A long settled point of U.S. law regarding patentability of genes has recently become unsettled. Whether the USPTO will henceforth issue any new patents claiming genes as well as whether already-issued gene patents will survive a validity challenge has been called into question. The issue revolves around one of the conditions for patentability embodied in U.S. patent law: The requirement that the invention not have been obvious at the time the patent application was filed.

A single U.S. statute governs patentability of all inventions in the U.S., regardless of the technology. The unique features of gene inventions have posed a number of unique statutory interpretation issues for the USPTO and federal courts. One of those issues was presumably settled in 1995 in a far-reaching case decided by the U.S. Court of Appeals for the Federal Circuit (CAFC): In re Deuel, 34 USPQ2d 1210.

Deuel Standard for Obviousness

In Deuel, the CAFC held that the USPTO cannot reject a gene patent on the mere ground that prior to the patent application’s filing date, there existed a motivation to try cloning the gene and an obvious technique one could have used to clone it. The court noted that inventor Deuel was claiming a gene, not a cloning method, so the obviousness of the cloning method was irrelevant.

Instead, the court said that the proper standard for judging whether a gene is obvious and thus unpatentable requires that one ask the following questions: Was there a motivation to try cloning the gene, and was the nucleotide sequence of the gene predictable from what was known in the field prior to the patent application’s filing date? If the answer to both questions is yes, the gene is obvious.

Since the precise nucleotide sequence of a gene is, with trivial exceptions, entirely unpredictable, this holding in Deuel essentially abolished obviousness as an issue for nearly all gene patents in the U.S., until now, that is.

Obviousness Requirements in Flux

The U.S. Supreme Court addressed the general issue of obviousness in the recent patent case KSR v. Teleflex, 127 S.Ct. 1721 (2007) on appeal from the CAFC. The invention at issue in KSR was far removed from anything resembling a gene; it involved an automobile gas pedal. According to the Supreme Court, the CAFC had applied too lax a standard and should have found the gas pedal patent invalid for obviousness.

The Supreme Court, however, clearly intended its broad pronouncements to apply to all inventions, regardless of the technology. There are, of course, many important differences between the facts of the KSR case and those of most gene cases. Nevertheless, anyone considering the obviousness of any invention henceforth will have to take into account the general principles expounded by the Supreme Court in KSR. The USPTO’s Board of Patent Appeals and Interferences recently attempted to do just that in a gene case decided a few months after KSR: Ex parte Kubin, 83 USPQ2d 1410 (BPAI 2007).

Kubin Overrules Deuel

An inventor named Kubin applied for a patent claiming a novel gene encoding the protein NAIL. The USPTO examiner assigned to the case agreed that the NAIL gene was novel but rejected the claims anyway, saying that based on what was known about the NAIL protein at the time Kubin cloned the gene, it would have been obvious to clone it.

Kubin appealed to the USPTO’s board, arguing that this obviousness rejection was contrary to the holding in Deuel. The board decided that Kubin’s gene invention was indeed obvious, because there was both a motivation to clone the gene and a known technique for doing so. They thus resurrected the standard that the CAFC deemed incorrect 12 years earlier.