For the third time on the trot, the decision to allow drug-maker Natco to make its less expensive version of Bayer’s advanced kidney cancer Nexavar has prevailed.
But the fight over the country’s first-ever compulsory licence (CL) on a drug — issued to Natco in 2012—is far from over.
Responding to the Bombay High Court decision to uphold the CL on Nexavar (sorafenib tosylate), German drug-maker Bayer said the decision will be appealed at a higher court (the Supreme Court).
“We are disappointed by the decision of the High Court. We will continue to defend our intellectual property rights and appeal this decision,” a Bayer spokesperson said. In the interest of public health, a compulsory licence allows a third party to make an innovative drug on the payment of royalty to the innovator.
IP heartburn In 2012, India’s Patent Controller PH Kurian took the giant step of issuing the country’s first CL to Natco allowing it to make a less expensive version of the drug, on the payment of a 6 per cent royalty to Bayer.
The decision meant that patients would get a generically similar version of the innovator’s drug, but at a price that was 97 per cent less.
At the time this case was being argued at the Patent Office, Bayer’s Nexavar was priced at ₹2.8 lakh for a month’s supply of 120 tablets, while Natco was to sell its version of the medicine at ₹8,800.
The decision was contested at the Intellectual Property Appellate Board and the IPAB too, upheld the CL decision in 2013, merely revising the payable royalty to 7 per cent.
High-profile debates The matter then landed up at the Bombay HC doorstep.
The CL on Nexavar has been at the heart of several high-profile debates on intellectual property, where India has been criticised for its implementation of the amended Patents Act and its track-record of protecting innovative research.
Sharing this contentious platform is the other watershed decision from the Supreme Court last March, where Novartis’ application for a patent on blood cancer drug was dismissed.
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