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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
A US court of appeals rules on patent litigation for AstraZeneca's asthma drug Pulmicort Respules (budesonide).
AstraZeneca received a mixed decision regarding US patent litigation for its asthma drug Pulmicort Respules (budesonide). A US federal appeals court has reversed and remanded for further proceeding a trial-court decision that generic-drug company defendants involved in the litigation did not infringe a US patent (US Patent No. 7,524,834) protecting the drug. That patent covers sterile glucocorticosteroids and sterile formulations containing glucocorticosteroid and use thereof in the treatment of an allergic and/or inflammatory condition of the nose or the lungs (1). The US federal appeals court, however, upheld the trial-court’s decision that another patent (US Patent No. 6,598,603) protecting AstraZeneca’s Pulmicort Respules in the US is valid. That patent provides a method of treating respiratory diseases (e.g., pediatric asthma) in a continuing regimen with not more than one daily dose of the drug budesonide using a nebulizer (2).
Pulmicort Respules is one of AstraZeneca's key drugs with 2012 revenues of $866 million. The trial-court decision dates back to earlier this year. On Apr. 1, 2013, the US District Court for the District of New Jersey ruled that AstraZeneca’s patent (US Patent No. 6,598,603) protecting Pulmicort Respulses in the US was invalid. The court further ruled that the generic-drug company defendants involved in the litigation did not infringe AstraZeneca’s second patent, US Patent No. 7,524,834.
AstraZeneca had filed patent-infringement lawsuits against the generic-drug companies Apotex Inc., Apotex Corp., Watson Laboratories (a subsidiary of Watson Pharmaceuticals; Watson Pharmaceuticals acquired Actavis in 2012 and later took the Actavis name), Breath Limited (a UK-based subsidiary of Watson), and Sandoz Inc., for infringement of US patents directed to methods of use and formulation and form of the active ingredient (budesonide) for Pulmicort Respules. At the trial, AstraZeneca contended that the defendants’ generic budesonide inhalation suspension products and their use would infringe the claims of the two AstraZeneca patents should those defendants market their generic products in the US. The defendants denied that they would infringe and asserted that each patent was invalid under US patent laws.
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 launched their generic products. Apotex was previously enjoined from launching a generic product. On May 24, 2013, AstraZeneca announced that the US Court of Appeals for the Federal Circuit issued a temporary injunction blocking the generic-drug manufacturers from distributing generic versions of Pulmicort Resuples in the US during the pendency of AstraZeneca’s appeal. Under agreement with AstraZeneca, Teva Pharmaceutical Industries has a generic version of Pulmicort Respules product on the market.
AstraZeneca said "it has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules," according to an AstraZeneca statement. The patents protecting Pulmicort Resuples in the US expire in 2018, with pediatric exclusivity extending into 2019.
1. A.K. Karlsson et al., "Sterile Powders, Formulations and Methods for Producing the Same (US Patent 7,524,834), Apr. 28, 2009.
2. B. Andersson et al., "Treating Respiratory Diseases" (US Patent 6,598,603), July 29, 2002.