AstraZeneca loses US Pulmicort patent
pharmafile | February 16, 2015 | News story | Sales and Marketing | AstraZeneca, Budesonide Inhalation Suspension, asthma, pulmicourt, respiratory
British drugmaker AstraZeneca has been dealt a blow by the courts in the US, after a district judge ruled its patent for one of its formulations of its asthma drug Pulmicort is invalid in the country.
A US federal judge said that AstraZeneca’s patent on its Pulmicort Repsules (Budesonide Inhalation Suspension) was invalid. This leaves the company open to competitors who are free to launch cheaper generic versions in the US.
The firm says the decision is limited to the US and has no impact on the validity of patents related to Pulmicort respules in other countries. The patent 834 was set to expire in 2018, with paediatric exclusivity extending into 2019.
AstraZeneca also adds that the decision will not impact AstraZeneca’s financial performance in 2015, which it recently warned investors would suffer a ‘mid-single-digit percent’ dip in sales revenue at constant exchange rates.
Nonetheless it is considering its legal options that include lodging an appeal, Paul Hudson, president of AstraZeneca US and executive vice president for North America says.
“AstraZeneca strongly disagrees with the Court’s decision [and] 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 legal wrangle over the Pulmicort patent has already dragged on for several years and had several twists and turns. In April 2013, the US District Court for the District of New Jersey overturned AstraZeneca’s Pulmicort patent. The ruling was later reversed in October 2013 by the US Court of Appeals for the Federal Circuit.
Total branded and generic sales of Pulmicort over the twelve months ended June 30, 2014 were approximately $1.1 billion, according to Actavis.
Lilian Anekwe
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