Bombay HC in favor of Natco\’s Compulsory License

Recently, Bombay High Court supported the Granted compulsory license to Indian pharma company Natco for the sale of a generic version of Bayer’s anti-cancer drug Nexavar. 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.

 “We don’t see a reason to interfere with the order passed by IPAB and, therefore, the case is dismissed,” said justice M.S. Sanklecha.

“We are disappointed by the decision of the High Court. We will continue to defend our intellectual property rights and appeal this decision,” Bayer said in a statement.

• In Early March 2012 the Indian patent office granted Natco a compulsory license for the generic version of Bayer’s anti-cancer drug Nexavar.
• The compulsory license allowed Natco pharma to sell a generic version of Bayer’s Nexavar at Rs 8,800 per month as against Bayer’s price of Rs 2,80,000 per month.
• The German based Pharma giant Bayer challenged this compulsory license at the Intellectual Property Appellate Board.
• Later this was rejected in March 2013.

Firstly, The Bombay High Court ruled no because Bayer supplied to just about 200 of over the 8800 patients suffering from such cancers.

Patent lawyer and Senior Counsel Prathibha Singh say, “The court has done the right thing. What it has said is that the reasonable affordable price for every drug could be different. So what the court is trying to say is please compare what the patentee is giving and what the proposed licensee has proposed. If the proposed licensee has put up a price which is really different in terms of- here it could be Rs 3 lakhs versus Rs 8000- which is a huge difference”.

He also added, “The facts of this case are too gross. 200 bottles in three years, when there was a demand of almost 9000 patients a month. So the facts are too tilted and that is the whole problem in this case. I am sure there are compulsory licenses which have been rejected in India. If you balance it out with those, I think this was an exceptional case on the facts. There are other licenses which have been rejected and may be rightly so and therefore the Supreme Court, I would think, ought to entertain this petition definitely at least to lay down the different standards and the bars that are required under compulsory licensing and it would be again another landmark judgment, I think, of the Supreme Court”.

Photo by opensourceway / CC BY