Murray & Poole Enterprises Ltd v. Institut De Cardiologie De Montréal

1. Case Identification

• Case #: IPR2023-01064
• Patent #: 11,400,063
• Filed: June 16, 2023
• Petitioner(s): Murray & Poole Enterprises Ltd.
• Patent Owner(s): Institut de Cardiologie de Montreal
• Challenged Claims: 1-50

2. Patent Overview

• Title: Early Administration of Low-Dose Colchicine After Myocardial Infarction
• Brief Description: The ’063 patent relates to methods of treating patients after a myocardial infarction (MI) by initiating the administration of a daily low dose of colchicine. The claims specify initiating treatment without a pre-loading dose and within particular timeframes, such as within about 3 days or 30 days of the MI.

3. Grounds for Unpatentability

Ground 1: Claims 1-13, 17-26, 28, 40-46, 49, and 50 are anticipated by Bouabdallaoui

• Prior Art Relied Upon: Bouabdallaoui (a 2020 publication in the European Heart Journal).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Bouabdallaoui published the same post hoc analysis of the COLCOT clinical trial data that the Patent Owner relied upon to support the claims of the ’063 patent. Petitioner asserted that Bouabdallaoui explicitly discloses every limitation of the challenged claims, including treating recent post-MI patients, initiating a daily low dose of colchicine (0.5 mg) without a pre-loading dose, and an initiation timeframe of 0-3 days post-MI. The reference also allegedly disclosed the use of percutaneous coronary intervention (PCI) in the patient population and the resulting reduction in cardiovascular events, directly mapping to independent claims 1 and 8 and their dependents.
  • Key Aspects: Petitioner contended these claims are not entitled to a priority date preceding Bouabdallaoui’s publication. Therefore, the patent claims are anticipated by a public disclosure of the very same data and analysis used to obtain them.

Ground 2: Claims 1-50 are obvious over Nidorf in view of COLCOT Protocol, ESC Guidelines, and COLCRYS

• Prior Art Relied Upon: Nidorf (Patent 10,206,891), COLCOT Protocol (a 2017 clinical trial protocol), ESC Guidelines (2017 European Society of Cardiology guidelines), and COLCRYS (a 2009 FDA package insert).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that the combination of these references rendered all claims obvious. Nidorf, which describes the LoDoCo trial, taught the use of low-dose (0.5 mg/day) colchicine for secondary prevention in patients with a history of MI who were on standard therapies like aspirin and statins. The COLCOT Protocol taught initiating this same treatment within a 30-day window post-MI. The ESC Guidelines recommended initiating secondary prevention therapies as early as possible, typically around 2-3 days post-MI prior to hospital discharge, to improve outcomes. Finally, COLCRYS established the common availability of film-coated colchicine tablets suitable for the claimed methods.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine these teachings as a matter of routine clinical optimization. A POSITA would be motivated to shorten the treatment initiation window from Nidorf’s study of stable patients (≥6 months post-MI) to the more acute 30-day window taught by the COLCOT Protocol. Furthermore, the ESC Guidelines provided a clear motivation to initiate treatment even earlier—around 2-3 days post-MI—to maximize therapeutic benefits and patient adherence. This trend was reinforced by the CANTOS trial, which validated the underlying anti-inflammatory hypothesis for secondary prevention.
  • Expectation of Success: A POSITA would have a reasonable expectation of success. Nidorf had already demonstrated colchicine’s efficacy in reducing cardiovascular events in a similar patient population. The only significant variable being modified was the timing of administration, and established medical practice (per ESC Guidelines) strongly supported earlier intervention for secondary prevention post-MI. Therefore, applying a known effective drug earlier in the treatment course for a known benefit would have been an obvious strategy with a high likelihood of success.

• Additional Grounds: Petitioner asserted that claims 27, 29-36, and 39 are anticipated by the COLCOT Protocol. Petitioner also asserted an additional obviousness challenge against claims 1-26, 28, and 40-50 over Bouabdallaoui in view of COLCRYS, arguing it would have been obvious to use the film-coated tablets from COLCRYS to practice the method disclosed in Bouabdallaoui.

4. Key Claim Construction Positions

• Petitioner argued that several preamble and "wherein" clauses should be treated as non-limiting statements of purpose or intended result that do not add patentable weight to the method steps.
• The preamble term "treating" (claims 1-26, 40-50) was argued not to require any degree of clinical efficacy, but merely the administration of the drug with the objective of managing a condition.
• The preamble "reducing the risk of a stroke" (claims 27-39) and the clause "wherein the patient is at a lower risk of a cardiovascular event" were also argued to be non-limiting intended results of performing the claimed administration steps.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) is unwarranted because the Examiner made material errors during prosecution.
• Key asserted errors included: (1) selecting the wrong closest prior art and failing to consider anticipatory references like Bouabdallaoui and the COLCOT Protocol that were either not before the Examiner or not properly addressed; and (2) allowing claims based on an erroneous understanding that key limitations (e.g., PCI treatment, no pre-loading dose) were missing from the prior art, when in fact they were explicitly taught by overlooked references.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-50 of Patent 11,400,063 as unpatentable.