Milbank secured an important victory in the US Court of Appeals for the Federal Circuit on behalf of Orexo AB and Orexo US, Inc., in a patent infringement lawsuit against Actavis relating to patents that cover Orexo’s flagship Zubsolv® product. Zubsolv® is a sublingual tablet that is used to treat opioid addiction. As a result of the Court decision, Orexo has secured patent protection for Zubsolv® through patent expiration in 2032.
In May 2014, Actavis advised Orexo that it filed an Abbreviated New Drug Application with the FDA seeking approval to market a generic version of Zubsolv® before the expiration of patents that cover the product and its method of use. Orexo filed suit in the US District Court for the District of Delaware. The patents in suit were US Patent Nos. 8,454,996 and 8,940,330. The Court conducted a bench trial in June 2016. In November 2016, the Court held that the ’996 patent was valid and infringed by Actavis’s proposed generic product, but that the asserted claims of the ’330 patent were invalid as obvious. The ‘996 patent provides patent protection only through 2019.
Orexo appealed to the Federal Circuit the portion of the Court’s judgment relating to the invalidity of the ’330 patent. Briefing on the appeal concluded in April 2017 and oral arguments were presented on October 4, 2017. On September 10, 2018, the Federal Circuit overturned the District Court’s ruling, holding that Actavis failed to establish by clear and convincing evidence the invalidity of the ‘330 patent based on obviousness. In a precedential opinion, the Federal Circuit found Orexo’s patent represented a “significant improvement” in the treatment for opioid addiction, providing a novel formulation that is less subject to abuse and allows for reduced dosage.
The Federal Circuit sent the case back to the district court for further proceedings, where Orexo will ask the district court to enjoin Actavis from selling its generic Zubsolv® products until the patent expires in 2032.
The Milbank team representing Orexo is led by Litigation & Arbitration partners Errol Taylor and Fred Zullow, along with Litigation & Arbitration associates Anna Brook, Jordan Markham, Kyanna Lewis, and Venus Allahyarzadeh.
