US appeals court issues decision in PULMICORT RESPULES patent litigation

Wednesday, 30 October 2013

AstraZeneca today announced that the United States Court of Appeals for the Federal Circuit has reversed and remanded for further proceedings a trial court decision that generic defendants involved in the litigation do not infringe a patent (US Patent No. 7,524,834) protecting PULMICORT RESPULES in the US. The Court of Appeals upheld, however, the trial court’s decision that another patent (US Patent No. 6,598,603) protecting AstraZeneca’s PULMICORT RESPULES in the US is invalid.

On 24 May 2013, AstraZeneca announced that the US Court of Appeals for the Federal Circuit issued a temporary injunction blocking the generic manufacturers from distributing generic versions of PULMICORT RESPULES in the US during the pendency of AstraZeneca’s appeal.

AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES.

The patents protecting PULMICORT RESPULES in the US expire in 2018, with pediatric exclusivity extending into 2019.


About the litigation

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”), protecting PULMICORT RESPULES in the US, 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”).

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.

Two of the manufacturers, Apotex and Watson/Breath, had received FDA approval. A third manufacturer, Sandoz, received FDA approval while the appeal was pending. None of these manufacturers have launched their generic products. Apotex was previously enjoined from launching a generic product. Under agreement with AstraZeneca, Teva has a generic PULMICORT RESPULES product in the market.

At the trial, AstraZeneca contended that the defendants’ generic budesonide inhalation suspension products and their use will infringe the claims of the two AstraZeneca patents, should those defendants market their generic products in the US. The defendants denied that they will infringe and asserted that each patent is invalid under the US patent laws.

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:


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