Bulk Drug Manufacturers Association (BDMA), the apex body of bulk drug producers in the country, has come down heavily on the government for not taking advantage of the recent Doha declaration on TRIPS, while making amendments to the patent bill.
The joint committee on patents recently submitted a draft report of "The Patents (second Amendment) Bill, 1999" for passage in the budget session.
Raising a question that "Does our government know how to protect our industry under WTO regime?", Venkat Jasti, president of BDMA, said the joint committee has broadened the grounds for grant of compulsory licence, it has not fully taken advantage of the provisions rightfully given in Doha declaration.
Though the Doha declaration has given freedom to determine the grounds for granting compulsory licence, the draft report has restricted this to limited circumstances such as those of national emergency, extreme urgency and public non-commercial use, Venkat said and added that "this clause could have been broadened for the benefit of the Indian industry."
Lack of local production by the patentee within a specific period should be a ground for grant of compulsory licence, Venkat observed. Another drawback in the draft report is the provision of just ordering the patentee by the patent controller where as the right to grant compulsory licence is still vested with the patentee rather than the controller of patents.
With regard to the scope of patentability of drugs, the bill, by not clearly defining what is a patentable invention, allows patents for not only new drugs but also for new uses and formulations, BDMA pointed out.
"This leads to monopoly over formulations, which will do more damage to the industry than monopoly over that of bulk drugs", Venkat said.
