Patent on Hep C drug rejected in Ukraine: Price of sofosbuvir will significantly reduce

The Ministry of Economic Development and Trade of Ukraine (MEDT) refused to grant the pharmaceutical company Gilead a patent for hepatitis C drug sofosbuvir. 

On 2 March 2018, the MEDT issued the order (No. 305) which approved the decision to reject the patent application. If issued, a patent could give the company a 20-year monopoly on the import of sofosbuvir to Ukraine.

“This is a very important achievement for Ukrainian patients,” says Serhiy Dmitriev, head of the advocacy at the All-Ukrainian Network of People Living with HIV (the Network). “Thanks to this decision, we expect that the price of medicines may drop three-fold, and for us, this means that three times more patients with hepatitis C will have access to modern drugs.”

The decision of the MEDT was the result of the work of the Network which, since April 2015, has filed a number of oppositions to the Ukrainian Patent and Trade Mark (UA PTO), substantiating that the patent application did not meet the requirements of the law, in particular concerning novelty and inventive level.

Thanks to this decision, we expect that the price of medicines may drop three-fold, and for us, this means that three times more patients with hepatitis C will have access to modern drugs – Dmitriev

“Each time, after consideration of the oppositions filed by the Network, UA PTO issued a preliminary refusal to grant a patent, giving Gilead the opportunity to provide counter-arguments regarding the compliance of the application with the patentability criteria established by law,” says Serhiy Kondratyuk, the Network’s human rights and intellectual property expert. “Finally, on 6 July 2017, UA PTO decided to finally refuse to grant the company a patent. After an unsuccessful attempt of Gilead to appeal against UA PTO’s decision in the Appeals Chamber, on 2 March 2018, the MEDT finally approved the refusal to grant a patent.”

Refusal to grant a patent means that other manufacturers of this drug will be able to enter Ukrainian market in the near future, and also Ukrainian pharmaceutical companies will be able to produce this product within the country.

Thanks to the previous advocacy activities of the Network, today the price for sofosbuvir treatment course in Ukraine is 750 USD. For countries which do not have a monopoly on this medicine and have several manufacturers present on the pharmaceutical market, the price is usually about 200-300 USD for the course of treatment. As a result of the Network’s successful patent oppositions, the price is expected to reduce down, when other manufacturers enter the market, and access to sofosbuvir in Ukraine could be tripled.

It is estimated that around 1 million people are infected with hepatitis C in Ukraine and around 48,000 are waiting for urgent treatment. Currently, no more than 10,000 patients are being treated by the state. The high price is one of the key barriers to the rapid expansion of the state programme. It should be noted, that the data exclusivity (monopoly) of the originator’s company for sofosbuvir is valid until 2020, but if the patent had been granted, the monopoly would have been extended until 2031.

Related news: Patent Challenges, Ukraine