Recently the Australian Federal Court decided to uphold a patent on the genes BCRA1 and BCRA2, both genes are somewhat predictive of the heritable risk of breast cancer and ovarian cancer.
The judge recognised the importance of the decision and ultimately decided that in isolating the DNA from the cell there was a “manner of manufacture” what made the gene patentable.
For more information on the decision I suggest you read this article on the Conversation
This comment in particular added some insight;
Couple of things from someone who makes a living managing and licensing life sciences patents. First, the case doesn’t establish that genes can be patented, it expressly finds that genes as found in the body can not be patented. Genes only become a ‘manner of manufacture’ once isolated, purified, and put to a use (such as diagnosing a disease).
Secondly, the case is about whether isolated, purified DNA/RNA with a stated use can possibly be the subject of a patent. It doesn’t say that every application for such a patent will succeed. The application still needs to establish the other criteria for the grant of a patent; novelty, inventive step and utility.
Thirdly, if you’re a researcher, section 119C of the Patents Act means that the patent can’t hold up research on the gene, and no ‘gene’ patent can hold up research on the gene that it relates to.
Fourthly, the Patents Act makes provision for forcing patent owners to license patents to third parties if they are not acting reasonably in meeting the needs of the public for the patented invention.
On the general policy issue, if companies cannot patent diagnostic tests using genes, they will not develop them. It would be nuts for a company to spend tens or hundreds of millions of dollars on research to develop a test, if it could be copied cheaply as soon as it came on the market. So an absence of ‘gene patents’ doesn’t mean no dastardly multinationals asking to be paid for cancer diagnosis – it means no new tests for cancer diagnosis. Now that would be something for the plaintiff to cry about.
As for the pseudo-metaphysical guff in various commentary about how gene patents involve ‘owning life’ – how, exactly, does a commercial monopoly right over the use of isolated, purified copies of a gene, outside the body, in a necessary and life-saving medical process, result in some insult to humanity? In any event, the Court held that the genes as existing in a person cannot be the subject of the patent right.
I personally quite strongly disagree with this decision, clearly there are legal grounds in which to uphold the patent. However I don’t see how you can patent the gene itself. The gene is a naturally occurring sequence whether it is in the cell or not. I have fears for the future of medicine if these kind of cases continue.
What is your opinion? Leave a comment.