Section 3(d): Implications and Key Concerns For Pharmaceutical Sector

16-26<span style="font-size:11.0pt;font-family: " times="" new="" roman","serif";mso-fareast-font-family:"times="" roman";mso-bidi-font-family:="" mangal;mso-ansi-language:en-gb;mso-fareast-language:en-us;mso-bidi-language:="" hi"="" lang="EN-GB">TRIPS has granted certain flexibilities to the member nations in framing their Patent Laws considering their social and economic needs. Flexibility provided in TRIPS has been utilized by member countries as a safeguard to mitigate the potential adverse effects that drug patents might have on medicine supply. A clause - Section 3(d) - has been redesigned in the Indian patent legislation to restrain the ever-greening of drug patents. Section 3(d) of the Indian Patents Act allows patents on variants of only those chemical compounds that show significant enhancement in therapeutic efficacy. The revised Section 3(d) is deterrent against ever-greening of patent and subsequent monopoly of the multinational drug corporations. Since its introduction, it has been widely discussed for not supporting innovation. The multi-national pharma companies (MNCs) and the US-India Business Council (USIBC) have suggested in their report for elimination of Section 3(d) so that drug patents can be granted in India for incremental improvement and modification. As per US 301 report, India is listed among countries with inadequate IP regime. Keeping all these aspects into consideration, this paper discusses various issues and key concerns pertaining to impact of Section 3(d) with special emphasis to its interpretation.