In a decision yesterday the US patent and trademark office (PTO) threw out all 191 claims against BDSI’s product Onsolis, ruling that production methods used to make the BioErodible MucoAdhesive (BEMA) technology on which it is based do not breach MonoSol’s patent number 7,824,588.
BDSI CEO Mark Sirgo said: “This is a very significant and positive development for BDSI and its commercial partners involved in this case," and added that “we intend to continue to aggressively pursue whatever actions are necessary to defend our position and expect that all of MonoSol's claims will ultimately be defeated."
New Jersey, US-based MonoSol and commercial partner Mediatech, which have not commented on the latest USPTO ruling, have two months to respond.
Process patents
The USPTO ruling is latest twist in the drug delivery technology firms’ legal battle that began in November last year after MonoSol filed a suit in the New Jersey Court alleging that manufacturing techniques BDSI uses infringe on its own patented production method.
The heart of the issue is that while BDSI holds patents for the BEMA technology, it does not hold any for the manufacturing processes it and contract manufacturing organisation (CMO) Aveva use to make Onsolis. Instead BDSI regards these methods as a company trade secret.
The rational for this approach, according to Sirgo in a recent interview with North Carolina’s Triangle Business Journal, is that: “Most people avoid process patents because once that becomes public knowledge, people can design around it.”
But while the latest ruling is a victory for BDSI, it is unlikely to be the end of the battle.
In September this year MonoSol expanded its original suit by claiming that BDSI’s product also breached patents 7,357,891 and 7,425,292, which cover various preparation methods for drug delivery films.