Intellectual Property and Public Health Emergency: Bolar Provision and Parallel Import

DOI

10.2991/assehr.k.211112.015How to use a DOI?

Keywords

intellectual property rights; Bolar provisions; parallel imports; generic drugs; patents

Abstract

Parallel import and Bolar provisions are excluded from criminal provisions and civil lawsuits. Bolar provision is a policy that allows third parties to test, use and make patented drugs for the purpose of seeking approval from the Food and Drug Administration before the patented drug expires. This provision aims to provide opportunities for the national pharmaceutical industry to conduct further research and development, testing for production, and product registration in the period before the expiration of its patent period. Parallel imports are exceptions to be penalized or sued for the importation of patent-protected pharmaceutical products into a country without the permission of the patent owner and patent holder in the country of origin. It aims to provide an opportunity to get better access to cheaper and more affordable pharmaceutical products. Both provisions are an exception to the exclusive rights owned by the patent holder. However, in practice, such provisions are not necessarily possible. The regulations are so brief and not detailed that it requires interpretation in the process. Therefore, this study will try to find a solution to why the regulations that exist can not be applied in practice. The method of this research is normative legal study. The study found that the implementing rules of the provisions of Bolar and parallel imports are required. Although there has been an implementing rule on drug registration, in practice, the rule still does not protect the rights of patent holders.

Copyright

© 2021 The Authors. Published by Atlantis Press SARL.

Open Access

This is an open access article under the CC BY-NC license.

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TY  - CONF
AU  - Lily Evelina Sitorus
PY  - 2021
DA  - 2021/11/23
TI  - Intellectual Property and Public Health Emergency: Bolar Provision and Parallel Import
BT  - Proceedings of the 2nd International Conference on Law and Human Rights 2021 (ICLHR 2021)
PB  - Atlantis Press
SP  - 121
EP  - 126
SN  - 2352-5398
UR  - https://doi.org/10.2991/assehr.k.211112.015
DO  - 10.2991/assehr.k.211112.015
ID  - Sitorus2021
ER  -