HC upholds Natco's plea on cancer drug Nexavar

Bayer had approached the Bombay High Court after it lost an appeal in the IPAB in Chennai last year

The high court here on Tuesday upheld the compulsory licence granted to Hyderabad-based Natco Pharma to manufacture an affordable generic version of Nexavar (sorafenib tosylate), a kidney cancer drug patented by German drug major Bayer AG.

The Nexavar issue dates back to March 9, 2012, when the Controller General of Patents, Designs and Trademarks had granted a compulsory licence to Natco in this regard. At that time, the Centre had said under World Trade Organization (WTO) norms, it could issue compulsory licences to overcome barriers to a cheaper version of a patented drug, without the consent of the company holding the patent.

While Natco said it was "pleased" with Tuesday's court's ruling, Bayer said the decision left it disappointed. A Bayer spokeswoman said the company would continue to defend its intellectual property rights in India.

On Tuesday, the Natco Pharma stock closed at Rs 1,061.7 on the BSE, up four per cent. The court order came a few minutes before the markets closed.

Bayer had approached the Bombay High Court after it lost an appeal in the Intellectual Property Appellate Board (IPAB) in Chennai last year. The board had upheld the compulsory licence issued to Natco. Bayer held the patent for Nexavar in India until 2020 and wanted to defend its intellectual property rights within the Indian legal system, Bayer had said at that time.

In its verdict in March 2013, the IPAB ruled the government was using its rights under WTO norms to issue compulsory licences. It added though Bayer had obtained a patent for Nexavar in India in 2008, it could not make available the kidney and liver cancer drug on a large scale and at an affordable price, within the stipulated time.

Rejecting the IPAB ruling, a Bayer spokesperson had said the drug maker had produced sufficient quantities of Nexavar to meet the demands of Indian patients using the medicine.

The patent office had asked Natco Pharma to make a monthly dose of 120 tablets of Nexavar available to cancer patients at Rs 8,800, compared with Rs 280,000 charged by Bayer.

DRUG DEALS

• On March 9, 2012, the Controller General of Patents, Designs and Trademarks had granted a compulsory licence to Natco
• The Centre had said under WTO norms, it could issue compulsory licences to overcome barriers to a cheaper version of a patented drug, without the consent of the company holding the patent
• In its verdict in March 2013, the IPAB ruled the government was using its rights under WTO norms to issue compulsory licences