The international humanitarian medical organisation Médecins Sans Frontières (MSF) has welcomed the Supreme Court's order on December 12 in which the apex court has rejected the multinational drug major Bayer’s appeal against the country's first-ever compulsory license (CL) on cancer drug sorafenib tosylate (marketed as Nexavar).

“Amidst intense ongoing US government pressure tactics being waged on India on behalf of the US pharmaceutical industry, today’s Indian Supreme Court decision demonstrates the independence of the Indian judiciary in upholding India’s right to legislate with public health interests in mind.

“MSF is encouraged by this particularly strategic win for public health and access to medicines, whereby the Supreme Court has worked to ensure continued patient access to affordable versions of this lifesaving cancer drug, in spite of a multi-year campaign by Bayer to reverse the decision.

“It was clear not only to MSF but also to the Indian judiciary that Bayer’s so-called patient access programme was reaching only around 2% of patients in need, and that furthermore, Bayer’s full R&D costs for development of the drug had been recouped in just one year.  In response, the Indian government used legal flexibilities allowed in international law to jumpstart generic production, so that a patent-based monopoly on the drug would not be the culprit standing in the way of saving lives.

“Today we applaud this heartening news, which reaffirms India’s critical role in forging a new and progressive path in balancing intellectual property and public health,” said Leena Menghaney, Regional Head, South Asia, MSF Access Campaign.  

“This decision will prompt innovator companies to price their drugs appropriately in order to maintain viability, and at the same time, deal with the objective of avoiding a compulsory license," said Adheesh Nargolkar, IP Partner, at law firm Khaitan & Co.
"Patent holders now need to take appropriate precautions while negotiating voluntary licenses with counterparties so as to avoid a scenario where this forms the pedestal for a compulsory license application," he added.

Since 2012, the Indian generic company Natco has been allowed to produce an affordable generic version of Bayer’s cancer drug, which at US$ 5,500 per person, per month in India, was deemed unaffordable by the Indian Patent Office.  At that time, the Indian Patent Office granted Natco the country’s first-ever compulsory license (CL) as a way to make the medicine more accessible: the move was effective in bring down the price by 97% to $175 per person, per month, in exchange for which Natco pays Bayer a royalty fee.  Bayer has been appealing the decision ever since, but today’s Supreme Court’s decision, which upholds the legal validity of the CL and dismisses Bayer’s Special Leave Petition, is a major win for public  health and concludes the legal proceedings on the CL.