PTAB

IPR2022-00517

Mylan Pharmaceuticals Inc v. Bayer Pharma AG

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1. Case Identification

2. Patent Overview

  • Title: Reducing the Risk of Cardiovascular Events
  • Brief Description: The ’310 patent discloses methods for reducing the risk of cardiovascular events (myocardial infarction, stroke, cardiovascular death) by co-administering specific doses of rivaroxaban and aspirin to patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-4 by EMA

  • Prior Art Relied Upon: EMA (European Medicines Agency, Assessment Report for Xarelto, 2013).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that EMA, in a single, continuous disclosure, teaches every element of claims 1-4. The EMA report documents the European approval of a treatment regimen comprising twice-daily 2.5 mg rivaroxaban co-administered with once-daily 75-100 mg aspirin. This regimen was approved for preventing cardiovascular events in patients after an acute coronary syndrome (ACS). Petitioner contended that a person of ordinary skill in the art (POSA) would have understood ACS to be a form of CAD, thereby meeting the patient population limitation of the claims. The report's conclusion of efficacy and approval by a major regulatory body was argued to satisfy the "clinically proven effective" limitation.

Ground 2: Anticipation of Claims 1-2 by Foley

  • Prior Art Relied Upon: Foley (T.R. Foley et al., Antithrombotic therapy in peripheral artery disease, VASCULAR MED., 2016).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Foley describes the COMPASS Phase III clinical trial, which evaluated the exact method claimed. Foley explicitly teaches administering "2.5 mg of rivaroxaban twice daily and aspirin (100 mg once daily)" to patients with CAD or PAD for the "Prevention of Major Cardiovascular Events," including myocardial infarction, stroke, or cardiovascular death. Petitioner argued that the "clinically proven effective" limitation is inherently met by Foley’s disclosure of this specific, known regimen for its intended purpose, as efficacy is inherent to the disclosed administration.

Ground 3: Obviousness of Claims 3-4 and 6-7 over Foley and Plosker

  • Prior Art Relied Upon: Foley (2016) and Plosker (G.L. Plosker, Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, DRUGS, 2014).

  • Core Argument for this Ground:

    • Prior Art Mapping: Foley teaches the core combination of twice-daily 2.5 mg rivaroxaban with 100 mg once-daily aspirin. Plosker, a review article discussing the same clinical data, teaches the broader, approved aspirin dosage range of 75-100 mg/day for the same indication. Petitioner argued that Plosker’s disclosure of the 75-100 mg range renders the specific dependent claim limitations for 75 mg and 81 mg aspirin obvious variations of Foley’s 100 mg dose.
    • Motivation to Combine: A POSA would combine the teachings of Foley and Plosker because Plosker provides additional context and confirms the established efficacy and approved dosage ranges for the exact drug combination evaluated in the trial described by Foley. The motivation was to apply a known, effective dosage range (from Plosker) to the established treatment method (from Foley).
    • Expectation of Success: A POSA would have a high expectation of success because both references describe the same successful clinical regimen, and Plosker confirms the clinical equivalence of aspirin doses within the 75-100 mg range. Petitioner noted these dosages merely reflect different, commercially available strengths in various global markets.

  • Additional Grounds: Petitioner asserted that claims 1-8 are obvious over EMA alone. Petitioner also asserted that claims 1-2, 5, and 8 are obvious over Foley alone, arguing that even if not anticipating, Foley's disclosure of all elements would make their combination obvious to a POSA.

4. Key Claim Construction Positions

  • "Clinically Proven Effective": Petitioner argued this functional language does not impart a patentable limitation beyond the specific dosages recited in the claims. Alternatively, Petitioner contended that a POSA would understand this term to be satisfied by the approval of the recited regimen by any major government health agency, such as the European Medicines Agency (EMA), and not be limited to approval by the U.S. FDA, which occurred after the patent’s priority date. This construction was central to the anticipation argument based on the EMA reference.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under Fintiv would be inappropriate. The core reasons provided were that the parallel district court litigation was in its initial stages with no trial date set, this IPR petition was filed diligently and well within the statutory time limit, and Petitioner stipulated it would not pursue the same invalidity grounds in the district court if the IPR is instituted. Petitioner also argued the strong merits of the anticipation grounds weigh heavily in favor of institution.

6. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1-8 of Patent 10,828,310 as unpatentable.