Nippon Shinyaku.,Ltd. vs. Sarepta Therapeutics, Inc., et al

Case Background

On July 13, 2021, Plaintiff Nippon Shinyaku Co., Ltd. filed a Patent Infringement lawsuit in the United States District Court, District of Delaware (Case number: 1:21cv1015). Judge Jennifer L. Hall presided over this case.

Cause

Nippon Shinyaku is a renowned pharmaceutical company from Japan. It initiated a patent infringement lawsuit against Sarepta Therapeutics, Inc., a Delaware-based corporation. The lawsuit accuses Sarepta of breaching contract and violating multiple patents. These patents are related to Nippon Shinyaku’s groundbreaking exon-skipping therapies designed to treat Duchenne Muscular Dystrophy (DMD). The dispute began after Sarepta filed seven Inter Partes Review (IPR) petitions with the Patent Trial and Appeal Board (PTAB). Sarepta sought to invalidate Nippon Shinyaku’s patents. Nippon Shinyaku had invested significant resources into developing VILTEPSO® (viltolarsen). VILTEPSO® is a therapy approved by the U.S. Food and Drug Administration (FDA). It is designed to increase dystrophin levels in DMD patients. Sarepta’s product, VYONDYS 53, used similar antisense oligomer technology targeting exon 53. Nippon Shinyaku alleged that VYONDYS 53 infringed its patents. These actions created substantial conflict, damaging Nippon Shinyaku’s exclusive rights to its innovative exon-skipping therapies in the field of Duchenne Muscular Dystrophy trea