On 28 December 2016, the All-Ukrainian Network of People Living with HIV/AIDS submitted a patent invalidation claim against Gilead patent on tenofovir alafenamide fumarate (TAF).
The claim, presented to the Kiev Commercial Court, aims to revoke the patent, which currently allows Gilead a monopoly on TAF. This covers the tenofovir pro-drug which is used in HIV and Hepatitis B treatment.
The Network is opposing the patent on the grounds that it does not comply with the required criteria of ‘novelty’, ‘inventive step’ and ‘industrial applicability’. Additionally, several patent claims of tenofovir pro-drug patent were absent in Gilead’s initial application submitted to the Ukrainian Patent and Trademark office, which itself is a legal ground for their cancellation.
Mykyta Trofymenko, Intellectual Property Counsel at the Network states: “In our opinion, the tenofovir pro-drug patent does not comply to the requirements of Ukrainian legislation and may pose a threat to access to HIV/AIDS medicines in Ukraine. Gilead by obtaining this patent tries to prolong a monopoly on tenofovir, which may cause overpricing of tenofovir-based medicines in the future.”
According to Othoman Mellouk, the Intellectual Property and Access to Medicines Lead at the International Treatment Preparedness Coalition (ITPC): “It is important to make TAF available in Ukraine. This modified version of Tenofovir, an old and well-known medicine, presents the advantage of low dosage and fewer side effects. It can really improve the quality of life of people living with HIV by reducing toxicity on their kidneys and bones. TAF will be also used very soon to prevent HIV transmission through pre-exposure prophylaxis.”
The Kiev Commercial Court has scheduled the first court hearing for 26 June 2017. During proceedings the Court will consider the Network’s claims. If the court agrees that patent does not comply with legislative requirements it will be invalidated.
Tenofovir was first synthesized back in the 80s and was patented shortly after. Therefore without any inventive step or novelty, the patent should have long expired. However, to prolong its monopoly and maximize profits Gilead attempts to register new tenofovir-related patents in different countries, including Ukraine.