PerkinElmer Inc. et al. v. Intema Ltd., case number 2011-1577 (Nov. 20, 2012).

Intema’s U.S. Patent 6,573,103 claims a method for determining the risk of Down’s syndrome in a prenatal test that is less invasive and risky than amniocentesis. The method involves measuring the level of a sample or ultrasound screening marker in the first trimester of pregnancy, measuring the level of a second sample and/or ultrasound marker in the second trimester, and determining the risk of Down’s syndrome by comparing the two marker levels with the observed relative frequencies of those markers in Down’s syndrome and normal-fetus pregnancies.

When Intema brought suit against PerkinElmer for infringement of its ‘103 patent, the district court determined that the patent was drawn to patent-eligible subject matter under §101, but invalid as anticipated by and obvious over the prior art. On appeal, the Fed Circuit considered only the §101 issue, and concluded that the claimed invention did not meet the requirements of §101, applying the reasoning from the Supreme Court’s Prometheus decision (Mayo Collaborative Servs. v. Prometheus Labs, Inc., 132 S.Ct. 1289 (2012)) and its own recent Myriad decision on rehearing (Ass’n for Molecular Pathology v. PTO, 689 F.3d 1303 (Fed. Cir. 2012)).

The Fed Circuit determined that the claimed assay method in Intema’s patent embodied a law of nature -- in this case, a “natural law” that linked the value of certain first and second trimester markers with an increased risk of Down’s syndrome -- and failed to meet any of the subtests that can rescue a law-of-nature from patent ineligibility. One subtest asks whether the process claim, apart from the ineligible natural law itself, contains more than “well-understood, routine, conventional activity previously engaged in by researchers in the field,” that is, whether it contains an inventive concept sufficient to ensure that “the patent in practice amounts to significantly more than a patent upon the natural law itself.” A second subtest asks whether the claimed process meets the machine-or-transformation test emphasized by the Fed Circuit in its en banc Bilski decision. A third subtest, and one applied in the Fed Circuit’s Myriad decision, asks whether the claimed method requires a statutory machine, manufacture, or composition or composition for its operation?

In Myriad, a screening method for cancer treatment involved comparing the growth rates of cells transformed with a cancer-causing gene in the presence and absence of a test compound. Despite the fact the comparison step was a patent ineligible mental step, the claimed was redeemed as patent eligible because it required cells that were themselves patent-eligible under the Chakrabarty “hand-of-man” standard.

The third subtest would appear to be grounded in the language of 35 USC §101. A method that requires a patent-eligible machine, manufacture, or composition of matter for its operation can be viewed as a “new and useful improvement thereof,” bringing it within the ambit of §101. Or, as the court in Myriad stated, “once one has determined that a claimed composition of matter is patent-eligible subject matter, applying various known types of procedures to it is not merely applying conventional steps to a law of nature.”

Although the claimed process in Intema failed to meet any of the above subtests, it cannot have been lost on the court that its reliance on the third subtest in both its Myriad and Intema decisions was inconsistent with the Supreme Court’s Prometheus decision. The process claims before the Court in Prometheus were to a diagnostic assay that required, as its first step, “administering a drug providing 6-thioguanine to a subject having [an] immune-mediated gastrointestinal disorder.” The claimed method clearly requires the use of a 6-thioguanine drug, itself a patent-eligible compound. The Supreme Court’s emphasis on the “law-of-nature” prohibition may have blinded it to the more salient fact that the claimed process in Prometheus is a new and useful improvement of a patent eligible drug (6-thioguanine) -- an improvement that allows the drug to be administered at an optimized dose when used in treating an immune-related gastrointestinal disorder.