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Indivior to appeal court rulings

01 September 2017 08:13

Indivior is to appeal against a US District Court ruling to defend its intellectual property.

The company said that while the US District Court for the District of Delaware found the asserted claims of US Patent Nos. 8,017,150; 8,603,514; 8,900,497 were valid, it ruled that Dr. Reddy's did not infringe any asserted claims of those patents, and that Watson (Actavis) and Par did not infringe the asserted claim of the '497 Patent.

It said the court has also issued a separate ruling denying Watson's and Par's motions to reopen the court's June 2016 judgment finding that their respective proposed generic products infringe valid claims of the '514 patent; therefore, the court's ruling enjoining marketing approval and sale of Watson's and Par's proposed generic products until the expiration of the '514 Patent in 2024 remained in place.

The company said it intended to continue vigorously defending its intellectual property and believed that it had grounds to appeal the ruling.

It said: "Unless and until the Court's ruling is reversed on appeal, and in the absence of other judicial relief, the xompany will not be able to rely on the '514, '150, and '497 patents to prevent Dr. Reddy's from manufacturing and marketing a generic film alternative in the US.

"Further, the xompany may have increased difficulty successfully defending its intellectual property against future ANDA filers.

"As noted above, Watson and Par remain enjoined from manufacturing and marketing a generic film alternative in the US by the court's June 2016 ruling. However, Watson and Par are now able to pursue their respective appeals at the US Court of Appeals for the Federal Circuit.

"As of 29 August 2017, FDA has not announced that it has granted tentative or final marketing authorisation to any generic Suboxone Film (buprenorphine and naloxone) alternative.

"If FDA grants approval to Dr. Reddy's, 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 Dr. Reddy's if the company prevails on appeal."

Indivior said that although it was 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 believed 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.

It said that in 2016, the average market share in the US for Suboxone Film was 61% (2015: 60%), and was 59% in H1 2017 (H1 2016: 61%) and sales of Suboxone Film in the US represented approximately 80% of Indivior's revenue for the year ended 31 December 2016.

Chief executive Shaun Thaxter said: "Today's news is disappointing to Indivior, given the belief that the company has in its intellectual property for Suboxone Film. We will appeal the ruling and defend our intellectual property.

"We remain confident in Indivior's long-term outlook and vision.

"Our confidence is based on our market leading position in the addiction disease space forged over the past 20 years that has created unrivalled relationships with healthcare professionals, medical societies, regulators, payors and policymakers to expand access to opioid dependence treatment.

"Our focus and dedication continue to drive our innovative pipeline, particularly RBP-6000, which we expect will be a potentially transformational new option for the treatment of opioid use disorder.

"As always, our unwavering focus is on addressing the unmet needs of opioid dependent patients. On behalf of the millions of patients who struggle to overcome opioid addiction, the majority of whom need help but go untreated, we remain relentless in our pursuit to transform addiction from a global human crisis to a recognised and treated disease."

At 8:13am: (LON:INDV) Indivior Plc share price was -150.85p at 265.75p

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