31st Oct 2013 12:07
(Correcting day to Thursday.)
LONDON (Alliance News) - AstraZeneca PLC said Thursday that it would be returning to court over the infringement of a patent protecting its Pulmicort Respules asthma nebulizers in the US.
The US Court of Appeals for the Federal Circuit reversed and remanded for further proceedings a trial court decision that generic defendants involved in the litigation do not infringe the patent. The appeal court did, however, uphold the trial court's decision that another patent that protects the product in the US is invalid.
On May 24 AstraZeneca said that the court had issued a temporary injunction which blocked generic manufacturers from distributing generic versions of Pulmicort Respules in the US as it appealed the decision. AstraZeneca said that the patents protecting its product expire in 2018, with paediatric exclusivity extending into 2019.
AstraZeneca filed patent infringement lawsuits against Apotex Incorporated, Apotex Corporation, Watson Laboratories and Breath Limited and Sandox Incorporated in April. None of these manufacturers have launched their generic products, although Apotex and Waston and Breath have received FDA approval, and Sandoz received FDA approval whilst AstraZeneca's appeal was pending.
AstraZeneca shares were down 2.4% at 3,249.00 pence per share early Thursday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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