Putting gene patents under the legal microscope

The highest court in Australia has delivered judgment in a divisive case with significant implications for the privacy of medical patients. In D’Arcy v Myriad Genetics^[1] the High Court found in favour of Yvonne D’Arcy, a cancer survivor after D’Arcy challenged a patent over genetic material in partnership with Cancer Voices Australia.

The decision has large implications for the medical research industry as well as the costs associated with testing for various illnesses, and clarifies the status quo of medical patent law in Australia.

Myriad Genetics is a research agency that identifies and collects human genes for the purpose of medical research. Genes are a central part of a cell’s DNA which is responsible for storing information that can have significant impacts on human health.

Myriad collected gene samples from over 13,000 patients. The gene samples were mutated genes known to be found in people with a higher susceptibility to breast and ovarian cancers and in 1995, Myriad Genetics obtained patent in suit over two mutated genes.

Prior to D’Arcy v Myriad, the legality of gene patents had never been tested in Australia. Australian patent law generally prohibits patents over things that are “discovered”, such as plants found in nature, but allows patents over things that are “invented” or altered to be more useful, such as solar technology that imitates plant photosynthesis. Accordingly, debate has been had over the last few years over the brewing legal storm surrounding genetic patents, and the question of whether patented genetic material could be characterised as an invention or a discovery.

In 2010 this issue was put under the microscope when D’Arcy filed an application in the Federal Court of Australia challenging the patents held by Myriad Genetics.  The application argued that the genes which were the subject of the patents were not patentable inventions within the meaning of the Patents Act 1990 (Cth).

The application was dismissed by Nicholas J of the Federal Court. His Honour upheld the patents and reasoned that once genetic material had been extracted from its natural environment within a cell, it could only continue to exist or be used as a result of human intervention. It was deemed to constitute an ‘artificial state of affairs’ which was akin to invention and was thus capable of being patented. On appeal, the Full Court of the Federal Court affirmed the decision of Nicholas J.

D'Arcy appealed and the issues came before the High Court. D’Arcy’s argued that merely isolating a person’s naturally occurring blood does not constitute a manufacture.

The High Court ultimately found that naturally occurring DNA sequences, even when isolated from other human material such as cells, cannot be the subject of patent protection.

The High Court unanimously acknowledged that Myriad identified the location of the genes, and that Myriad had identified the genes’ nucleic acid sequence, collated data related to the characteristics and sites of specific mutations from 13,000 patients.

However, the Court’s decision rested on its finding that Myriad did not create or alter the nucleic acid sequence in the BRCA1 gene. Neither did Myriad create or alter any of the mutations in the genes. Each mutation contained the same information sequence in its native state in the cell as it did when isolated. Myriad’s discovery that specific genetic mutations are indicative of higher susceptibility to breast and ovarian cancers could not constitute patentable material.

Myriad was claiming a patent in the isolated gene which provided a state of knowledge for the person upon which to contemplate, or assess, treatment. The High Court pointed out that what made this possible is the code in the isolated gene. As the information stored in the genetic materials was identical to the genetic information which remained in the person from whom the genetic materials had been extracted, the High Court determined that the extracted genetic materials did not constitute an invention and were not capable of being patented.

The Court also considered the original finding that the genes owed their continued existence and utility to the efforts of external human action. The Court characterised the appropriate question as whether the human activity required to create an artificial state of affairs to ensure the continued existence and utility of the genetic material was sufficient to allow the patents. 

When considering this issue, the High Court considered CCOM Pty Ltd v Jiejing Pty Ltd^[2]. In CCOM, the High Court concluded that a method of production could influence whether something could be patented if the method of production constitutes “a mode or manner of achieving an end result which is an artificially created state of affairs of utility in the field of economic endeavour.

The High Court ultimately found that the emphasis on the chemical changes in the isolated nucleic acid was incorrect. The High Court identified that the process of isolating nucleic acid was not a dynamic process and that it did not make a difference to the coding sequence. In the end, there was no difference between the isolated nucleic acid and the nucleic acid sequence in the body.  The DNA sequences were naturally occurring and did not change when isolated. The Claim was for a monopoly of isolated fragments of naturally occurring DNA and accordingly, the claim extended too far. 

This is the first High Court decision related to the scope of patentable genetic material. The High Court’s focus on the information content of the naturally-occurring DNA as ‘an essential element of the invention as claimed’ would be of concern to the biotechnology industry. This case exemplifies the limitations in the way subject matter is assessed in Australian patent law. Brad Sherman, Professor of Law at the University of Queensland, provided two alternative ways to deal with these issues in his paper discussing gene patenting.^[3] Professor Sherman first highlighted that some of the issues with the approach taken by the High Court is that no criterion were provided to determine how to judge the difference. No guidance was given in relation to the quantitative or qualitative limitations on the type of difference that is needed for something to be determined ‘artificial; and therefore eligible for patent.

One alternative to this approach that was discussed was to abandon the doctrinally focused approach Australian Courts have taken and instead to look at the repercussions of granting or not granting protection. This would require extensive policy analysis and therefore unlikely to be adopted; however, it can be said that policy considerations will likely be taken into account in the current approach by Australian courts.

Another alternative would be to adopt the Europe Patent Office’s approach. The European Patent office adopted the ‘any hardware approach’ where the existence of any type of technology was enough for something to be determined eligible for patent. According to this method, the presence of any technological artefact or process, regardless of how old or lacking in inventiveness is sufficient to pass the threshold.

Although the Myriad litigation clarifies some aspects of the threshold for patent eligibility, a lot of questions remain unanswered as no guidance has been provided in relation to making the determination of patent eligibility any clearer. It will be interesting to see whether any legislative changes are made in response to this decision.