Myriad decision applied in diagnostic claims case
The US District Court for the Northern District of California has found that diagnostic claims covering conventional detection methods do not make the use of a natural phenomenon patent eligible.
It is one of the first district court decisions to apply the patent eligibility standard decided by the Supreme Court earlier this year in the Association for Molecular Pathology v Myriad Genetics, Inc case.
The Supreme Court found that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”
Ariosa Diagnostics Inc, formerly known as Aria Diagnostics Inc, filed an action in December 2011 seeking declaratory judgment that its non-invasive prenatal “Harmony” test, which uses the cell-free foetal DNA (cffDNA) present in pregnant woman’s blood to assess the risk of foetal chromosome conditions, does not infringe Sequenom Inc’s patent 6,258,540.
The claims of the ‘540 patent cover methods of detecting paternally inherited nucleic acids of foetal origin. Ariosa argued that the claims are not patent eligible because paternally inherited cffDNA, a type of nucleic acid, is a natural phenomenon.
“The claims of the ’540 patent merely add well-understood, routine, conventional activity in the field to that natural phenomenon,” it said in the order.
Sequenom argued that the claims are patentable because they are novel uses of a natural phenomenon, rather than a patent on the phenomenon itself.
In March 2012, it filed a counterclaim and a preliminary injunction to stop Ariosa from making and selling the Harmony test, which the court denied, finding that Ariosa had “raised a substantial question with regard to the validity of the ‘540 patent based on Ariosa’s argument that the ‘540 patent does not cover patent eligible subject matter.”
Sequenom appealed against the decision at the US Court of Appeals for the Federal Circuit, which on August 9, 2013 vacated the court’s order denying the preliminary injunction and remanded the case with directions that the district court examines the patent eligibility of claims in light of the Myriad decision.
On October 30, district judge Susan Illston granted Ariosa’s motion for summary judgment and denied Sequenom’s motion, invalidating the ‘540 patent.
Antoinette Konski, a partner at Foley & Lardner LLP in Palo Alto, said: “The court clearly set the discussion around the technology applied to practice a method that may include a natural phenomenon or law of nature.
She added that in the court’s view, the application of conventional techniques to the use of a law of nature of natural phenomenon will not satisfy Myriad or Prometheus: “Thus, under this decision, use of techniques such as PCR [polymerase chain reaction] or immunohistochemistry will not rescue a claim only reciting a natural phenomenon or law of nature.
“However, modification of an existing technology in an unconventional manner or the application of a new technology (such as a novel antibody or technique) would appear to be a move toward satisfying the new patent-eligibility standard and could distinguish this holding.”
