AstraZeneca Plc said a U.K. court ruled that the patent on the Seroquel XR antipsychotic, the drugmaker’s second-biggest seller, is invalid.
The decision only relates to the extended-release version of the drug and is limited to the U.K. market, AstraZeneca said in a statement. The ruling was in response to a legal challenge by Novartis AG’s Sandoz generic unit, Teva Pharmaceutical Industries Ltd., Accord Healthcare Ltd., Intas Pharmaceuticals Ltd. and Hexal AG.
AstraZeneca, Britain’s second-largest drug firm behind GlaxoSmithKline Plc, is struggling to protect sales of the Seroquel franchise after the London-based company booked $5.8 billion of sales from the drug last year. Seroquel XR is patent protected in the U.S., the drug’s biggest market, until 2017 while the older version loses U.S. patent protection this month. The company says a U.S. decision on the drug’s exclusivity is still pending.
“AstraZeneca is disappointed with the court’s decision,” the company said in the statement. “However, the company remains committed to defending its intellectual property.”
AstraZeneca is defending Seroquel XR patents and exclusivity rights in “numerous” other cases, which includes a trial decision still pending in the U.S., the company said.
In a bid to stem generic threats, the drugmaker entered into an agreement with Handa Pharmaceuticals LLC last year that granted the closely held company a license to sell copies of the medicine in the U.S. starting in 2016.
AstraZeneca also sued the U.S. Food and Drug Administration on March 13 in an attempt to overturn the regulator’s denial of a request that Seroquel generics come with warnings about high blood sugar and suicidal tendencies.