US Appeals Court puts temporary stop on sales of generics of AstraZeneca's Pulmicort Respules

Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced last Friday (May 24) that the US Court of Appeals for the Federal Circuit issued a temporary injunction blocking generic manufacturers from distributing generic versions of Pulmicort Respules (budesonide inhalation suspension) in the USA until the Court rules on AstraZeneca’s appeal of a District Court decision that found one patent protecting the product to be invalid and another patent not infringed. As a condition of the injunction, the Court has also ordered that AstraZeneca post a bond in the amount of $72 million.

“We intend to vigorously defend the intellectual property rights protecting Pulmicort Respules,” said Paul Hudson, executive vice president, North America.

Generics major (NYSE: ACT) Actavis launched its generic product on April 1, 2013, following a ruling from the US District Court for the District of New Jersey that Actavis' generic version of Pulmicort Respules did not infringe US Patent No 7,524,834 (the '834 Patent) and that US Patent No 6,598,603 was invalid. Last month, the District Court issued a temporary restraining order prohibiting sales of Actavis' generic product to permit AstraZeneca an opportunity to seek injunctive relief with the Federal Circuit (The Pharma Letter April 2, 2013.