Latest in Australia's position on DNA-based detection: patent for detection of foetal DNA upheld

The Full Federal Court has confirmed that Sequenom, Inc's invention covering methods for detection of foetal DNA in maternal blood plasma for diagnostic testing is patentable in Australia (Ariosa Diagnostics, Inc & Ors v Sequenom, Inc [2021] FCAFC 101; Clayton Utz acted for Sonic Healthcare Ltd).

The decision comes amid some global divergence on the subject: the equivalent patent was held invalid in the USA on the basis it claimed non-patentable subject matter and in the UK, the equivalent patent was held valid, under a slightly different test for patentable subject matter. The Full Court's decision confirms the position in Australia and further clarifies the boundaries of the High Court's decision in D'Arcy v Myriad that isolated naturally occurring DNA sequences were not themselves patentable.

The Full Court also held that, although the patent was valid and was infringed by carrying out testing in Australia, it was not infringed where blood samples were sent overseas for testing and the results conveyed to Australia. This is because the test results were held to be mere information, and not a "product" in the context of exploitation of the patent.

The patent for detecting foetal DNA

Sequenom, Inc is the owner of Australian patent no. 727919 (the "Patent") which concerns non-invasive prenatal diagnostic methods for detecting the presence of foetal DNA in serum or plasma taken from a maternal blood sample. The Patent followed on from the discovery that foetal DNA was present in the blood plasma and serum of the expectant mother, creating the potential for prenatal genetic testing without the need for the risks of amniocentesis.

Claim 1 of the Patent claims "A detection method performed on a maternal serum or plasma sample taken from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample."

Ariosa Diagnostics Inc marketed a non-invasive prenatal test, the "Harmony Test", which was conducted under licence in Australia by Sonic Healthcare Limited and Clinical Laboratories Pty Ltd. For a period of time, Sonic and Clinical Laboratories also sent Australian samples to Ariosa which performed the Harmony Test on those samples in the USA and subsequently communicated the results to Sonic and Clinical Laboratories. The Harmony Test involved the amplification and analysis of foetal DNA from a maternal blood sample to screen for genetic conditions, reporting on the presence of aneuploidies, and, where requested, the sex of the foetus.

Sequenom sued Ariosa, Sonic and Clinical Laboratories (collectively, the "appellants") alleging the Harmony Test infringed the Patent. The appellants cross-claimed for revocation. At first instance, the appellants failed to establish invalidity for all but one of the Patent claims and Sequenom succeeded in its infringement case in all but that claim. The appellants appealed to the Full Federal Court.

The Patent claims fell on the correct side of the line between discovery of a scientific fact or law of nature, and an invention

The appellants argued the invention in each claim of the Patent was not a "manner of manufacture" as required under the Patents Act 1990 and therefore not patentable. They submitted that while the claims were drafted as methods of detection or diagnosis, the invention in substance was a mere discovery of a naturally occurring phenomenon (being the presence of foetal DNA in maternal plasma or serum). Referring to the High Court in Myriad, the appellants further contended that, properly understood, the end result of the invention as claimed was simply information and, accordingly, there was no artificially created state of affairs as required to satisfy the test for "manner of manufacture" under the Patents Act.

The Full Court rejected the appellants' submission, holding that the appellants' approach obscured the correct identification of the invention – not the mere observation of foetal DNA in maternal plasma or serum but also the context of the explanation as to how that knowledge could be used. The Court observed "It is the idea coupled with a practical means of application that makes the invention." The Full Court distinguished the case from Myriad, finding the relevant claims were not, as a matter of substance, directed to genetic information, but to a method involving the practical application of a means for identifying and discriminating between maternal and foetal DNA. While foetal DNA occurs in nature, the substance of the invention was not the foetal DNA itself but the identification of that particular nucleic acid as part of a method. Notably, the Full Court stated that "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."

