BIO Asks Supreme Court to Overturn Bilski Ruling

Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

On August 6, the Biotechnology Industry Organization (BIO) filed an amicus brief asking the US Supreme Court to overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit.

On August 6, the Biotechnology Industry Organization (BIO) filed an amicus brief asking the US Supreme Court to overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involves Bernard L. Bilski’s method for hedging risks in commodities trading.

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,” BIO said in a press release. The test is known as the machine-or-transformation test.

In the Bilski decision, Chief Judge Michel wrote that the US Court of Appeals’s reasoning was partly based on a review of Supreme Court cases that enunciated and consistently applied the machine-or-transformation test to patent claims for processes.

In its amicus brief, BIO said that the application of the machine-or-transformation test to biotechnology process inventions is contrary to Supreme Court precedent. The Court has consistently interpreted 35 USC § 101, which governs patent eligibility, to exclude only claims to abstract ideas, laws of nature, and natural phenomena from patent eligibility, the organization wrote.

Biotechnology process inventions are not abstract ideas, laws of nature, or natural phenomena, but rather provide “a useful and tangible end” that could potentially address unmet medical needs, according to the amicus brief. Examples of biotechnology process claims include “those to processes for diagnosing or prognosing diseases and those to ‘biomarkers,’” BIO said in the brief.

Applying Bilski to biotechnology process inventions would create uncertainty regarding their patent eligibility, even for inventions that have already been patented, said BIO in the brief. This uncertainty would deter the investment necessary to encourage innovation in biotechnology, according to the organization.

In its brief, BIO asked the Court to set aside the machine-or-transformation test and “reaffirm” that the statute regarding patent eligibility should be read broadly. Broad patent-eligibility standards are necessary to foster innovation in biotechnology, said BIO in its brief.