In Re: Constantin Efthymiopoulos

Docket No. 2016-1003

October 18, 2016

Brief Summary: Board decision that claims to methods for administration of zanamavir by mouth inhalation (Relenza®) would have been obvious affirmed.

Summary: Inventor CE appealed Board affirmance of Examiner’s obviousness rejections (Ser. No. 08/737,141 claiming methods for treating influenza by admininistering zanamivir by mouth inhalation). This case relates to GSK’s Relenza® product for which no patents are listed on the FDA Orange Book. According to PAIR, there are no applications relating to the ‘141 application currently pending at the PTO. The claims were rejected as obvious over an AU application (AU 2724292A1 (“Von Itzstein II”)) disclosing treatment of influenza by inhalation of an “adjacent homologue” of zanamivir in view of “Von Itzstein I” (WO 91/16320) which “suggested administering [zanamivir] to the respiratory tract to treat or prevent influenza.” The examiner “noted that, with respect to administration, there are only two possible inhalation methods: through the mouth (oral) or through the nose (nasal).” And “other prior art” was found to teach “the well-known availability of inhalers, that oral inhalation delivers more drug to the lungs than nasal inhalation, and the fact that influenza infects the lungs”. Thus, the examiner rejected the claims as obvious and the Board agreed, also finding CE’s “evidence of secondary considerations-namely of unexpected results…unpersuasive.” The FC panel agreed with the Board because, e.g., “Von Itzstein does not limit its disclosure to nasal inhalation…reasonably understood to disclose inhalation by either the nose alone, the mouth alone, or both”, “the references teach that the compounds may be administered in many forms, including as a dry powder through an inhaler”, and “the state of the art at the time of invention established that dry-powder compositions were often used specifically for oral inhalation”, and that there was a reasonable expectation of success in combining the references. The FC panel also agreed with the Board that CE’s expert testimony was unpersuasive (e.g., “Dr. Hayden himself conceded that the conclusion of the study he conducted was that ‘adding intranasal administration of zanamivir did not obviously improve’ the results of using oral administration alone’….”) Thus, the Board decision was affirmed. Judge Newman’s dissent argued this conclusion is improper because “there is no reference, no prior art, no suggestion, proposing that this mode of application might succeed, or that it should be tried”, “[t]here was evidence of skepticism even as oral inhalation was evaluated”, there is “no contrary evidence”, the court relied on “evidence in the patent application itself”, and “[t]he Board did not hold the result here was expected” but rather “held that the claimed subject matter was obvious, on a rationale akin to ‘obvious to try’” (“in the unpredictable arts such as medicinal treatment, for a method to be obvious to try, there must be some suggestion in the prior art that the method would have a reasonable expectation of success” (citing KSR and Kao (FC 2011)).

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