Teva, Cephalon Sue Dr. Reddy’s Over Leukemia Drug Patent

On Thursday a complaint was filed in the District of Delaware by Teva Pharmaceuticals International, GMBH, Cephalon Inc. and Eagle Pharmaceuticals Inc. against Dr. Reddy’s Laboratories, LTD. This action alleged the defendant infringed 14 patents held collectively by Eagle Pharmaceuticals and licensed to Teva Pharmaceuticals.

The patents concern the creation and manufacture of bendamustine hydrochloride, an alkylating drug that is indicated for the treatment of patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The patents are owned by Eagle Pharmaceuticals. 

The patents were assigned to Cephalon, and later to Teva, with an exclusive license under the patent. According to the filing, Dr. Reddy’s is a laboratory specializing in the creation, importation, and distribution of generic drugs. While a generic drug does not always infringe upon the original patented name-brand drug, use of the patented materials in either the creation, manufacture, or final product can infringe on the patent holder’s rights.

Dr. Reddy’s filed a notice of intent to seek approval for their generic drug with the FDA and included a Paragraph IV certification stating that the creation of the drug did not infringe upon the patents and, if it did, it alternatively stated that the Patents in suit were invalid. Review of the notice and of the publicly available information was not sufficient to determine if the generic drug would infringe upon the patents, and Teva was not able to come to an agreement with Dr. Reddy’s for further confidential access to ascertain if the generic product would be infringing. After confirmation that Dr. Reddy’s would continue to pursue approval with the FDA, Teva and the remaining plaintiffs filed suit.

Teva is suing for infringement of each of the 14 patents, and seeking for the effective date of approval for the generic drug be delayed until the latest of the expiration date of the patents, as well as seeking an injunction regarding the import, sale, or any action taken in furtherance of the generic drug. The plaintiffs are represented by Shaw Keller