Ariosa says the sky is not falling, so Federal Circuit decision must stand
Ariosa Diagnostics has urged the US Court of Appeals for the Federal Circuit to reject Sequenom’s en banc request, stating that behind its “sky is falling” rhetoric is really a demand for courts to revise the US Supreme Court’s two-part test in determining the eligibility of a patent.
Ariosa filed its response to Sequenom’s en banc request on Monday, October 19, arguing that Sequenom’s demand is asking the court to “replace the Supreme Court’s two-part test” in determining whether a patent covers ineligible subject matter “with a fundamentally different inquiry”.
The two-part test requires courts to firstly assess whether a patent covers naturally occurring phenomenon and secondly, whether the claims asserted transform it into a patentable application.
“They [Sequenom] would have this court focus on whether a combination of known steps has ever been routinely applied to an unpatentable natural phenomenon. Sequenom’s reformulation of the patent-eligibility standard would collapse the Supreme Court’s two-part test that would be satisfied by any patent claim reciting a newly discovered natural phenomenon,” Ariosa said.
Ariosa has argued that Sequenom’s position amounts to granting protection to the first person to claim a naturally occurring process by adding “any steps” to the “newly discovered natural phenomenon”.
The dispute concerned Ariosa Diagnostics’s Harmony Test, a non-invasive test for pre-natal diagnosis of foetal qualities, which Sequenom claimed infringed its patent number 6,258,540, obtained in 2001.
The ‘540 patent is directed to the method of detecting the paternally inherited cell-free fetal DNA (cffDNA) in maternal plasma in pregnant women.
In 2012, Ariosa sought a declaratory judgment from the US District Court for the District of Northern California. Sequenom counterclaimed and requested a preliminary injunction. The district court ruled that the ‘540 patent is invalid.
The federal circuit affirmed the invalidity of the patent in June, citing the 2012 Mayo v Prometheus decision that the patent covered a natural phenomenon. Despite unanimity among the panel that the patent was invalid under US law, Judge Richard Linn, in a separate opinion, expressed concerns about the “broad language” in the Mayo decision.
As a result of the existing law, Linn lamented, Sequenom’s “breakthrough invention” is invalid.
Ariosa’s brief follows Sequenom’s request in August for an en banc hearing.
Sequenom had argued in that request that the federal circuit’s misinterpretation of Mayo represented an “existential threat to patent protection”.
“A person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the step she teaches to use it is independently novel,” Sequenom argued in its petition.
Sequenom’s position was bolstered by the intervention of 23 university professors and the Biotechnology Industry Organization. Both parties publicly supported Sequenom’s attempt to reverse the June ruling in amicus briefs filed at the court.
The professors argued that the federal circuit’s decision undermined the fundamental purpose of a patent system: to incentivise inventors and businesses to develop new ideas.
“The panel decision ... disincentivises making the massive R&D investments required to create new innovation in the twenty-first century. This is neither hyperbole nor conjecture,” the university professors said.