In determining the "output" of the invention as claimed, the Full Court also dismissed the appellants' submissions that the output of the method was mere information which could not amount to a manner of manufacture. The Full Court found it was impermissible to separate the method from the result and that the claim, properly constructed as a whole, necessarily involved an artificially created state of affairs yielding an outcome that is of economic utility.

While the Full Court found the claims of the Patent valid, it cautioned that not every method yielding information will be patentable, and that consideration of patentable subject matter does not involve a one size fits all approach. Nevertheless, this decision provides comfort to patentees that post-Myriad, diagnostic methods that involve the detection of naturally occurring DNA remain patentable in Australia.

The international community has diverged on the question of patentable subject matter

Equivalent patents to that in dispute in this proceeding have been the subject of litigation overseas. Notably, the invention has been held to be patentable in the UK but not in the USA. In making its judgment in the Australian decision, the Full Court considered there was no real prospect of falling out of step with the international community of patent decisions because "there are disparate approaches being taken abroad to the question of patentable subject matter, involving different legal tests, none of which is in the same form as that which has been developed in Australia". The Court further stated that "legal analysis developed over recent years in the United Kingdom (and Europe) and the United States diverges from that identified in the line of authorities identified in NRDC, Apotex and Myriad." These comments highlight the importance of drafting and evaluating patent claims on a jurisdiction-specific basis, especially for methods involving DNA or other naturally occurring materials.

Other grounds and outcome on validity

The Full Court also dismissed the appellants' submissions that the Patent claims were invalid for lack of sufficiency and lack of fair basis. With respect to sufficiency, the Full Court rejected the appellants' submissions that the High Court's decision in Kimberly-Clark requires an inquiry into whether there is more than one "true embodiment" of an invention disclosed. In considering these aspects of the decision it should be noted that the applicable legislative scheme for the Patent was that preceding the "raising the bar" amendments to the Patents Act 1990.

Providing results from testing conducted overseas did not infringe the Patent

At first instance, the primary judge (Justice Beach) held that an approach in which blood samples were sent to the USA where Ariosa conducted the Harmony Test, before sending the results (in paper or electronic form) back to Australia (the "send away model") infringed the Patent. On appeal, the appellants submitted that in the case of the send away model, the primary judge erred in finding infringement in the send away model because the Harmony Test results which were sent back to Australia were in substance information only and did not constitute a "product" within the definition of "exploit" in the Patents Act 1990.

"Product" is not defined in the Patents Act. However, "exploit" is defined as follows:

"exploit, in relation to an invention, includes:

(a) where the invention is a product – make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or

(b) where the invention is a method or process – use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use."

The appellants were successful on this ground of appeal. The Full Court disagreed with the primary Judge's conclusion at first instance that a "product" within the meaning of "exploit" covers "anything resulting from the patented method that can be commercially exploited." In rejecting this conclusion, the Full Court noted that the meaning of "product" must be ascertained in the context of the definition of "exploit". In such a context, the Full Court found:

• the definition of "exploit" in (b) of the definition of "exploit" requires that a product result from the use of the method or process of the invention, suggesting that the method or process must be one that manufactures the product; and
• the language and notion in (a) of the definition of "exploit" of making, hiring, disposing of and keeping, most naturally connote acts done with tangible things.

The Full Court also observed that manner of manufacture cases indicate it is possible for the use of a method or process to not yield a product of any type. For example, in the seminal case of NRDC, there was no "product" in the use of a selective herbicide to kill weeds, even though the outcome of the use of that invention was something resulting from the method that could be commercially exploited.

Finally, the Full Court noted that mere information is not patentable subject matter and the fact such information may be derived from a patentable process or method cannot render the information itself patentable. Permitting mere information to be a "product" within the definition of "exploit" could also lead to results that are not sensible. For example, if the oral communication of the outcome could be an infringement, and a person who had heard that outcome (which the Court said may be as simple as "it's a girl!") – arrived in Australia with that information – the person could infringe by importing that information.

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