AstraZeneca files lawsuit over bipolar drug

Pharmaceutical company AstraZeneca has filed a patent infringement lawsuit against drug maker Pharmadax after it applied to market a generic version of a schizophrenia and bipolar disorder treatment.

AstraZeneca said the US subsidiary of Taiwan-based Pharmadax would infringe its patent for the Seroquel XR (quetiapine fumarate) drug if it were to market a generic version.

According to the complaint, Pharmadax informed AstraZeneca last month that it had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration to seek approval to manufacture, use and sell extended- release quetiapine fumarate tablets as generic versions of AstraZeneca’s Seroquel.

In the lawsuit, filed at the US District Court for the Central District of California, AstraZeneca said the ANDA would infringe the process of preparing and using its drug, the claims of which are covered by its US patent number 5,948,437.

The patent, called “Pharmaceutical compositions using thiazepine”, was issued on September 7, 1999 and does not expire until 2017.

AstraZeneca claimed the commercial manufacture, use, sale or offer for sale within the US, or the importation into the US, will infringe one or more claims of the ’437 patent.

According to the complaint, filed on October 23, AstraZeneca is demanding that the date of the approval of Pharmadax’s ANDA be no earlier than the patent’s expiry date.

AstraZeneca is also seeking a judgment that the patent remains valid and has been infringed by the ANDA application, alongside attorney’s fees.