(CN) – The Federal Circuit upheld an order blocking Apotex from making and selling a generic version of AstraZeneca’s Pulmicort Respules, a prescription asthma treatment for children.
Each “respule” is a plastic vial containing a single dose of the anti-inflammatory steroid budesonide, suspended in a sterile liquid.
“The drug is administered by squeezing the entire contents of a vial into a jet nebulizer and inhaling the resulting mist through a mask attached to the nebulizer,” according to the ruling.
AstraZeneca’s patents for the treatment refer to a once-daily dosage. But the drug label says the treatment can be administered once or twice a day, and cautions users to take the lowest effective dose.
Generic drug maker Apotex sought the government’s approval to manufacture a generic version of the Pulmicort Respules for twice-daily use, with a label that similarly instructed users to minimize their daily dosage.
AstraZeneca claimed the generic version would infringe its patents, because the label effectively instructed customers to use the drug once a day.
The federal appeals court in Washington, D.C., agreed, ruling that AstraZeneca’s patented method claims are valid, and that a generic drug would likely infringe on those patents.
But the Federal Circuit tossed AstraZeneca’s cross-appeal challenging the invalidity finding concerning its “kit claims,” or assertions that the drug and the instructions on its label are “inextricably interrelated.”
“The instructions in no way function with the drug to create a new, unobvious product,” Chief Judge Richard Linn wrote.
In a partial dissent, Judge William Bryson agreed that the kit claims are invalid, but said the court should have reversed the injunction, because Apotex “has presented a substantial question concerning the validity of the … patent’s method claims.”