Australia’s Latest Position on DNA-Based Detection: Fetal DNA Detection Patent Confirmed

The full Federal Court confirmed that the subject matter of a patent for the detection of fetal DNA in the mother’s blood plasma is patentable, but the importation of the results of tests carried out abroad did not infringe .

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

The decision comes amid a worldwide disagreement on the matter: the equivalent patent was found invalid in the US on the basis that it claimed unpatentable subject matter and in the UK the equivalent patent was found to be valid, under a slightly different test for the subject matter patentable. The Full Court decision upholds Australia’s position and further clarifies the limitations of the High Court’s decision in D’Arcy v Myriad that isolated natural DNA sequences were not in themselves patentable.

The Full Court also ruled that while the patent was valid and infringed by performing tests in Australia, it was not infringed when blood samples were sent overseas for testing and the results were forwarded in Australia. Indeed, the test results were considered as mere information and not as a “product” in the context of the exploitation of the patent.

The patent for the detection of fetal DNA

Sequenom, Inc is the owner of Australian patent no. 727919 (the “Patent“) which relates to non-invasive prenatal diagnostic methods for detecting the presence of fetal DNA in serum or plasma taken from a sample of maternal blood. The patent follows the discovery that fetal DNA was present in plasma pregnant woman’s blood and serum, creating the potential for prenatal genetic testing without the need for amniocentesis risks.

Claim 1 of the patent claims “A method of detection performed on a sample of maternal serum or plasma taken from a pregnant woman, which method comprises detecting the presence of nucleic acid of fetal origin in the sample”.

Ariosa Diagnostics Inc has marketed a non-invasive prenatal test, the “Harmony Test”, which was performed under license in Australia by Sonic Healthcare Limited and Clinical Laboratories Pty Ltd. For a while, Sonic and Clinical Laboratories also sent Australian samples to Ariosa. who performed the harmony test on these samples in the United States and then reported the results to Sonic and Clinical Laboratories. The harmony test involved the amplification and analysis of fetal DNA from a maternal blood sample to screen for genetic diseases, reporting the presence of aneuploidy and, if so, the sex of the fetus.

Sequenom sued Ariosa, Sonic and Clinical Laboratories (collectively, the “callers“) alleging that the test of harmony infringed the patent. The appellants counterclaimed for revocation. At first instance, the appellants did not establish the invalidity of all but one of the claims of the patent and Sequenom obtained successful in its action for infringement of all claims except this claim, the appellants appealed to the full Federal Court.

Patent claims were on the right side of the line between the discovery of a scientific fact or law of nature and an invention

The appellants argued that the invention in each claim of the patent was not a “method of manufacture” as required by the Patent Act of 1990 and therefore was not patentable. They argued that even though the claims were framed as methods of detection or diagnosis, the invention was in substance a mere discovery of a natural phenomenon (being the presence of fetal DNA in maternal plasma or serum). Referring to the High Court in the Myriad case, the appellants further argued that, correctly understood, the end result of the claimed invention was merely information and, therefore, there was no state of affairs created. artificially as required to meet the “manner of manufacture” test under the Patent Act.

The Full Court rejected the appellants ‘argument, finding that the appellants’ approach obscured the correct identification of the invention – not the mere observation of fetal DNA in maternal plasma or serum, but also the context. explaining how this knowledge could be used. . The Court observed that “It is the idea coupled with a means of practical application that makes the invention.” The Full Court distinguished the Myriad case, holding that the relevant claims did not relate, in essence, to genetic information, but to a method involving the practical application of a means of identification and discrimination between maternal DNA and fetal. Although fetal DNA is present in nature, the substance of the invention has been do not fetal DNA itself, but the identification of that particular nucleic acid as part of a method. Notably, the Full Court stated that “The claimed invention is not simply a result, but the process of detection which produces a result. It is the very type of subject considered to lie on the correct side of the line between the discovery of a scientific fact or the law of nature and invention.

