Short Summary
Fresenius Kabi SwissBioSim petitions the PTAB to invalidate Regeneron’s anti‑VEGF eye‑drug patent, asserting that the Dix ’226 reference anticipates all challenged claims and that the patent owner has not shown any criticality for the claimed formulation parameters.
Detailed Summary
In Petition IPR2025‑01268, Fresenius Kabi SwissBioSim GmbH challenges U.S. Patent No. 11,084,865, which claims ophthalmic formulations of the VEGF antagonist aflibercept for intravitreal administration. The petitioner contends that the prior‑art U.S. Patent No. 10,406,226 (Dix ’226) discloses every element of the independent and dependent claims, including the specific concentration ranges, excipient percentages, and inherent stability properties. Because the patent owner has not demonstrated that the 40 mg/mL concentration or other claim limitations are critical, the petitioner argues the claims are anticipated under 35 U.S.C. § 102. The petition also references a recent Federal Circuit oral argument that emphasized the burden of proving criticality, and notes that the related appeal was settled before an opinion was issued. The Board is asked to institute review and find the claims unpatentable.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before local courts. Understanding the court's reasoning in Fresenius Kabi SwissBioSim GmbH et al. vs Regeneron Pharmaceuticals, Inc. is valuable context for structuring arguments or assessing risk in similar proceedings.
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