Journal of Intellectual Property (J Intellect Property; JIP)

KCI Indexed
OPEN ACCESS, PEER REVIEWED

pISSN 1975-5945
eISSN 2733-8487
Research Article

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

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

Correspondence to Kwanshik Kim, E-mail: kwanshik@gmail.com

Volume 19, Number 1, Pages 79-107, March 2024.
Journal of Intellectual Property 2024;19(1):79-107. https://doi.org/10.34122/jip.2024.19.1.4
Received on January 29, 2024, Revised on February 15, 2024, Accepted on February 29, 2024, Published on March 30, 2024.
Copyright © 2024 Korea Institute of Intellectual Property.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits use, distribution and reproduction in any medium, provided that the article is properly cited, the use is non-commercial and no modifications or adaptations are made.

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

Notes

Conflicts of Interest

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

Funding

The author received manuscript fees for this article from Korea Institute of Intellectual Property.

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