Eurand v. Mylan –A “School Of Obviousness"
/>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.
I won’t try to summarize, or re-write the entirety of the obviousness section of the opinion, which occupies 31 pages, but I really woke up when I hit part C, where the panel tackles the weight to be given to secondary considerations, including long-felt need and the failure of others. The panel also clearly includes unexpected results as a secondary consideration, which is important, because some commentators have argued that it is should be given added evidentiary weight. The panel found that the judge had made up her mind after hearing the body of evidence relating to the determination of the “PK/PD” profile and then weighed the secondary considerations and found them wanting:
“The district court erred, however, by making its finding that the patents in suit were obvious before it considered the objective considerations and by shifting the burden of persuasion to Cephalon (the plaintiff). In doing so, the district court contravened this court’s precedent requiring that a fact-finder consider all evidence relating to obviousness before finding a patent invalid on those grounds, and the court imposed a burden-shifting framework in the context in which none exists.” (emphasis added, slip op. at 21).
The panel goes on to blame past decisions of the Fed. Cir. which appear to sanction deferral of objective considerations until after the fact finder makes an obviousness finding. The panel begins by quoting extensively from Stratoflex, Inc. v. Aeroquip Corp., including, “Indeed evidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often establish that an invention appearing to be obvious in light of the prior art was not.” We patent attorneys are probably all familiar with this quote, but the panel reads it as “holding that a fact finder in [d.c.] litigation may not defer examination of objective considerations until after the fact finder makes an obviousness finding.” Slip. op. and 21-22. The panel criticizes past panels of the Fed. Cir. “which have spoken of the obviousness analysis in terms of a ‘prima facie’ case which must then be ‘rebutted’ by the patentee.” The panel reviews two pages of Fed. Cir. decisions and concludes:
“Thus, a reading of these cases that permits a fact finder to reach a conclusion of obviousness before consideration of objective considerations, would not only conflict with Stratoflex’s directive that objective considerations are ‘to be considered as part of all the evidence, not just when the decision maker remains in doubt after reviewing the art….but it would ignore their actual holdings.” Slip. op. at 25.
The panel goes on to review Deere, KSR and even i4i, and to find that these courts “provided no indication that [they believed] the burden of persuasion should shift to the patentee.” Slip. op. at 28. About 18 months ago, I gave a talk at AIPLA about how to block a court or Examiner from using hindsight reconstruction to resolve the obviousness question, and I wish I had the Eurand panel’s discussion of the role of secondary considerations in blocking hindsight on my desk when I did the slides:
“In other words, knowing that the inventor succeeded in making the patented invention, a fact finder might develop a hunch that the claimed invention was obvious, and then construct a selective version of the facts that confirms that hunch . This is precisely why the [S. Ct.] explained [in Deere] that objective considerations might prevent a fact finder from falling into such a trap, observing that objective considerations might serve to ‘resist the temptation to read into the prior art the teachings of the invention at issue.’ 383 U.S. at 36.”
I couldn’t have said it better myself, and I didn’t. Even patent prosecution gets some of the ”blame” for opinions for the Fed. Cir. that “require a burden-shifting framework in derogation of Stratoflex’s directive that objective evidence be considered before making an obviousness determination and in disregard of where the burdens of proof and persuasion are properly placed in district court litigation.” Slip op. at 30. :
“Unlike in district court litigation, a burden-shifting framework makes sense in the prosecution context. . The prima facie case [of obviousness] furnishes a ‘procedural tool of patent examination, allocating the burdens of going forward as between examiner and applicant’…During prosecution, a patent applicant, as a practical matter, may not have the opportunity to present objective evidence unless and until an examiner reviews the application and issues an obviousness rejection…’If that burden is met [of presenting a p.-f. case of obviousness], the burden of coming forward with evidence or argument shifts to the applicant.’..In litigation, all relevant evidence is presented to the fact finder in a single proceeding. There is simply no practical need to impose a burden shifting framework in litigation.” Slip op. at 31.
For years, I have argued that the two most important deficiencies in the PTO examination process are that many examiners, especially inexperienced examiners, do not understand the concepts of burden of persuasion (or “proof”) and what is and is not evidence of patentability. I recently had an Examiner tell my applicant that applicant had failed to establish a long-felt need to treat cancer(!). The Eurand panel goes on to provide an extensive discussion of the quality and importance of evidence of long-felt need and failure of others to meet that need, but this note is already longer than I intended. I will just repeat myself: Every examiner should read this opinion and so should every patent attorney – and I think that is the first time I have urged that level of attention – ever.
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