The High Court of Australia is to hear whether Myriad Genetics’ gene patent stands in an appeal by Queensland cancer survivor Yvonne DÁrcy
In September 2014, breast cancer sufferers were devastated at a decision by the full bench of the Federal Court that a private company (Myriad) may have the right to control human genes through the grant of a Patent. The relevant patent document includes a claim to the BRCA1 and BRCA2 genes. If present, the BRCA1 and BRCA2 genes significantly increases the probability of developing breast cancer.
This was reported a win for Myriad, and the owner of the Australian licence for the test, Genetic Technologies. In particular, a statement from the law firm, which acted for Myriad in Australia, said patents drove innovation. “Myriad invested hundreds of millions of dollars in research and development, patient and physician education, insurance reimbursement and operational excellence in laboratory operations which has resulted in a gold standard test, BRAC Analysis, for the testing of predisposition to hereditary breast and ovarian cancer risk at an affordable cost”.
There is a call from a sufferer of breast cancer to obtain finance and an all-out development of a treatment of her type of breast cancer to help many present and future sufferers. This has led to her undertaking an important appeal case, which has been brought before the High Court of Australia today against the decision by the Full Federal Court. This appeal contests the allowability of a patent claim directed to the specific gene sequence defined by BRCA1 and BRCA2. This is said to be an inherent state of nature in the sufferer.
Clearly we can all understand the desire for improved cancer treatments, and want the result of financing an all-out development of a treatment of breast cancer. The question is whether this is the best way?
It appears that this is a valid case. The sufferer is taking one approach to obtaining an outcome of improved research and development in this area.
Competing questions arise of:
- Do we need patents to obtain certainty of commercial monopoly such that large firms will expend dollars in research to obtain the results?
- Otherwise, can we rely on government research bodies and universities to find public money or private donations to be able to fund the required research and development of a cure or treatment?
- A still further option is whether an open source of the gene information will result in multiple research entities undertaking research and development of a cure or treatment?
The granting of a patent generally represents an award system for invention/innovation that improves quality of life for all. This usually means that someone has invested considerable time, effort and expense into inventive ingenuity and application, and in return for a full disclosure of the advance, a limited monopoly right is granted, provided there is an invention over existing art, to exclude others from exploiting the subject matter of a claim of the patent. The patent therefore acts as an investment incentive to the patentee, but might cause a disincentive to a competing firm. Is the commercial balance between these a winning formula? A major issue to remember is that patents are published with all information within 18 months and patents have a maximum 20 year term.
In recent history, Governments are decreasing funding for research and development. Hence more reliance in this space is placed on investment capital, private capital, and donations to research institutes. Therefore Governments may not be able to fulfil their constituents wishes without further taxes or government paid incentives.
Open source and open competitiveness might provide wider application to the problem and quicker and better results. However if there is no patent monopoly reward, we might see less technological advance or technological advance at a less than desirable rate. It is unclear if the pure economic incentive is there but we need to be reliant on social support using medical foundations or the like.
It would appear that we return to the primary distinguishing factor that mere discoveries and pure sciences are usually not patentable while applying that science or discovery provides a patentable result and encourages and fast tracks a practical treatment.
History of the patent system tells us that subject matter of a patent has to be provided through the intervention of woman/man. A product which is inherent in nature therefore cannot ordinarily be the subject of a patent, i.e. should be available to all. The question(s) can be properly asked
- is the isolation of a specific gene sequence proper subject matter of a patent monopoly right even if the presence of which is detected in the human genome and understood to indicate an increase likelihood of breast cancer; and
- what are the alternatives of breast cancer diagnosis and treatment that can be patented?
The High Court is being asked this in a technical way, is a discovery patentable or does it need to be the application of science. It would appear on the face of it that gene sequencing is a discovery – but would we have found it as soon without the incentive of patents?
It is always good to fine tune the balance of the above issues. We all hope the High Court of Australia’s review will give a better result in this balance of no patent and freedom to act or patent and incentivised monopoly, to give the practical result of all out research. This is what we all want.