascular disease, as many existing treatments are recommended for acute conditions (’281 Patent, col. 1:52-61).
  • The Patented Solution: The invention discloses a method of treating or preventing a cardiovascular event by administering a composition comprising "no more than about 0.6 total mg" of colchicine, administered "once per day" (’281 Patent, Claim 1). This specific low-dose, once-daily regimen is presented as a safe and effective method for chronic use, distinguishing it from higher-dose or more frequent regimens used for conditions like gout (’281 Patent, Abstract; col. 5:39-42).
  • Technical Importance: The invention's focus on a specific, low, once-daily dosage suggests a therapeutic window that balances the anti-inflammatory benefits of colchicine for cardiovascular risk reduction with the safety requirements for long-term administration.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶24).
  • Essential elements of Claim 1:
    • A method for treating and/or reducing the risk of a cardiovascular event in a subject.
    • The method comprises administering a therapeutically effective amount of a composition comprising no more than about 0.6 total mg of colchicine (or a salt thereof).
    • The composition is administered once per day.
  • The complaint reserves the right to assert dependent claims 1-3, 5, 6, and 8 (Compl. ¶49).

U.S. Patent No. 11,026,899 - "Treatment or Prevention of Cardiovascular Events via the Administration of a Colchicine Derivative", Issued June 8, 2021

  • Technology Synopsis: This patent claims a method for reducing the risk of a cardiovascular event by administering a composition comprising "about 0.5 total mg" of colchicine. The method specifies that the composition is administered "orally and once per day" (’899 Patent, Claim 1). This patent refines the dosage to a specific amount while also requiring oral, once-daily administration.
  • Asserted Claims: Independent claim 1 (Compl. ¶¶27, 56).
  • Accused Features: The complaint alleges that Cigna's policies induce doctors to prescribe 0.6 mg colchicine for cardiovascular indications, which it contends infringes the "about 0.5 total mg" limitation (Compl. ¶56).

U.S. Patent No. 11,026,900 - "Treatment or Prevention of Cardiovascular Events via the Administration of a Colchicine Derivative", Issued June 8, 2021

  • Technology Synopsis: This patent further narrows the patient population from the ’899 patent. It claims a method for reducing the risk of a cardiovascular event by administering "about 0.5 total mg" of colchicine orally and once per day, specifically wherein the subject "has clinically stable coronary disease" (’900 Patent, Claim 1).
  • Asserted Claims: Independent claim 1 (Compl. ¶¶30, 63).
  • Accused Features: The complaint alleges Cigna's policies induce the prescription of 0.6 mg colchicine for atherosclerotic diseases, which includes the patient population with clinically stable coronary disease (Compl. ¶63).

U.S. Patent No. 11,026,901 - "Treatment or Prevention of Cardiovascular Events via the Administration of a Colchicine Derivative", Issued June 8, 2021

  • Technology Synopsis: This patent narrows the therapeutic goal from the ’899 patent. It claims a method for treating or reducing the risk of "acute myocardial infarction" specifically by administering a composition comprising "about 0.5 total mg" of colchicine orally and once per day (’901 Patent, Claim 1).
  • Asserted Claims: Independent claim 1 (Compl. ¶¶33, 70).
  • Accused Features: The complaint alleges Cigna's policies induce the prescription of 0.6 mg colchicine to treat atherosclerotic diseases, which the plaintiff contends is a method for reducing the risk of acute myocardial infarction (Compl. ¶70).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is not a physical product but rather a set of health insurance coverage policies and formulary requirements implemented by Cigna (Compl. ¶34).

Functionality and Market Context

The complaint alleges that Cigna's policies induce infringement by third parties (doctors and patients) (Compl. ¶42). The first policy, outlined in Cigna's "Formulary Exception Criteria," allegedly required that a "Patient has tried colchicine 0.6 mg tablets or capsules [documentation required]" before Cigna would approve coverage for LODOCO®, a 0.5 mg colchicine tablet FDA-approved for cardiovascular disease (Compl. ¶34). A table from this document shows the explicit requirement for prior use of 0.6 mg colchicine (Compl. ¶34). Subsequently, Cigna allegedly published a "Medication Coverage Changes 2024" document stating that LODOCO® would no longer be a covered medication and identified "colchicine 0.6mg, MITIGARE" as a "covered alternative" (Compl. ¶¶38, 44). A table from this document shows LODOCO being removed from coverage and replaced with a 0.6 mg alternative (Compl. ¶38). The complaint asserts these policies create a "strong financial incentive" for doctors to prescribe, and patients to use, 0.6 mg colchicine off-label for cardiovascular conditions, thereby performing the steps of the patented methods (Compl. ¶44).

IV. Analysis of Infringement Allegations

10,206,891 Infringement Allegations

The complaint does not provide an embedded claim chart but alleges a theory of induced infringement, wherein doctors are the direct infringers.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating and/or reducing the risk of a cardiovascular event in a subject...comprising: administering colchicine...to a subject at risk of a cardiovascular event or who has had a cardiovascular event Doctors prescribe, and patients take, 0.6 mg colchicine for the treatment of atherosclerotic diseases, which places them at risk of cardiovascular events, as directed and incentivized by Cigna's formulary policies. ¶42-¶43 col. 3:56-63
wherein the cardiovascular event is acute coronary syndrome, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke The complaint alleges that the off-label treatment of atherosclerotic disease induced by Cigna is for the purpose of reducing the risk of these specific cardiovascular events, which are known consequences of atherosclerosis. ¶42 col. 4:1-2
  • Identified Points of Contention:
    • Scope Questions: The central legal question is whether an insurer's formulary policy, which governs reimbursement rather than directly mandating medical treatment, constitutes an "active step" taken with the specific intent to "induce" infringement under 35 U.S.C. § 271(b).
    • Technical Questions: A key factual question will be what evidence demonstrates that doctors who prescribed 0.6 mg colchicine under Cigna's policy did so specifically for the purpose of reducing the risk of the three events recited in the claim (acute coronary syndrome, cardiac arrest, or stroke), as opposed to for a more general treatment of atherosclerosis.

