(Mia Burns, assistant online editor for Pharmalive.com, produced this piece.)
Generic drug makers and disadvantaged patients are the winners here, because India's Intellectual Property Appellate Board rejected a petition from Bayer on Friday that sought a stay on an order of Controller of Patents. What this now means is that the Hyderabad-based Natco Pharma Limited, a generic drug company, can act on its compulsory license for Bayer's kidney and liver cancer drug Nexavar.
Natco received the first compulsory license ever to make a generic version of Bayer's Nexavar back in March. In May, Bayer challenged this move. This decision only covers domestic distribution, and was based on the Bayer drug being too expensive to most patients. The Nexavar price is expected to drop from $5,500 per person each month to $175, a 97 percent decline. The drug generated $934 million in global sales in 2010, according to India’s Patent Office, which also noted, however, that Nexavar was barely sold in India and called this “neglectful." Under the World Trade Organization’s TRIPS Agreement, which governs trade and intellectual property rules, compulsory licenses are a legally recognized means to overcome barriers in accessing affordable medicines.
Patient advocacy groups and non-governmental organizations say the decision reaffirmed last Thursday to issue the license is a game changer. The move prompted Cipla, another Indian generic drug maker, to reduce the price of three cancer drugs by 80 percent, making them cheaper than the Natco version. Meanwhile, Roche announced plans to sell two of its cancer drugs, Herceptin and MabThera, at lower prices.
In July, the U.S. Patent and Trademark Office became involved in the debate over intellectual property rights and compulsory licenses. In testimony before the House Subcommittee on Intellectual Property, Teresa Stanek Rea, the undersecretary of commerce for intellectual property and deputy director of the USPTO, stated that the agency is working to deter countries from issuing licenses.
Now that Natco has won its battle, expect the company to seek more compulsory licenses in India. China has also amended its patent laws in a way that would permit compulsory licensing. The amended Chinese patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, unusual circumstances or in the public interest.
(hat tip to The Hindu)