Russian Intellectual Property Rights Court ordered the Federal Service for Intellectual Property (Rospatent) to extend the period of patent protection for the drug Sofosbuvir, which is used to treat viral hepatitis C, for another three years, until March 2031.
The American company Gilead Pharmasset received patent registration No. 2478104 in 2013. In 2018, it was partially revoked, and the pharmaceutical company filed patent No. 2651892 with a term of protection until 2028.
Rospatent excluded from patent protection some of the claims, including those that protected the substance sofosbuvir. At the same time, Rospatent upheld the claim with an ambiguous clause, which retained legal uncertainty regarding the termination of protection for sofosbuvir, despite the exclusion of some of the other claims.
The patentee, realizing the threat of entering the generics on the market, applied for an extension of the patent No. 2651892, but Rospatent refused due to partial identity of the invention characteristics in the previously issued and partially canceled patent No. 2478104.
Pharmstandard, which manufactures the drug on the basis of a patent license of an American company, filed a lawsuit. On the side of Rospatent, the Russian drug manufacturer Pharmasyntez also joined. An additional argument against the extension of the term of protection was the public interest in the protection of the public domain, and the actions of the right holder that pose a threat to the protection of the life and health of citizens.
However, IP-court sided with the American company. Pharmsynthez announced that they intend to appeal this decision to the Supreme Court.
Sofosbuvir is a key antiviral drug used in almost all recommended treatment regimens of viral hepatitis C and is included in the list of essential drugs in Russia. According to experts, there are more than 3.5 million people are diagnosed with chronic hepatitis C in Russia.
Earlier, Pharmasyntez, the Russian partner of Gilead, announced its readiness to reduce the price of Sofosbuvir by 41% – from $1.7 thousand to $ 1 thousand.