Prior Obviousness Developments
The Federal Circuit in Kubin was profoundly influenced by the U.S. Supreme Court’s recent obviousness pronouncements in KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727 (2007) and the implications for inventions that may be obvious to try and result in an expected outcome. In KSR, the Supreme Court rejected a rigid application of the “teaching, suggestion, or motivation” test and mandated an expansive and flexible approach to determine whether a patent is obvious under 35 U.S.C. §103 of the Patent Act.
The Supreme Court stated that an invention may be obvious when there is market pressure to solve a problem and when there are a finite number of identified, predictable solutions, so that a person of ordinary skill has good reason to pursue the known options within his/her technical grasp. If this leads to the anticipated success, according to the Court, it is likely not the product of innovation but of common sense.
However, the invention in KSR did not concern biotechnology, but rather was directed to a mechanical device. The Court’s “obvious to try” and “predictable-result” approach is a workable rationale for addressing the obviousness of combining known physical components to produce a device with predictable features.
But at issue in the patentability or obviousness of claimed genetic sequences is the very nature of the predictability of the result. While it may well be predictable that an accurate nucleic acid structure will result from a particular sequencing methodology, the resulting chemical structure itself (i.e., the cDNA sequence) still cannot be predicted a priori. Moreover, the Federal Circuit had previously recognized that biotechnology is an unpredictable art, and that, most often the problems addressed in molecular biology do not have predictable solutions.
Gene Patent Precedents
The Federal Circuit’s ruling in Kubin was a marked departure from settled law controlling the obviousness standard for patenting genes. In In re Bell, 991 F.2d 781 (Fed. Cir. 1993), the Federal Circuit ruled that claims directed to nucleic acids encoding human insulin-like growth factors were not obvious, even though the amino acid sequences for such human growth factors were disclosed in the prior art, as were the general methods for isolating a gene by using degenerate probes corresponding to short amino acid sequences of the known protein.
Following Bell, in Deuel, the Federal Circuit ruled that a combination of a reference disclosing a partial amino acid sequence of a heparin-binding growth factor protein, together with a prior-art reference teaching a method of gene cloning, does not render the claims directed to cDNA molecules encoding the protein obvious.
The Federal Circuit considered the claimed DNA sequences as “new chemical entities in structural terms” and concluded that the obviousness rejection based on the alleged obviousness of a method of making such molecules, not the obviousness of the structurally similar molecules themselves, is improper. In the wake of the Kubin case, however, the reasoning in Deuel and Bell can no longer be relied upon.