Pete Marston
The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement
By Pete Marston on Dec 19, 2024
Posted In Patents
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a patent, the US Court of Appeals for the Federal Circuit upheld the district court’s finding of noninfringement. Galderma Laboratories, L.P....
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