Drug Administration Route Found Obvious

Oct 25, 2016

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The court considered and rejected the applicant’s expert’s arguments that oral inhalation of zanamivir provided unexpected results. PTAB and the court found that a study presented by the expert did not show unexpectedly superior results and that another study was not persuasive because it dealt with the prevention of influenza, not the treatment of it.

In dissent, Judge Newman argued that the court failed to properly consider the applicant’s expert’s opinion. Specifically, the expert concluded from a large international study that the effectiveness of orally inhaled zanamivir as compared with nasal administration could be considered an unexpected result. Judge Newman also criticized the court’s finding because for a method to be obvious to try in unpredictable arts, such as medicinal treatment, there must be some suggestion in the prior art that the method would have a reasonable likelihood of success. Judge Newman noted that the prior art did not suggest oral inhalation was a method for administration of zanamivir. In addition, Judge Newman found that the court’s statement that inhalation is reasonably understood to include oral inhalation is without authority.

In re: Constantin Efthymiopoulos, Case No. 2016-1003 (Fed. Cir. Oct. 18, 2016).

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