siRNA Drug Amvuttra Patent Research and Practical Operation Guide

Small interfering RNA (siRNA) are short double-stranded RNA molecules, typically 21-25 nucleotides long. On June 13, 2022, Alnylam's siRNA drug Amvuttra® (Vutrisiran) was approved by the FDA for treating polyneuropathy in adults with hereditary transthyretin-mediated (hATTR) amyloidosis. As Alnylam's flagship product, Amvuttra generated $560 million in sales in 2023. Compared to Alnylam's Onpattro, Amvuttra has lower manufacturing costs, requires less frequent dosing, and offers convenient subcutaneous injection, potentially leading more patients to switch to Amvuttra. Over 20 companies globally are developing siRNA drugs, but Alnylam dominates the market with a robust patent strategy covering Amvuttra's core components, delivery agents, sequences, and modifications. Alnylam utilizes divisional and continuation applications to maintain extensive patent protection, serving as a model for siRNA drug patenting. This report focuses on siRNA drug patent searches, using Alnylam's Amvuttra as a case study to illustrate the research process. It also provides an overview of the latest patent landscapes in the U.S. and China.