Gilead - Viread: patently wrong

Brazil’s government has turned down a patent application from US drugmaker Gilead Sciences for its HIV/AIDS drug Viread (tenofovir disoproxil fumarate -TDF), after the country’s patent office ruled that it lacked technological inventiveness.

The patent application had been opposed by a coalition of Brazilian nongovernmental organizations (NGOs) and a government pharmaceutical laboratory, and represents the first time that a patent related to an antiretroviral (ARV) medicine has been rejected as a result of a pre-grant opposition in Brazil.

After the patent office made its ruling, the Health Ministry formally announced its opposition to the patent, saying the drug is “in the public interest” and that granting a patent would hamper the country’s highly-successful free HIV/AIDS treatment plan. The drug is currently used by more than 31,00 patients enrolled in the plan and the numbers are expected to rise to 38,000 by the end of this year.

While Gilead is reportedly now in talks with the Ministry, the ban has been welcomed by international aid agency Medecins Sans Frontieres (MSF – Doctors Without Borders), which points out that Indian drugmakers produce World Health Organization (WHO)–approved tenofovir costing $158 for one patient's annual treatment, compared to the $1,387 charged by Gilead in Brazil.

TDF is a cornerstone drug, recommended by the WHO both for patients starting treatment and for those whose medications are no longer working, and securing wider access to it is “absolutely crucial,” said Tido von Schoen-Angerer, executive director of MSF's Access Campaign. “In the past, Brazil’s production of ARV drugs has helped to bring down prices of ARVs globally. We hope this will happen again,” he said. The decision, which means that the medicine can be produced by Brazilian generic companies or imported from other sources from abroad, also sets “an important precedent,” noted Leena Menghaney, MSF’s access campaigner in India. “In India, where MSF purchases most of our ARVs, civil society organisations have filed a similar opposition to Gilead’s patent application, and we hope that the Indian patent office will be taking note of the Brazilian decision,” she said.

By Lynne Taylor
PharmaTimes