The price for sophsbuver will be significantly reduced
The Ministry of Economic Development and Trade of Ukraine (MEDT) refused to grant the pharmaceutical company Gilead a patent for a modern hepatitis C drug Sofosbuvir. On March 2, 2018, the MEDT issued the order No. 305 which approved the decision to refuse the patent issue. Such patent could give the company a monopoly on the import of Sofosbuvir to Ukraine for a 20-year period.
“This is a very important achievement for Ukrainian patients,” said Serhiy Dmitriev, the head of the Network’s Advocacy Department. “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 active work of the Network which, since April 2015, had filed a number of objections to Ukrpatent, substantiating that the patent application did not meet the requirements of legislation, in particular concerning novelty and inventive level.
“Each time, after consideration of the objections filed by the Network, Ukrpatent made 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,” said Serhiy Kondratyuk, the intellectual property expert. “Finally, on July 6, 2017, Ukrpatent decided to finally refuse to grant the company a patent. After an unsuccessful attempt of Gilead to appeal against Ukrpatent’s decision in the Appeals Chamber, on March 2, 2018, the MEDT finally approved the refusal to issue a patent.”
Refusal to issue a patent means that other producers of this drug will be able to enter the Ukrainian market in the near future, and Ukrainian pharmaceutical companies will be able to produce this product in Ukraine.
We are reminded that thanks to efforts of the Network, today the price of the Sofosbuvir treatment course is 750 USD. However, in connection with the successful appeal of the Network against patent granting, access to Sofosbuvir in Ukraine will be tripled. According to the experience of countries which do not have a monopoly on this drug and have several manufacturers on the pharmaceutical market there, the price of this drug is about 200-300 USD for the course of treatment.
In Ukraine, as of early 2018, about 1 million people are infected with hepatitis C, and about 48 000 are waiting for urgent treatment. No more than 10 000 patients are being treated at public expense. The high price is one of the key barriers to the rapid expansion of the state programme of the hepatitis C treatment. We would like to remind that the exclusivity (monopoly) of the originator’s company for the key hepatitis C drug is valid until 2020, but if the patent had been granted, the monopoly would have been extended until 2031.