Federal Circuit Upholds Obviousness Rejection of Claimed Influenza Inhaler

federal-circuit-cafc-1aIn Re: Efthymiopoulos (Before Prost, C.J., Newman, and Bryson, J.) (Opinion for the court, Prost, C.J.) (Dissenting opinion, Newman, J.)

A divided panel of the Federal Circuit affirmed the Board’s rejection of all pending claims as obvious in an appeal arising from a method for treating or preventing influenza by oral inhalation of zanamivir.

One reference disclosed that zanamivir can be inhaled intranasally to treat and prevent influenza, and a second reference disclosed that a compound similar to zanamivir can be administered by “inhalation” to treat and prevent influenza.

Zanamivir and the similar compound are “adjacent homologues,” meaning “they are part of a series of compounds that differ in structure only by a single substituent.” The Court agreed with the Board’s finding that substitution of zanamivir for this similar compound for oral inhalation would have been obvious.

The second reference “expressly discloses administration through ‘oral,’ ‘nasal,’ or other forms ‘suitable for administration by inhalation.’” The Court further agreed with the Board that: “[I]nhalation can only be carried out via the nose or the mouth. Since [the second reference] does not limit its disclosure to nasal inhalation, it is reasonably understood to disclose inhalation by either the nose alone, the mouth alone, or both.”

The appellant argued that a person of ordinary skill would not expect oral zanamivir to be effective and would instead expect only nasal inhalation to work.  The Court rejected this argument, noting that it was known in the art that “although the influenza virus primarily attacks the upper respiratory tract, certain strains of the virus also attack the lower respiratory tract” and “oral inhalation delivers more drugs to the lungs as compared to nasal inhalation.”

The Court also upheld the Board’s finding that the appellant’s proof of unexpected results was unpersuasive, and substantial evidence supported the Board.

In her dissent, Judge Newman stated that “there is no reference, no prior art, no suggestion, proposing that this mode of application might succeed, or that it should be tried.” She found that to reach their conclusion, “[t]he evidence on which the Board and now [the Federal Circuit] rely is the evidence in the patent application itself, describing oral inhalation, its benefits, and its effectiveness.” In her opinion, the Board and her colleagues, “deem this treatment of influenza obvious on the ground that inhalation occurs only through the nose or the mouth. Thus the court rules that the discovery of effective treatment by oral inhalation is obvious to the court, although not obvious to experts, and not suggested in the prior art.”

References can be combined to show that it would have been obvious to zero in on one of a few options disclosed in the prior art.



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Robert Schaffer

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

Robert Schaffer

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

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Discuss this

There are currently 2 Comments comments.

  1. Valuationguy October 28, 2016 3:03 pm

    This was yet another sad Prost-authored decision where she decided the case on the basis of evidence which was not in the record of the case. (Kudo’s to Newman for clearly pointing out Prost’s blatant importation of HER opinion into the evidentiary record.) The reference used to to invalidate the patent as obvious listed all the various ways drugs could be delivered EXCEPT the specific one named in the small inventor’s patent and the only evidence in the case pointed to the reference (and general knowledge of a practicioner) teaching away from using an oral inhaller (since it wouldn’t deliver any of the drug to the nasal passages…which is where everyone thought the infections occurred.

  2. Bystander October 29, 2016 10:11 am

    I have to wonder if the federal circuit will remain a patent death squad.

    Its really becoming clear that a seat on the circuit requires an engineering degree, and a membership to the patent bar. As soon as a judge starts searching for analogies, which is an admission that they lack the training to review the engineering document known as a patent. In that moment, the judge has imported an “abstract idea” into the case. In that case, the opinion needs to be struck down precisely for the same reasons they are striking down perfectly interesting inventions.