Uppsala-based company wins important patent dispute – but the decision is subject to appeal

A US district court has ruled in favour of Orexo in a dispute over the patent protecting the Swedish company’s drug Zubsolv, developed for treating patients with opioid addiction. However, the opposing party, the Indian company Sun, is not giving up and has filed an appeal.

The litigation has been going on since September 2020 when Sun applied for approval to market generic versions of Zubsolv (buprenorphine and naloxone), which is the leading product of the Uppsala-based company Orexo.

On 30 June this year, the US District Court for the District of New Jersey announced its decision, which was in Orexo’s favour. The court concluded that Orexo’s patents are valid and that Sun is prohibited from launching its generic versions of Zubsolv until September 2032.

The decision caused Orexo’s shares to rally by almost 80%.

Commenting on the significance of the decision in the company’s interim report on 18 July, Nikolaj Sørensen, President and CEO of Orexo, wrote:

”During the last three years the uncertainty from the patent litigation against Sun Pharmaceutical to protect the innovation and exclusivity of Zubsolv, has had significant negative impact on all areas of the Orexo business. To prevail in the patent litigation is similar to a new beginning for the company, foremost as it removes a lot of uncertainty around our main product.”

However, it became clear last week that the patent dispute is not over just yet. Sun has filed an appeal against the district court’s decision with the US Court of Appeals for the Federal Circuit.

Nevertheless, Nikolaj Sørensen remains optimistic about the outcome.

“The District Court’s decision was very well motivated, and it clearly outlines the extensive flaws in Sun’s claims regarding the patents’ validity and infringement issue. We remain very confident about the strength of the Zubsolv patent portfolio and believe that the Court of Appeals will reach the same conclusion”,  he says in a press release.

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