For more than thirteen years, biotechnology companies have been able to count on one thing: a claim to a novel gene was non-obvious where the gene?s sequence was unknown in the prior art. Under In Re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), even where one of skill in the art might have a reasonable expectation of success at cloning an unknown gene, the gene itself was still held to be non obvious: “the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious . . . . A general incentive does not make obvious a particular result.” Deuel, 51 F.3d at 1559.

The Deuel rule no longer applies. On April 3, 2009, the Federal Circuit issued In re Kubin[1], No. 2008-1184. The court reconsidered Deuel, and concluded that it had been overruled by the Supreme Court?s recent decision in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Now, a claim to a novel gene may be obvious if the prior art teaches “a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions” for methods to isolate the gene that provide a reasonable expectation of success. (Kubin, slip op. at 16.) The Kubin case marks a substantial shift in the law of obviousness as applied to biotechnology inventions.

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