The Supreme Court’s rejection in Bilski of the machine-or-transformation test as the sole test for determining patentability of a process has generated discussion in the medical device field as to the patentability of method patents, particularly in regard to diagnostic methods and methods of treatment.
Background: Under the exclusive machine-or-transformation test, for a method to be patentable under § 101 it must be (1) tied to a particular machine or apparatus, or (2) transform a particular article into a different state or thing. Medical methods tied to a patentable device easily satisfied the “machine” requirement. The “transformation” element, however, has been more difficult to apply to methods of treatment and diagnosis, which often include testing, data gathering, and/or tissue manipulation steps that are more independent of any particular device.
Before the Bilski decision, the boundary of how the “transformation” prong of the text might be analyzed in the general life science field seemed to have been bracketed by two recent decisions of the Federal Circuit: Prometheus v. Mayo and Classen v. Biogen. In Prometheus, the court found that a method for administering a drug then determining the optimal level of drug metabolites satisfied the “transformation” element of the test. The court effectively treated the diagnostic method as a method of treatment, and held that methods of treatment “are always transformative when a defined group of drugs is administered to the body . . .” Specifically, the court found that physical changes in drug metabolites and manipulation of a sample were transformative. In Classen, however, the court held in a non-precedential opinion that a broad method of determining the effectiveness of an immunization schedule by immunizing a treatment group and comparing the immunized treatment group with a control group did not meet the "machine" or "transformation" requirements, thus was not patentable under §101.
The Ruling and Developments: The Supreme Court in Bilski held that the machine-or-transformation test was inappropriate as an exclusive test for patent-eligibility because the Patent Act was intended to encompass “new and unforeseen inventions” that may not satisfy the antiquated requirements of that test. The Court noted that “new technologies may call for new inquiries.” The Court even referenced “advanced diagnostic medicine techniques” as one such technology, although it declined to comment on the patentability of such techniques. While noting that methods not satisfying the exclusive test might still be patentable, the Court reiterated that methods directed solely to natural phenomena and abstract ideas were not patentable under § 101.
Conclusion and Application: Although the machine-or-transformation is no longer the exclusive test for patentability, it remains the initial indicator of patentable subject matter for method claims under § 101. Examiners have been instructed to continue using the machine-or-transformation test in determining patentability of methods under § 101. If a method meets the test, the invention is likely patent eligible unless there is a clear indication it is directed to an abstract idea; if it fails the test, the Examiner “should reject the claim under § 101 unless there is a clear indication that the method is not directed to an abstract idea.” Once rejected under § 101, the applicant then has the opportunity to explain why the method is not drawn to an abstract idea.
Under the “transformation” standard of Prometheus, methods of treatment currently seem to enjoy a presumption of being “transformative,” thus patentable under § 101. In light of Bilski, however, the Court remanded both Classen and Prometheus back to the Federal Circuit. Given that methods are no longer required to be “transformative” to be patentable, it remains unclear whether the Federal Circuit will continue to find that methods of treatment are transformative in nature, particularly in view of the Supreme Court’s rejection of a categorical exclusion and the Court’s implication that the machine-or-transformation test is more aptly applied to Industrial Age technologies. Regardless of the specific Federal Circuit holdings in the remanded cases, the machine-or-transformation test will remain an important tool for determining patentability of medical methods. Even if medical methods of treatment and diagnosis are deemed non-transformative, after Bilski such claims may still be patentable under § 101 if the claims are clearly not directed solely to an abstract idea.
Consequently, applicants would be advised to draft method claims which highlight the transformational aspects of the method, particularly aspects of the claim which involve physical acts and do not solely rely on natural phenomena or abstract principles. This may include adding a broad additional treatment step to be taken in light of diagnostic information, such as “providing a warning” or “altering a therapy,” to remove the method from a series of abstract mental steps or observations.
Claim validity may benefit from clear indicators that the method is not solely directed to abstract ideas or natural phenomena, which for broad diagnostic patents may include identifying the medical condition or including specific treatment regimen.