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India may have to change its patent law if it accepts the European Union’s (EU) proposal on patent term extension for pharmaceutical products under the free trade agreement (FTA).
According to sources in the know, EU has demanded the patent term for medicines be extended from the current 20 years to accommodate the time taken in regulatory procedures, approvals, and delays. This would mean that if a patent approval takes five years, the innovator company may claim a patent protection for 25 years, keeping generic penetration at bay during that period.
Currently, article 33 of the World Trade Organization’s (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) provides for 20 years of patent protection from the date of filing of patent application.
Those against such demands say that the 20-year period was agreed upon under TRIPs after considering the time required for regulatory compliances etc., and hence, EU is trying to write-off provisions of TRIPs through such FTAs outside the WTO agreement.
“The 20-year term was agreed upon in TRIPs after considering that an average of eight to 10 years would be required for filing of application, regulatory examination and approvals. So now, EU is trying to push for patent term extension outside TRIPs,” says Anand Grover, senior counsel and director of Lawyers Collective. Grover also represented Cancer Patients Aid Association in Supreme Court recently against Novartis in the Glivec patent protection case.
If EU’s demands are accepted, India may have to revise its patent law to accommodate such provisions. Interestingly, India’s patent law was recently lauded internationally because of its provisions to safeguard medicines against evergreening of patents, etc.
To protest against EU’s demands, various patient groups and health activists rallied on the streets in New Delhi today calling on the government to reject EU’s demands in the FTA with India.
This comes in the wake of Prime Minister Manmohan Singh visiting Germany to meet Chancellor Angela Merkel with FTA topping of the agenda. Commerce Minister Anand Sharma is also scheduled to be in Brussels, Belgium for ministerial level negotiations on April 14-15 to finalise the FTA.
While both India and EU are pushing for early conclusions of the FTA, the civil society and patient groups are concerned that if EU’s proposal on intellectual property related issues gets through, it may adversely impact access to medicines across the developing world.
“As it is, 20 years is a long time frame for patent holders to have a monopoly in developing nations. An extension of this term will help the prices to remain high and multinationals to make profits while essential medicines will continue to be out of reach of poor patients in need of treatment,” said Y K Sapru of Cancer Patients Aid Association.
