Stay on cancer drug licence may harm public: Natco Pharma
Public interest would be seriously affected if the order of compulsory licence issued in favour of Natco Pharma Ltd to make and sell the cancer drug is stayed, the company's counsel argued here Tuesday.
Hearing the final arguments, the Intellectual Property Apellate Board (IPAB) reserved its orders on the case between Bayer Corp and Natco Pharma.
Bayer Corp, the north American subsidiary of German company Bayer AG, has challenged in the IPAB the March order of the Controller General of Patents, Designs and Trade Marks of compulsorily licensing Natco Pharma to market the generic version of Nexavar (sorafenib tosylate).
Bayer filed the petition against Natco Pharma, the controller of general patents and the central government asking for the staying of the compulsory licence.
Incidentally, this was the first time that the compulsory licence provision in the Indian Patent Act was invoked.
Natco Pharma's counsel Rajeshwari Hariharan said patent was not a hunting licence or a right given to a patent holder to sue others for manufacturing a product when public interest was involved to a large extent.
She said the patent law had imposed a duty on the patentee/patent holder/monopoly to work on the patent like marketing the product within a reasonable timeframe.
Hariharan said the patentee had to declare to the Controller of Patents as to how he had exploited the patent commercially.
According to her, the golden thread running around the patent law was the working on the patent (marketing of the patented product in India) and said Bayer had not done that effectively in India since it was awarded the patent in the country in 2008.
She said Bayer has failed to exploit the market for the drug and had not sold the drug to majority of the cancer patients (liver and kidney) who were in the terminal stage.
Unlike in the West, Hariharan said, the liver and kidney cancer was diagnosed in India at the very last stage of the disease as people did not go for regular medical check ups.
She said the potential market size for Nexavar in India was around 30,000 patients and not just 8,000 as Bayer claimed.
On Bayer's charge that Natco Pharma had been exporting the drug in violation of the compulsory licensing terms, she said the products found in Pakistan and China were not from her client's company.