German drugmaker Bayer has kicked off its bid to overturn a decision in India that has paved the way for cheaper copycat versions of its cancer drug Nexavar while the medicine is still under patent.
In March, India issued its first-ever compulsory licence allowing the company Natco to legally make and sell a low-cost version of Nexavar (sorafenib), which is used to treat kidney and liver cancer, in order to secure a more affordable alternative in the interest of public health.
The landmark move brought the price of the drug down 97%, from over $5,500 per month to $175, and set a new precedent for allowing the sale of generic versions of new medicines that are still under patent to widen access to those in the country who need them most.
However, Bayer is arguing that the compulsory licence should be withdrawn because a generic form of Nexavar is already sold in India by Cipla - in breach of the patent - and therefore there is already a low-cost alternative available.
Bayer's stance on the issue has angered humanitarian health organisation Médecins Sans Frontières (Doctors Without Borders).
“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.
"By appealing this decision, Bayer is trying to prevent the use of a key public safeguard that can in the future act as a lifeline, allowing people, governments and treatment providers like MSF access to the newest drugs from India,” she argued.
Along with Novartis' current legal challenge against India's patent laws - taking issue with the section stating that a modification of a known chemical composition is non-patentable - these landmark cases are under close global scrutiny because the outcome could have a seismic impact on the landscape of drug pricing in the country.