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Legal Affairs : Apr 1, 2008 ( )
U.S. Gene Patents in Legal Limbo –– for Now
USPTO’s Rejection of Kubin Patent Due to Obviousness Raises Questions
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.
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.
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.
Normally, the board is obligated to follow the CAFC’s interpretations of the law and cannot ignore or replace them with contrary assessments. The board, however, apparently felt justified in ruling contrary to the Deuel case, because the Supreme Court stirred up issues related to the law regarding obviousness, calling into question the viability of many previous CAFC pronouncements on that subject.
Until the CAFC has an opportunity to reconsider the issue, gene patents are left in legal limbo. Only the CAFC and, ultimately, the Supreme Court has the authority to overrule Deuel and articulate what standard is correct. For now, Deuel remains the law, notwithstanding the board’s bold attempt to upend it.
Biotech Industry Implications
Whatever the obviousness standard turns out to be for gene inventions, it will have repercussions for gene patent applications still under consideration, those yet to be filed, as well as patents already issued.
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