In a closely watched biotechnology case, the U.S. Court of Appeals for the Federal Circuit has ruled that an invention related to the isolation and sequencing of a human gene was “obvious to try.” The decision, In re Kubin, stems from an appeal to a 2007 USPTO Board of Patent Appeals and Interferences (BPAI) decision that applied the landmark Supreme Court ruling in KSR v Teleflex. That KSR decision rejected the Federal Circuit’s teaching-suggestion-motivation (TSM) test for obviousness, saying it was inconsistent with an “expansive and flexible approach.” The KSR judgment was viewed as making it easier for defendants to attack patents based on obviousness, but the findings have been applied mostly in mechanical fields. In Kubin, a three-judge panel of the Federal Circuit said the appellants 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, PhD, partner in the Washington, DC office of Foley & Lardner LLP, the Kubin decision is “not a clear or satisfying outcome for biotechnology.” The Court’s emphasis on the “reasonable expectation of success” standard was misguided, Henschel says, 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, professor at the University of Missouri-Kansas City School of Law, said the ruling was not as far-reaching as some have suggested. “Many have interpreted Deuel as imposing an extremely low bar to the patentability of cloned cDNA molecules, and indeed biotechnology in general, and have accepted the conventional wisdom that the disclosure of a protein in the prior art does not render the successful cloning and sequencing of the gene encoding the protein obvious,” Holman wrote. “On the other hand, I have felt that Deuel should be read much more narrowly, particularly in view of subsequent developments in the technology of cloning and the law, particularly the Supreme Court’s decision in KSR v. Teleflex. I think that in Kubin the Federal Circuit has answered that question pretty emphatically: while not expressly overruling Deuel, it appears to have effectively limited Deuel to the facts of that case.

“While many view Kubin as a substantial change in the law of obviousness, I disagree,” he added. “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,” he wrote.

Go to: Managing Intellectual Property and Holman’s Biotech IP Blog

Posted April 15th, 2009 under Tech Transfer

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