Flu new drug approved only 1 year, Shi Yao Ou Yi that is the first copy! Roche responds...

On October 14, according to the latest batch of drug approval documents obtained by NMPA, Shiyao Ouyi's Mabaloxavir tablets were approved for marketing, giving China its first copycat of the single-dose oral anti-influenza drug.

It is reported that Marbaloxavir is an RNA polymerase inhibitor, which can directly act on the replication and transcription of influenza virus RNA, and is called a new generation of anti-influenza "miracle drug". Originally developed by Yoshi Shiono of Japan, the drug was licensed to Roche to develop and market Xofluza in the United States, China and other markets. In 2018, Mabaloxavir was approved for sale in Japan and the United States.

In China, the approval of mabaloxavir soon attracted the attention of the drug regulatory authorities, and it was included in China's List of Clinically Urgent Overseas New Drugs (the Third batch) and obtained the priority evaluation qualification of CDE. In April 2021, Marbaloxavir tablets were approved in China for use in patients aged 12 years and older with simple influenza A and B, including previously healthy patients and those at high risk of influenza complications. It was rushed into the new version of the NHS just eight months after it was approved. Roche is responding to the NMPA approval of Schering-Plough's first domestic copy of Marbaloxavir tablets, just a year and a half after the original product was approved.

Roche claimed: The innovative drug Marbaloxavir tablets (trade name: Fuda ®) and its active ingredients are protected by Chinese Invention Patent No. ZL201180056716.8. The patent concerns a compound patent with a stable expiration date of September 21, 2031. In accordance with the relevant provisions of the Patent Law of the People's Republic of China, no person or entity shall manufacture, use, sell or promise to sell Marbaloxavir compound and/or pharmaceutical products containing Marbaloxavir compound for the purpose of production and distribution in the Mainland of China without the permission of the patent holder. The holder of the Chinese patent No. ZL201180056716.8 has never licensed any person or entity other than ourselves and our affiliates to manufacture, use, sell or promise to sell compound marbaloxavir and/or pharmaceutical products containing compound marbaloxavir for manufacturing and distribution purposes in mainland China.

In particular, it should be pointed out that the approval of Euyi's generic drug by the National Medical Products Administration does not mean that Euyi can manufacture, sell or promise to sell its generic drug Marbaloxavir tablets for the purpose of production and business, otherwise it will constitute infringement of the above patent.

Roche's innovative Marbaloxavir tablet was approved in April 2021, but only three months later a generic application was filed in Italy. Since July 2021, Roche has repeatedly communicated with Euyi on intellectual property issues. However, Euyi, on the one hand, argues that its approved generic falls under the protection of Chinese invention patent No. ZL201180056716.8 and, on the other hand, has so far refused to undertake not to infringe the said patent during the period of its protection. Roche believes that EuroItaly's actions have caused significant disruption to the subsequent development and commercialization of the marbaloxavir tablets.

Roche also calls for the API/pharmaceutical producing enterprises, pharmaceutical trading sales unit, medicines procurement and sales platform, to respect intellectual property rights of medical institutions, jointly safeguard legitimate domestic pharmaceutical market fair management order, not manufacture, sell or promise sales enroach on roche's legitimate rights and interests of medicines, act infringes upon the lawful rights and interests of roche provide convenience and help, Prudently evaluate and actively resist other acts that infringe upon Roche's legal rights and interests. Patentees have filed a patent-link action in Europe against Italy over its application to market the generic.