Germany invalidates Seroquel patent; Merck drops combo diabetes drug development

Anglo-Swedish drug major AstraZeneca (LSE: AZN) said last evening that the Federal Patent Court in Germany has found the formulation patent protecting its schizophrenia drug Seroquel XR (quetiapine fumarate) prolonged-release tablets – marketed as Seroquel Prolong in Germany – to be invalid.

The patent was challenged by generic drug makers Accord Healthcare, Hexal AG and Teva Deutschland GmbH. This Court decision is limited to Germany and is not binding in other countries, said AstraZeneca, expressing its disappointment with the decision and added that it is engaged in numerous other proceedings regarding Seroquel XR-related patents and regulatory exclusivity for its product, which generated total sales in Germany for the 10 months ended October31, 2012, of $82 million. Third-quarter 2012 global sales of the product were up 8% at $373 million.

The patents protecting Seroquel XR are set to expire in the USA, the largest pharma market, in late 2017, and AstraZeneca agreed to allow Intellipharmaceutics to sell an authorized generic version starting in November 2016, The Associated Press noted. Other drug companies are also seeking approval to market generic versions of the drug.