Generics
Orexo wins appeal against Actavis on Zubsolv patent in the US Court of Appeals
11 September 2018 -

Orexo AB (STO:ORX), a developer of improved pharmaceuticals based on innovative drug delivery technologies, announced on Monday that the US Court of Appeals for the Federal Circuit found Orexo's long term Zubsolv patent US 8,940,330 to be valid and reversed the invalidity decision previously rendered by the District Court of Delaware in November 2016. This '330 patent expires in 2032.

Reportedly, this decision was rendered in the patent litigation alleging that Actavis' generic Zubsolv 1.4/0.36 mg and 5.7/1.4 mg buprenorphine/naloxone products infringe Orexo's US Patent Nos. 8,454,996 (expiring in September 2019) and 8,940,330 (expiring in September 2032).

Under the judgement of 15 November 2016, the district court held that Orexo's '996 patent is valid and infringed by Actavis and that Orexo's '330 patent was invalid. Orexo had appealed the decision regarding the '330 patent to the Court of Appeals for the Federal Circuit on 8 December 2016 and the district court's decision has now been reversed by the Court of Appeals confirming the validity of the '330 patent until 2032.

Also, the decision on the '996 patent was not appealed and not affected by the decision of the Court of Appeals.

According to Orexo, it will now request the District Court of Delaware to issue a judgment that Actavis's generic Zubsolv products infringe the '330 patent, and will not be FDA approved until 2032.

This decision does not change Orexo´s 2018 financial guidance provided previously, the company added.

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