Twenty amicus briefs have been filed in support of a petition to the Supreme Court to review the Federal Circuit’s decision in Arisioa Diagnostics v. Sequenom. That decision affirmed a district court’s determination that Sequenom’s patent was nothing more than a patent on a natural phenomenom. Only one amicus brief in opposition has been filed.
Sequenom’s invention is a non-invasive, prenatal test for finding fetal abnormalities by detecting the paternally inhereted nucleic acid within the a mother’s serum or plasma. The test is based on a discovery that fetal DNA can be detected in the mother’s serum or plasma.
Several Federal Circuit judges felt that a patent on the test was something that should be patentable. But they lamented that, under the Supreme Court’s 2012 opinion in Mayo Collaberative Services v. Prometheus Laboratories they had no choice but hold that the claim to a method for applying the discovery to detect fetal abnormalities using conventional methods of applyfing the paternally inhereted nucleic acid was nothing more than a claim to natural phenomonom itself. Although the Mayo decision is only 4 years old, agree with the amici that it has caused considerable damage.
The Mayo opinion exemplifies the evils that come from judges legislating from the bench. It reinvigorated a discredited line of jurisprudence. Its test for eligibility create uncertainty and is difficult and costly to apply (as evidenced by the PTO’s own internal guidance). And renders unpatentable inventions that in Europe and most of the rest of the world are patentable, puting US innovators and businesses at a substantial disadvantage and discouraging investment in new products and companies, particularly in the life sciences.
Under Mayo’s test, a claim “directed to” — what “directed to” means is not clear — a natural phenomenom, a law of nature, or an abstract idea must involve something more than a routine or conventional application of these “implicit exceptions” to patentability. The invention must lie in the application of the exception, and not in its discovery.
In the 1970s and early 1980s, the Court addressed in a series of decisions the issue of patent eligiblity in the context of patents directed to software implemented inventions patenting of software. Thos decisions misinterpreted and misapplied old cause law and contradicted each other. However, the last of those decisions, Diamond v. Diehr appeared augured the patenting of software impelmented inventions. Fortunately, the Court laid low for a number of years, but reasserted itself 2010, when it issued its decision in Bilksi v. Kappos. Unfortunately, that decision pretended that all of the Court’s prior decisions on eligibility were consistent, and opened the door for Mayo to bring back a line of thinking that Diehr, and subsequently, a number of subsequent decisions by the Federal Circuit, had burried.
No one appears to have ever raised the basic issue of whether the Court is doing more than applying the statute in its decisions. The most compelling amicus brief in support of review was filed by two well-known professors of patent law, Jeffry Leftstin and Peter Metell. Their main argument is that the Supreme Court has engrafted on to patent law dditional requirements that contradict Congress’s “carefully crafted framework.”
The most important innovation of the 1952 Act was to provide distinct statutory requirements to test the validity of patents, including an express non- obviousness requirement. Out of the amorphous concepts of “invention” and “undue breadth” that prevailed before the 1952 Act came § 101’s eligibility standard, § 102’s novelty standards, § 103’s non- obviousness requirement, and § 112’s disclosure requirements. By shoehorning an extra requirement for inventiveness and a concern over undue preemption into § 101, Mayo contradicts Congress’s carefully crafted framework and ignores the legislative mandate to weigh inventiveness and preemption concerns under § 103 and § 112, respectively.”
Congress provided a comprehensive regime for the granting exclusive rights in inventions that strikes a balance between exclusionary effects and incentives for promoting innovation. The Court should not — cannot? — require anything more than what the statute requires , especially if it contradicts it. The Court’s judgment cannot supplant Congress’ judgment on the appropriate balance. As pointed out by Leftsin and Menell:
The Court’s suggestion in Mayo that patent eligibility turns on concerns about the extent to which a technological discovery will be preempted misapprehends the inherent logic of the patent system. Congress has repeatedly expressed its judgment that discoveries embodied in one of the statutory classes of subject matter should be eligible for patents, notwithstanding the costs entailed by the temporary monopoly of a patent. As this Court has recognized, whether a long-standing legislative directive represents the optimal balance to promote innovation is a question reserved to Congress. See Eldred v. Ashcroft, 537 U.S. 186, 211-17 (2003).”
Although I’m not expecting that it will, I am holding out some hope that some members of the Court will take up the challenge and bring intellectual honesty and rigor to the analsyis to the issue of whether its current test is consistent with the statutory scheme and Congressional intent.
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