By IPRIA researcher, John Liddicoat

Australia – Patentability of Genes?

A term of reference for the current Senate inquiry into gene patents includes whether naturally occurring gene sequences should be excluded from patentable subject matter. A trigger for the Senate inquiry was that Genetic Technologies, the exclusive licensee of Myriad’s breast and ovarian cancer genes in Australia (BRCA1 & 2), sent infringement notices to some of Australia’s leading cancer research and treatment institutes.

USA – Gene Patent Invalidated

However, Myriad’s BRCA gene patents have since been invalidated by a US court in Ass’n for Molecular Pathology v. United States PTO, Myriad Genetics 2010 U.S. Dist. LEXIS 30629 (S.D.N.Y. Mar. 29, 2010) (Myriad). Subsequently, the invalidation of Myriad’s BRCA gene patents in the US by an American district judge is topical but also causes us to reflect on the state of our own law and question whether the same outcome could be reached here in Australia. The US litigation should inform the current Australian inquiry of approaches to patent law amendments.

The United States Patent & Trademark Office (USPTO) had, prior to the decision, assumed for around 30 years that gene patents, even those with sequences that were identical to naturally occurring genes, constitute patentable material. The recent decision Myriad overturns this assumption.

The Decision

The primary issue in Myriad was whether per se product claims for isolated, and/or purified gene sequences, identical to those in nature, satisfied the products of nature doctrine; there was also an issue of whether diagnostic comparisons of sequences satisfied as a patentable method, but this article will focus on the product claim. The doctrine, which is a product of a series of Supreme Court cases from over 100 years of section 101 of Title 35 U.S.C interpretation, was succinctly articulated by the US Supreme Court in
Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (U.S. 1948)  (Funk) as, ‘manifestations of laws of nature [are] free to all men [sic] and reserved exclusively to none’.

In the landmark case of Diamond v. Chakrabarty, 447 U.S. 303 (1980) the US Supreme Court held that manifestations of natural laws are patentable products when they contain ‘markedly different characteristics from any found in nature’. Subsequently, one of the pivotal arguments in Myriad was whether isolated and/or purified BRCA sequences contain markedly different characteristics to naturally occurring DNA.

Myriad’s primary argument was that the chemical nature of isolated and purified DNA is different compared to its natural counterpart. In particular they argued that cDNA (an “artificial” creation) which is isolated and purified, when compared to genomic DNA is physically quite different. In his decision, Sweet J did find that naturally occurring BRCA DNA had undergone very similar chemical changes in vivo to the creation of cDNA but in deciding whether the isolated sequence had markedly different characteristics focused not on the DNA’s physical composition, but on its function.

Sweet J held that DNA’s function as a carrier of information – directing the production of RNA and proteins – is the relevant characteristic for naturally occurring DNA sequences that must be distinguished. Subsequently, if an isolated and purified gene, that is identical to a naturally occurring sequence is used to make cDNA, RNA or a protein, and the natural characteristics embodied by the sequence do not change, what is being claimed is a product of nature and therefore unpatentable.

Sweet J’s emphases on DNA’s information based characteristics as opposed to its physical characteristics might be most contestable aspect part of his judgment. But beyond the above reasoning, there are several other intriguing aspects to Sweet J’s decision; it is a summary judgment and 20 of the 152 pages in the judgment are devoted to the relevant molecular science.

In view of what is in the judgment, there is more to be articulated about how different isolated sequences may be from their natural counterparts. Similarly there are more detailed arguments to be made about the law, especially about the uniqueness of DNA compared to other chemicals and whether a DNA patent must have a differently encoded function, but we will have to wait for the appeal before we see these issues resolved in full.

Could it Happen in Australia?

s 18(1)(a) of the Patent Act (Cth) dictates that to qualify as patentable subject matter an invention must be a ‘manner of manufacture’ within the meaning of s 6 of the Statute of Monopolies. Relevant to gene patents that mimic nature, the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) has held that to be a patentable manner of manufacture, the invention must ‘consist in artificially created state of affairs’.

In an opposition hearing Kirin-Amgen Inc v Board of Regents of University of Washington (Kirin), the Deputy Commissioner of Patents found that isolated and/or purified DNA satisfied the artificiality requirement from NRDC. Kirin is not a judicial decision, but it does represent IP Australia’s and the conventional wisdom on naturally occurring gene sequence patents.

Moreover, the High Court in NRDC also explicitly diverged from Funk stating that ‘laws of nature’ is too vague a term and only confuses the issue of patentable subject matter. Consequently, a product of nature doctrine has never been found in Australia and accordingly, Australia does not have a judicial history defining the boundaries of such a doctrine.

A result of the rejection of laws of nature doctrine means that an argument emphasising the information and functional aspects of DNA as a product of nature is unlikely to succeed because there is no ‘manifestations of nature’ argument to rely upon. Similarly, in regards to artificially, there is no requirement for markedly different characteristics and as such, genes isolated from their natural environment, regardless of physical changes, will likely pass this low threshold test. Nonetheless, taking advantage of a US expert commentator’s title in a review of Sweet J’s decision, maybe ‘Pigs Fly’ from the US to Australia.

What appears for certain is that the patenting landscape of genes in the US is changing. With Re Kubin last year ostensibly raising the bar on inventive step (or non-obviousness as it is known in the US) and now Myriad, Australia does appear to be diverging from the US in terms of patent laws for biotechnology. If the Senate inquiry wants to prevent patents for naturally occurring genetic sequences, perhaps they should take a more technology neutral stance and consider whether specifically including a US style products of nature doctrine is the way to achieve this.