A Criticism of the Approach Adopted by the Industrial Property Parliamentary Plan Regarding the Exclusion of New Medical Usesfrom the Patentable Subject Matters Using the Comparative Law with an Emphasis on Economic Impacts

Identifying new therapeutic uses that known as Drug Repurposing in the pharmaceutical industry, is a process by which new medical indications for existing drugs are identified. Given the benefits of this process compared to identification and development of a new chemical entity, many pharmaceutical companies have focused on this strategy. There is no single approach in international and regional instruments, so that some of them do not have a rule in this regard, some have considered these inventions as patentable subject-matters and some other have excluded them from patentability. Despite the silence of the Iranian Patent, Industrial Design and Trademark Law of 2007 concerning patentability of new therapeutic uses, such inventions could be considered as patentable based on the Article 2 and 4 of this law. However, one of the exclusions from patentable subject-matter under Article 4 (2) of the new Industrial Property Protection Parliamentary Plan relates to the new use of known products or processes. This paper seeks to review and compare the approaches adopted by international instruments, national laws and the advantages and impacts of drug repurposing from an economic point of view.

The research method is Analytical-Comparative. It has been prepared and compiled by library method using Note-taking techniques.

In all stages of writing this paper, the ethical principles of research, especially, the originality of the text, honesty and confidentiality have been fully observed.

The findings indicate that one of the reasons for lack of legal protection for these inventions is the adverse economic effects that may occur on the activities of generic drug makers and raising drug prices in the market, so that the entry of these companies into the market face serious obstacles and increase subsequently drug prices.

Some legal approaches to exclusion of new therapeutic uses from patentable subject-matter are resulted from lack of enough attention to the nature and scope of protection of such inventions, their economic benefits compared to developing new chemical entity, skinny labeling and therefore lack of disrupting effects on the generic drug makers and lack of increase in drug prices.Please cite this article as:Parvin MR, Jabbari AR. A Criticism of the Approach Adopted by the Industrial Property Parliamentary Plan Regarding the Exclusion of New Medical Uses from the Patentable Subject Matters Using the Comparative Law with an Emphasis on Economic Impacts. Medical Law Journal. 2022; 16(57): e5.