By Kevin E. Noonan —
Two pronouncements, one from the Supreme Court and the other from the Federal Circuit, portend the parlous state that could await American innovation should judges come to believe that that their judgment is as sound as that of actual innovators.
From the Federal Circuit's In re Kubin decision (citing In re O'Farrell):
Specifically, this court observed that an obviousness finding was appropriate where the prior art "contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful." 853 F.2d at 902 (emphasis added). Responding to concerns about uncertainty in the prior art influencing the purported success of the claimed combination, this court stated: "[o]bviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success." Id. at 903-04 (emphasis added). The Supreme Court in KSR reinvigorated this perceptive analysis.And, of course, from the Supreme Court in KSR Int'l Co. v. Teleflex Inc.:
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.The combination of these sentiments leave open the question: what isn't obvious? We know that the Supreme Court has never disclaimed the discredited "flash of genius" requirement from Cuno Engineering Corp. v. Automatic Devices Corp., despite Congressional abrogation in the last sentence of 35 U.S.C. § 103: "Patentability shall not be negatived by the manner in which the invention is made." Indeed, the Court opined in Graham v. John Deere Co. that Congress merely intended to codify the Court's own obviousness jurisprudence. Fortunately not, since even members of the Court had come to recognize, in the years just prior to the 1952 Act, that the Court's overt hostility to patents had become extreme: Justice Robert Jackson was moved to remark that the remedy for "bad patents" (sound familiar?) was not "an equally strong passion in this Court for striking them down so that the only patent that is valid is one which this Court has not been able to get its hands on." Jungersen v. Ostby & Barton Co., 335 U.S. 560, 572 (1949).
We again seem to be in a period, as in the 1940's, of frank hostility to patents and patent law from the Supreme Court. Indeed, if the following quote:
(from Atlantic Works v. Brady, 107 U.S. 192, 200 (1882)) appeared in the KSR decision (or, for that matter, on the Coalition for Patent Fairness' website), would anyone have been surprised or thought it out of place?
The difference, of course, is that today we have the Court of Appeals for the Federal Circuit, capable (but lately seemingly unwilling) to provide legal analysis to assist the Court in its heretofore infrequent forays into waters it rarely, uncomfortably, and maladroitly treads. However, as the CAFC has shown in Kubin, and earlier in Pfizer, Inc. v. Apotex, Inc., Aventis Pharma Deutschland GmbH v. Lupin, Ltd., and Pharmastem Therapeutics, Inc. v. Viacell, Inc., the KSR influence is strong on the Court. All is not lost, of course: there have been plenty of decisions since KSR where the Federal Circuit upheld the non-obviousness of pharmaceutical patents, including Sanofi-Synthelabo v. Apotex, Inc., Eisai Co. v. Dr. Reddy's Laboratories, Inc., Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., Forest Labs, Inc. v. Ivax Pharm., Inc., and Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. However, in every case, the bases for so holding has been the application of traditional principles of chemical structural non-obviousness ("structure, structure, structure" according to Judge Rader) and none of these cases has focused on the more liberal "obvious to try" standard enunciated in In re Kubin.
The Federal Circuit's Kubin decision (and to a lesser extent, the Court's disregard of the Graham secondary indicia of non-obviousness in the Pharmastem decision) raises the legitimate issue of what won't be obvious by the application of the Kubin doctrine. For example, an analogy could be drawn between the way the court applied obviousness law to the facts in Kubin and the situation for most monoclonal antibody claims. Just like the p38/NAIL protein in Kubin, antigens (particularly antigens to pathogens) are frequently known in the art. Indeed, the existence in the art of such pathogen-derived antigens would presumably engender an even greater motivation for the skilled worker to make an antibody than the existence of p38 in the prior art motivated Kubin to isolate NAIL cDNA. As in Kubin, the methods for making monoclonal antibodies are just as established (perhaps even more so, having been judicially recognized as "extensive, but routine" in In re Wands and Noelle v. Lederman), and obtaining a monoclonal antibody just as "predictable" (perhaps more so) as obtaining a cDNA in Kubin. And the final similarity is that the structure of the antibody is equally as unknown in the prior art (and unrelated to the structure of the antigen) as is the protein structure to the nucleic acid comprising the gene encoding it. (It is probably a wash that the genetic code provides some means for determining "a" — as opposed to "the" — nucleotide sequence encoding a known amino acid sequence, versus the binding affinity between an antibody and its cognate antigenic epitope, since neither the identity of the epitope — for antibodies — nor the complete amino acid sequence — for genes — is typically known.) Thus, it can fairly be asked whether claims to a monoclonal antibody are now prima facie obvious under the Kubin doctrine.
Indeed, something of this sort has already happened, in the Federal Circuit's In re Tzipori decision. From a Patent Docs post on that case:
Taken to its extreme, everything thus becomes obvious.
In the last century, Learned Hand (at right; a jurist whose insight and intellect were indeed what current members of this or any Court should hope they would possess) recognized the problem and its rational solution:
Courts, made up of laymen as they must be, are likely either to underrate, or to overrate, the difficulties in making new and profitable discoveries in fields with which they cannot be familiar; and so far as it is available, they had best appraise the originality involved by the circumstance which preceded, attended and succeeded the appearance of the invention. Safety Car Heat & Light Co. v. General Electric Co., 155 F.2d 937 (2d Cir. 1946).
Hat tip to Bob Harmon for the Learned Hand quotes.
Antibody image: Tom Vickers, Wikipedia Commons
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