On Friday a case was filed in the District of Delaware by HQ Specialty Pharma Corp. against Fresenius Kabi USA, LLC. The case is regarding the infringement on patents owned by HQ Specialty.
Calcium gluconate is used to treat hypocalcemia, a condition where the body has too little calcium, leading to muscle cramps, confusion and tingling in the extremities. HQ Specialty Pharma Corporation is the holder of two patents regarding a liquid suspension of calcium gluconate in sodium chloride solutions for easy and effective IV treatment of the condition. The treatment is listed in the Orange Book in 2018 and 2019.
HQ Specialty Pharmacy sent Fresenius Kabi USA, LLC a cease and desist letter demanding that Fresenius cease producing and selling the suspension, but Fresenius did not respond. Fresenius later sent an sNDA application to the Food and Drug Administration (FDA), for approval as a generic, which was granted. However, HQ Specialty is suing regarding the patent infringement, seeking declaratory judgment and injunctive relief as well as damages. The plaintiff is represented by Morris, Nichols, Arsht & Tunnell LLP and Rothwell, Figg, Ernst & Manbeck, PC.
