In yet another landmark decision, the Bombay High Court has upheld the compulsory license (CL) granted to Natco Pharma for manufacturing Nexavar, sending a strong message by sticking to the patent office's patient centric decision to ensure availability of affordable life saving drugs to the patients.  With this decision, Natco will now be legally able to manufacture and sell the generic copy of sorafenib tosylate, a patented kidney cancer drug invented by German pharma giant Bayer, at a far more affordable price.

In March 2012, changing the history of intellectual property rights in India,  the Controller General of Patents Design and Trademarks, P H Kurian had granted the first-ever compulsory license to Hyderabad-based Natco Pharma to sell a generic version of Nexavar under Section 84 (1) (b) of the Patents Act, 1970. Following which Bayer approached the Intellectual Property Appellate Board (IPAB) by challenging the order.

However, in the March 2013, even IPAB found the CL justified permitting Natco Pharma to manufacture and sell the generic copy of the patented drug Nexavar. Following which the multinational drug company Bayer had moved Bombay High Court challenging the Intellectual Property Appellate Board (IPAB)'s order which had upheld India’s first ever CL.

Referring to the compulsory license issued by the Indian patent office in March 2012 on Bayer's patented cancer drug Nexavar justice M S Sanklecha said, “We don’t see a reason to interfere with the order passed by IPAB and, therefore, the case is dismissed.”

Under the World Trade Organization’s TRIPS Agreement which governs trade and intellectual property rules, compulsory licences are a legally recognised means to overcome barriers in accessing affordable medicines. It allows the production of a generic version of a patented medicine and sell it at a cheaper price. Interestingly, the drug is being sold by the German giant at a huge price of Rs. 2,80,428 per month, whereas Natco has requested Bayer for licence to manufacture the generic version of the same at a more affordable price of Rs. 8,880 per month which Bayer had rejected.

Now as per the patent office's decision price of the drug covered by the patents sold by the company shall not exceed Rs. 8,880 for a pack of 120 tablets which is the requirement for one months treatment. It also demanded the company to pay royalty of 6 per cent of the net sales of the drug on a quarterly basis.