konstantinchristian-shutterstock-com
KonstantinChristian / Shutterstock.com
17 June 2015Americas

Federal Circuit invalidates Sequenom patent, cites Mayo

A US appeals court has affirmed that a patent covering the method of detecting foetal abnormalities in pregnant mothers is ineligible for protection because it applies to a “natural phenomenon”.

The US Court of Appeals for the Federal Circuit ruled that Sequenom’s patent directed to the method of detecting the paternally inherited cell-free fetal DNA (cffDNA) in maternal plasma in pregnant women was invalid as it lacked an inventive step.

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.

After Sequenom claimed the Harmony Test infringed its patent, Ariosa sought a declaratory judgment from the US District Court for the Northern District of California in 2012 that it did not infringe the patent. Sequenom counterclaimed and sought a preliminary injunction.

In 2013, the district court rejected the request for a preliminary injunction and said Ariosa had not infringed the ‘540 patent. It also invalidated the patent. Following an appeal by Sequenom, the federal circuit reversed the district court’s decision and remanded it back to the lower court.

The district court later ruled that the patent was “directed to the natural phenomenon of paternally inherited cffDNA” and was therefore ineligible for protection. Sequenom appealed against the decision.

But the latest ruling from the federal circuit, on June 12, backed the district court. The three judges ruled unanimously in Ariosa’s favour, with Judge Jimmie Reyna writing that “the method at issue here amounts to general instruction to doctors to apply routine and conventional techniques when seeking to detect cffDNA”.

Citing the US Supreme Court’s 2012 Mayo v Prometheus decision, he added: “Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful.”

Despite the unanimous verdict, Judge Richard Linn expressed concerns about the “broad language” used in the US Supreme Court’s ruling in Mayo.

He described Sequenom’s patent as “meritorious” and a victim of the “broad language in excluding a meritorious invention from the patent protection it deserves.

“The Supreme Court’s blanket dismissal of conventional post-solution steps leave no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers,” he added.

Lisa Haile, partner at law firm DLA Piper, said the latest decision is a key one in life sciences and patent law, and is consistent with Mayo.

“The courts and the US Patent and Trademark Office are now consistently saying that if method claims do no more than recite routine or conventional methods and steps, and the claims do not provide significantly more, then they will be found to be invalid or patent ineligible,” she added.

Sequenom said in a statement that it is considering appealing against the decision.

“The ruling has little business impact, as it has been operating under the district court’s invalidity ruling since October 2013,” it added. “The company understands that patent eligibility under section 101 is an emerging and complex set of issues and is considering its options for further appeal.”

Ken Song, chief executive of Ariosa, said: “We are pleased with the outcome of the federal circuit’s affirmation of the invalidity of the ‘540 patent.”


More on this story

Americas
19 August 2015   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.
Americas
2 September 2015   A group of 23 law professors has urged the US Court of Appeals for the Federal Circuit to re-hear the Ariosa v Sequenom dispute en banc.
Americas
22 October 2015   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.

More on this story

Americas
19 August 2015   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.
Americas
2 September 2015   A group of 23 law professors has urged the US Court of Appeals for the Federal Circuit to re-hear the Ariosa v Sequenom dispute en banc.
Americas
22 October 2015   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.