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8/11/2015
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2353
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patent law
Recently you may have missed the news that Yvonne D’arcy won her case in the Australian High Court. D’arcy had been involved in legal action against Myriad Genetics, a US biotech firm that developed a test to determine if people have a predisposition towards breast cancer. This was ground breaking stuff — and showed that, at least sometimes, the human will overcome corporate goals.
To discuss why this result is so important, we need to go back to the early years of the 21st century — 2003 to be exact. A quick disclaimer is required here. My medical training is limited to occasionally being able to get a ‘band-aid’ to remain where I want it for a period of more than a couple of hours: so the explanation of why this court case and its implications are important isn’t full of medical English.
In 2003, scientists completed the mapping of the human genome: in essence humans could now read and manipulate the biological codes written in the 3 billion building blocks of who we are and how we exist —
our genome (or DNA). The formal project took 13 years. Although DNA had been identified 50 years prior to the finalisation of the Genome Project, and some items of DNA were worked on prior to ‘the project’, it took a while to work out what the 3 billion building blocks actually did. While it took 50 years to gain the understanding, now that we have it, those with the knowledge can compare what is in your body to what is expected to be there and identify a treatment for
you, rather than for the average person of your age, gender, weight and so on, which leads to less adverse side effects and the better use of resources.
U.S.News
reported:
Genomic medicine may help determine a person's risk of developing several specific medical conditions, including:
Cancer
Cardiovascular disease
Neurodegenerative diseases
Diabetes
Obesity
Neuropsychiatric disorders
Researchers are actively investigating the genomic and genetic mechanisms behind — and developing predictive testing for — such diverse medical conditions as:
Infectious diseases, from HIV/AIDS to the common cold
Ovarian cancer
Cardiovascular disease
Diabetes
Metabolic abnormalities
Neuropsychiatric conditions, such as epilepsy
Adverse drug reactions
Environmental exposure to toxins
It is possible to ask your general practitioner to arrange for your DNA to be mapped to identify potential problems. Before you go rushing down to see your doctor, however, consider this: if you discover that you have a predisposition for a form of cancer, you would have to disclose that information to your partner, your family as well as potentially those that make a business decision to insure you. In addition, in a similar way to saying those that live in Southern Tasmania are less likely than Queenslanders to acquire skin cancer, while you may have a predisposition it doesn’t necessarily follow that you will acquire the particular cancer. In May 2013, actor Angelina Jolie decided to undergo a preventative double mastectomy due to family history of breast cancer, supported by testing that revealed she carried mutated BRCA1 and BRCA2 proteins — indicators of a predisposition towards acquiring
breast cancer. She had no signs of breast cancer when she underwent the operation and while the probability is that she would have developed the condition, it’s not a certainty.
Those who have, or have seen those close to them, endure cancer treatment over the years would be aware that medical advances, such as better testing, have meant that treatments for cancer are more effective and less debilitating now than they were 10 or more years ago. While in the past, it was common for people to lose their hair and be incapacitated for days after treatment; it is a far less common occurrence today. To an extent, this is an outcome of personalised medicine; the science has identified the correct targeting and dosage of the medicine to reduce adverse side effects while still being effective.
Medical science could now go from ‘taking a punt’ on a standardised dose of medicine having a beneficial effect to creating medicine based on the person it is meant for.
Personalised medicine is still in its infancy — there seems to be a lot of potential for further advances. As you would expect however, some of the testing and development for the processes to be used is expensive. And here is the point of this article.
Some companies will develop a process, be it for medicine, software or vehicle safety (as examples) and patent it. According to IP Australia (the Government body that registers patents in Australia),
a patent is:
… a right that is granted for any device, substance, method or process that is new, inventive, and useful.
A patent is legally enforceable and gives you (the owner), exclusive rights to commercially exploit the invention for the life of the patent.
Others may determine that the invention is so important to humanity or their reputation that they decide not to profit directly from the invention. You sometimes hear of ‘open source’ computer software — it is software that is developed by a group and freely available for use by anyone. The theory is that others will improve further on the developed software, to the benefit of all.
Some things cannot be patented: again according to
IP Australia:
You cannot patent human beings or the biological process for their generation, artistic creations, mathematical models, plans, schemes or other purely mental processes.
