Will appellate body uphold grant of compulsory licence to cancer drug?

Hearing on Bayer's appeal against manufacture of generic version of Nexavar to conclude this week

By Kundan Pandey
Published: Monday 21 January 2013


The final hearing on German pharma company Bayer Healthcare's appeal against grant of compulsory licence (CL) for manufacture and sale of the generic version of its cancer drug, sorafenib tosylate, began in Chennai last week at the Intellectual Property Appellate Board (IPAB). The CL, the first ever in India, was granted by the patent controller to generic drug company Natco Pharma of Hyderabad in March 2012.

The patent on the cancer drug, sold under brand name Nexavar, was granted to Bayer in March 2008. Natco applied for a CL in July 2011. After the decision by the patent controller, the price of sorafenib was slashed by 97 per cent, from US $5,500 (Rs 2.8 lakh) to $175 (Rs 8,880). As per the decision of patent controller, Bayer is being paid a six per cent royalty on sales by Natco.

In its appeal, Bayer has argued that the patent controller erred in the decision to grant the CL, and should have allowed the company more time to “work” the patent, over and above the three years entitled under law. Indian patent law provisions require a generic competitor to wait three years after the grant of a patent before an application for a licence to market a more affordable generic version can be filed.

In the hearings, Natco is currently defending the patent controller’s decision. The hearing is expected to conclude this week itself. The next hearing is scheduled on January 23.

Three more CLs in pipeline

Meanwhile, there are reports that the Union Ministry of Health and Family Welfare has selected three other anti-cancer drugs—trastuzumab, ixabepilone and dasatinib—which could be granted CL. The three drugs are patented in India and cost approximately Rs 70,000 (US$1,290) per vial, Rs 60,000 ($1,110) per vial and Rs 2,700 ($50) per tablet, respectively. The Department of Industrial Policy and Promotion is now expected to formally implement the ministry recommendations.

Medicins Sans Frontieres (MSF) had welcomed the efforts being made by the health ministry to identify patented drugs that are exorbitantly priced and face no generic competition. Leena Menghaney of MSF Access Campaign said that it is good move by the government of India. “But they have just begun the process of identifying the drugs. There is a lot more to do,” she said. The Cancer Patient Aid Association (CPAA) also welcomed the government move. Y K Sapru, founder and CEO of CPAA, said that granting CLs to few more drugs is vital for the welfare of cancer patients. There are a large number of cancer patients who are dying but cannot afford these high cost medicines, he said and demanded that the government should also bring those drugs in same category and grant CL for manufacture and sale of their generic versions.

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