Aug 6 2009
In an amicus brief filed today, BIO urged the Supreme Court to overturn the decision of the U.S. Court of Appeals for the Federal Circuit in Bilski v. Doll.
In its decision, the Court of Appeals created a new test under which a method or process is only patent-eligible if it is tied to a specific machine or if it transforms a particular article or substance to a different state or thing. This test, which has become known as the “machine-or-transformation” test, is now the eligibility threshold that a patent application has to meet before it is examined for novelty, inventiveness, and usefulness.
“In 1980, the Supreme Court defined patent-eligible subject matter in a flexible and inclusive way that has fostered the tremendous growth of biotechnology for the benefit of millions of patients, farmers, and consumers around the world,” stated BIO General Counsel Tom DiLenge. “If the Court of Appeals’ contrary approach in the Bilski case is permitted to stand, it would create uncertainty that would negatively impact investment in biotechnology, and thus stifle future growth of this remarkably beneficial industry.”
The biotechnology industry is among the many stakeholders that are concerned about this new rule because it applies to all technologies, even though it was crafted to deal with business methods and abstract, disembodied processes involving logical operations and human thinking.
“The implications of this case for biological, diagnostic, and personalized medicine methods that depend on biomarkers or other correlations between a genetic or physiological predisposition and disease-susceptibility or likelihood of treatment success must be carefully considered by the Supreme Court,” stated DiLenge. “This new rule could be applied in biotechnology patent litigation with very unclear and unsettling results.”
“Requiring that biotechnology process claims be tied to a machine or a transformation could jeopardize already-issued biotechnology claims and will create uncertainty surrounding future grants of biotechnology patents in these areas,” DiLenge concluded.
The brief is available at http://bio.org/ip/amicus/documents/08-964tsacBiotechnologyIndustryOrganizationetal.pdf .
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