By Brendan Pierson and Adam Jourdan
NEW YORK/SHANGHAI, June 19 (Reuters) – China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.
Gilead has drawn fire for the cost of its top-selling drug Sovaldi, priced at $1,000 per pill in the United States or $84,000 for a typical 12-week course and its patents have been challenged in the U.S., India and Europe.
The application China has rejected was for a so-called prodrug, the inactive form of the drug which then converts into the chemically active compound once in the body, the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) said.
Gilead, however, holds the China patent to the base compound in the drug, also known by its generic name sofosbuvir and China’s rejection of the prodrug patent does not open the way for copycat drugs to be made in the world’s No. 2 drug market.
China-based officials for Gilead were not immediately available for comment. Emails and calls to Gilead’s U.S. offices outside office hours went unanswered.
Officials at China’s State Intellectual Property Office did not confirm the decision when contacted by Reuters, but a notice posted on the body’s website said Gilead’s application for “nucleoside phosphramidates”, a kind of prodrug, had recently been rejected.
China’s move follows a decision by India’s patent office in January to reject Gilead’s patent application for Sovaldi, finding it was not inventive enough. Gilead is appealing the ruling.
Under pressure to cut prices, the California-based firm agreed last year to make the drug available for lower prices in 91 developing countries.
I-MAK has brought legal challenges against Gilead’s patents or patent applications in five countries not covered by the agreement: China, Argentina, Brazil, Russia and Ukraine.
Charities in Europe have also challenged Gilead’s patent over its prices.
The World Health Organization says as many as 150 million people worldwide live with chronic hepatitis C infection, most of them in low and middle-income countries. It recently added Sovaldi to its essential medicines list and urged lower prices, especially in middle income countries.