The US Court of Appeals for the Federal Circuit has issued a temporary injunction blocking generic manufacturers from distributing generic versions of AstraZeneca's Pulmicort Respules in the US until the Court rules on AstraZeneca’s appeal of a District Court decision that found one patent protecting the product to be invalid and another patent not infringed.
As a condition of the injunction, the Court has also ordered that AstraZeneca post a bond in the amount of $72 million.
“We intend to vigorously defend the intellectual property rights protecting Pulmicort Respules.” said Paul Hudson, executive vice president, North America.
The patents protecting Pulmicort Respules expire in 2018, with paediatric exclusivity extending into 2019.
On 1 April 2013, the US District Court for the District of New Jersey ruled that AstraZeneca’s US Patent No. 6,598,603 (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 (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. Neither manufacturer launched its generic product. 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.
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.