District Court Upholds Orexo Patent for Opioid Dependency Treatment Over Actavis’ Generic

The infringement judgment entered by the District of Delaware, which is non-appealable, prevents Actavis from being able to commercialize its generic opioid dependency treatment until Orexo’s patent rights expire in September 2032.

Orexo Patent for Opioid Dependency Treatment Blocks Actavis' GenericOn Thursday, January 10, U.S. District Judge Colm Connolly of the District of Delaware entered an order and judgment in a patent infringement case brought by Swedish specialty pharmaceutical firm Orexo against global generic pharmaceutical company, Actavis, which was acquired by Teva Pharmaceuticals in 2016. Judge Connolly’s order held that Actavis’ generic version of Orexo’s Zubsolv opioid dependency treatment infringed upon an Orexo patent that had previously been found invalid in district court before being revived by the U.S. Court of Appeals for the Federal Circuit.

The patent-at-issue in this order was U.S. Patent No. 8940330, titled Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence. Issued in January 2015, it discloses a “sublingual tablet formulation that is less subject to abuse [and that] enhances the agonist effectiveness of buprenorphine, permitting a reduced amount of buprenorphine in the tablet and thus reducing the amount available on dissolving and injecting the product,” according to the Federal Circuit’s opinion. Buprenorphine is an opioid medication for pain that differs from other opioids by creating less euphoria in patients and a relatively mild withdrawal profile leading to a lower potential of misuse. The claimed invention solved an unmet need for an abuse-resistant product for opioid-dependence substitution therapy with increased buprenorphine bioavailability, allowing for a formulation including fewer opioids which could be available for intravenous abuse.

Orexo first filed its Hatch-Waxman litigation against Actavis in Delaware in June 2014, prior to issuance of the ‘330 patent and after Actavis had filed an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) for a generic Zubsolv formulation. After Orexo added the ‘330 patent to the infringement claims in the case, U.S. District Judge Sue Robinson issued an opinion in November 2016 which found that, while one patent asserted by Orexo was both valid and infringed by Actavis’ generic product, the asserted claims of the ‘330 patent were invalid as obvious.

However, the ‘330 patent claims were resurrected on appeal to the Federal Circuit, when an appellate panel comprising Circuit Judges Pauline Newman, Todd Hughes ,and Kara Stoll found that the claims were not proven obvious by clear and convincing evidence. The Federal Circuit disagreed with Actavis’ argument that the formulation covered by the ‘330 patent was obvious despite the fact that it provided an improved function. Further, the panel found that the prior art asserted by Actavis didn’t suggest that the claimed combination would achieve enhanced therapeutic effect while being less subject to abuse.

The judgment of infringement entered by the District of Delaware court, which is non-appealable, prevents Actavis from being able to commercialize its generic opioid dependency treatment until Orexo’s patent rights expire in September 2032. The judgment covers all dosage levels of the Actavis generic product.

Following the judgment, Orexo has withdrawn other lawsuits that asserted claims of other patents covering Zubsolv, including U.S. Patent No. 92594321 and U.S. Patent No. 9439900, both having the same title as the ‘330 patent. There is still ongoing litigation between Orexo and Actavis regarding Actavis’ generic versions of Suboxone and Subutex opioid addiction medications in which Orexo has asserted claims of U.S. Patent No. 8454996, titled Pharmaceutical Composition for the Treatment of Acute Disorders.

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