Where the product of an Australian method patent is unpatentable subject matter, the Full Federal Court of Australia has determined that such patents are only infringed by a third party conducting the method in Australia.

In our article Beyond Borders: Extraterritorial Reach of Australian Patents, we explored the scope of the extraterritoriality of the Australian Patents Act in the determination of an infringement. Amongst our conclusions, we reasoned that based on the decision in Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011 (Sequenom), any product existing in Australia that was produced from an Australian patented method would be regarded as an infringement, irrespective of where the method was conducted. Specifically, the Federal Court held that “product” should be afforded its ordinary meaning as "covering anything resulting from the patented method that can be commercially exploited".

Diagnostic tests

In diagnostic testing, it will be appreciated that “the product” is the result of the testing; that is, information. Accordingly, based on the broad definition of “product”, diagnostic testing conducted by obtaining a sample in Australia, for testing external to Australia (but importing the results of the testing into Australia) will constitute infringement of an Australian patent for the diagnostic test. Since this was precisely the situation in Sequenom, the Federal Court found that its patent had been infringed.

The Sequenom patent

Sequenom’s patent 727919 claim 1 was in the following terms:

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

Amongst the claims enforced by Sequenom, claim 13 was for “detecting the sex of the foetus”.

Using the so-called “send out model”, Sonic Healthcare Limited and Clinical Laboratories Pty Ltd obtained samples of blood from pregnant women in Australia and sent the samples to Ariosa Diagnostics, Inc. in the US for testing. Since the Sequenom US patent had been found unenforceable, Sequenom could not rely on this US patent to prevent Ariosa from conducting its testing. By Ariosa communicating the results of the testing (“the product” of the patented method) to Sonic Healthcare Limited or Clinical Laboratories Pty Ltd, each was alleged to be an infringer.

Full Federal Court of Australia appeal - Ariosa Diagnostics

In Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 the appeal court was required to decide a number of matters relevant to validity, as well as the scope, of “the product”. Since the validity of the patent was maintained, a determination of infringement by the product was critical.

“It’s a girl!”

Recalling that claim 13 related to detecting the sex of a foetus, the court hypothesised:

“…that if the outcome of the test is a “product” then the oral communication of that outcome can be an infringement, and a person who has heard the outcome (which may be as simple as “it’s a girl!”) and who flies into Australia with that information may infringe by importing that outcome.”

Such a result was described by the court as “not sensible”. In particular, it was noted that claims to mere information are not patentable. Further, the court stated:

The fact that such information is derived from a patentable process or method cannot render the information itself patentable. In those circumstances, we do not consider that the word “product” in para (b) of the definition of “exploit” should be interpreted as extending the patentee’s monopoly to information which could not itself constitute patentable subject matter since it would have the unintended and odd consequence of permitting the patentee to obtain patent protection in respect of subject matter that has long been held to be unpatentable.

Product scope?

Whilst this decision clearly excludes information from the definition of “product”, what else might be excluded? In our view, the court’s finding is that information is but one example of unpatentable subject matter. On this basis, any product that does not qualify as patentable subject matter is excluded from the definition of “product”. In addition, it accords with the US position, namely that importation of a non-physical product cannot infringe a patented process or method claim.