In determining the “yield” of the claimed invention, the Full Court also rejected the appellants’ arguments that the result of the method was mere information which could not constitute a method of manufacture. The Plenary Court held that it was inadmissible to separate the method from the result and that the request, correctly constructed as a whole, necessarily involved an artificially created state of affairs producing a result of economic utility.

Although the Full Court found the patent claims to be valid, it cautioned that not all methods of providing information will be patentable and that examination of patentable subject matter does not involve a one-size-fits-all approach. However, this decision reassures patentees that post-Myriad diagnostic methods that involve the detection of natural DNA remain patentable in Australia.

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

Patents equivalent to the one in dispute in this procedure have been the subject of litigation abroad. Notably, the invention was considered patentable in the United Kingdom but not in the United States. In rendering its judgment in the Australian decision, the Full Court held that there was no real prospect of the international community of patent decisions becoming out of sync because “disparate approaches are being taken abroad on the question of patentable subject matter, involving different tests, none of which is of the same form as that which has been developed in Australia. “The Court further stated that” the legal analysis developed in recent years years in the UK (and Europe) and the US diverge 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 natural materials.

Other grounds and result on validity

The Full Court also rejected the appellants’ arguments that the patent claims were invalid for want of sufficiency and fair basis. On sufficiency, the Full Court rejected the appellants’ arguments that the High Court’s ruling in Kimberly-Clark requires an investigation to determine whether there is more than one “true embodiment” of a disclosed invention. . In considering these aspects of the decision, it should be noted that the applicable patent legislative regime was that which predated the “raising the bar” amendments to the Patent Act of 1990.

Providing the results of tests carried out abroad did not infringe the patent

At first instance, the senior judge (Justice Beach) held that an approach whereby blood samples were sent to the United States where Ariosa performed the harmony test, before returning the results (in paper or electronic form) ) in Australia (the “send model“) infringed the patent. On appeal, the appellants argued that in the case of the send model, the senior judge erred in finding that the consignment model was infringed because the results of the harmony test which were returned to Australia were in substance information only and did not constitute a “product” within the meaning of the definition of “exploit” in the Patents Act 1990.

The term “product” is not defined in the Patent Act. However, “operate” is defined as follows:

“feat, in relation to an invention, comprises:

(a) where the invention is a product – making, renting, selling or otherwise disposing of the product, offering to make, selling, renting or otherwise disposing of it, using or letting it ‘import, or keep it for the purpose of doing any of these things; or

(b) where the invention is a method or process – using the method or process or performing any act mentioned in paragraph (a) with respect to a product resulting from such use. “

The appellants were successful on this ground of appeal. The Full Court disagreed with the conclusion of the trial judge that a “product” in the sense of “to exploit” covers “everything which results from the patented method which can be exploited commercially”. In rejecting this conclusion, the Full Court noted that the meaning of “product” must be determined in the context of the definition of “exploit”. In such a context, the Plenary Court noted:

  • the definition of “exploit” in (b) of the definition of “exploit” requires that a product results from the use of the process or process of the invention, suggesting that the process or process should be that which produces the product; and
  • the language and notion in (a) of the definition of “exploit” consisting of making, renting, disposing and conserving, most naturally connote acts performed with tangible things.

The Plenary Court also observed that cases relating to the method of manufacture indicate that it is possible that the use of a method or a process will not result in any product of any kind. For example, in the founding case of NRDC, there was no “product” in the use of a selective herbicide to kill weeds, even though the result of using this invention was something resulting from the method that could be exploited commercially.

Finally, the Full Court noted that mere information is not patentable subject matter and the fact that this information may be derived from a patentable process or method cannot make the information itself patentable. Allowing simple information to be a “product” in the definition of “exploit” could also lead to results that are not meaningful. For example, if the oral communication of the result could be an offense and a person who had heard that result (which the Court said could be as simple as “it’s a girl!”) – arrived in Australia with this information – the person could infringe by importing this information.

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