On October 14, according to the latest batch of drug approval documents to be obtained by NMPA, Shiyao Ouyi's mabaloxavir tablet was approved for marketing, gaining the first imitation drug of this single-dose oral anti-influenza drug in China.
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". The drug was originally developed by Japan's Yoshi Shiono and later licensed to Roche to develop and sell 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. And just eight months after it was approved, it was rushed into the new version of the national health insurance.
Roche is responding to the NMPA approval of the first domestic copy of Marbaloxavir tablets, from Shi Yi, only a year and a half after the original product was approved.
Roche said: The innovative drug Marbaloxavir tablets (trade name: Fuda ®) and its active ingredients are protected by Chinese Invention Patent No. ZL201180056716.8. The patent relates to a compound patent with stable validity and expires on 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 patenteer of China Patent No. ZL201180056716.8 has never licensed any person or entity other than us and our affiliates to manufacture, use, sell or promise to sell the compound marbaloxavir and/or pharmaceutical products containing the compound Marbaloxavir for the purpose of production and distribution in the Mainland of 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 EuroItaly submitted a generic application only three months later. Since July 2021, Roche has repeatedly communicated with Euyi on the issue of intellectual property rights. However, Euyi, on the one hand, believes that its approved generic drugs fall within the protection scope of Chinese invention patent No. ZL201180056716.8, and on the other hand, has so far refused to commit not to infringe the patent rights during the protection period of the above patent. Roche believes that EuroItaly's actions have caused significant disruption to the subsequent development and commercialization of 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. The patentee has filed a patent-link lawsuit against EuroItaly for its application to market generic drugs.
