By Ian Walker
LONDON--AstraZeneca PLC (AZN.LN) said Monday that a U.S. court
has ruled that its pulmicort respules patent is invalid in the
U.S., and it is considering whether to appeal.
The British pharmaceutical giant said the U.S. District Court
for New Jersey has ruled that U.S. Patent No. 7,524,834, protecting
pulmicort respules in the U.S. is invalid.
AstraZeneca said it "strongly disagrees" with the decision and
is considering its options, including an appeal.
Pulmicort respules is a corticosteroid administered via a
nebuliser for the treatment of asthma in children and adults.
The decision is limited to the U.S. and has no impact on
pulmicort respules in other countries, AstraZeneca said. The patent
was set to expire in 2018, with pediatric exclusivity extending
into 2019.
"This decision will not impact AstraZeneca's guidance for 2015,
which is that sales revenue is expected to decline by mid
single-digit percent at constant exchange rates and core EPS is
expected to increase by low single-digit percent at CER,"
AstraZeneca said.
AstraZeneca had filed patent infringement lawsuits against
Apotex Inc., Apotex Corp., Watson Laboratories and Breath Ltd.; and
Sandoz Inc., for infringement of U.S. patents directed to methods
of use and formulation and form of active ingredient for pulmicort
respules.
Write to Ian Walker at ian.walker@wsj.com; @IanWalk40289749
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