Production, use, transfer of prodrug substances, and direct or indirect infringement of the patent: Focusing on the dapagliflozin formate case

Production, use, transfer of prodrug substances, and direct or indirect infringement of the patent: Focusing on the dapagliflozin formate case

Blog Article

This study explored whether the utilization of dapagliflozin formate, a dapagliflozin prodrug, constitutes direct (including literal infringement and infringement under Movie (2007) the doctrine of equivalents) and indirect infringement, against a patent covering a broader concept encompassing dapagliflozin.Dapagliflozin formate differs from the patented invention in its formate component; hence, neither literal infringement nor use infringement can be recognized.Although the requisite conditions for infringement under the doctrine of equivalents for a dapagliflozin Cat Wet prodrug have been met, upon reviewing the prosecution history, it is reasonable to refute infringement due to the intentional exclusion of dapagliflozin formate.Moreover, even if dapagliflozin is generated as a metabolite within the body, it is not justifiable to consider it as the product of a patented article.Therefore, indirect infringement cannot be established.