Drugmakers criticise Mashelkar committee's report

NEW DELHI: The commerce ministry’s decision to accept the Mashelkar committee’s revised report that recommends not to restrict patenting to new

drugs has come in for strong criticism from health activists and some generic drugmakers even as patent experts supported the move that’s in line with international norms.

Earlier this month, the ministry accepted the controversial report, first released in 2007 but withdrawn over allegations of plagiarism and technical flaws.

The conclusion of the study however remains the same, recommended that granting patents only to new drugs will be a violation of the TRIPS, or Agreement on Trade Related Aspects of Intellectual Property Rights, that sets minimum standards for intellectual property regulations under the World Trade Organisation (WTO).

The adoption of the Mashelkar committee report means that India will continue to allow patent on incremental innovation under Section 3(d) of the Indian Patent Act, if it provides enhanced therapeutic efficacy.

Health activists have been seeking a ban on this provision, saying multinational drugmakers use it to extend patents for drugs by making minor innovations and, thus, blocking competition from low-cost drugmakers. This process is known as evergreening of patents.

“The government’s move may restrict global supply of cheaper medi-cine,” said Leena Menghaney, India project manager of Medicine sans Frontiers, a global social organization lobbying for easier access to es-sential medicine, as multinationals will use evergreening to extend their market exclusivity by decades. “India should progressively move towards stricter patent law to ensure that only a completely new drug is granted patent, which is possible under TRIPS,” she added.

“The commerce ministry has accepted the recommendations of the Mashelkar Committee without any debate or discussion with the domestic industry,” said B K Keayla of National Working Group on Patent Laws.

The Mashelkar committee was set up mainly to examine whether it would violate provisions of TRIPS if India restricted the grant of patents to only new chemical entities (NCEs).

But, Shamnad Basher, professor of intellectual property law at the National University of Juridical Sciences (Kolkata), supported the committee’s view. “Limiting patents only to new drugs would violate Article 27 of TRIPS, which mandates that patents shall be granted without discrimination to all inventions in all fields of technology,” he said.

It’s a major setback for the industry, said Amar Lulla, joint managing director of generic drugmaker Cipla, which is challenging the most number of patents in India.

If patents were to be granted only for new drugs, it would have fur-ther squeezed the scope of getting patents under the country’s laws, which is already one of the strictest in the world.

Another Delhi-based patent lawyer Pratibha Singh says the actual impact will be clearer if the government brings any amendment in the existing laws.