The Journal of Intellectual Property (J Intellect Property; JIP)

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

CONTENTS

Research article

Citation: Kim K. 2024. Production, use, transfer of prodrug substances, and direct or indirect infringement of the patent: Focusing on the dapagliflozin formate case. The Journal of Intellectual Property 19(1), 79-107.

DOI: https://doi.org/10.34122/jip.2024.19.1.4

The Journal of Intellectual Property, 2024 March, 19(1): 79-107. 

Received on 29 January 2024, Revised on 15 February 2024, Accepted on 29 February 2024, Published on 30 March 2024.

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

Kwanshik Kim

Professor of Law, Hannam University, Ph. D. in Law, Ph. D. in Physics, Republic of Korea

*Corresponding Author: Kwanshik Kim (kwanshik@gmail.com)

Abstract

This study 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, it is not justifiable to consider it as the product of a patented article. Therefore, indirect infringement cannot be established.

Keywords

prodrug, infringement under doctrine of equivalents, intentional exclusion, indirect infringement, dapagliflozin

Funding

The author received financial support for this article from Korea Institute of Intellectual Property.

Conflicts of interest

No potential conflict of interest relevant to this article was reported.