Generic / Small Molecule

Court Rules: AstraZeneca Asthma Drug Patent Invalid

Feb 17, 2015

AstraZeneca announced that the U.S. District Court for the District of New Jersey ruled “the ‘834 patent”, protecting Pulmicort Respules in the United States, is invalid.

“AstraZeneca strongly disagrees with the Court’s decision,” said Paul Hudson, president, AstraZeneca US and executive VP, North America. “AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. We are reviewing the decision and considering our legal options, including an appeal.”

The decision is limited to the United States and has no impact on the validity of patents related to Pulmicort Respules in other countries. The 834 patent was set to expire in 2018, with paediatric exclusivity extending into 2019, the release said.

According to a Reuters article, Actavis Plc said that the U.S. District Court for the District of New Jersey ruling prompted it to release a generic version of the lung drug. Another generic version of Pulmicort Respules from Teva Pharmaceutical Industries, under a previous agreement with AstraZeneca, has been on the market for some time, the article said.

Read the full release