Appeals Court Lengthens Injunction Forbidding Generic Pulmicort Sales

A federal appeals court has extended an injunction barring four companies from marketing generic versions of AstraZeneca’s blockbuster inhaled asthma drug Pulmicort Respules while it hears an appeal of a lower court ruling that invalidated the brandmaker’s patent on the drug.

The U.S. Court of Appeals for the Federal Circuit on Thursday issued the ruling against generics makers Actavis (formerly Watson), Breath Limited, Sandoz and Apotex.

The generics makers had won a consolidated legal challenge against Pulmicort’s (budesonide inhalation suspension) ‘834 patent in New Jersey district court, but AstraZeneca appealed in order to protect its $1.1 billion-a-year therapy.

The appellate court last month granted the brandmaker a temporary injunction halting further sales of generic Pulmicort that had hit the market just days earlier. The injunction now extends for the length of the appeal, Astrazeneca v. Breath Limited, Apotex Corp., Apotex, Inc., Sandoz Inc., And Watson Laboratories.

Actavis said the court has set an expedited briefing schedule in the case. — Bryan Koenig