PTAB

IPR2022-01513

Teva Pharmaceuticals USA 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 myocardial infarction, stroke, or cardiovascular death in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD). The claimed method involves co-administering a specific dosage regimen of rivaroxaban (2.5 mg twice daily) and low-dose aspirin (75-100 mg daily).

3. Grounds for Unpatentability

Ground 1: Anticipation over EMA - Claims 1-4 are anticipated under 35 U.S.C. §102 by EMA.

  • Prior Art Relied Upon: EMA (European Medicines Agency, Assessment Report, Xarelto, 2013).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the 2013 EMA report, which documents the European approval of rivaroxaban (Xarelto), explicitly discloses every limitation of claims 1-4. The report described Phase II and III clinical trials establishing that administering 2.5 mg rivaroxaban twice daily in combination with 75-100 mg daily aspirin reduced cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS), which Petitioner asserted is a form of CAD. The disclosed patient population, specific drug dosages, administration schedule, and clinically proven therapeutic effect were alleged to map directly onto the claim limitations.
    • Key Aspects: The argument centered on the assertion that EMA is a single, prior art reference that explicitly teaches the entire claimed method, which had already received regulatory approval in Europe years before the ’310 patent's priority date.

Ground 2: Anticipation over Foley - Claims 1-2 are anticipated under §102 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 contended that Foley, a 2016 cardiology journal article, anticipated claims 1-2 by describing the design of the COMPASS clinical trial. Foley expressly taught a method of preventing major cardiovascular events in patients with CAD or PAD by administering "2.5 mg of rivaroxaban twice daily and aspirin (100 mg once daily)." Petitioner argued that the clinical efficacy of this regimen is inherent in its administration and that a person of ordinary skill in the art (POSA) would have known this specific regimen was clinically proven effective for the recited indications based on other publicly available data.
    • Key Aspects: Petitioner emphasized that Foley described the very clinical trial that formed the basis for the ’310 patent, yet was published as prior art, making the claimed invention not new.

Ground 3: Obviousness over Foley and Plosker - Claims 3-4 and 6-7 are obvious under §103 over Foley in view of Plosker.

  • Prior Art Relied Upon: Foley (T. R. Foley, et al., Antithrombotic therapy in peripheral artery disease, VASCULAR MED., 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: Petitioner asserted that Foley taught the base combination of twice-daily 2.5 mg rivaroxaban with 100 mg aspirin. Plosker, a 2014 review article, discussed the same combination therapy for ACS and specified that the "recommended dosage...should be co-administered with...low-dose aspirin (75-100 mg once daily)." The dependent claims recite specific aspirin amounts (75 mg and 81 mg) that fall squarely within the range expressly taught by Plosker.
    • Motivation to Combine: A POSITA would combine Foley and Plosker because Plosker provided further detail and clinical context for the precise drug combination being evaluated in the trial that Foley described.
    • Expectation of Success: A POSITA would have a high expectation of success in using the 75 mg or 81 mg doses of aspirin recited in the dependent claims. Plosker confirmed the known effective range was 75-100 mg, and the claimed amounts were simply well-known, commercially available dosages within that established therapeutic window.

  • Additional Grounds: Petitioner asserted additional obviousness challenges (claims 1-8 over EMA; and claims 1-2, 5, and 8 over Foley) arguing that, to the extent the references were found not to anticipate, a POSA would have readily combined the disclosures within each reference with a reasonable expectation of success.

4. Key Claim Construction Positions

  • "Clinically Proven Effective": Petitioner argued this term is satisfied by the claims' own recitation of specific, known-effective doses (2.5 mg rivaroxaban and 75-100 mg aspirin). Petitioner further contended that a POSA would understand that regulatory approval by a major government health agency, such as the European Medicines Agency, would establish that a regimen was "clinically proven effective," irrespective of its approval status with the U.S. FDA at the patent’s priority date.
  • "First Product"/"Second Product" (Claim 5): As these terms are not defined in the specification, Petitioner asserted that a POSA would interpret them broadly to include the co-administration of separate rivaroxaban and aspirin pills, either simultaneously or sequentially. This construction would not require a single, fixed-dose combination product.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not exercise discretionary denial under §314(a) or §325(d). The petition was filed concurrently with a motion to join IPR2022-00517, an already-instituted review of the same patent. In that proceeding, the Board had already determined that the asserted grounds presented "compelling evidence of unpatentability," thereby precluding discretionary denial under the Fintiv factors.

6. Relief Requested

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