Pharmaceutical multinational Bayer AG of Germany has appealed to the Intellectual Property Appellate Board against the grant of a licence by the Indian Patents Office to local generic drug producer Natco Pharma for its high-selling kidney and liver cancer medicine, Nexavar (See: Natco granted compulsory licence for Bayer's Nexavar) .
The replicated drug will cost a patient Rs8,800 for a packet of 120 tablets, or a month's dosage. Bayer's original version costs around 30 times as much at Rs2.8 lakh for 120 tablets.
India's patents chief ruled in March that the price of the Bayer version was outrageous and gave Hyderabad-based Natco a 'compulsory' licence – the first of its kind issued in the country – to replicate the drug. Under the ruling, Natco would only have to pay Bayer six per cent royalty on sales of the drug.
"We strongly disagree with the conclusions of the Patent Controller of India and have appealed his order on 4 May 2012 with the Intellectual Property Appellate Board," Bayer said in a statement from Munich.
"We will rigorously continue to defend our intellectual property rights, which are a prerequisite for bringing innovative medicines to patients," the spokesperson added.
However, commentators say the patent office order, issued under Section 84 of the Indian Patents Act, is in compliance with the TRIPS agreement of the World Trade Organisation.
Under the WTO's TRIPS Agreement, which governs trade and intellectual property rules, compulsory licences are a legally recognised means to overcome barriers in accessing affordable medicines.
In his order, Controller of Patents P H Kurian had said the move was triggered by Bayer not doing enough to scale up the sale of the drug or lower its prices despite getting patent for it in India in 2008.