22 INDIAN PATENT LAW Up for a fight
International damage may result from India’s steps to formalise its isolationist patents regime, says Jason Rutt.
LSIPR Newsletter 04:14
India has been the hub for all that excites ire and admiration in those with an interest in pharmaceuticals. Generic manufacturers and access-for-medicine foundations applaud, and innovators seethe at the way India has become a tough place for innovative companies to do business. Tere is frequent debate about the extent to which Indian law is being correctly applied and whether Indian statute is compliant with the World Trade Organization’s Trade-Related Aspects of IP Rights (TRIPS) Agreement.
Amid the controversy, many forget that the issues associated with Indian patent law have a strong retrospective element. Aſter India signed up to TRIPS at the beginning of 1995, it was granted ten years to introduce all the necessary changes. Te key one for the pharmaceutical industry was the introduction of pharma product patents in 2005. Given that the lead time for development of a new pharmaceutical is more than ten years, a product marketed in 2014 was probably the subject of a pre-2005 patent application. Glivec (imatinib) is a good example of such a product.
Given how much conflict is based on past law, what can we expect in the future? Te Indian Patent Office (IPO) has issued draſt guidance to examiners on how to treat future applications. India is unrepentant, unapologetic and bristling for future clashes.
Te preamble to the guidance gives a useful insight into the IPO’s mindset. It acknowledges the value that good patents bring in terms of ‘promoting innovation and technological development’ (para 1.17). However, it is proud of the way that India is viewed as the ‘pharmacy of the world’ (para 1.16) and quotes a World Health Organization request to the Indian government in 2004:
“As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need access to antiretrovirals, without adopting unnecessary restrictions that are not required under the TRIPS Agreement and that would impede access to medicines.”
Tis is the ‘level playing field’ point frequently made by innovative pharmaceutical companies. Medicines are researched, developed and sold in a global marketplace. Pharmaceuticals are
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