On Friday, Celgene Corporation filed a complaint in the District of New Jersey. The case was filed against Biocon Pharma Inc. The action focuses on potential patent infringement regarding ten patents held by Celgene which would potentially be infringed upon by a potential generic drug created by Biocon.
The patents address methods for treating cancer, specifically multiple myeloma and related blood and bone marrow cancers. The patents resulted in a drug regimen specifically designed to treat these patients after bone marrow transplantation, under the name Revlimid.
Biocon 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 holders rights. Biocon has 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, in the alternative stated that the patents in suit were invalid. Celgene alleged that the information submitted to the FDA on its face shows intent to infringe upon the patents held by Celgene and seeks redress.
Celgene is suing for infringement of each of the 14 patents, and seeking to 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. The plaintiffs are represented by Saul Ewing Arnstein & Lehr.
Interested in learning more about legal issues facing pharmaceutical companies? Learn more about the regulation of the industry in Regulation of Pharmaceutical Manufacturers, from Full Court Press and Fastcase.