Published Aug 29, 2026 | 4:53 PM ⚊ Updated Aug 29, 2026 | 4:53 PM
PH Kurien, Controller General of Patents, Designs and Trade Marks.
Synopsis: PH Kurien’s landmark 2012 order granting Natco Pharma a compulsory licence to sell a far cheaper version of Bayer’s cancer drug Nexavar became a defining moment in India’s battle to make life-saving medicines affordable and accessible. Issued on his last day as the country’s top patent official, the decision challenged the limits of patent protection while putting patients’ access to essential cancer treatment at the heart of the debate.
When PH Kurien signed the order allowing a domestic drugmaker to sell a cheaper version of a multinational company’s cancer medicine, he made a decision that would outlive his tenure as India’s top patent official.
Issued on his last day in office in March 2012, the 68-page order granted India’s first compulsory licence for a patented drug and put the affordability of a life-saving medicine at the centre of a landmark patent dispute.
Kurien, who died on 27 August in Thiruvananthapuram at the age of 67, had by then spent more than two decades in the civil service, serving in key positions in Keralam and at the Centre.
His career took him from administration and information technology to revenue and disaster management, including a key role in the state’s response to the 2018 floods.
But the Nexavar ruling gave his name wider resonance, turning an administrative decision into a landmark in India’s public-health and patent history.
The order followed a battle between Natco Pharma and Bayer over sorafenib tosylate, marketed as Nexavar, a drug used to treat advanced kidney and liver cancers. Bayer was charging about ₹2.5 lakh for a month’s treatment, while Natco proposed to sell the same treatment for ₹8,800.
Natco argued that Bayer was not making the drug available to enough patients, its price was beyond the reach of most Indians who needed it, and that the patent was not being adequately worked in India. Kurien’s order accepted all three grounds and allowed Natco to manufacture and market the generic version, subject to conditions including a royalty payment to Bayer.
For Kurien, the decision came at the end of his tenure as Controller General of Patents, Designs and Trade Marks. For India, it became a test of how far patent protection should extend when the price and availability of a medicine put it beyond the reach of the people who needed it.
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The dispute that eventually led to India’s landmark compulsory licence for Bayer’s cancer drug Nexavar began in August 2011.
It followed after Indian generic drugmaker Natco Pharma approached the Controller of Patents, seeking a compulsory licence to manufacture and sell sorafenib tosylate, a patented drug used to treat advanced kidney and liver cancers, sold under the brand name Nexavar.
Bayer, which had developed the drug with California-based biotechnology company Onyx Pharmaceuticals, mounted a determined legal challenge to Natco’s bid.
The German pharmaceutical giant first sought a stay of the compulsory licence proceedings before the patent office.
When that effort failed to halt the process, Bayer moved the Bombay and Delhi High Courts, challenging the Controller’s initial finding that the case appeared fit for consideration of a compulsory licence.
The courts eventually allowed Bayer to contest the prima facie findings before the patent office itself, setting the stage for a prolonged battle over whether Natco should be allowed to enter the market.
Natco’s case rested on three central grounds: that Bayer had failed to make the drug available in adequate quantities in India, the medicine was priced beyond the reach of most patients, and 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.
Nexavar belongs to a class of compounds known as carboxyaryl-substituted diphenyl ureas and was developed for patients suffering from renal cell carcinoma, a form of kidney cancer, and hepatocellular carcinoma, 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 the disease. Clinical studies showed that the drug could extend survival by a median of roughly three months in certain patients with advanced kidney or liver cancer.
For Bayer, the case was about protecting the value of years of research and development and the patent rights attached to the drug. For Natco, it became a test of whether those patent rights could take precedence when a life-saving medicine remained unaffordable and insufficiently available to patients in India.
That clash between patent protection and access to essential medicines would make the Nexavar case one of the most closely watched compulsory-licensing battles in India.
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Natco Pharma challenged Bayer Corporation’s patent over the cancer drug Nexavar, arguing that the German company had failed to make the medicine adequately available and affordable to Indian patients.
Natco pointed out that Bayer was supplying the drug to only about 2% of the nearly 88,000 patients estimated to need it.
This, it argued, fell far short of the requirement under India’s Patents Act that a patented medicine should meet the “reasonable requirements of the public”.
The company also questioned Bayer’s pricing of Nexavar.
A month’s treatment was being sold for around ₹2.8 lakh, while Natco said it could supply the same quantity for ₹8,800.
At the time Natco filed its application, Bayer’s price was about ₹2,50,428 for a month’s treatment.
Natco further contended that Bayer was not producing the drug in sufficient quantities in India and, therefore, had not met the statutory “working” requirement under the Patents Act.
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 for a voluntary licence to manufacture and market the drug in India. Bayer rejected the request, leaving Natco to move the authorities for a compulsory licence under Section 84(1) of the Patents Act, 1970, read with Rule 96 of the Patent Rules, 2003.
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The decision came on 9 March 2012 — the final day in office for Kurian as Controller General of Patents, Designs and Trademarks.
It proved to be a consequential closing chapter to his tenure, as the Indian Patent Office granted Natco Pharma the country’s first compulsory licence to manufacture and market an anti-cancer drug.
After examining the evidence and hearing arguments from both sides, Kurian delivered what was widely regarded as a landmark, carefully reasoned order in favour of Natco. The ruling, which runs into 68 pages, opened the door for a domestic manufacturer to produce Bayer’s patented cancer drug Nexavar at a substantially lower price.
A key question before the Patent Office was whether Bayer was meeting the “reasonable requirements of the public”, as required under India’s Patents Act. The authority found that it was not. According to the evidence placed before it, Bayer’s supply of Nexavar was reaching only about two per cent of the patients who needed the drug.
The Patent Office relied heavily on Bayer’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 while assessing whether the public’s requirements were being met. The Patent Office rejected that argument.
Price was another decisive factor.
Bayer was selling a month’s supply of Nexavar for about ₹2.8 lakh, a price the Patent Office considered beyond the reach of ordinary patients. It concluded that the public was not purchasing the drug because its price was not affordable.
Bayer maintained that pharmaceutical research and development involved enormous expenditure and that continued investment was necessary to develop new medicines. It also argued that affordability could not be judged uniformly, given the different economic circumstances of various sections of society.
The Patent Office acknowledged these arguments but found that 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. It interpreted the requirement that a patent be “worked in the territory of India” as requiring manufacture in India to a reasonable extent, rather than simply bringing the patented product into the country.
The decision thus went beyond the immediate dispute between Bayer and Natco. It underscored the balance Indian patent law seeks to strike between exclusive patent rights and the wider public interest — particularly when the availability and affordability of essential medicines are at stake.
Public health activist Dr B Ekbal remembered Kurien’s role in the compulsory licensing case.
Dr 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. It also recorded the profits Bayer earned from the sale of the cancer medicine and highlighted the difficulty patients faced in accessing it.
Bayer 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.
Dr Ekbal described Kurien’s order as a defining moment in India’s public-health movement and noted that no other medicine has since received a compulsory licence amid continuing pressure from multinational pharmaceutical companies.
(Edited by Majnu Babu).
