PTAB

IPR2015-01718

Coalition for Affordable Drugs VII LLC v. Pozen Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Method for Treating a Patient at Risk for Developing an NSAID-Associated Ulcer
  • Brief Description: The ’621 patent discloses methods for reducing the incidence of gastric ulcers associated with non-steroidal anti-inflammatory drug (NSAID) use, particularly in patients also taking low-dose aspirin. The method involves administering a coordinated, unit dose form composition comprising naproxen (an NSAID) and esomeprazole (a proton pump inhibitor).

3. Grounds for Unpatentability

Ground 1: Claims 1-16 are obvious over Plachetka in view of Graham and Goldstein

  • Prior Art Relied Upon: Plachetka (Patent 6,926,907), Graham (a 2002 article in Archives of Internal Medicine), and Goldstein (a 2004 article in Clinical Therapeutics).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Plachetka disclosed all elements of the claimed method, including a unit dose form with enterically coated naproxen (500 mg) and esomeprazole (20 mg) for reducing NSAID-induced ulcers. Plachetka also recognized the specific problem of reduced efficacy in patients concurrently taking low-dose aspirin (LDA). Graham and Goldstein were argued to directly address this problem by teaching that combining an NSAID with a proton pump inhibitor (PPI) like lansoprazole was more effective at preventing ulcers in patients taking LDA than in those not taking LDA.
    • Motivation to Combine: A POSITA, aware of the specific problem identified in Plachetka regarding LDA patients, would combine Plachetka’s composition with the teachings of Graham and Goldstein. The motivation was to apply the known solution (using a PPI to protect LDA patients) from Graham and Goldstein to improve the specific composition and method of Plachetka, thereby achieving the predictable result of reduced ulcer incidence in this high-risk patient subgroup.
    • Expectation of Success: Petitioner asserted a high expectation of success because esomeprazole (from Plachetka) and lansoprazole (from Graham/Goldstein) are both PPIs that are structurally similar, functionally the same, and have the same mechanism of action (inhibiting the H+/K+-ATPase pump). A POSITA would have reasonably expected that substituting the esomeprazole taught by Plachetka for the lansoprazole in the Graham/Goldstein studies would yield the same improved efficacy in LDA patients.

Ground 2: Claims 1-16 are obvious over Plachetka

  • Prior Art Relied Upon: Plachetka (Patent 6,926,907).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Plachetka disclosed the claimed composition (PN400, a combination of 500 mg naproxen and 20 mg esomeprazole) and its use for reducing NSAID-induced ulcers. The key limitation distinguishing the ’621 patent claims—that the composition is "more effective" in patients taking LDA—was argued to be an inherent property of the composition disclosed by Plachetka.
    • Motivation to Combine (for §103 grounds): This ground is based on a single reference and an inherency argument. The motivation was to use the composition disclosed in Plachetka for its stated purpose: reducing the risk of gastrointestinal side effects in patients taking NSAIDs, including those with risk factors like chronic LDA use which Plachetka explicitly identified.
    • Expectation of Success (for §103 grounds): Petitioner contended that the superior efficacy in LDA patients is a natural, necessary, and inherent result of administering the Plachetka composition. Petitioner argued that the ’621 patent’s own specification and prosecution history, which presented clinical data on the PN400 formulation to demonstrate this "unexpected result," served as evidence of this inherency. The argument was that the mere recitation of a newly discovered property (superior efficacy in LDA patients) inherently possessed by a prior art composition does not render the method of using that composition nonobvious.

4. Key Claim Construction Positions

  • “Low Dose Aspirin” and “LDA”: Petitioner argued that based on the ’621 patent’s specification, these terms should be construed to mean "dosages of aspirin that are ≤ 325 mg." This construction was central to mapping the Graham and Goldstein studies, which involved patients on LDA for cardiovascular prophylaxis, to the claims.
  • “Unit Dose Form” and “Unit Dosage Form”: Petitioner asserted these terms are used interchangeably in the patent and should be construed, based on the specification, as "a single entity for drug administration." This construction supported the argument that Plachetka’s disclosed tablets and capsules met this limitation.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-16 of Patent 8,945,621 as unpatentable.