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US District Court Decision in PULMICORT RESPULES® Patent Litigation

By Pharmaceutical Processing | February 17, 2015

AstraZeneca has announced that the US District Court for the District of New Jersey ruled US Patent No. 7,524,834 (“the ‘834 patent”), protecting PULMICORT RESPULES in the US, is invalid.

“AstraZeneca strongly disagrees with the Court’s decision,” said Paul Hudson, President, AstraZeneca US and Executive Vice President, 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.

This decision will not impact AstraZeneca’s guidance for 2015, which is that sales revenue is expected to decline by mid single-digit percent at Constant Exchange Rates (CER) and Core EPS is expected to increase by low single-digit percent at CER.

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