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

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This study Endcap Kit explored whether the utilization of dapagliflozin formate, a dapagliflozin prodrug, constitutes direct (including literal infringement and infringement under 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 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, Heart Health it is not justifiable to consider it as the product of a patented article.

Therefore, indirect infringement cannot be established.