Wednesday, August 19, 2009

Patent This

Recently there has been an ongoing debate in both the legal and scientific communities, my two favourite communities, over the controversy of gene patenting. Isolating and identifying genes, as well as the uses for those genes, are all becoming increasingly important and these advancements are occuring more frequently with improved technology.

So, what's a gene patent and why should you care? I guess I should start by describing what a patent is for all of those out there who aren't familiar with it, or aware of it's changing standards.

Patents are licenses granted by a government to an inventor to give them more exclusive rights to their invention. Through the courts it allows the prevention of rivals or other people from using or selling a patented invention without permission. It allows the invention to be treated as property and therefor, the patent can be bought, sold rented or hired.
In Australia there are 2 types of patents;
  • "a standard patent gives long-term protection and control over an invention for up to 20 years.
  • an innovation patent is a relatively fast, inexpensive protection option, lasting a maximum of 8 years. The innovation patent replaced the petty patent on 24 May 2001"
Gene Patenting
"A patent is a right granted for any device, substance, method or process which is new, inventive and useful." - government patent site

As can be seen in the quote patents can be given only to something that's both inventive and useful. The "inventive" requirement for patents is one of the major focuses in the debate of gene patenting. Gene patents are "patents that claim genetic materials or biological materials in various ways, either as the materials themselves, and the uses of those materials in various medical and scientific ways." - Luigi Palombi, Law Report
Being able to isolate genes is incredibly important as their use is a key element in a variety of research. Recently there has been a senate inquiry into gene patenting that has been looking at
"The impact of the granting of patents in Australia over human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in an isolated form, with particular reference to:
  • the impact which the granting of patent monopolies over such materials has had, is having, and may have had on:
  1. the provision and costs of healthcare,
  2. the provision of training and accreditation for healthcare professionals,
  3. the progress in medical research, and
  4. the health and wellbeing of the Australian people;
  • identifying measures that would ameliorate any adverse impacts arising from the granting of patents over such materials, including whether the Patents Act 1990 should be amended, in light of the any matters identified by the inquiry; and
  • whether the Patents Act 1990 should be amended so as to expressly prohibit the grant of patent monopolies over such materials." - Senate Website
So essentially what's happened with gene patents so far and what might happen, what that will effect, and then either what can be done to reduce negative effects if gene patenting is allowed or should it be prohibited explicitly in an amendment to the Patents Act.

'An article in 'The Australian
' reported that "Restricting the research use of a gene sequence could delay the development and testing of truly inventive and practical uses of the gene and its protein product for diagnosis and therapy. This would be to the detriment not only of the wider community, but also of the biotechnology industry itself." This can be seen in the following case.

The senate committee was a result from a letter sent out mid last year. The letter was one of a series of letters from an American company called Myriad Genetics demanding that all public labs in Australia cease performing breast and ovarian cancer gene testing within 7 days because it was in violating 4 patents granted to them, and that the Australian company Genetic Technologies was the only Australian licensee.

The test in question was one where they would look for mutations within the specific BRCA1 and BRCA2 genes. The US National Cancer Institute gives the following explanation of the genes;
"A woman's risk of developing breast and/or ovarian cancer is greatly increased if she inherits a deleterious (harmful) BRCA1 or BRCA2 mutation. Men with these mutations also have an increased risk of breast cancer. Both men and women who have harmful BRCA1 or BRCA2 mutations may be at increased risk of other cancers..."
As can be seen from this, testing for the gene mutations is fundamental in identifying elevated risk of breast cancer in men and women.

So if there had been compliance with the demands there would have been the instigation of an exclusionary monopoly on gene testing all throughout Australia. All labs and the hospitals that used these labs woulds be directed to send samples to be tested at the Genetic Technologies' laboratories in Melbourne.

The Country Woman's Association is one of the many groups that are taking part in the senate's hearing. They argue that currently woman can receive these tests at public laboratories and those scans will be done without charge. They say however that if the company were to be granted it's legal rights, and were to assert them as it seems they will do, those scans will be done at a figure closer to $2,100 per test. They conclude that this will not be a public good.

In the ABC law report interview of Patent Lawyer Luigi Palombi by Damien Carrick, Palombi went on to say the following about Gene Patenting;

Luigi Palombi: Strictly speaking, the patent monopoly should only be granted in respect of something that is an invention, and that's one of the things that this inquiry's going to be looking at: are genes in an isolated form — and by that I mean genes that have been removed from the human body or removed from their natural environments — are these inventions? And the scientific community seems to be pretty clear that they're not, and I'm certainly of the view, and I have been for many years as a patent lawyer, of the view that they are not inventions and cannot be inventions, because essentially they are identical or substantially identical to what exists in nature.

Damien Carrick: So you would argue that when scientists identify or isolate a gene or similar sort of material, they are discovering something that already exists, they are not inventing something, and therefore they are not deserving of an exclusive right, which is traditionally seen as a reward for inventiveness.

Luigi Palombi: Well that's correct. In short, a patent is about an invention, and if you don't meet that threshold for whatever reason, you just don't have an entitlement to a patent.

Damien Carrick: Isn't in the modern day, the test a little more complicated? You need to establish these days, in order to get a patent that there is a new and practical use for the sequence that you've isolated, or identified. That is evidence of inventiveness, that there is a practical application sometimes.

Luigi Palombi: Well I don't think it's evidence of inventiveness, it's just evidence of further discovery. Merely linking an isolated gene to a particular function, whether it be in the form of the production of a hormone, or linking it to a mutation which is associated with a particular disease, that's just no more than an extension of discovery, that's still not an invention.

The company is also being fought domestically within the USA on pretty much the same grounds that are in dispute here. There is however a great importance in patenting for the scientific community and the general community if patents are issued appropriately. Patents allow for an increase in investors who see a probable return, these kind of developments aren't free and therefor there needs to be means for financial reimbursement for advancements. However, it comes down to that these are not inventions, they are discoveries. Discoveries, even if they are of something as complex as a gene, can not be patented.

Patents do still play an important part in gene technologies. If something useful is invented using genetic material that achieves a new and useful result then it should be entitled to a patent. Things like vaccines, treatments and things like that are all examples of gene related inventions that can be patented. Palombi argues that some things, like the test for BRCA1 and BRCA2 was "so elementary, so obvious, that it really lacks inventive steps". He claims that this was more a discovery of correlation. Requiring a higher level of an inventive step is something also required to issue a patent.

Even with all this debate, there is debate over whether or not gene patents have had an actual negative effect so far. There have been studies in Canada finding no evidence of any negative effects of patents so far. These studies are restricted however and though they do hold some weight they are limited in scope; they had a small amount of respondents and limited questions being asked. It is clear to me though, that whether or not they had caused problems, if this injunction is forced upon Australian hospitals and labs, there will be.

Word of the Blog
1. a trifling away of time; dawdling.
2. amorous toying; flirtation.
3. a tongue beast?

Video of the Blog
If you thought guns were just generally a bad idea, this ridiculous invention won't be inspiring any hope. Watch till the end for the grenade rounds. No surprise, there are some really offensive comments on the video so I advise not paying any attention to there.