The decision, published today, means that Indian generic drug maker Natco will be able to produce a version of sorafenib, which is used to treat kidney and liver cancer, for sale in India.
Natco had applied for a compulsory licence under section 84 of the Patent Act. It cited three grounds: (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.
All three grounds were upheld in the decision signed by the outgoing head of India’s IP Office, PH Kurian.
A spokeswoman for Bayer told Managing IP that the company was disappointed with the decision and will now evaluate its options to defend its IP rights.
But it was welcomed by Médecins Sans Frontières, which campaigns for better access to medicines. It said the decision sets an important precedent.
“It means that new medicines in India that are now under patent – including some of the newest HIV medicines – could potentially have generic versions produced for a fraction of the cost, making them more affordable, and widening access to those who need it most,” the group said.
The licence requires Natco to pay a royalty rate of 6% of the net sales of the drug and the licence is in force for the remaining term of the patent.
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