U.S. District Court Invalidates AstraZeneca's Asthma Drug Patent

A U.S. District Court in New Jersey ruled that the patent protecting AstraZeneca's inhaled asthma drug Pulmicort Respules is invalid, opening the door to generic competition.

Generics makers Breath Limited, Apotex, Sandoz and Watson Laboratories argued that AZ's '834 patent covering Pulmicort Respules (budesonide inhalation suspension) was invalid, claiming the method AZ used to sterilize budesonide for inhalation was natural, rather than an innovation.

The cases were heard together in the fall of 2014, and in her Feb. 13, 2015, decision, Judge Renee Marie Bumb sides with the generics makers, saying there were multiple well-known ways to utilize sterile filtration in combination with aseptic processing, even as far back as 1997. Someone possessing the proper skills and equipment would have had a reasonable chance of success, she says.

Further, she says, the technology also existed in 1997 to prevent agglomeration, caking and particle growth, and there was no reason to assume that a skilled person could not perform this task.

AstraZeneca filed an intent to appeal last Monday. The cases are AstraZeneca v Breath Limited, AstraZeneca v Apotex, AstraZeneca v Sandoz and AstraZeneca v Watson Laboratories.

The '834 patent is set to expire in 2018, with pediatric exclusivity running into 2019. The company doesn’t expect the decision to affect its 2015 revenues. — Lena Freund