Diagnostic Methods in Australia – Patent Eligibility Confirmed

The Full Federal Court of Australia, in Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101, has unanimously upheld the decision that a method of detecting cell-free fetal DNA (cffDNA) in the plasma and serum of pregnant women is patent eligible subject-matter.

Background

In Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, the Federal Court confirmed that diagnostic methods constitute patent eligible subject-matter in Australia. The case related to Australian Patent No. 727919 entitled ‘Non-invasive prenatal diagnosis’. The patent is predicated on the discovery that fetal DNA can be detected from cell-free fetal DNA (cffDNA) in plasma and serum of pregnant women through standard techniques and not only through fetal cells which are obtained through invasive procedures.

For a quick summary, Sequenom (the Applicant) sought relief for infringement of their patent. Ariosa (the Respondent) cross-claimed on a number of grounds (including the patent being non-patentable subject-matter). Ariosa argued that the claims were directed to a mere discovery of a natural phenomenon (cffDNA being detectable in maternal blood) and that there was no practical application in the discovery. Ariosa also contended that none of the claims provided an outcome where there was an artificially created state of affairs. Further to this, Ariosa asserted that even where human intervention may have been involved, the result is information only (e.g., diagnosis).

The Federal Court found that the substance of the claims was not directed to cffDNA per se or the relevant genetic information that existed. Instead, the Federal Court found that the claims were directed to a method whereby the discovery of the existence of cffDNA in maternal blood can be put to practical use. Whilst the invention is based on a naturally occurring phenomenon (the presence of cffDNA in maternal blood), the Federal Court found that it builds on and practically applies this to provide a useful and artificial method of detection of cffDNA, and that this method is of economic significance. Furthermore, the Federal Court found that the invention offered a non-invasive approach for prenatal diagnosis.

The Federal Court found that the claims were valid and infringed by Ariosa. In response, Ariosa appealed the decision.

Present Case

Ariosa relied on the Myriad decision (D’Arcy v Myriad Genetics Inc [2015] HCA 35) to argue that the “substance” of the invention was the mere discovery of a pre-existing, natural state of affairs (cffDNA is detectable in maternal blood). However, the Full Federal Court agreed with the decision of the Federal Court that:

The artificially created state of affairs is the detection of cffDNA in the tested sample. This “product” is, by definition the result of human action and is not naturally occurring. The inventive method does not simply produce an abstract, intangible situation. It is not just the “information” encoded by the naturally occurring cffDNA itself

Furthermore, the Full Federal Court stated that the present claims were not directed to the nucleic acids per se, but:

a method involving the practical application of a means for identifying and discriminating between maternal and foetal nucleic acid. Although foetal nucleic acid occurs in nature, the substance of the invention is not cffDNA itself, but the identification of that particular nucleic acid as a part of a method. It is impermissible to disaggregate the integers of the method to point only to the cffDNA as the “invention”. Identification of the substance of the invention does not involve disregarding material aspects of the claim language. The invention as claimed is not merely output, but the detection process which yields an output. This is the very type of subject matter considered to fall on the correct side of the line between discovery of a scientific fact or law of nature and invention: NRDC at 264

Finally, the Full Federal Court confirmed that:

the invention as claimed carries into effect an idea that the presence of information within the naturally occurring code of a person will be useful. By a process of detection that information is yielded up. The claim construed as a whole necessarily involves an artificially created state of affairs yielding an outcome that is of economic utility. We reject the submission that because, disaggregated from the method, the result of the detection of foetal nucleic acid is information about a naturally occurring state of affairs … [t]he invention as claimed cannot be separated into discrete parts.

This decision has further confirmed that diagnostic methods involving practical application of a natural phenomena is patent-eligible subject-matter. This is in contrast to the position in the United States. The present decision could still be appealed to the High Court of Australia. We will keep you updated as to any further developments. In the meantime, please do not hesitate to contact me if you have any questions or queries.

written by David Tso, Senior Associate

blood vials for testing

 

 

 

 

 

 

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