Branded Company’s Own “Skepticism” Insufficient To Overcome Obvious Treatment Method Patent Claims

Last week the Federal Circuit affirmed a ruling that an AstraZeneca method of use patent was invalid as obvious.  AstraZeneca LP v. Breath Ltd. (Fed. Cir. Oct. 30, 2013).  At trial two patents were at issue: one was held to be not infringed, the other was held to be anticipated and obvious in light of the prior art.  The patent at issue in this post was directed to a once-daily dosing of nebulized budesonide, primarily for use by children.  Because the Federal Circuit affirmed the lower court’s finding on obviousness, it did not address anticipation.

AstraZeneca argued that its patent filled two gaps in the prior art: (1) use of a once-daily nebulizer budesonide treatment and (2) a once-daily treatment of children.  The Federal Circuit noted that a recent piece of prior art, though flawed in its identification of a binding site, nonetheless taught that budesonide would exhibit a depot effect, making possible a once-daily dosage.

On the issue of the treatment of children, the court pointed to expert testimony and numerous studies teaching treatment of children with inhaled budesonide.  For example, the court noted that clinicians were instructed to titrate the drug to the lowest possible dose—a once-a-day dose.  It also noted that a person of ordinary skill in the art would not have been concerned about once-daily dosage in children, because the principles underlying such treatment in children and adults were the same.  The Federal Circuit dismissed AstraZeneca’s rebuttal evidence, which merely showed asthma is particularly dangerous for children rather than showing any discrepancy between adults and children in the safety and efficacy of once-daily dosing.

Moving on to secondary considerations, the Federal Circuit dismissed AstraZeneca’s argument that there was industry skepticism of the patent’s essential teaching.  Prior to development of the claimed treatment, AstraZeneca did not believe once-daily dosing would be effective, and proffered its multiple clinical studies of once-daily dosing as evidence of this skepticism.  But the court found that this was simply “evidence of corporate prudence based on [its] own misgivings rather than industry skepticism.”  The company also argued long-felt, unmet need, noting one asthma drug had been available for twice-daily dosing since 1990, but once-daily dosing of nebulized budesonide was not investigated prior to 1997.  Though perhaps mitigating for validity, the court dismissed the argument, stating that it was “insufficient in the circumstances of this case to support the argument of non-obviousness.”

This case shows the power of combining good prior art evidence with a clear focus on the issues to be decided.  For example, the prior art that wrongly identified the receptor targeted by budesonide was nevertheless correct in pointing out the depot effect that made a once-daily dosage possible.  Also, it was not enough for AstraZeneca to show that asthma is particularly dangerous for children in order to overcome the prior art regarding the treatment of children.  The important question, which AstraZeneca had failed to address, was whether there was any discrepancy between adults and children in the safety and efficacy of once-daily dosing.