Otsuka Sues Over Kidney Treatment Patent

On Friday a case was filed in the District of Delaware by Otsuka Pharmaceutical Company LTD against Teva Pharmaceuticals Inc. and their subsidiaries. The case is regarding patent interference regarding the pharmaceutical tolvaptan.

Tolvaptan, brand name Jynarque, is an “orphan drug” used to treat kidney function decline in adults for are at risk for rapidly progressing autosomal dominant polycystic kidney disease, the complaint said. The “orphan drug” status grants exclusive use of the product for the specific disease regardless of patent status. The plaintiff is the holder of two patents and the new drug application for the product, and the “orphan drug” exclusivity period expiration is April, 2025. The plaintiff accuses Teva of filing an Abbreviated New Drug application (ANDA). There has not been a license granted for the patents and no negotiation has been made.

Plaintiff is suing for patent infringement and seeks declaratory judgment as to the infringement as well as injunctive relief and damages. Plaintiff is represented by Morris Nichols Arsht & Tunnell LLP.