Last Thursday, the Biotechnology Industry Organization (BIO) weighed in on a patent issue that will soon be before the Supreme Court. In an amicus brief, BIO argued that the Court should overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involved Bernard L. Bilski’s method for hedging risks in commodities trading.
In its press release about the amicus brief, BIO says 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.” The test is known as the machine-or-transformation test.
Is the test new? Au contraire. The Court of Appeals based its reasoning in Bilski on three Supreme Court decisions made between 1972 and 1981. Several judges on the Court of Appeals argued that these criteria can be traced to the framers of the Constitution. Rather than being novel, the test seems to rely on an established precedent.
“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,” said Tom DiLenge, BIO’s general counsel, in the press release. He went on to say that Bilski “would negatively impact investment in biotechnology, and thus stifle future growth of this remarkably beneficial industry.”
I believe that Bilski establishes prohibitions that will benefit the industry rather than stifling its growth. In my reading, Bilski would prevent biomarkers from being patented. It also would prevent someone from patenting the understanding that particular biomarkers are associated with particular diseases or conditions.
To patent the association of a biomarker with a disease, or to patent any other diagnostic method, would be to patent basic science, which would have the effect of restricting knowledge. Bilski ensures that science is no one’s exclusive property and thus fosters the development of new biopharmaceuticals, which are BIO’s bread and butter. I hope the Supreme Court acknowledges the sound reasoning and long precedent behind Bilski.