India permissions generic imitate of patented Bayer drugs
India’s government first time will admit a generic-drug maker to bring about and sell cheaper imitates of a patented cancer medicine, a decision that forces brand producers to lower costs.
Natco Pharma Ltd. (NTCPH) received a supposed mandatory license to make Bayer AG (BAYN)’s Nexavar, which goes along the generic name sorafenib to forbid the kidney and cancer of the liver discourse, and will have to sell it at a 97 percent discount to Bayer’s living product, India’s Controller General of Patents Designs and Trademarks said yesterday in a statement on its site.
Bayer Corporation- a auxiliary of the German pharma giant in Pittsburgh, Pennsylvania; markets sorefinib as Nexavar for about $5,600 a month in India under a 2008-2020 patent, making it “not accessible to the nation at a fairly low-cost price,” the patent office governed.
“A right cannot be absolute,” it said. The office can forcefulness fellowships to allow licenses to generics in cases of public emergency or wherever they can show patented products are priced unreached.
Natco said its edition would cost Indian patients $175 a month.
More patients forced out versions of additional patented treatments, specified new HIV drugs, in India, international aid organization Medecins Sans Frontieres said in a statement.
Under a World Trade Organization agreement known as Trade- related aspects of cerebral property rights or TRIPS, member countries can use these compulsory licenses to ensure access to affordable medicines, MSF said. Governments can grant compulsory licenses to allow a company to make a patented product or use a patented process without the consent of the patent owner.
“We are disappointed about this decision,” Bayer spokeswoman Sabina Cusimano said from Berlin, adding that the company was considering a legal challenge. “We will see if we can further defend our intellectual property rights in India.”
The drug is practiced for the discourse of advanced stage kidney and liver cancer. Nexavar, which sells for more than 280,000 rupees ($5,605) a month in India, can broaden the life of a kidney cancer patient by four to five years, the patent office said.
Under the terms of the license, Natco can charge a maximum of 8,800 rupees for a monthly dose of 120 tablets. The company would have to pay 6 percent of its sales revenue to Bayer as royalty and supply the drug at no cost to at least 600 needy patients each year, the patent office said.
A patent must be at least 3 years old before a generics company can apply for a compulsory license. Still, many Indian companies have been reluctant to push for compulsory licenses where they might jeopardize agreements to manufacture other drugs for wealthy Western drug companies.
Cipla Ltd. (CIPLA), India’s third-biggest drugmaker, also sells a generic version of the treatment for 28,000 rupees a month and had sales of about 90 million rupees last year, Hitesh Mahida, a Mumbai-based analyst at Fortune Equity Brokers, said in an interview.
