MonoSol Rx announced that the U.S. Patent and Trademark Office (USPTO) will decide by August 2015 whether BioDelivery Sciences International's ($BDSI) BEMA drug delivery technology infringes on a patent protecting its Suboxone sublingual film.
By granting MonoSol's petition for inter partes review, the USPTO has agreed to intervene in the patent dispute because it believes "that there is a reasonable likelihood that the petitioner would prevail with respect to at least one claim challenged," as stated on the agency's website.
MonoSol claims BDSI's film-based product Bunavail violates its '167 patent entitled "Uniform Films for Rapid-dissolve Dosage Form Incorporating Anti-tacking Compositions." MonoSol claims Bunavail has the same active ingredients, according to a lawsuit filed in September. Both products have been approved by the FDA for the treatment of opioid dependence.
The main difference between the two products is that the sublingual film strip Suboxone is delivered under the tongue, while Bunavail uses buccal delivery, meaning it enters the body from the inside of the cheek.
Bunavail was approved by the FDA earlier this year. CEO Mark Sirgo previously told FierceDrugDelivery he is confident that the product can grab a large chunk of the $1.7 billion market from competitor Suboxone because its delivery point is more convenient.
BioDelivery Sciences' BEMA technology delivers buprenorphine to the bloodstream via a polymer film that attaches to the mucous membrane and dissolves within 15 to 30 minutes, according to the company's website. The now-disputed patent was granted in 2012.
"BDSI continues to attempt to develop and market products without proper consideration of MonoSol Rx's pioneering patent portfolio relating to film drug delivery. We will not tolerate infringers of our technology, and we will continue to aggressively assert our patent rights against all such infringers," said MonoSol CEO Mark Schobel in a statement.
Other companies are entangled in the dispute as well. Reckitt Benckiser is listed as a plaintiff because it holds an exclusive license to sell Suboxone in the U.S., while Quintiles ($Q) is a defendant because it is helping market Bunavail in the U.S.
- read the release
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