CAFC must end ‘existential threat’ to patents, argues Sequenom
Sequenom has requested an en banc review of the US Court of Appeals for the Federal Circuit’s decision to invalidate one of its patents in its dispute with Ariosa Diagnostics, arguing that the decision creates an “existential threat” to patent protection.
In June, a three-judge panel decided that Sequenom’s patent, directed to a method of detecting the paternally inherited cell-free fetal DNA (cffDNA) in maternal plasma in pregnant women, was invalid on the grounds that it covered a “natural phenomenon”.
The court cited the US Supreme Court’s decision in Mayo v Prometheus as the basis for its determination that the patent covered ineligible subject matter.
In its petition for an en banc review, filed on August 13, Sequenom argued that the federal circuit “misinterprets Mayo”.
Sequenom said that if the June decision stands it will “create an existential threat to patent protection for an array of meritorious inventions”.
“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.
The dispute began in 2012, when Ariosa filed for a declaratory judgment at the US District Court for the Northern District of California.
The company, having being accused of infringement by Sequenom, asked the court to rule that the Harmony Test that it makes, a non-invasive test for pre-natal diagnosis of foetal qualities, did not infringe Sequenom’s patent.
Sequenom then filed a counterclaim and sought a preliminary injunction against the sale of the test.
According to Sequenom, the test infringed its US patent number 6,258,540 which covers the method of detecting foetal abnormalities in pregnant mothers.
In 2013, the district court rejected the request for a preliminary injunction and said that Ariosa had not infringed the ‘540 patent and that it should be declared invalid.
Following an appeal against the decision by Sequenom, the federal circuit reversed the district court’s ruling in 2013 and remanded it back to the lower court.
But the district court then ruled that the patent was “directed to the natural phenomenon of paternally inherited cell-free fetal DNA” and was therefore ineligible for protection.
Sequenom then appealed against the decision again prompting the federal circuit’s June ruling.
Despite the federal circuit’s verdict being unanimous, Judge Richard Linn wrote a separate opinion in which he expressed concerns about the Supreme Court’s “broad language” in the Mayo decision.
Such “broad language”, Linn wrote, excludes Sequenom’s patent from having the “protection it deserves”.
“But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible,” he added.
Tom Goldstein, partner at law firm Goldstein & Rusell, said: "This case shows why the en banc federal circuit needs to step in and clarify the scope of Section 101, before critical biomedical innovations are lost to a lack of patent protection.
"The Supreme Court has ruled that a patent may issue with respect to a new natural phenomenon that is applied through a new combination of known techniques.
"Under that rule, this pathbreaking invention is patentable. And the patent system is designed to foster innovation just like it," he added.
Lisa Haile, partner at law firm DLA Piper, said the petition is based on the premise “that the panel’s decision allegedly misinterprets Mayo both by failing to read that decision in light of the key Supreme Court precedent that Mayo endorses and by reaching a result the Supreme Court has twice disavowed in recent opinions”.
Haile added that it is unclear whether the federal circuit will hear the case with “several Supreme Court cases hanging over it in the diagnostics field”.
