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17 November 2016Americas

Orexo delays Actavis generic until at least 2019

The US District Court for the District Court of Delaware has ruled in favour of Sweden-based pharmaceutical company Orexo in a patent battle against Actavis over Zubsolv (buprenorphine and naloxone).

Zubsolv is a maintenance treatment for people suffering from opioid dependency.

Orexo filed a complaint for patent infringement back in June 2014 after Actavis filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market and sell a generic version of Zubsolv.

The two patents involved are US numbers 8,454,996 and 8,940,330, which are due to expire in September 2019 and September 2032 respectively.

The court handed down a mixed ruling on Tuesday, November 15, in which it held the ‘996 patent to be valid and the ‘330 patent to be invalid.

Both the decisions regarding the patents were made based on obviousness.

The ruling prevents Actavis from bringing its generic version of Zubsolv to market before September 2019.

According to a press release by Orexo, the company stressed that Actavis’ generic entry to market could potentially be postponed until late 2032 if the decision regarding the ‘330 patent is reversed on appeal.

The company said that entry could also be delayed if the court rules in favour of Orexo in a separate litigation involving US patent number 9,259,421, which also covers Zubsolv.

Orexo was also recently issued US patent number 9,439,900, which lasts until September 2032.

Nikolaj Sørensen, CEO and president of Orexo, said in a  statement: “With the validation and proven infringement of the ‘996 patent, we will be able to continue our current strategy and leverage the opportunities arising from patients gaining expanded access to treatment in the US until at least late 2019.”

He added: “While I am disappointed with portions of the court’s decision not to confirm the validity of the ‘330 patent, I maintain confidence in the strength of our new ‘421 and ‘900 patents, and we are reviewing the possibilities to reverse the ‘330 decision through appeal with our lawyers.

“A positive outcome in the litigation of the new patents will sustain the exclusivity of Zubsolv until 2032.”