US District Court decision in PULMICORT RESPULES® (budesonide inhalation suspension) patent litigation

Friday, 13 February 2015

AstraZeneca today 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.

NOTES FOR EDITORS

About the litigation

AstraZeneca had filed patent infringement lawsuits against Apotex Inc., Apotex Corp., Watson Laboratories and Breath Limited; and Sandoz Inc., for infringement of US patents directed to methods of use and formulation and form of active ingredient (budesonide) for PULMICORT RESPULES.

On 1 April 2013, the US District Court for the District of New Jersey ruled that AstraZeneca’s US Patent No. 6,598,603 (“the ‘603 patent”) is invalid. The Court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca’s second patent, US Patent No. 7,524,834 (“the ‘834 patent”).

On 30 October 2013, AstraZeneca announced that the United States Court of Appeals for the Federal Circuit had reversed and remanded for further proceedings the US District Court decision that generic defendants involved in the litigation do not infringe the ‘834 Patent. The Court of Appeals upheld, however, the trial court’s decision as to the ‘603 Patent.

At the remand, AstraZeneca contended that the defendants’ generic budesonide inhalation suspension products and their use will infringe the claims of the ‘834 Patent. The defendants denied that they will infringe and asserted that the ‘834 Patent is invalid.

Under agreement with AstraZeneca, Teva has a generic PULMICORT RESPULES product in the market.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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