Negotiators from the 27-member bloc have been insisting that India allow European pharmaceutical companies to extend the life of their patented drugs in the Indian market beyond the commitments made under the Trade Related Aspects of Intellectual Property Rights (Trips).
They argue that the European parliament does not allow bilateral trade deals that does not include an agreement on intellectual property. Patents worth an estimated $150 billion, held by European pharmaceutical companies, are set to expire over the next five years.
"Although India sent out a strong message last year during the negotiations that it would not agree to go beyond the commitments made under Trips, the EU is now saying that it has to get some concessions beyond the mandate of Trips," an Indian official told ET.
Following EU's insistence, India agreed in August to hold special sessions on Trips and services. Last week, several rounds of talks were held between senior officials from the two sides in Delhi, but they failed to reach a conclusion.
With patents on many blockbuster drugs set to expire soon, an estimated $250 billion in sales are at risk between now and 2015, according to data from Evaluate Pharma, an on-line pharmaceuticals research company.
US drug major Pfizer has already reported a sharp dip in profits after the patent on its cholesterol-lowering drug Lipitor ran out last year. European drug companies including Sanofi-Aventis and Astro Zeneca are among companies that are likely to get hit over the next few years.
What the EU primarily wants from India is data exclusivity, which refers to exclusive rights of a company over the clinical data for its drugs, without actually holding a patent for it.
"This would allow patent holders to make slight changes in formulations once the patent life of a product comes to an end and immediately file for data exclusivity," the official said.
"Since generic producers, or manufacturers of copied version of the originally patented drugs, are not allowed to produce drugs with data exclusivity for 10 years, the product would have several years of extended protection."
India gives patent protection for a period of 20 years, which it considers adequate. "We are not in favour of giving data exclusivity at all as it could make life saving medicines unaffordable in the country," the official said.
"The EU wants to carve out a deal that would not affect live-saving medicines. We have to see what they have in mind."
The Indian pharmaceutical industry is the third largest in the world in terms of volume.
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2 Comments on this Story
Parimal Shah2984 days ago
India need NOT, and MUST NOT agree to data exclusivity or patent extension in any form. The EU is trying to evergreen the patents. This will impoverish not only current but also future generations of India.
Venki2985 days ago
"The European Union is making frantic efforts to convince India to 'liberalise' its patent regime..."
Amiti, That should say, make the patent regime more 'restrictive', not 'liberalise'.