MonoSol Rx, BioDelivery Sciences trade accusations in lawsuit

Two drug-delivery companies are sparring with dueling press releases over a lawsuit alleging patent infringement and, in the latest development, false marking.

In one corner there is New Jersey-based MonoSol Rx, which filed a patent infringement lawsuit in November against three of its competitors, BioDelivery Sciences, Meda Pharmaceuticals and Aveva Drug Delivery Systems. MonoSol alleges that the thin-film painkiller Onsolis--manufactured by Aveva, marketed by Meda and licensed by Biodelivery Sciences--infringes on MonoSol's patent. The patent relates to methods of preparing thin films with just the right amount of an active compound that will dissolve in water, but may be exposed to higher temperatures without degrading. The recent amended complaint adds an additional false marking claim with respect to a different patent.

And in the opposite corner there is BioDelivery Sciences, based in Raleigh, N.C., which issued a release "to strongly refute MonoSol's claims" and vowed not to make it a distraction.

"After careful examination, we refute MonoSol's assertion of patent infringement, which relates to our confidential, proprietary manufacturing process for Onsolsis, as without merit. We intend to defend this case vigorously, and we are very confident that MonoSol's claims will be rejected," BDSI CEO Mark A. Sirgo said in a statement. "Our manufacturing process for Onsolis, which MonoSol asserts infringes its process patent, is a trade secret for which no one has any access."

- here's MonoSol's release
- and BioDelivery Sciences' response
- here's the patent involved in MonoSol's false marking claim
- and the patent MonoSol alleges has been infringed
- and, lastly, here's the lawsuit filed last November

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