Diagnostic Method Patenting After Bilski

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What is the law on patent-eligible method after Bilski?

When the Supreme Court granted Certiorari in In re Bilski, much was anticipated from the decision, not just on the patent-eligibility of business methods, but also for other unconventional methods, such as, diagnostic methods, methods involving software programs, and biotech processes. The Court of Appeals for the Federal Circuit has long struggled to come up with a satisfactory objective standard for determining patent-eligibility of such methods with intermittent help from the Supreme Court. The statutory basis for determining patentable subject matter is 35 USC § 101 that allows patenting of “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. Process is unhelpfully defined under 35 USC § 100(b) as “process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.” While both the lower court and Justice Stevens in his concurring opinion in Bilski v. Kappos (Bilski) found the definition circular and unhelpful, Justice Kennedy, writing for the Supreme Court in Bilski made much of the guidance provided by § 100(b).

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