The much awaited hearing in the German drug major Bayer's appeal against the grant of compulsory licence on its anti-cancer drug Nexavar has been completed at the Intellectual Property Appellate Board (IPAB) in Chennai. The hearing in the case has concluded and the bench has reserved its order, it is learnt.
According to information, both the parties, Bayer and Natco Pharma, have made their arguments before the two-member bench of the IPAB, Justice Prabha Sridevan, and DPS Parmar, Technical Member (Patents) on September 3 and 4. The arguments are now over and the bench has reserved its order. However, no date has been fixed for the judgement yet.
After the Indian Patent Controller P H Kurian issued the first-ever compulsory licence (CL) on March 9 this year to the Hyderabad-based Natco Pharma to manufacture an affordable generic version of sorafenib tosylate, the anti-cancer drug for which Bayer had obtained a patent IN215758 in India in 2008, the German drug major had filed an appeal against the compulsory license order before the IPAB in Chennai. It has in particular sought to have the operation of the CL order stayed till the appeal hearings are completed and IPAB passes its decision.
The Patent Controller in his decision found that Bayer had made the drug available only to a small percentage of eligible patients (approximately slightly above two per cent), which did not meet the requirements of the public. The price of Rs.280,000 per month (approximately US$ 5,500) was not "reasonably affordable."
The compulsory license achieved its objective with the price of sorefanib tosylate coming down by 97 per cent in the Indian market from over US$ 5,500 per month to $175 per month.
Meanwhile, the international humanitarian health organisation Médecins Sans Frontières (MSF) has criticised Bayer for resorting to litigation on this issue. “Bayer's appeal against this landmark ruling in India is predictable. They're using litigation rather than addressing the reality that their prices are too high,” said Leena Menghaney, campaign manager in India for MSF’s Access Campaign.
“It is not the use of a compulsory licence that should be challenged, but the continued pursuit of excessively high profits over public health needs," she said.