Defense of U.S. Patent Against BioDelivery Sciences International
Warren, NJ (February 23, 2012) – MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology, is preparing to defend its U.S. Patent No. 7,425,292 (“the ‘292 patent”) at the U.S. Patent and Trademark Office (“PTO”) from a reexamination challenge brought by MonoSol Rx’s competitor, BioDelivery Sciences International, Inc. (NASDAQ: BDSI, “BDSI”).
On January 20, 2012, BDSI filed a request at the PTO for an ex parte reexamination, challenging the validity of the ‘292 patent. MonoSol Rx believes this request was merely a litigation tactic intended to slow down the lawsuit MonoSol Rx had filed previously against BDSI and its partners MEDA Pharmaceuticals Inc. (“MEDA”), and Aveva Drug Delivery Systems, Inc. (“Aveva”) for patent infringement in federal court in Trenton, New Jersey. While it is typical for the PTO to grant such a request (statistical data from the PTO indicates that ~92% of ex parte reexamination requests are granted), doing so does not constitute any judgment as part of an ongoing court case.
On February 16, 2012, the PTO granted BDSI’s request and issued an Office Action, allowing MonoSol Rx two months within which to file its initial response. During the pendency of the reexamination process, the claims of the ‘292 patent remain valid and in full force until a final ruling is made otherwise by the PTO.
A. Mark Schobel, President and Chief Executive Officer of MonoSol Rx, stated, “We are in the process of drafting our response to BDSI’s challenge to our ‘292 patent and are pleased that the PTO has adopted only a limited number of the requested rejections. We are confident that at the end of the reexamination process, the PTO will confirm the patentability of our claims. We look forward to keeping the focus on our ongoing federal court litigation, with no further attempts to delay put forth by BDSI. We believe such tactics in the federal case fail to serve any of the parties involved and are likely to indicate BDSI’s lack of confidence in its claim to have not infringed our patents.”
Mr. Schobel concluded, “MonoSol Rx will continue to assert the ’292 patent, as well as the balance of MonoSol Rx’s broad and robust patent portfolio. We are and will remain the industry leader in the development of drug-containing film products.”
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals -Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the maintenance treatment of opioid dependence.
MonoSol Rx’s commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.
For press releases and other company information visit www.monosolrx.com.