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April 01, 2008 (Vol. 28, No. 7)

U.S. Gene Patents in Legal Limbo –– for Now

USPTO’s Rejection of Kubin Patent Due to Obviousness Raises Questions

  • 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.

    The USPTO has already indicated its intention to follow the board’s reasoning in Kubin. In October 2007, it published a set of examination guidelines in which Kubin is cited as an example of how USPTO examiners should formulate obviousness rejections.

    As a practical matter, if obviousness of a gene hinges on whether there was a known technique that could have been used to clone the gene, few if any gene inventions will pass muster. Thus, unless and until the CAFC overrules Kubin and reasserts the Deuel standard, we can expect issuance of new gene patents in the U.S., which has already been tapering off in recent years as the genome becomes thoroughly mined, to slow to a trickle and perhaps cease altogether.

    Probably more disconcerting for the biotechnology industry is that Kubin calls into question the validity of many if not most gene patents that have been issued since Deuel became the touchstone.

    Historically, patent owners and their competitors concerned with freedom to operate, based investment decisions on an assumption that issued gene patents were unassailable on obviousness grounds. Undermining this assumption could have wide-ranging implications.

    For example, investors may now desert companies whose viability depends on gene patents. Conversely, firms may decide that the risks incurred when using a competitor’s patented genes as targets for drug discovery are not as great as previously thought, emboldening them to flaunt the patents that used to curb these lines of research.

    While the board’s rulings apply only to the standards to be followed by the USPTO in examining applications and do not affect already-issued patents, the question of whether Deuel is still good law will persist until the CAFC has spoken on the issue. Meanwhile, uncertainty will reign. --- Janis K. Fraser, Ph.D., is a principal in the Boston office of Fish & Richardson P.C. She focuses her practice on patent prosecution, opinions, due diligence, and client counseling for companies in the biotechnology and pharmaceutical industries. Web: www.fr.com. Phone: (617) 521-7037. E-mail: [email protected]

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