Intellectual Property Rights Effects on India's Pharmaceutical Industry.

Abstract

The Indian pharmaceutical industry took full advantage of the "process patent regime". It aggressively pursued the expansion of its market share by offering the most reasonably priced generic versions of pharmaceuticals to emerging and developing nations. The Indian government remained neutral over the implementation of the TRIPS agreement until 2005. Indian pharmaceutical patent law is distinct from legislation in other nations in several ways, some of which are among the most critical intellectual property issues in the nation. Over the past thirty years, the lack of product patent protection has been a significant setback for the Indian pharmaceutical business. "Molecules" that were patented and protected internationally but which India failed to protect. The Act's ambiguity makes it common for opponents of pharmaceutical patents to file unreasonable serial pre-grant oppositions. In addition, the number of pre-grant opposition filings is surging exponentially. The potential for revocation, oppositions before and after the grant, and counterclaims in cases of infringement are just a few of the challenges that may arise during the process of a patent. The TRIPS Agreement compliance of the Indian patent system will be guaranteed by the Patents (Amendment) Rules, 2005, and the Patents (Amendment) Ordinance, 2004. Nonetheless, another notable accomplishment of the Ordinance and the Rules is the progressive change of the Indian patent prosecution system. In keeping with its international obligations, the Indian government is working to create a patent system that encourages technical development. Additionally, India is working to alleviate concerns about the inadequate enforcement of its current intellectual property rules.