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.
The decision was rendered in the patent litigation alleging that Actavis’s 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). In the November 15, 2016 judgment, the district court held that Orexo’s ‘996 patent is valid and infringed by Actavis, and that Orexo’s ‘330 patent is invalid. Orexo appealed the decision regarding the ‘330 patent to the Court of Appeals for the Federal Circuit on December 8, 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. The decision on the ‘996 patent was not appealed and not affected by the decision of the Court of Appeals. Orexo 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.
“We have continuously been confident in our IP protecting Zubsolv, not only in the US, but on a global basis. The decision today confirms the strength of our IP for Zubsolv until 2032. The patent litigation process with Actavis has been a lengthy and resource consuming process for Orexo and we are pleased we can now fully focus on growing our Zubsolv business and expanding our product pipeline, without the uncertainty created by the patent litigation process,” says Nikolaj Sørensen, President and CEO of Orexo.
The ‘330 patent expires in 2032. The decision does not change Orexo´s 2018 financial guidance provided previously.
Photo of Nikolaj Sørensen, President and CEO of Orexo
Source: Orexo press release