Pharma

BioDelivery Sciences disputes patent infringement claim

BioDelivery Sciences International, a Raleigh, North Carolina, company whose lead product delivers a pain-killing cancer drug, says that a patent infringement lawsuit filed by New Jersey-based MonoSol Rx has no merit.

BioDelivery Sciences International (NASDAQ:BDSI) is now firing back at a New Jersey company, refuting claims that the Raleigh, North Carolina, firm has infringed on a patent for drug delivering films.

BDSI was served on Wednesday with the patent infringement lawsuit from New Jersey-based MonoSol Rx, though the suit was filed in New Jersey in November. BDSI’s lead product, Onsolis delivers to cancer patients a quick dose of the pain-killing drug Fentanyl through a small piece of dissolvable film placed on the inside of the cheek. The product is intended for patients who suffer “breakthrough pain” not readily addressed by other products.

Privately-held MonoSol also makes products that deliver drugs through films. In its suit, the company claims BDSI’s manufacturing process infringes on MonoSol’s patented manufacturing process. MonoSol later amended its complaint adding a claim of false marking, or incorrectly claiming that a product is covered by a patent.

BDSI has never claimed that Onsolis is covered by any patent, even one of its own. In a prepared statement issued Friday, BDSI’s CEO Mark Sirgo said MonoSol’s claims are without merit and Onsolis is made through a proprietary manufacturing process, “a trade secret for which no one has any access.”

Sirgo said that BDSI remains committed to moving forward on its pipeline. While MonoSol has only made claims regarding the manufacturing process for Onsolis, the suit’s outcome could affect future BDSI products. The company’s pipeline revolves around the same drug delivery technology of dissolvable films.

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