This past week in Cancer Voices Australia v Myriad Genetics, the full bench of the Federal Court upheld the decision that human genes are patentable.
In this Alert, Partner Hayden Delaney and Associate Hayley Tarr explore the possible consequences of this recent Myriad Genetics decision for genome sequencing innovation.
Key points:
- Given the pace of technological advancement in the field of genetics, it is insufficient to evaluate the legal developments as against what is currently possible. Rather, we must think a step ahead to what will soon be feasible.
- When factoring in what will soon be feasible, the patenting of human genes may impede development and use of new gene sequencing technologies.
- This may interfere with medical research more than even Cancer Voices Australia have anticipated.
Patenting of human genes
To be patentable, an invention must comprise an artificially created state of affairs. The full bench of the Federal Court held that isolated genes do not exist in nature and are therefore an artificially created state of affairs. In this way, even though a gene is patentable, you do not infringe the patent simply by existing. Nor do you infringe the patent each time your cells reproduce and therefore create a new copy of that gene. This is because, all of this occurs while the gene is part of the genome. The monopoly granted by the patent only exists where the gene is separated from the genome.
For organisations such as Cancer Voices, even this narrowed scope of monopoly is hugely objectionable. The primary use for genes which have been separated from the genome is for medical research. Thus Cancer Voices and other critics of the Myriad Genetics decision argue that patents over human genes increase the cost of medical research using those genes. This, in turn, delays the discovery of new treatments or renders them inaccessible (due to affordability issues).
Yet, others are less concerned, citing reasons why the impact will be minimal. They claim that important genetic research techniques will remain unaffected.
Gene sequencing - how it's done
One such important research technique that is currently popularly thought will remain unaffected is genetic sequencing, such as is done by organisations such as Queensland's Diamantina Institute. Genetic sequencing is a method of sequencing a person's entire genome, to diagnose disease or identify any predispositions for a disease. Genetic sequencing is now both affordable and readily available, and is set to become a standard component of all medical treatments in the very near future. This is the new age of medicine.
Genome sequencing will almost certainly revolutionise medical treatment. Once a person has had their genome sequenced, doctors will be able to tailor their medical treatments in light of their genome. Given that the majority of adverse drug reactions arise in persons with unexpected gene variations and that the difference between success or failure of a medicine in targeting a particular cancer boils down to the specific genetic mutation causing that cancer, this targeting process will have profound effects in terms of whether many patients either live or die.
In layman's terms, the current technique for sequencing a genome is to cut the genome up into millions of tiny pieces and then have a computer reassemble those pieces like a puzzle. In putting those pieces of the puzzle together and seeing where they fit, the computer realises the sequence of the genome. There are problems with this technique however, and scientists will be looking to improve upon it.
Currently, most whole genome or whole exome sequencing is conducted by first splicing the DNA sequence into such small fragments that no single fragment comprises an entire gene. Thus, no genes are isolated from the genome, meaning that human gene patents are not infringed.
Once the small fragments have been created, computers are then enlisted to recreate the genome by aligning the small fragments (by matching the overlapping nucleotide sequences that exist on the ends of each of the small fragments). This has inherent problems associated with parts of the sequence that repeat. Computers cannot tell where the genetic material has been spliced and errors occur in the recreation process.
Genetic sequencing - how it could soon be done
One way of rectifying this would be to move to splicing the gene at the start of the actual gene locus, by splicing at a promoter region for example. Obviously, if we knew how to do this, we would be doing it already. It would simplify the gene sequencing process dramatically.
Researchers are no doubt brainstorming and experimenting with methods to achieve this desired outcome. Given the rate of advancement in genome sequencing methods to date, with the cost of sequencing of a human genome dropping from $3 billion dollars to $1000 in the last decade alone, it would not be surprising if the efforts of these brilliant researchers results in technologies such as this sooner than we might expect.
Achievement of this desired outcome would unfortunately cause new problems to arise because complete genes would then be isolated from the genome during the gene sequencing process, resulting in infringement of human gene patents.
Summary
Therefore, granted, it is true that whole genome sequencing and whole exome sequencing does not currently result in infringement of human gene patents because our existing sequencing techniques require that we splice the DNA into such small fragments that no full gene is isolated. Nevertheless, just because this is the current state of affairs does not obviate the need for any further thought on the matter. We should heed that science is changing. Methods of sequencing are changing. And as these changes occur, we will need to keep up. We should be looking ahead to the advancements that are likely to take place in the near future, and have some idea of how the law might react and accommodate such advances.
When we do this, will it dawn on us that as we progress our sequencing technology, human gene patents may provide an obstacle to advancements in the techniques used for whole genome or whole exome sequencing?
As this improvement occurs, can we be so sure that genetic sequencing will remain unaffected by the Myriad Genetics decision?
Is our current blasé attitude realistic, or short sighted?
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