The China National Intellectual Property Administration (CNIPA) has granted Swiss pharmaceutical giant Roche (SWX: ROG) a Patent Term Extension (PTE) for its drug Evrysdi (risdiplam), under patent NO. ZL201580027306.9. This marks the first case of its kind in China, where the SMN2 splicing modifier will now enjoy patent protection until June 16, 2035, instead of the original expiration date of May 11, 2035.
CNIPA’s Interim Measures for Post-Patent Law Revision Review Management
In May 2021, CNIPA released a notification outlining “interim measures related to post-patent law revision review management.” These measures are significant for the pharmaceutical industry, as they provide a framework for patent protection extensions. According to the interim measures, a patentee can file for patent period compensation within three months following New Drug Application (NDA) approval, effective from June 1, 2021. The relevant fees for this extension are to be paid later, as per the payment notice issued by the bureau.
Implications for Roche and the Pharmaceutical Industry
The extension of Evrysdi’s patent protection is a significant development for Roche and sets a precedent for other pharmaceutical companies operating in China. It highlights the importance of intellectual property rights in the pharmaceutical sector and the potential for extended market exclusivity periods following regulatory approvals.-Fineline Info & Tech