The Human Genome Project has identified that a piece of protein known as BRCA1 and BRCA2 suppresses tumours in breasts and other organs by trying to fix damaged DNA or destroy what it can’t fix. A company in the USA called Myriad Technologies developed a test to determine the ‘health’ of the BRCA1 and BRCA2 protein and patented the mutated ‘indicator’ proteins that it identified during its research.
Myriad Technologies launched their product that would test for the mutated BRCA1 and BRCA2 protein in 1996. Myriad, a spin off from the University of Utah and others, had a business practice of ensuring exclusivity for its testing product to allow a return of the money that investors placed into the company. Myriad, which commenced operations in 1994, employed around 2,000 people, was publically traded and boasted revenue of USD723.1 million
in 2015
After Myriad had sent a number of research bodies ‘cease and desist’ letters in regard to the identification of mutated BRCA1 and BRCA2 protein, the US Association of Pathologists as well as some researchers took Myriad to court over the patenting of ‘non-patentable material’. After a prolonged period and a number of court cases, the plaintiffs won the final avenue of appeal in the US court system, thus invalidating
the patents.
Yvonne D’arcy — assisted by a well-known legal firm — was going through a similar struggle in Australia. After an appeal to the High Court, she won the case, which ensures that others can supply test kits for the proteins in question. A legal precedent has now been created, making it more certain that the court system will not entertain future claims of a similar nature.
Unfortunately it was not the first time that a company that commercialises medical research had relied on exclusivity to gain a return on their investment.
In 2004, a subsidiary of the Mayo Clinic in the USA commenced offering testing for some auto-immune diseases where the drug dosage had to be managed to ensure benefit to the patient, rather than buying the ‘test kit’ from Prometheus, who licenced the technology embedded in the tests from a Montreal hospital. Prometheus sued the Mayo Clinic subsidiary in the California District Court and lost. The case was appealed through the US Court system leading to the patent being invalidated.
Medical research is expensive and has to be done correctly. That is why it is so expensive. When the product has an unintended side effect, the results can be deadly. Thalidomide was ‘invented’ in 1957 and was routinely given to pregnant mothers in the late 1950s and early 1960s to overcome the effects of ‘morning sickness’ across various countries, including
Australia. Unfortunately, the drug caused a large number of birth defects and miscarriages. While the drug is still in use, regulators across the world introduced controls over the development and usage of drugs as a result of the shortcomings surrounding the inappropriate use of that drug early in its life.
So where to from here? We now have the technology to determine at a human protein level what is needed to sustain a healthy life — and the technology to individually treat people to rectify mutated or defective DNA on a personal level. Unfortunately the research and development of these options is not cheap. Our society operates on the basis that we are all entitled to receive reward for our labour — regardless of the type of labour. By the same token, the cost of research and some profit for the drug development company could preclude the availability of the drug for those without sufficient income.
Yvonne D’arcy and her legal team have made a stand that suggests that companies that go from nothing to over USD700 million in revenue in a period of about 20 years is not equitable or fair to those that cannot afford the testing that is potentially life saving. As a result, the testing for the ‘breast cancer’ DNA should be a lot cheaper due to competition. In contrast the medical development company would suggest to you that they need to make money ‘while the sun shines’ as the next project may cost tens of millions and then be a complete failure at the final hurdle before release.
While no one would want another Thalidomide tragedy, the cost to government of health care in Australia is increasing rapidly. There is a need for proper research, development and testing — all of which costs money. While former Treasurer
Hockey’s claim that ‘The starting point is if our health and welfare and education systems stay exactly the same, Australia is going to run out of money to pay for them’, might be overblown, there has to be a point where the ethics of trying to provide a reasonable quality of life for people and the cost of doing so can balance.
If there were no legal way to protect the investment made in researching, developing and commercialising a test or drug that contains human proteins — and is therefore not able to be patented — would the test or drug come to market? There are other options to commercialise the product and retain some control but they would reduce profit margins. Would that be acceptable to the company shareholders? The dilemma is profit versus human condition. It’s a shame that (in Australia anyway) only ethics towards shareholders is legislated.
What do you think?
The world of medical research and new drugs and tests is a complex one. As 2353 explains, attempts to patent genetic material have been overturned in US and Australian courts but will that slow down essential research if companies cannot protect their ‘discoveries’? There are many conflicting issues involved that need to be guided by medical ethics but do profits or ethics come first?
Next week 2353 continues looking at ethics when he compares the ethical behaviour of some corporations and our government in ‘The year of morals and ethics’.
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