The hearing into Bayer’s appeal over the grant of a compulsory licence for Nexavar/sorafenib tosylate concluded late yesterday in the Chennai-based Intellectual Property Appellate Board (IPAB). The judgment order will be issued in the coming weeks, according to reports.
A release from Médecins Sans Frontières (MSF) states that at the hearings which commenced on September 3 as scheduled, Bayer was attempting to overturn the decision made by the Patent Controller in March to allow generic competition and production – by issuing a ‘compulsory licence’ – of a more affordable version of Bayer’s Nexavar, a liver and kidney cancer drug, sorafenib tosylate.
According to media reports, Bayer’s argument was that since a local company (Cipla) was already selling a generic version of the same drug, there was already a low-cost alternative available in the market, therefore meeting one of the conditions for grant of a compulsory license.
“With the hearing now concluded, we must wait to see what the outcome is,” said Leena Menghaney, Campaign Manager in India for MSF’s Access Campaign. “We sincerely hope the Appellate Board will uphold the decision to grant a compulsory licence. It’s an important precedent for us.”
As people living with HIV develop drug resistance and need to be switched to more expensive newer treatment in its medical projects, MSF expressed hope that the grant of compulsory licences in India would open up access to affordable generic versions of expensive HIV medicines currently under patent.
The Patent Controller’s decision in March this year was based on its observation that Bayer had made the drug available only to a small percentage of eligible patients (around two per cent), which did not meet the requirements of the public. The price of Rs 280,000 per month (approximately $5,500) was not ‘reasonably affordable.’ MSF noted that the compulsory licence achieved its objective with the price of sorefanib tosylate coming down by 97 per cent in the Indian market from over $5,500 per month to $175 per month.
Agencies, EP News Bureau