Full Court Finds Dis-Harmony in Trial Judge’s Judgment

In Ariosa Diagnostics Inc v Sequenom Inc 2021 FCAFC 101 the Full Court of the Federal Court (FCAFC) rejected Ariosa’s appeal against the trial Judge’s finding that Sequenom’s non-invasive prenatal diagnosis patent is valid, but held that the trial Judge erred in finding some of the patent claims infringed.

The claimed invention related to non-invasive prenatal diagnosis methods by detecting foetal nucleic acids in serum or plasma from a maternal blood sample based on the surprising and unexpected finding that foetal DNA is detectable in maternal serum or plasma samples. Prior to the discovery it was known that whole fetal cells circulate in the blood of a pregnant woman and laborious techniques had been developed to distinguish those from maternal cells. However, it was discovered that cell-free fetal DNA (cffDNA) could be detected in the plasma and serum within the blood of pregnant women, and Sequenom used that discovery to claim various non-invasive prenatal diagnosis methods.

Sequenom claimed that Ariosa infringed 12 claims of its patent by conducting a non-invasive prenatal diagnostic test known as the Harmony Test and that by licensing other parties to use the Harmony Test Ariosa is a joint tortfeasor in infringement by those other parties. Ariosa cross-claimed that the patent is invalid for the following reasons: (a) the relevant claims are not for a manner of manufacture; (b) the claimed invention lacks an inventive step; (c) the relevant claims are not useful; (d) the relevant claims are not fairly based; (e) there is a lack of sufficiency; and (f) the claimed invention was obtained by false suggestion or misrepresentation. The trial Judge found all but one of the asserted claims to be valid and infringed by the use of the Harmony Test.

On appeal before the FCAFC Ariosa claimed that the remaining 11 asserted claims are invalid due to not being a manner of manufacture; not being fairly based; and lack sufficiency, and also claim that aspects of the Trial Judge’s infringement determinations are wrong.

Regarding manner of manufacture the trial Judge found that the subject matter of the patent avoided making claims to cffDNA as a product or to its presence as such claim types had been held impermissible by the High Court in D'Arcy v Myriad Genetics Inc 2015 HCA 35 (see summary here). In contrast, the trial Judge found the method claims made practical use of the discovery in methods that involve human mediated discrimination between cell-free maternal and fetal DNA in an artificially prepared plasma or serum sample extracted from a pregnant female. Given that cffDNA in the maternal blood has not and cannot be detected without human action the invention claimed adds to human knowledge and involve artificially created state of affairs and has economic significance on account of the considerable advantage the method provides over pre-existing foetal DNA detection methods. As such they were held to be a manner of manufacture within the scope of the principles given in National Resource Development Corporation v Commissioner of Patents [1959] HCA 67. The trial Judge went on to hold that the patent would not have a chilling effect as its boundaries are clear and commensurate with the invention described and couldn’t be innocently infringed, and further that the finding on manner of manufacture is consistent with or distinguishable from that in other jurisdictions.

On appeal Ariosa submitted that the trial Judge neglected to ask whether that end result involved an artificial effect, which Ariosa answered in the negative after characterising the invention as simply information about the DNA of the foetus. They further submitted that apart from involving the discovery that cffDNA is detectable in maternal serum or plasma the claims only involve the use of known methods and so simply claim the identification or discernment of the naturally occurring phenomenon.

The FCAFC found Ariosa’s approach tends to obscure the correct identification of the invention, as the invention does not lie in the mere observation that cffDNA is to be found in maternal plasma (or serum) and held that the trial Judge was correct in holding that the end result of the method is not just the “information” encoded by the naturally occurring cffDNA itself. Rather, correctly understood, the invention lies in the explanation of how to extract the cffDNA from the plasma or serum. It is the idea coupled with a practical means of application that makes the invention, and it is impermissible to disaggregate the integers of the method to point only to the cffDNA as the invention.

The FCAFC rejected Ariosa’s insufficiency arguments in which it had sought to segregate the invention into three separate methods - the qualitative method the correlative quantitative method and the comparative quantitative method – and then argue that the latter two had not been enabled by the description. The FCAFC found that approach unjustified on the basis that there is only one invention described and the patentee only has to provide one means of utilizing the invention provided the person skilled in the art can produce something within each claim without new inventions or additions or prolonged study of matters presenting additional difficulty. The FCAFC considered Ariosa’s segregation of the invention to artificially narrow its scope, agreeing instead with the trial Judge that the description discloses a method of detection that can be used in several ways.

Ariosa also challenged the trial Judge’s finding of infringement during the period when third parties would send blood samples from Australia to Ariosa in the United States, who would then conduct the Harmony Test and report back the results via a file sharing platform.  The primary Judge noted that the term “product” in the definition of “exploit” is not defined in the Act and construed the term to cover anything resulting from the patented method that can be commercially exploited. Consequently, the trial Judge found that the Harmony Test results constitute a “product” resulting from the use of the method of the patent and so held Ariosa infringed by importing, supplying, offering to supply or otherwise disposing of the Harmony Test results in Australia. Ariosa contended that the trial Judge erred in that conclusion and also contended that the Harmony Test results should not qualify as a “product” as they are merely information.

The FCAFC agreed with Ariosa, finding that the trial Judge’s construction of “product” in the context of the definition of “exploit” for a process claim was too broad as it does not recognise that not all methods or processes will lead to a product resulting from their use. The trial Judge’s finding that the Harmony Test results were a product was also considered to lead to undesirable results by allowing oral communication of the result to potentially constitute infringement and would be counter to the patent law principal that a claim to mere information is not patentable.

Author: Quinn Miller

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