The US Patent and Trademark Office’s (USPTO) rejection of Gilead Sciences’ patent application for the AIDS drug, Viread, is expected to have a strong impact in the Indian as well as global HIV/AIDS drug market. The rejection may affect the decision of the Indian Patent Office on Gilead’s patent application for Viread here. Last year, Cipla had filed a pre-grant opposition with the Indian patent office against Viread, the much sought after second line AIDS drug, arguing that the grant of the patent in India will make the HIV drug unaffordable to patients worldwide.
On Wednesday, USPTO rejected four patents on Viread, claiming the molecules are known. But the ruling is not final and Gilead claims that the patents will be upheld. “Now, since the patent application is rejected in the US, chances for the application getting rejected in India become high and Gilead will be forced to withdraw the application,” a patent attorney told FE.
According to analysts, Cipla will be benefited from the verdict. Cipla is marketing a generic version of tenofovir at a cost of $700 per person per year in India, while Gilead’s tenofovir costs $5,718 per patient per year in developing countries. However, Cipla officials refused to comment citing that the matter was sub judice.
Last year, Gilead signed license agreements with 11 Indian Companies for manufacturing and selling Viread in 95 countries, including India. Cipla, which refused Gilead’s licensing offer, challenged Viread’s validity by filing a pre grant opposition, apart from Delhi Network of Positive People, an NGO. However, Indian firms who entered into agreements with Gilead remain unfazed by the verdict. MM Srinivas Reddy, director, marketing, Hetero Drugs, told FE, “We are not worried at all over the verdict. Gilead has the chance to go for further appeal. Let the final verdict come.”
Gilead sells tenofovir alone and in combination with other drugs like Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company reports. (Source: Financial express)
On Wednesday, USPTO rejected four patents on Viread, claiming the molecules are known. But the ruling is not final and Gilead claims that the patents will be upheld. “Now, since the patent application is rejected in the US, chances for the application getting rejected in India become high and Gilead will be forced to withdraw the application,” a patent attorney told FE.
According to analysts, Cipla will be benefited from the verdict. Cipla is marketing a generic version of tenofovir at a cost of $700 per person per year in India, while Gilead’s tenofovir costs $5,718 per patient per year in developing countries. However, Cipla officials refused to comment citing that the matter was sub judice.
Last year, Gilead signed license agreements with 11 Indian Companies for manufacturing and selling Viread in 95 countries, including India. Cipla, which refused Gilead’s licensing offer, challenged Viread’s validity by filing a pre grant opposition, apart from Delhi Network of Positive People, an NGO. However, Indian firms who entered into agreements with Gilead remain unfazed by the verdict. MM Srinivas Reddy, director, marketing, Hetero Drugs, told FE, “We are not worried at all over the verdict. Gilead has the chance to go for further appeal. Let the final verdict come.”
Gilead sells tenofovir alone and in combination with other drugs like Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company reports. (Source: Financial express)
