On June 13, 2013 the Supreme Court drew a sharp line between isolated DNA (not patentable subject matter) and cDNA (patentable subject matter), but did not offer guidance on the patent-eligibility of method claims directed to DNA. See Association for Molecular Pathology v. Myriad Genetics, 569 U.S.__(2013).
Processes or methods have long been recognized as patentable subject matter. In an early test developed by the Federal Circuit, the court found that a method must be tied to a particular machine or transform an article into a different state or thing in order to achieve patentability. “Patent-eligibility trilogy”: Gottschalk v. Benson, 409 U.S. 63 (1972); Parker v. Flook, 437 U.S. 584 (1978); Diamond v. Diehr, 450 U.S. 175 (1981). However, the Supreme Court in Bilski v. Kappos found that while the “Court’s precedents establish that the machine-or-transformation test is a useful and important clue… [it] is not the sole test for deciding whether an invention is a patent-eligible ‘process.’” Bilski v. Kappos, No. 08–964, slip op. at 8, (S. Ct. 2010).
In addition, the Court indicated that analysis of whether a process is patent-eligible should take into account prior case law including Benson, Flook, and Diehr. Id. at 13. The Court in “Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’” Diehr, 450 U.S., at 187. However, Diehr also explained that “the prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant post solution activity.’” Diehr, 450 U.S., at 191-192.
Because the Supreme Court in Myriad only addressed whether isolated genes and cDNA were patent-eligible, guidance on the patent-eligibility of method claims is found in Federal Circuit’s decision in Ass’n for Molecular Pathology v. United States PTO. Ass’n for Molecular Pathology v. United States PTO, 689 F.3d 1303 (Fed. Cir. 2012). In this case, the Federal Circuit found method claims directed to “comparing” or “analyzing” DNA sequences are patent-ineligible, but methods for screening cancer therapeutics are patent-eligible. Id. Therefore, when drafting diagnostic method claims directed to DNA, a method for making a determination must be specified whenever steps involve a “determination,” “correlation,” “comparison,” or “analysis.” An active step which recites the performance of a physical action on a DNA sequence to be measured (e.g., “extracting” or “sequencing” or “amplifying”) should be included, followed by a subsequent active step to ensure that the physical action performed in the previous step is not considered an insignificant post-solution activity.
In addition, incorporation of the machine-or-transformation test directly into a diagnostic method claim is advisable. The test should include active steps tied to a particular machine or apparatus and active steps that transform a particular article to a different state or thing. However, claim limitations should also be included to ensure that a step which meets the machine-or-transformation test is not considered an insignificant post-solution activity.
As the lower courts offers further clarity of the Myriad decision, these considerations will likely fit into wider controversies regarding the patenting of methods in business, software and general human activities.