US Appeal Court backs preliminary injunction against Apotex over AstraZeneca's Pulmicort Respules; rejects Eli Lilly's Gemzar appeal

Anglo-Swedish major AstraZeneca (LSE: AZN) says the US Court of Appeals for the Federal Circuit affirmed the District Court’s issuance of a preliminary injunction barring Canada-headquartered Apotex from launching a generic version of the firm’s Pulmicort Respules (budesonide inhalation suspension) in the USA.

The Court of Appeals upheld the injunction on a two to one vote. The Preliminary Injunction issued by the District Court in May 2009 therefore remains in place. No trial date for the patent litigation has been set.

Patents covering Pulmicort Respules expire in 2018 with pediatric exclusivity extending to 2019, said AstraZeneca. The drugmaker added that has full confidence in the strength of its intellectual property rights protecting its asthma drug and “will continue to vigorously defend and enforce its intellectual property.”