On Tuesday a case was filed in the Delaware District Court. The case was filed by Eagle Pharmaceuticals Inc., Teva Pharmaceuticals International GMBH, and Cephalon, Inc. against Hospira Inc. The case is regarding possible infringement of the patents held by the plaintiff regarding the injectable Bendeka.
Bendeka is a drug used in the treatment of leukemia by alkylating the DNA in cancer cells and preventing them from replicating. Eagle is the holder of the patent on this particular formulation and it was licensed to Cephalon and Teva Pharmaceuticals for commercialization and distribution of the product. Hospira has submitted a New Drug Application (NDA) to the FDA which has received tentative approval prior to the expiration of the patents held by Eagle. This NDA is for a bio-equivalent version of the patented drug, but the plaintiffs argue that the drug goes beyond bioequivalence and still violates the valid patents prior to their expiration.
The plaintiffs are suing for violation of the patents and seek injunctive relief prohibiting the manufacture and sale of the Hospita products prior to the expiration of the patents without license from the plaintiffs. The plaintiff are represented by Shaw Keller LLP, with of counsel representation by Latham & Watkins LLP and Williams & Connolly LLP.