German drugmaker Bayer has failed in the first stage of its bid to stop Indian group Natco from selling a rock-bottom-priced version of its liver and kidney cancer drug Nexavar in India.
Bayer was looking for an immediate stay on the order by the Controller of Patents in India that issued the first-ever compulsory licence in the country for Nexavar (sorafenib), enabling Natco to legally make and sell a low-cost version of the drug before its patents have expired, to secure a more affordable alternative in the interest of public health.
The landmark move slashed the price of Nexar by 97%, and set a new precedent for allowing the sale of generic versions of new medicines still under patent, removing affordability barriers and thus widening access to patients in the country.
In its appeal, Bayer is arguing that the compulsory licence should be withdrawn because a generic form of Nexavar is already available in India through drugmaker Cipla - in breach of the patent - and so a low-cost alternative is already available.
The company is alleging that the decision of the Indian Patent Controller is illegal and unsustainable, and was therefore requesting an immediate stay until its appeal could be heard. But this has been now been rejected by Intellectual Property Appellate Board.
Jeopardising public interests?
"If [a] stay is granted, it will jeopardise the interests of the public who are in need of the drug," said one Board member as reported by local publication The Hindu.
The move has been applauded by humanitarian health organisation Médecins Sans Frontières (Doctors Without Borders).
"This decision affirms that courts can and should act in the interest of public health in the case of pharmaceutical products," said Leena Menghaney, of the group's Access Campaign, also noting that "high prices caused by patents in India are a growing problem that needs to be grappled with".
But Bayer has reportedly said it will continue to defend its intellectual property rights, "which are a prerequisite for bringing innovative medicines to patients by pursuing the appeal as such which has not yet been heard or decided," according to The Economic Times of India.