Bayer loses patent war as India backs copy
Source: Agencies |
March 13, 2012, Tuesday
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Print Edition
Print Edition
INDIA'S patent office effectively ended Bayer's monopoly on a patented cancer drug yesterday by allowing a generic copy to be made at a fraction of the price.
Under a Indian legal provision aimed at keeping prices from skyrocketing beyond patients' reach, the patent office approved Natco Pharma Ltd's application to produce the kidney and liver cancer treatment sorefinib.
Bayer Corp, a subsidiary of the German pharma giant in Pittsburgh, markets sorefinib as Nexavar for about US$5,600 a month in India under a 2008-2020 patent, making it "not available to the public at a reasonably affordable price," the patent office said in its ruling. "A right cannot be absolute," it said. The office can force companies to grant licenses to generics that show patented products are priced out of reach. Natco said its version would cost Indian patients US$175 a month.
Unique rules
It was the first case of compulsory licensing under India's unique patent rules. Under the license Natco must pay 6 percent in royalties to Bayer.
The decision was likely to upset Western pharmaceuticals, which have been pushing for stronger patent protections and rules to clamp down on a US$26 billion Indian generics industry they say is overstepping intellectual property rights. Aid groups counter that Indian generics are a lifesaving resource for patients in poor countries who cannot afford Western prices to treat diseases like cancer, malaria and HIV.
"We are disappointed about this decision," Bayer spokeswoman Sabina Cusimano said from Berlin, adding that the company was going over the ruling and considering a legal challenge. "We will see if we can further defend our intellectual property rights in India." A patent must be at least 3 years old before a generics company can apply for a compulsory license.
Under a Indian legal provision aimed at keeping prices from skyrocketing beyond patients' reach, the patent office approved Natco Pharma Ltd's application to produce the kidney and liver cancer treatment sorefinib.
Bayer Corp, a subsidiary of the German pharma giant in Pittsburgh, markets sorefinib as Nexavar for about US$5,600 a month in India under a 2008-2020 patent, making it "not available to the public at a reasonably affordable price," the patent office said in its ruling. "A right cannot be absolute," it said. The office can force companies to grant licenses to generics that show patented products are priced out of reach. Natco said its version would cost Indian patients US$175 a month.
Unique rules
It was the first case of compulsory licensing under India's unique patent rules. Under the license Natco must pay 6 percent in royalties to Bayer.
The decision was likely to upset Western pharmaceuticals, which have been pushing for stronger patent protections and rules to clamp down on a US$26 billion Indian generics industry they say is overstepping intellectual property rights. Aid groups counter that Indian generics are a lifesaving resource for patients in poor countries who cannot afford Western prices to treat diseases like cancer, malaria and HIV.
"We are disappointed about this decision," Bayer spokeswoman Sabina Cusimano said from Berlin, adding that the company was going over the ruling and considering a legal challenge. "We will see if we can further defend our intellectual property rights in India." A patent must be at least 3 years old before a generics company can apply for a compulsory license.
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