The Thai Network of People Living with HIV/AIDS (TNP+) filed an opposition to a patent application filed by the U.S.-based pharmaceutical giant Gilead Sciences and Ireland-based Janssen for the combination of rilpivirine (RPV) and tenofovir disoproxil fumarate (TDF). The big pharma companies are seeking to extend its patent monopoly on the drug combination until 2031.
Rilpivirine is an ARV recommended in Thailand’s HIV national guidelines as an alternative treatment for people living with HIV who cannot use some ARVs (efavirenz and dolutegravir) due to side effects.
“This is an essential drug for people living with HIV, especially those who have few options for drugs to stop the virus from spreading and prevent further transmission,” said Chalermsak Kittitrakul, Project Manager for Access to Medicines at TNP+. “Gilead’s and Janssen’s patent monopoly extension would be disastrous for people living with HIV in Thailand. We need to take a stand against big pharma and their exploitation tactics which prioritize their profits over public health.”
Evergreening is a common strategy used by pharmaceutical companies, who obtain secondary patents on different aspects of known medicines or minor modifications of an old drug. This enables them to continue having the exclusive rights to sell medicines or vaccines, and prevents production of affordable generic versions.
“We filed the opposition because this patent application does not comply with the Thai patent law,” said Kittitrakul. “This secondary patent application does not pertain to any novelty or innovation in RPV and TDF,” adding that they are not new drugs – and that combining them does not have any new effects.
People living with HIV in Thailand currently take TDF and RPV as separate pills.
If the patent is permitted, Kittitrakul said it would artificially extend Gilead’s and Janssen’s monopoly on the drug, limiting opportunities for local manufacturing of generic versions of TDF and RPV, even though Gilead and Janssen do not currently produce and market TDF and RPV in Thailand. The patent may also prevent production and availability of RPV in combination with other ARVs in the future – or prevent TDF and RPV drugs from being combined in one pill, so it is more convenient for people living with HIV.
If granted, this patent extension would prevent and delay production and importation of TDF and RPV. According to Kittitrakul, Gilead’s and Janssen’s efforts to unlawfully extend this patent undermines efforts to combat HIV/AIDS in Thailand. “If we can stop pharmaceutical companies like Gilead and Janssen from continuing to extend their unlawful, profit-motivated monopolies, we can ensure people living with HIV in Thailand have a chance at a healthy, long life,” he said.
