The case, In re Kubin, stems from an appeal of a 2007 USPTO Board of Patent Appeals and Interferences (BPAI) decision that applied the landmark Supreme Court ruling in KSR v Teleflex, which rejected the Federal Circuit's rigid teaching-suggestion-motivation (TSM) test for obviousness, saying it was inconsistent with an "expansive and flexible approach".
The judgment was viewed as making it easier for defendants to attack patents on the ground that they are obvious and harder for applicants to prove their inventions are not obvious, but has been applied mostly in the mechanical fields.
Citing KSR, a three-judge panel of the Federal Circuit said that the appellants, Marek Kubin and Raymond Goodwin, failed to show that their invention met the KSR standard for non-obviousness, and that a person of ordinary skill in the art would have had a "resoundingly 'reasonable expectation of success' in deriving the claimed invention in light of the teachings of the prior art".
Quoting KSR, the decision said: "The record shows that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Therefore, the claimed invention is 'the product not of innovation but of ordinary skill and common sense.'"
The Court also agreed with the BPAI's claim that "KSR unambiguously discredited" the Federal Circuit's prior holding in the 1995 case, In re Deuel, which said that "knowledge of a protein does not give one a conception of a particular DNA encoding it".
According to Ric Henschel of Foley & Lardner, the decision was "not a clear or satisfying outcome for biotechnology".
He said that the Court's emphasis on the "reasonable expectation of success" standard was misguided, since "most modern inventions involve such an expectation of success where, as here, the invention's expected function and properties were known but its eventual structure was not. The court ignored that the prior art never isolated the p38 protein that is coded for by the claimed DNA".
But in his blog post on the topic, Christopher Holman, a law professor at the University of Missouri-Kansas City School of Law, said that the ruling was not as far-reaching as some have suggested.
He said: "While many view Kubin as a substantial change in the law of obviousness, I disagree. Kubin basically says that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a 'reasonable expectation of success,' based on 'detailed enabling methodology' in the prior art. There is nothing remarkable about this standard - it is entirely consistent with the law of obviousness as it is applied outside the context of gene cloning, and it surprises me that people have believed that a very different standard applies to gene cloning."
Holman urged the patent community to counter the notion that Kubin will have significant negative impact on biotech inventions, since "a perception among investors that biotechnology has been harmed by Kubin could cause more damage to biotechnology than the decision itself".
