The government has allowed a local drugmaker to make and sell a patented cancer drug at a fraction of the price charged by Germany's Bayer AG, setting a precedent for more such efforts by Indian firms and heightening the global pharmaceutical industry's anxiety over the use of the controversial compulsory licensing provision.
The outgoing patent controller of India, PH Kurian, on Monday granted the country's first compulsory licence to Hyderabad-based Natco Pharma, permitting it to manufacture and market a generic version of Nexavar, a medicine used for treating liver and kidney cancer, in India for just 3% of the patented drug's price in return for paying 6% royalty on sales to Bayer.
While healthcare activists were quick to welcome the order and said it would discourage innovator companies from selling medicines at exorbitant prices, Bayer and OPPI, the body that represents foreign drug companies in India, expressed their disappointment at the development. "The solution to helping patients with innovative medicines does not lie in breaking patents," said OPPI Director-General Tapan Ray.
Bayer is expected to legally challenge the decision. "We will evaluate our options to further defend our intellectual property rights in India," a company spokesman said.
The order may encourage other Indian drugmakers to file for compulsory licences, setting the stage for a spate of regulatory disputes between Indian and foreign drug companies over pricing and patent issues.
"The patent controller has ruled that if a product is not manufactured in India after three years of receiving a patent, it will be a candidate for compulsory licensing. This can have huge consequences as most patented products sold in India are imported," said DG Shah, secretary general of the Indian Pharmaceutical Alliance. Since 2007, at least 18 patented HIV and cancer drugs have been launched in the country.
The outgoing patent controller of India, PH Kurian, on Monday granted the country's first compulsory licence to Hyderabad-based Natco Pharma, permitting it to manufacture and market a generic version of Nexavar, a medicine used for treating liver and kidney cancer, in India for just 3% of the patented drug's price in return for paying 6% royalty on sales to Bayer.
While healthcare activists were quick to welcome the order and said it would discourage innovator companies from selling medicines at exorbitant prices, Bayer and OPPI, the body that represents foreign drug companies in India, expressed their disappointment at the development. "The solution to helping patients with innovative medicines does not lie in breaking patents," said OPPI Director-General Tapan Ray.
Bayer is expected to legally challenge the decision. "We will evaluate our options to further defend our intellectual property rights in India," a company spokesman said.
The order may encourage other Indian drugmakers to file for compulsory licences, setting the stage for a spate of regulatory disputes between Indian and foreign drug companies over pricing and patent issues.
"The patent controller has ruled that if a product is not manufactured in India after three years of receiving a patent, it will be a candidate for compulsory licensing. This can have huge consequences as most patented products sold in India are imported," said DG Shah, secretary general of the Indian Pharmaceutical Alliance. Since 2007, at least 18 patented HIV and cancer drugs have been launched in the country.
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