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D'Arcy v Myriad Genetics Inc [2015] HCA 35 BRCA1 gene patent revoked

On 7 October 2015, the High Court of Australia unanimously upheld an appeal concerning a patent over the “isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide” and in the process, revoked Myriad Genetics Inc’s patent over the BRCA1 gene.

This case concerns the interpretation and application of “manner of manufacture” in section 18 of the Patents Act 1990 (Cth) which provides as follows:

“Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:

(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies”

“Manner of manufacture” had recently been considered by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 253 CLR 284 (“Apotex”). Apotex followed National Research Development Corporation v Commissioner of Patents (1959) 192 CLR 252 (“NRDC”), and had established what had been viewed as a de facto rule that, for an invention to be patentable as a manner of manufacture, the product had to:

  1. Be a product that consisted of an artificially created state of affairs which had economic significance; and
  2. If a process did not produce a new substance, result in a new and useful effect so that the new result is an artificially created state of affairs providing economic utility.

This extension to the concept of manner of manufacture was the focus of the arguments in the Federal Court where it was held that, based on those “tests”, the isolation of the relevant gene was an artificially created state of affairs such as to be patentable. This necessarily focused on the issue of whether the gene was a product of nature (the gene is merely replicated and extracted from DNA) or an artificially created product (the isolated gene is not naturally occurring).

In D’Arcy, the High Court clarified that:

  • The terminology of “artificially created state of affairs of economic significance” in NRDC was not intended as an exhaustive formula to determine if there was a manner of manufacture;
  • The significance of NRDC was that it permitted the extension of “manner of manufacture” on a case by case basis; and
  • The High Court’s decision in Apotex did not lay down a formula that required a finding of inherent patentability if the formula was met.

As a result, the High Court highlighted that both the single Judge of the Federal Court and the Full Court of the Federal Court had erred in interpreting NRDC and Apotex as laying down strict rules or formulas that mandated a patent being granted over the particular product.

In relation to the BRCA1 gene patent in question, the High Court noted that any product produced pursuant to a patent must be something that is brought about by human action. In the case of the BRCA1 gene, whatever is created using the patent depended on the characteristic of the human being from whom the gene is isolated (it is not a characteristic shared by all human beings). As a result, the isolation of the gene had nothing to do with the person who isolates it, rather, it was dependent on the person tested.

The High Court also held that focusing on whether the patented product was an “artificially created state of affairs” was, in effect, putting the cart before the horse because the central issue was whether the genetic information was a category of product which could be “made”. The High Court stated that because the existence of the requisite mutations or polymorphisms of the gene is a matter of chance, the gene was not something that was “made” and it was not something “artificially created”.

It appears however, that the driving force behind the decision was the public policy considerations associated with allowing a patent over a gene. In particular, the Court held that:

“where an affirmative application of the concept is likely to result in the creation of important rights, as against the world, to involve far-reaching questions of public policy and to effect the balance of important conflicting interest, the question must be asked whether that application is best left for legislative determination. The patentability of nucleotide sequences derived from human DNA is in that category.”

In particular, the Court believed that there was a real risk that the chilling effect of a patent over the gene “would lead to the creation of an exorbitant and unwarranted de facto monopoly on all methods of isolating nucleic acids containing the gene”.

As a result of this case, it is unlikely that a patent will be granted over a gene unless the Patents Act is amended or a specific enabling Act is legislated by Parliament.

Cowell Clarke has experience in dealing with patent claims and disputes. Please contact us if you would like to discuss this type of matter or any other patent or dispute matter generally.

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