BioDelivery Sciences ‘pleased’ with mixed ruling over Opioid drug claims
A Delaware Federal Court has upheld some of the validity of challenged claims in two patents related to BioDelivery Sciences’ (BDSI) opioid medication Belbuca (buprenorphine), but invalidated others.
In an opinion handed down by Monday, December 20, the US District Court for the District of Delaware ruled that BDSI could maintain its patent exclusivity against Alvogen until 2032.
Alvogen challenged the validity of the patents after being sued by BDSI for its planned Belbuca generic, managing to convince the court that some of the asserted claims were invalid under Section 103.
Alvogen had previously admitted to infringing the three Belbuca patents, opting instead to focus on challenging their validity.
Judge Colm Connely ruled that both asserted claims of US patent 9,901,539 and two of the four claims of 8,147,866 were valid. He also found that all asserted claims of the 9,655,843 patent and the remaining two claims of the ‘866 patent were invalid.
Jeff Bailey, CEO of BDSI said: “We are pleased with the court’s decision and look forward to continuously supplying Belbucato chronic pain patients.
“We would like to thank our shareholders for their support during the lengthy litigation period. With the removal of this legal overhang, we will continue to focus on business development and creating additional shareholder value.”
Dechert was the lead counsel representing BDSI.
Obviousness and anticipation
BDSI claims that Alvogen’s submission of an Abbreviated New Drug Application (ANDA) for approval of a generic of BioSDelivery’s Belbuca drug constituted infringement of three of its key patents.
Alvogen argued that claims 3, 4, 5 and 10 of the 866 patent and claims 8 and 20 of the ‘843 patent were anticipated by a parent application submitted by BioDelivery, and that the patents were not entitled to the priority date of the application as it did not specify specific pH ranges claimed in the ‘866 and ‘843 patents.
However, Connely remained unconvinced, holding that the two patents could claim priority as a person of ordinary skill would infer the relevant pH levels outlined in the patent claims from the application.
Alvogen argued that the ‘539 patent was obvious, claiming that the backing layer of pH limitations of the ‘539 patent are inherent in prior art referred to as Vasisht I.
But, judge Connely ruled that Alvogen did not show that an artisan of ordinary skill would have been motivated to achieve the required pH ranges in Vasish, and therefore did not show that the claims of the ‘539 patent were obvious.
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