Hyderabad: Natco Pharma Ltd, which has started selling a generic version of Bayer AG’s patented cancer treatment Nexavar in India at a fraction of the price charged by the German firm, plans to use the so-called compulsory licensing route to try and win the right to copy more patented drugs, said vice-chairman and chief executive officer Rajeev Nannapaneni.
The Hyderabad-based company has already identified the patented drugs for which it will seek a compulsory licence, Nannapaneni said in an interview on Wednesday.
“There are certain products which are eligible for compulsory licensing,” he said.
Natco Pharma made global headlines in March when it became the first Indian drug maker to win a compulsory licence from the Indian patent office to produce and sell a generic version of a patented drug without the consent of the patent holder. The patent office acted on the grounds that the life-saving drug was not available at a reasonably affordable price even three years after the Nexavar patent had been granted to Bayer.
Natco has started selling its copy of the liver and kidney cancer drug, whose generic name is sorafenib, at Rs 8,800 for a month’s treatment, a fraction of Bayer’s Rs 2.8 lakh for a month’s therapy. The patent office stipulated that Natco pay 6% of net sales as royalty to Bayer.
Experts such as Shamnad Basheer, a professor of intellectual property (IP) law at the Kolkata-based National University of Juridical Sciences (NUJS), say the company may be eyeing compulsory licences for drugs such as Pfizer Inc.’s anti-HIV/AIDS treatment Selzentry and anti-cancer therapy Sutent, and Roche Holding AG’s Tarceva, another anti-cancer drug.
Nannapaneni declined to disclose the drugs that Natco Pharma will target. In an interview with The Economic Times newspaper published in March, he had said the company was collecting data on drugs that could be potential candidates for compulsory licensing.
Natco sought a compulsory licence for Nexavar after Bayer rejected its request for a commercial licence to manufacture it. Natco has indicated that the market size of Nexavar in India could be around Rs 25-30 crore.
“I don’t want to get into the pipeline,” Nannapaneni said. “Again, nobody likes disclosing their pipeline.”
Multinational drug makers and the US government have expressed concern over the provision of compulsory licensing, saying it may dilute safeguards for IP rights of innovator companies in India. Bayer has appealed against the patent office’s ruling on Nexavar at India’s Intellectual Property Appellate Board.
“It’s a big concern,” said Sanjit Singh Lamba, president of Eisai Pharmatechnology and Manufacturing Pvt. Ltd, the Indian subsidiary of Japanese pharmaceutical company Eisai Co. Ltd.
“Protection of intellectual property is extremely important, specially in a situation where the pipeline is completely drying up for new molecules; otherwise there will be no incentive for research and development of innovative products,” he said.
Prices of cancer treatment drugs have fallen sharply, meanwhile.
Shares of Natco Pharma have gained 12.76% on BSE since 12 March, when the company won the compulsory licence for Nexavar, while the benchmark Sensex index has declined 1.76% in the same period. Natco Pharma stock rose 1.24% on Thursday to close at Rs 355.15, on a day the Sensex gained 0.55%.
Drug makers may not find compulsory licences easy to come by, said Hemant Bakhru, an analyst at Mumbai-based foreign brokerage firm CLSA Asia-Pacific Markets. “The government will be under pressure from WTO (World Trade Organization), from other organizations, as well as the US and Western Europe to limit the number of licences,” he said.
While the domestic industry has backed the compulsory licensing provision, concerns that the Nexavar ruling would open the way to a flood of such applications are “uncalled for”, said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, which represents domestic drug manufacturers. “As of now, domestic companies are not looking at compulsory licences as a business model.”
“The cost of development, the litigation cost, it is not a business proposition. It’s more of a social need,” Shah said.
According to the World Health Organization, India has an estimated 29,000 liver and kidney cancer patients at whom Nexavar is targeted.
An email sent on Wednesday to the Organisation of Pharmaceutical Producers of India, the body that represents multinational drug companies, did not elicit a response.
The licence granted to Natco for Nexavar hasn’t sparked a chain reaction yet, said Basheer of NUJS.
The reason could be that “for the patents and drugs that really matter, some of the generic companies could think that they have a good shot at invalidating the patents”, he said. “Invalidating a patent is better than compulsory licensing because you need not pay royalty.”
Nannapaneni stressed that to win a compulsory licence, a drug maker had to make an “iron-clad case” and clearly demonstrate the benefits it could bring, and not merely rely on “a very minor price difference” to seek a ruling in its favour. It would have to demonstrate that a multinational company hadn’t put a strategy in place to make a life-saving drug available to those who couldn't afford it.
Over and above its compulsory licensing strategy, Natco has locked horns with innovator companies elsewhere, challenging product patents.
The company recently lost a patent infringement case in the US with Israel-based Teva Pharmaceutical Industries Ltd over a drug called Copaxone, used in the treatment of multiple sclerosis and with an estimated market size of $2.5 billion.
Natco has challenged patents owned by Celgene Corp. on Revlimid, used to treat multiple myeloma, Shire Pharmaceuticals Group Plc’s patent on kidney drug Fosrenol, Gilead Sciences Inc.’s influenza treatment Tamiflu and GlaxoSmithKline Plc’s breast cancer drug Tykerb.
In order to mitigate high litigation costs in the US, Natco Pharma enters partnerships with other big generic drug makers such as Lupin Ltd, Dr Reddy’s Pharmaceuticals Ltd, Mylan Inc. and Watson Pharmaceuticals Inc.
“Our whole model is that our litigation is funded by our partners,” said Nannapaneni.
In the year ended 31 March, Natco Pharma sales grew 15% to Rs 555.58 crore, of which the oncology segment contributed about 60%. It earned a net profit of Rs 58.47 crore, an increase of 12.29% over the previous year.
Nannapaneni said he is confident the company will maintain 15-20% growth both in profit and revenue this fiscal year.