BioLineRx has announced that a Notice of Allowance has been received from the United States Patent and Trademark Office (USPTO) claiming the crystalline form of BL-1020, a first-in-class orally available treatment for schizophrenia.
The patent, when granted, will be valid at least until 2031, without taking into account any possible extension periods, which is nine years longer than the granted patent coverage previously reported by the Company.
Corresponding patent applications are pending in Europe, Japan, India, China, Brazil, Mexico, Canada, Australia and Israel.
"We are extremely pleased with the allowance of the patent covering BL-1020's crystalline form by the USPTO. There is now a significantly longer period of exclusivity to our lead product, which reflects substantial additional progress in its development towards commercialization. This approval, together with recent additional patent approvals regarding BL-1020 and other drug candidates, is a testament to our focused and highly professional patent application strategy," said Dr. Kinneret Savitsky, CEO of BioLineRx.
"We believe that the market potential for BL-1020 has increased over the past several months, as some larger pharmaceutical companies have reported failures during late-stage clinical trials, or have reduced the operations surrounding their schizophrenia therapies due to loss of patent protection."
Dr. Savitsky continued, "Today, almost 1% of the world’s population suffers from schizophrenia, most of whom suffer concomitant cognitive impairment that may severely affect daily functioning. Whereas current therapies for schizophrenia do not address this need, BL-1020 has shown to significantly improve cognitive function in schizophrenia patients, and we are currently conducting the Phase II/III CLARITY trial with BL-1020’s cognition enhancement as its primary objective. We eagerly look forward to the expected results in the second half of 2013.”
BL-1020's composition and its use for the treatment of schizophrenia are covered by a separate family of issued patents or pending patent applications in the U.S., Europe, Japan, India, China, Korea, Mexico, Israel and Australia.
The issued patents and any additional patents to be issued in the future based on pending patent applications of this family will expire, without taking into account any possible extension periods, in September 2022.