U.S. PTO's rejection of Gilead's antiretroviral patents might affect applications in India

Last week's rejection by the U.S. Patent and Trademark Office of four patents on Gilead Sciences' antiretroviral drug Viread might affect patent applications for the drug in India, the Times of India reports.

According to the Times of India, the PTO decision strengthens the opposition application filed in 2006 by the Indian Network for People Living With HIV/AIDS against patent applications filed by Gilead (Mukherjee, Times of India, 1/25).

Viread is known generically as tenofovir and is sold as part of Gilead's combination therapies Truvada and Atripla. The not-for-profit group Public Patent Foundation, or PUBPAT, last year submitted evidence to PTO that the scientific knowledge on which the four patents were based existed before Gilead held the patents. The foundation in its challenge to the patents submitted prior knowledge that Gilead had not disclosed to PTO during the patent application process. In its challenge, PUBPAT said that the prior knowledge would have prevented PTO from issuing the patents.

Gilead has the right to respond to the PTO decision, and the patents will be protected while Gilead responds (Kaiser Daily HIV/AIDS Report, 1/24).

According to the Financial Express, PTO's decision is expected to affect the Indian and global antiretroviral markets. India's Patent Office currently is considering Gilead's applications for Viread and might be affected by the decision. According to a patent attorney, because Gilead's "patent application is rejected in the U.S., chances for the application getting rejected in India become high, and Gilead will be forced to withdraw the application." Analysts say that such actions could benefit Indian pharmaceutical company Cipla, which markets a generic version of the drug in India at a cost of $700 per person annually. Cipla officials did not comment on the situation, the Express reports (Sharma/Balakrishnan, Financial Express, 1/24).