On August 16, a significant milestone was reached as the China National Intellectual Property Administration (CNIPA) awarded Japanese pharmaceutical company Takeda (NYSE: TAK)’s Entyvio (vedolizumab) a Patent Term Adjustment (PTA) for patent NO. ZL201711310404.0, marking the first case of its kind in China. This decision deviates from the typical Patent Term Extension (PTE), offering a unique outcome for the monoclonal antibody (mAb) medication.
Entyvio is designed to bind with α4β7 integrin, effectively blocking its interaction with mucosal addressing cell adhesion molecule-1 (MAdCAM-1). This mechanism prevents lymphocytes from infiltrating the intestinal mucosa, thereby mitigating intestinal inflammation. The drug received approval in China in March 2020 for the treatment of adult patients with moderate to severe active ulcerative colitis and Crohn’s disease, catering to those with an inadequate response to conventional treatments or tumor necrosis factor alpha (TNF alpha) inhibitors.
Takeda submitted a PTA application for the patent in October 2022, covering the Pharmaceutical Use of Biological Products. CNIPA’s decision granted a compensation of 44 days for the patent, originally set to expire on May 2, 2032, now extended to June 15, 2032. In a separate development on December 18, 2022, Takeda sought a PTE for the drug. However, given that more than three months had passed since its marketing approval, CNIPA opted not to review the PTE application.- Flcube.com
