The United States Patent and Trademark Office rejected all 191 claims made by New Jersey-based MonoSol Rx as unpatentable. The dispute centers on the technology that forms BDSI’s drug-delivery platform. Raleigh, North Carolina-based BDSI’s drug products and drug candidates deliver drugs via a small piece of film that is placed on the inside of the cheek. The film quickly administers medication as it dissolves. MonoSol has a patented thin film drug-delivery technology.
BDSI has used its “BioErodible MucoAdhesive” (BEMA) technology to commercialize Onsolis, a drug addressing breakthrough pain experienced by cancer patients. Besides Onsolis, marketed with drug partner Meda, the BEMA technology is also the basis for BDSI drug candidates being studied to treat chronic pain and drug dependence.
MonoSol last year filed a patent-infringement lawsuit claiming that BDSI’s proprietary manufacturing process for Onsolis infringes on a MonoSol thin film patent. MonoSol has since added two additional patents to its case. BDSI had denied MonoSol’s charges and described its manufacturing process as a trade secret.
The USPTO’s decision rejecting MonoSol’s initial patent claims against Onsolis is important for BDSI not only because Onsolis is the company’s only U.S. Food and Drug Administration-approved product, but also because the drug-delivery technology is the basis for the company’s drug pipeline. BDSI said the company believes MonoSol’s claims made for the two additional patents are also invalid and unenforceable.
MonoSol has two months to respond to the USPTO’s action.