Over a vigorous dissent, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision affirming rejection of all pending claims of a patent as being obvious, as supported by substantial evidence notwithstanding a showing of commercial success. In re: Efthymiopoulos, Case No. 16-1003 (Fed. Cir., Oct. 18, 2016) (Prost, CJ) (Newman, J, dissenting).

The patent application at issue related to methods of treating or preventing influenza by administering the drug zanamivir by oral inhalation. The Examiner, affirmed by the PTAB, rejected all pending claims as obvious, primarily over two prior art references: Von Itzstein II in view of Von Itzstein I.

The Federal Circuit agreed with the PTAB’s conclusion that the pending claims were obvious as supported by substantial evidence. In doing so, the majority opinion noted that Von Itzstein I disclosed the intranasal use of zanamivir to treat and prevent influenza, and that Von Itzstein II disclosed different administration methods, including “inhalation,” for an adjacent homologue of zanamivir to achieve the same result of treating or preventing influenza. Although Von Itzstein II did not teach oral inhalation specifically, the Federal Circuit agreed with the Examiner and PTAB’s conclusion that Von Itzstein II’s disclosure of administration through “inhalation” included oral inhalation. As to secondary considerations of non-obviousness, the Federal Circuit found that the PTAB, after thoroughly considering an expert’s declaration, properly concluded that the claimed method would not necessarily yield an unexpected result.

Judge Newman dissented, stating that zanamivir was a known drug for treatment of influenza administered by nasal inhalation. She disagreed with the majority’s holding that the discovery of effective treatment by oral inhalation was obvious even though it was “not obvious to experts, and not suggested in the prior art.” Judge Newman noted that there was extensive discussion in Von Itzstein II directed to all known forms of oral administration of the product that spanned several pages, but that it lacked any mention or suggestion of oral inhalation. She voiced her concern that it “cannot be ‘obvious to try’ the only form of oral administration that is absent from the Von Itzstein [II] recitations.” Rather, the omission of oral inhalation from this list of “all the ‘known options’ for this drug makes conspicuously clear that oral inhalation was not an ‘identified predictable solution.’” Judge Newman concluded that there was not substantial evidence to support the PTAB’s ruling of obviousness.