Indivior plc said it intends to appeal after it lost a second legal case in recent months in its fight to protect the patent of the Suboxone Film opioid addiction treatment that generates most of its revenues.
Indivior said a US District Court ruled that American generic drugs maker Alvogen had not infringed three Indivior patents, weakening its defense against rival versions of Suboxone Film.
“The company intends to continue vigorously defending its intellectual property and believes that it has grounds to appeal the ruling by the District Court of Delaware,” said Indivior.
“Unless and until the court’s ruling is reversed on appeal, and in the absence of other judicial relief, the company will not be able to rely on the ’514, ’150, and ’497 patents to prevent Alvogen from manufacturing and marketing a generic film alternative in the US.
“Further, the company may have increased difficulty successfully defending its intellectual property against future ANDA filers.
“As of 22 March 2018, FDA has not indicated that it has granted tentative or final marketing authorization to Alvogen’s generic Suboxone Film (buprenorphine and naloxone) alternative.
“If FDA grants approval to Alvogen, it would be able to market a generic alternative to Suboxone Film in the US.
“Any market launch would be on an ‘at risk’ basis, as the company would have a claim for damages against Alvogen if the company prevails on appeal.
“In addition, Indivior has asserted two new OrangeBook listed patents (the ’454 and ’221 patents) against Alvogen and certain other ANDA filers claiming infringement.
“Although it is not possible to quantify precisely the financial impact that the launch of generic alternatives to Suboxone Film would have on the company’s revenues generated from Suboxone Film in the US, or how quickly such an impact would take effect, the company believes that it could potentially result in a rapid and material loss of market share for Suboxone Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market.”
Indivior CEO Shaun Thaxter said: “We believe we have strong intellectual property for Suboxone Film.
“We will appeal this ruling and continue to vigorously defend our intellectual property, including asserting the two new Orange-Book listed patents that have been granted for Suboxone Film.
“We remain confident in Indivior’s long-term outlook and vision.
“With the successful launch of Sublocade (buprenorphine extended-release injection for subcutaneous use) earlier this month, we have the first and only once-monthly buprenorphine depot injection delivery system.
“With this potentially transformational treatment, we expect to extend our market leading position in the addiction disease space, and we remain confident in achieving at least $1 billion in peak Sublocade net revenue.”