Bombay HC to begin hearing in Bayer’s case against IPAB’s CL order on Nexavar today

Source: Pharmabiz, 29 Oct 13

The hearing in the high voltage Nexavar case by German drug major Bayer against India’s first ever compulsory license (CL) to Natco Pharma will begin in Bombay High Court on October 29.

In this case, the multinational drug company is challenging the Intellectual Property Appellate Board (IPAB)’s order in March this year in which the IPAB, Chennai had upheld India’s first ever compulsory license (CL) issued to Hyderabad-based generic drug company Natco Pharma for manufacturing and marketing generic copies of Bayer’s patented kidney cancer drug Nexavar.

“The court does not decide for, or against, a company. It takes a decision based solely on public interest,” Justice Prabha Sridevan, chairman of IPAB, while passing an order in March had said and added, “The price of a drug should be seen from the point of view of the public affordability and not on the based on R&D expenses.”

According to sources, the case will be heard by a division bench in the Bombay High Court comprising Justice SJ Vazifdar and Justice KR Sriram.

In its petition, the German drug major has sought the court’s intervention to protect its rights over patented cancer drug Nexavar. In the Bombay High Court, Mumbai-based IP practice law firm Gajaria & Co is representing Bayer, while Controller General of Patents Designs and Trademarks (CGPDT) is being represented by Advait Sethna in the case.

The Nexavar issue dates back to March 9, 2012, when the then Indian Patent Controller P H Kurian issued the first-ever CL to Hyderabad-based Natco Pharma to manufacture an affordable generic version of sorafenib tosylate, the anti-cancer drug for which Bayer had obtained a patent IN215758 in India in 2008.

However, the German drug major filed an appeal against the CL order before the IPAB in Chennai and has in particular sought to have the operation of the CL order stayed till the appeal hearings are completed and IPAB passes its decision.

However, the IPAB in September 2012 rejected Bayer’s request for a stay order against the grant of CL on its anti-cancer drug Nexavar to Natco Pharma. The final hearings in the case had started on January 23 and the IPAB heard all the parties involved in the case, Bayer Corporation, Union of India, the Controller of Patents and Natco Pharma Ltd.

After several months of hearing all the parties, IPAB chairman Justice Prabha Srideva in March this year upheld the CL issued to Natco for manufacturing and marketing generic copies of Bayer’s patented cancer drug Nexavar. However, the IPAB has increased the royalty due to Bayer from Natco under the compulsory license to seven per cent, from six per cent.

The CL allows a more affordable version of sorafenib tosylate to be produced and marketed, and brought the price of the patented drug down from over US$ 5,500 per month to $175 per month – a reduction of 97 per cent.

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