When I read the April 16th decision (App. No. 2011-1399, -1409 (Fed. Cir. April 16, 2012)) (a copy is available at the end of this post) in which a Fed. Cir. panel of Newman, O’Malley and Reyna reversed a district court’s finding that two Aptalis patents on a controlled-release form of a muscle relaxant were obvious, I expected a routine recitation of the KSR “standards” and not much more. Therefore, I was pleasantly surprised to find that Judge O’Malley had authored one of the clearest and most thorough explications of the obviousness inquiry that I have ever read in an opinion. Every patent attorney should read this decision and so should every examiner.
The claims in question are thick with “pharmacokinetic values” and the question confronted by the court was whether or not it would have been obvious to “ascertain the correct pharmacokinetic/ pharmacodynamic (‘PK/PD’) profile” wherein the “determination of a PK profile is a quantitative exercise. The determination of PD, or therapeutic effectiveness, however is a qualitative exercise.” Of course the holding was ultimately “no,” and the panel may have been a bit snowed by the technical arguments, but the explanation of the s. 103 standards mandating reversal are what gives this opinion its force.
