Warren, NJ (October 6, 2014) – The United States Patent and Trademark Office (USPTO) has granted MonoSol Rx, LLC’s (MonoSol Rx) petition for inter partes review (IPR) of all claims of US Patent No. 7,579,019 (“the ‘019 patent") and has instituted the IPR. The ‘019 patent, owned by Arius Two, Inc, a wholly-owned subsidiary of BioDelivery Sciences International, Inc. (NASDAQ: BDSI, “BDSI”), is cited by BDSI as a key patent in their BEMA drug delivery technology. Based on information provided by MonoSol Rx in its IPR petition, the USPTO’s decision to institute the post-grant USPTO trial was based on the USPTO’s agreement that MonoSol Rx established a reasonable likelihood that all of the claims in the ‘019 patent are invalid. The trial is now proceeding, with a final decision by the USPTO on whether any claims will survive expected by August 2015. Among the reasons for instituting the IPR are grounds of anticipation. Anticipation grounds are particularly powerful because they indicate that the invention lacks novelty, the very thing that BDSI touts as its strength in the BEMA technology. The USPTO’s institution of the IPR proceeding against all of the claims of the ‘019 patent is also a significant development because the ‘019 Patent is listed in the United States Food and Drug Administration’s “Orange Book” as a patent that specifically covers technology used in BDSI’s BUNAVAIL product.
A. Mark Schobel, Co-President and Chief Executive Officer of MonoSol Rx, commented, “The institution of the inter partes review of the ‘019 patent is a significant and positive development for MonoSol Rx. BDSI continues to attempt to develop and market products without proper consideration of MonoSol Rx’s pioneering patent portfolio relating to film drug delivery. We will not tolerate infringers of our technology, and we will continue to aggressively assert our patent rights against all such infringers.” It is MonoSol Rx’s position that BDSI’s other Orange Book-listed patents for
That lawsuit has yet to go ro court and btw, Monosil LX is the first to introduce litigation. Their efforts were not succeeding and so a larger player added their weight to the suit. Supposedly, the copyright office is involved in this and whether or not this suit actually goes to court hinges on a decision about "infrinegemnet" which the copyright office will make in August of 15. Until then BDSI was granted a "stay." (There is no basis for a copyright infringement unless the Copyright officice says there is grounds. Right now, both Monosol and Reckitt do not have those grounds) therefore no suit. But come August, this could change and if this does change, one can expect BDSI to go down by half just through the announcement alone. Conversely, the stock will rise on any affirmation of no copyright infrigement