Specialty pharmaceutical company BioDelivery Sciences International (NASDAQ:BDSI) can now claim patent victories against all three patent challenges levied by a rival in a long-running patent dispute.
The U.S. Patent and Trademark Office has rejected all claims made by MonoSol Rx in the third MonoSol patent that the New Jersey company alleged BDSI had infringed. In total, MonoSol had made 222 claims covering three of its patents. Patent officials have rejected all 222 claims.
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Both MonoSol and Raleigh, North Carolina-based BDSI have technologies that deliver drugs via a small piece of film that dissolves in the mouth. Onsolis, BDSI’s lead product, is designed to quickly deliver a pain-killer to cancer patients after being placed on the inside of the cheek. MonoSol’s products are placed beneath the tongue. MonoSol had filed suit against BDSI in 2010 claiming that BDSI’s manufacturing process for Onsolis infringed its patents.
The manufacturing process for BDSI’s drug-delivery technology is not patented. A patent would make that process public. Instead, the company maintains its proprietary manufacturing process as a company trade secret. While the USPTO’s rejection of MonoSol’s claims could end the matter, MonoSol still has the right to respond to the patent decision. But from BDSI’s perspective, the patent rulings don’t leave MonoSol much to challenge. “We believe it’s drastically weakened their position,” BDSI spokesman Al Medwar said.
BDSI’s dissolvable film drug-delivery technology is key to its entire drug portfolio platform. BDSI in January licensed another product candidate, BEMA Buprenorphine, to Endo Pharmaceuticals (NASDAQ:ENDP) in a deal that could pay BDSI up to $180 million if the chronic pain treatment reaches development and commercialization milestones. The company is also developing another product to treat opioid dependence. Both treatments were developed to work by delivering drugs via BDSI’s dissolvable film technology.
[Photo courtesy of BioDelivery Sciences International]
