PMO circulates note on after considering proposals by global drug makerssuch as Novartis, BMS, Eli Lilly and Pfizer besides executives of Organization of Pharmaceutical Producers in India(OPPI) a lobby group of international drug innovator companiesthat wants to do certain changes in the intellectual property rights regime of India that can compromise Indian drug makers’ ability to sell very low cost generic medicines and also,the proposals include changes in controversial matters such as ‘legislative review’ of the section 3(d) of the Indian patents Act and clearly redefining ‘efficacy criteria.’

Before 2005 Amendment Act, Multinational pharmaceutical companies have put on hold plans to introduce their patented drugs in India. While India moved to a product patent regime from January 2005 Amendment Act, companies such as Eli Lilly, Novartis , Pfizer and Merck Sharpe & Dohme are treading with caution. They are introducing a few of their patented drugs but keeping the rest of their sizeable basket safely away from India’s shores.Time to time US government has also urged India to take effective action to ensure stronger protection intellectual property rights.

After amendments in a new product patent regime in 2005, the government provides exclusive marketing rights for 20 years. But, global drugmakers have repeatedly voiced their concern about the implementation of the IPR regime, alleging it does not encourage innovation. As in section 3(d) of the Indian patents Act is not clearly redefining ‘efficacy criteria.’

Section 3(d):

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere new use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Section 3 of Indian Patent Act defines what is not patentable. Section 3d gives out that the mere discovery of a new form of an old drug does not make it an invention.Novartis faced the case in which they opposed on two issues; one is that the patent examiner should not have rejected their patent application, another is that Section 3d of the Indian Patent Act is wrong and by putting it in the Act the Indian Government is doing something which is against its international obligations.

As above in section 3(d) of Indian patent Act its restrict the patent for increment in innovations, unless it provides appropriate thereupatic advantages but Indian Patent office doesn’t define the term Efficacy. Indian courts and patent offices have shot down patent claims of several global drugmakers using this provision.

Global MNCs also seeks ‘alignment in applicable statutes’ to implement patent linkages, a provision that will allow global MNCs to prevent Indian drug regulator from permitting local companies from launching generic versions of patented medicines. This is another vexed issue between foreign drugmakers and local firms, who say the provision will delay launch of generic or low cost drugs.