PTAB

IPR2025-01269

Fresenius Kabi SwissBioSim GmbH v. Regeneron Pharmaceuticals Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders
  • Brief Description: The ’345 patent discloses methods for treating angiogenic eye disorders by sequentially administering multiple doses of a VEGF antagonist, aflibercept (also known as VEGF Trap-Eye). The claimed dosing regimen involves a single initial dose, followed by one or more secondary doses administered 4 weeks after the preceding dose, and subsequently one or more tertiary doses administered 12 weeks after the preceding dose.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-9 by Prior Disclosures of VIEW Clinical Trials - Claims 1-9 are anticipated under 35 U.S.C. §102 by each of Dixon, NCT-377, NCT-795, and Regeneron (8-May-2008) individually.

  • Prior Art Relied Upon: Dixon (a 2009 journal article), NCT-377 (a ClinicalTrials.gov record from 2008), NCT-795 (a ClinicalTrials.gov record from 2009), and Regeneron (8-May-2008) (a press release).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that each of the four cited references independently disclosed every limitation of claims 1-9. These references described the design and dosing protocols for the VIEW 1 and VIEW 2 Phase III clinical trials for treating neovascular age-related macular degeneration (AMD) with aflibercept. Petitioner asserted these protocols taught the claimed regimen: an initial dose, followed by secondary doses administered at 4-week intervals during the first year of treatment, and a second year of treatment where tertiary doses could be administered as infrequently as every 12 weeks. The references also disclosed the specific drug (aflibercept), its composition as a receptor-based chimeric molecule, dosages (0.5 mg and 2.0 mg), and intravitreal administration, thereby mapping to all limitations of independent claim 1 and dependent claims 2-9.
    • Key Aspects: Petitioner contended that Dixon, a peer-reviewed article, expressly cited and incorporated the disclosures of the NCT-377 clinical trial record. This incorporation made the detailed dosing protocol from NCT-377 an explicit part of Dixon’s teaching, strengthening the case for anticipation by a single reference.

Ground 2: Obviousness of Diabetic Retinopathy/DME Claims - Claims 10 and 11 are obvious over any one of Dixon, NCT-377, NCT-795, or Regeneron (8-May-2008) in view of Regeneron (18-Feb-2010) and a POSA's knowledge.

  • Prior Art Relied Upon: Any one of the primary references from Ground 1, combined with Regeneron (18-Feb-2010) (a press release announcing positive Phase 2 study results).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that the primary references taught the complete dosing regimen of claims 1-9 for treating AMD. The only new limitations in claims 10 and 11 are the application of this same method to treat diabetic retinopathy (DR) and diabetic macular edema (DME), respectively. Petitioner asserted that the Regeneron (18-Feb-2010) press release supplied the missing element, as it disclosed positive results from a Phase 2 study using aflibercept to treat patients with DME. This reference demonstrated the "biologic activity" and significant vision improvement for this specific patient population.
    • Motivation to Combine: A POSITA would combine the known VIEW trial dosing regimen with the treatment of DME for several reasons. First, it was well-known that AMD and DR/DME share the same underlying VEGF-driven pathogenesis. Second, aflibercept was known to target this shared pathway. Third, there was a recognized need in the art to reduce the burden of frequent intravitreal injections for DME patients, making the less-frequent dosing regimen of the VIEW trials an attractive and logical option to try.
    • Expectation of Success: The positive Phase 2 clinical data reported in Regeneron (18-Feb-2010), published more than a year before the patent's priority date, would have provided a POSITA with a strong and reasonable expectation of success in applying the specific dosing regimen from the VIEW trials to treat patients with DR and DME.

  • Additional Grounds: Petitioner asserted as an alternative that claims 1-9 are obvious over Dixon in view of NCT-377.

4. Key Claim Construction Positions

  • "treating": Petitioner proposed this term be given its plain and ordinary meaning, consistent with a PTAB decision in a related case: “administering a therapeutic to a patient, without a specific degree of efficacy required.” This construction is critical to rebutting any potential argument from the Patent Owner that the prior art fails to anticipate because it describes clinical trials that had not yet proven a specific level of efficacy.
  • "initial dose," "secondary dose," "tertiary dose": Petitioner argued these terms should be construed according to their express definitions in the ’345 patent’s specification, which define them based purely on the “temporal sequence of administration.” This construction prevents the terms from being limited by functional or efficacy-based criteria not present in the claims.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-11 of the ’345 patent as unpatentable.