PH Kurien's Landmark Nexavar Compulsory Licence: India's Defining Moment in Affordable Cancer Care
核心洞察
PH Kurien, India's Controller General of Patents, issued the country's first compulsory licence on 9 March 2012, allowing Natco Pharma to produce Bayer (搜索)'s cancer drug Nexavar.
The ruling slashed the monthly treatment cost from over ₹2.8 lakh to ₹8,800, a reduction of about 97%, dramatically improving access for kidney and liver cancer patients.
The Patent Office found Bayer (搜索) had failed to "work" its patent in India and was reaching only about 2% of the estimated 88,000 patients who needed the drug.
PH Kurien, who served as India's Controller General of Patents, Designs and Trade Marks, issued a landmark 68-page order on 9 March 2012 — his final day in office — granting the country's first compulsory licence for a patented drug. The ruling allowed Hyderabad-based Natco Pharma to manufacture and market a generic version of Bayer (搜索)'s cancer drug Nexavar (sorafenib tosylate), a medicine used to treat advanced kidney and liver cancers. Kurien died on 27 August in Thiruvananthapuram at the age of 67.
A Battle Over Access to a Life-Saving Medicine
The dispute began in August 2011, when Natco Pharma approached the Controller of Patents seeking a compulsory licence to manufacture and sell sorafenib tosylate, marketed by Bayer (搜索) under the brand name Nexavar. Bayer, which developed the drug with California-based biotechnology company Onyx Pharmaceuticals (搜索), mounted a determined legal challenge, first seeking a stay of proceedings before the patent office and later moving the Bombay and Delhi High Courts.
Natco's case rested on three central grounds: that Bayer (搜索) had failed to make the drug available in adequate quantities in India, that the medicine was priced beyond the reach of most patients, and that the patented invention was not being "worked" in India. After a series of hearings marked by strong objections from Bayer, the Patent Office accepted all three grounds and granted Natco the compulsory licence.
The Pricing Gap: ₹2.8 Lakh Versus ₹8,800
At the heart of the dispute was a stark affordability gap. Bayer (搜索) was selling a month's supply of Nexavar for about ₹2.8 lakh (approximately ₹2,50,428 at the time Natco filed its application), while Natco proposed to supply the same treatment for ₹8,800 — a reduction of about 97%.
Natco argued that Bayer (搜索) was supplying the drug to only about 2% of the nearly 88,000 patients estimated to need it, falling far short of the requirement under India's Patents Act that a patented medicine should meet the "reasonable requirements of the public." Availability was another concern: Natco said Nexavar was accessible only in a limited number of states, mainly through major metropolitan centres, leaving patients in places such as Madhya Pradesh and several parts of Maharashtra without adequate access.
Before seeking a compulsory licence, Natco said it had approached Bayer (搜索) for a voluntary licence to manufacture and market the drug in India. Bayer rejected the request, prompting Natco to move the authorities under Section 84(1) of the Patents Act, 1970, read with Rule 96 of the Patent Rules, 2003.
A Carefully Reasoned Ruling
The Patent Office relied heavily on Bayer (搜索)'s statements of working for the three calendar years following the grant of the patent. Those records indicated that the quantity of Nexavar imported into India was far below what was required to meet the needs of the country's patients. Bayer argued that sales of the drug by Cipla, which it accused of infringement, should also be considered when assessing whether the public's requirements were being met — an argument the Patent Office rejected.
Price was another decisive factor. The Patent Office concluded that the public was not purchasing the drug because its price was not affordable. Bayer (搜索) maintained that pharmaceutical research and development involved enormous expenditure and that affordability could not be judged uniformly given different economic circumstances. The Patent Office acknowledged these arguments but found they did not outweigh the evidence on affordability.
The ruling also settled an important question over what constitutes "working" of a patent in India. The Patent Office held that merely importing a patented product into the country could not, by itself, amount to working the patent as contemplated under the Patents Act, 1970. In reaching that conclusion, the authority examined the relevant provisions of Indian patent law alongside the Paris Convention and the TRIPS Agreement, interpreting the requirement that a patent be "worked in the territory of India" as requiring manufacture in India to a reasonable extent.
A Defining Moment for Public Health
Public health activist Dr B Ekbal noted that Kurien's decision drew not only on the submissions of the two companies but also on views and material from international health organisations, including the World Health Organisation and UNICEF, and experts such as Carlos Correa and James Love. He said the order went beyond the immediate patent dispute, documenting what he described as the aggressive pricing practices and marketing strategies of multinational drug companies, recording the profits Bayer (搜索) earned from the sale of the cancer medicine, and highlighting the difficulty patients faced in accessing it.
Bayer (搜索) challenged the decision before the Intellectual Property Appellate Board. The board, headed by Justice Prabha Sreedevan, rejected the challenge on 3 February 2013, holding that compulsory licensing was justified to ensure the drug was available to the public at a reasonable price.
"The meticulous 68-page ruling established a precedent for utilising patent law flexibilities to safeguard public health," Dr Ekbal said, describing Kurien's order as a defining moment in India's public-health movement. He added that the "momentous decision" reduced the monthly treatment cost for kidney and liver cancer patients "from over ₹2.8 lakh to just ₹8,800, making life-saving medication accessible."
Development economist Biswajit Dhar, a former professor at JNU, said: "Kurian understood the spirit of the Patents Act... He was the only one in the government who actually respected the will of the people, because this was the will of the Parliament."
A Precedent Without Successors
The compulsory licence has since become a sore point for innovator companies, with foreign governments' trade departments often raising the use of compulsory licensing as a point of concern. Dr Ekbal noted that no other medicine has since received a compulsory licence amid continuing pressure from multinational pharmaceutical companies, describing Kurien's decision as "a globally recognised milestone in making high cost essential medicines affordable to the people."
Nexavar belongs to a class of compounds known as carboxyaryl-substituted diphenyl ureas and was developed for patients with renal cell carcinoma (搜索), a form of kidney cancer, and hepatocellular carcinoma (搜索), the most common primary cancer of the liver. The drug is not generally described as a cure; it is used mainly to slow the progression of advanced cancers and ease the burden of disease. Clinical studies showed the drug could extend survival by a median of roughly three months in certain patients with advanced kidney or liver cancer.