[Ip-health] Economic Times: Compulsory licence likely for three cancer drug
thiru at keionline.org
Mon Jan 14 23:58:26 PST 2013
Compulsory licence likely for three cancer drugs
DIVYA RAJAGOPAL, ET Bureau Jan 14, 2013, 12.28AM IST
MUMBAI: The government has appointed a panel to look into issues related to compulsory licensing of drugs and whether cheaper versions of cancer medicines Trastuzumab, Ixabepilone and Dasatinib can be launched under the provision, a person with knowledge of the development said.
According to the person, the health ministry has sent its proposal regarding compulsory licensing for the three drugs to the Department of Industrial Policy and Promotion (DIPP), which in turn has sought the opinion of the department of pharmaceuticals. Srikant Jena, Minister of State for Chemicals and Fertilisers, however, denied having received any note.
The panel is lead by RK Jain, additional secretary and financial advisor in the health ministry, the person added.
Compulsory licensing is a provision under the World Trade Organisation that allows a government to permit a company to manufacture a patented drug without the consent of the innovator company.
Each of the three drugs cost over Rs 1 lakh for a month's dose. While Trastuzumab is manufactured by Roche, Ixabepilone and Dasatinib are products of Bristol-Myers Squibb.
In March last year, India had allowed Hyderabad-based Natco Pharma to make and sell a cheaper version of Bayer AG's patented cancer drug Nexavar on grounds of affordability. The move had multinational pharma companies worried about property protection.
According to intellectual property lawyer Aliasgar Dholkawala, the health ministry could apply for a compulsory licence (CL) under Sec 92 of the Indian Patent Act.
"The government can notify a patent for issuance of CL under Sec 92 if any of these three conditions are met: national emergency, cases of extreme urgency, or in case of public non-commercial use," Dholkawala of Wadia Ghandy and Co said.
Under Sec 92, the government can issue a compulsory licence on certain patents notified in the gazette. After the same is notified by the government, any company interested in its manufacture is allowed approach the patent controller for a licence.
Experts say the move could spark a fresh row in the area of intellectual property. Besides, the government is expected to release a draft report on price control for patented medicines, which may not leave much room for a compulsory licence, they add.
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