This article urges that the obviousness jurisprudence for claims to genetic sequences be overhauled to conform with the standard stated in KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007). An obviousness inquiry under 35 U.S.C. § 103 requires a determination of whether a skilled artisan would have found the claimed invention obvious in light of the analogous prior art. We demonstrate that the Court of Appeals for the Federal Circuit has established an overly rigid standard for determining the obviousness of claims directed to genetic sequences. This analysis is primarily concerned with whether structurally similar genetic sequences are known. This is misguided because such an inquiry elevates form over substance and fails to consider the unique relationship between a gene and the protein that the gene encodes. We urge that the CAFC revise and clarify the relevant obviousness standard in light of KSR.
To aid the CAFC, we propose an expansive yet flexible test for evaluating obviousness of claims to genetic sequences. Our test requires that one first establish a prima facie case of obviousness by demonstrating that both (1) the protein encoded by the claimed sequence(s) is known in the art; and (2) its amino acid sequence is known or can be readily determined by conventional methods in order to render claims to genetic sequences obvious. If the prima facie case is established, the claims at issue are obvious as a matter of law unless the applicant rebuts the prima facie case by, for example, relying on “secondary considerations,” unexpected results, and/or surprising or unexpected properties of the sequences to establish its nonobviousness. We believe that our proposed approach strikes a sensible middle ground between two extremes: holding all claims to genetic sequences nonobvious unless a structurally similar molecule is known in prior art and holding all claims to genetic sequences of a protein obvious if the protein is known in the art. Our test would also achieve a proper balance between encouraging scientific development by granting patents on true innovations and protecting the public from patents that should never be granted.
- genetic sequences,
Available at: http://works.bepress.com/mark_polyakov/2/