NARCAN® Nasal Spray Patents Ruled Obvious

Negative statements in prior art and objective indicia did not negate obviousness

In a case demonstrating the importance of winning factual issues at trial, a panel of the Federal Circuit, Judges Stoll and Prost, affirmed a district court's ruling that Adapt Pharma’s patents covering its NARCAN® product for treating opioid drug overdoses were invalid for obviousness. Judge Newman dissented from the panel’s ruling.

A key point to consider when interpreting these competing opinions from the Federal Circuit in this “close case” is that “[w]hat the prior art teaches (including whether it teaches away from the claimed invention), whether a skilled artisan would have been motivated to combine the prior art references, and the existence of and weight assigned to any objective indicia of nonobviousness are underlying factual questions” and “reviewed for clear error.” Thus, while Judge Newman’s opinion in dissent addresses contrary evidence, the majority did not view that conflicting evidence as rising to the level of clear error. Put another way, in view of the conflicting evidence, had the district court upheld the patent, it might be possible for that hypothetical decision to also have been affirmed under the clear error standard.

On the merits, the panel majority felt that there was sufficient evidence of a motivation to combine the prior art references to achieve the claimed combination and that there was not a “teaching away” of the combination after looking at the prior art as a whole. Regarding objective indicia of nonobviousness (unexpected results, copying, skepticism, long-felt need, and failure of others) the panel majority corrected a “harmless error” of the district court and found evidence of those indicia did not negate obviousness largely because the results flowed from what was expected in the prior art and the lack of persuasive evidence. Judge Newman felt that “there was no teaching or suggestion in the prior art to make this combination of ingredients for use in the claimed method to achieve the described beneficial results” and viewed the evidence of long-felt need, failure of others, unexpected results, commercial success, and copying as demonstrating nonobviousness.