10,265,281 Infringement Allegations

The complaint alleges a theory of induced infringement, wherein doctors are the direct infringers.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
administering to the subject a therapeutically effective amount of a composition comprising no more than about 0.6 total mg of...colchicine... Cigna's policies allegedly require or incentivize the use of 0.6 mg colchicine tablets (e.g., MITIGARE®), a dosage that satisfies the "no more than about 0.6 total mg" limitation. ¶49-¶51 col. 5:40-42
wherein the composition is administered once per day The complaint alleges that Cigna's policies induce the use of 0.6 mg colchicine as an alternative to LODOCO®, which is an FDA-approved once-daily medication, thereby instructing a once-daily regimen. ¶49-¶51 col. 2:50-51
  • Identified Points of Contention:
    • Scope Questions: As with the ’891 Patent, the primary question is whether Cigna's formulary policy legally constitutes inducement.
    • Technical Questions: The complaint does not present direct evidence from Cigna's policy documents specifying a "once per day" administration frequency. An evidentiary question will be whether Plaintiff can demonstrate that Cigna's policy, by positing 0.6 mg colchicine as an alternative to the once-daily LODOCO®, effectively and intentionally instructs a once-daily administration as required by the claim.

V. Key Claim Terms for Construction

  • The Term: "administering" (from claim 1 of both patents)

    • Context and Importance: This is the active step of the asserted method claims. The dispute will center on whether Cigna's actions rise to the level of inducing this step. Practitioners may focus on this term because Cigna will likely argue that its formulary policies relate to reimbursement decisions and do not constitute "instructing" or "encouraging" the medical act of "administering" a drug.
    • Intrinsic Evidence for Interpretation: The patents use the term in its conventional medical sense.
      • Evidence for a Broader Interpretation: The patent specifications do not limit how the "administering" is initiated, which could leave room for a court to find that creating a strong financial incentive for a doctor to perform the act is a form of inducement.
      • Evidence for a Narrower Interpretation: The patents describe administration in a purely clinical context, such as "in dosages and by routes consistent with the usual clinical practice" (’891 Patent, col. 8:39-41), without any reference to insurance or reimbursement mechanisms. This may suggest the term is confined to the direct physician-patient relationship.

  • The Term: "about 0.5 total mg" (from claim 1 of the ’899, ’900, and ’901 patents)

    • Context and Importance: The accused instrumentality involves a 0.6 mg colchicine product, while three of the five patents claim "about 0.5 total mg." The viability of these claims will depend on whether 0.6 mg is construed to be "about 0.5 mg."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The word "about" inherently provides some latitude. The specification of the related ’281 patent, from the same family, describes commercial tablets in strengths of "0.5-0.6 mg/tablet" (’281 Patent, col. 5:41-42), suggesting the inventors considered these doses to be therapeutically similar for this purpose.
      • Evidence for a Narrower Interpretation: The prosecution history (not provided) would be relevant to determine if the patentee distinguished the 0.5 mg dosage from other dosages to secure allowance. The repeated use of "about 0.5 mg" in later patents, while the earlier ’281 patent claimed "no more than about 0.6 mg," could suggest an intentional narrowing of scope.

VI. Other Allegations

  • Indirect Infringement: The complaint's theory of liability is exclusively based on induced infringement under 35 U.S.C. § 271(b). It is alleged that Cigna's formulary documents, which require prior use of 0.6 mg colchicine or designate it as a covered alternative to LODOCO®, actively and intentionally instruct and encourage doctors and patients to perform the patented methods (Compl. ¶¶42, 49, 56, 63, 70).
  • Willful Infringement: The claim for willfulness is based on alleged pre-suit knowledge. The complaint alleges that on January 4, 2024, Plaintiff sent Cigna a letter that identified the patents-in-suit and explained its infringement theory. The complaint further alleges that Cigna continued its conduct after receiving this notice, providing the basis for willful infringement (Compl. ¶¶35-37, 46).

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

  • A core issue will be one of legal causation: Can a health insurer’s formulary policy, which creates a strong financial incentive to use a generic drug for an off-label purpose, satisfy the legal standard for active inducement, which requires showing the alleged infringer acted with the specific intent to cause the infringing acts?
  • A key evidentiary question will be one of factual proof: Assuming Plaintiff can establish the legal theory of inducement, can it produce evidence that doctors, in response to Cigna's policy, actually prescribed 0.6 mg colchicine for the specific patient populations and indications (e.g., to reduce risk of acute myocardial infarction) and at the specific frequencies (once per day) required by the various asserted claims?
  • A central claim construction question will be one of definitional scope: For the three patents claiming "about 0.5 total mg," can this term be construed to read on the accused 0.6 mg dosage, or did the patentee define a scope that excludes it?