Australia's Federal Court recently decided that gene patenting is permitted in Australia, yet in the USA, "a landmark ruling by the US Supreme Court in June 2012 declared that naturally occurring DNA sequences were ineligible for patents in a case that involved the same breast cancer gene, and the same patent holder." This is despite there being an estimated 4,000 gene patents in the United States!
Rodney Scott, Professor of Genetics at University of Newcastle, Australia states that:
1. Genetic patents hinder, or don’t foster, innovation.
2. Patents have traditionally been granted for isolated genes rather than for any kind of innovation.
3. Gene patents for tests create monopolies that lead to high prices.
4. Monopolies lead to a lack of quality assurance.
Thank you for posting this very interesting article. It’s hard to understand why the Australia Federal Court would not agree with the arguments that the US Supreme Court found to be convincing, and also outlaw patenting of human genes. This ruling doesn’t impact CLL patients directly, since there is currently no gene in which mutations are known to cause CLL.
However, CLL is more common among people of Ashkenazi Jewish ancestry, who are also at increased risk of having one of three particular mutations in the BRCA1 and BRCA2 genes that cause hereditary breast and ovarian cancer. The fact that Myriad Genetics is allowed to continue their patent in Australia means that the cost of genetic testing for these mutations will be high, at least until their patent runs out.
Coincidentally, an article in the NY Times last week, reports that a recommendation by certain medical geneticists that all women of Ashkenazi Jewish descent be screened for these three mutations even if they do not have a prior family history of breast cancer. See nytimes.com/2014/09/05/heal...
Two personal stories regarding testing for the BRCA1 and BRCA2 genes:
1)I used to work in the field of medical genetics in Seattle, and once attended a meeting in which Dr. Mary-Claire King spoke. She is the researcher who first identified mutations in the BRCA1 gene as a cause of hereditary breast and ovarian cancer (and also the author of the study discussed in the NY Times article). Her discovery was sold by the University of Washington to Myriad Genetics, who then patented it. Selling such discoveries is commonly done in the US, as a way to support universities. Given that taxpayer money funded Dr. King’s discovery, selling it to a for-profit company does not seem right to me! She said that she was now only allowed to do a certain number of tests/year for her research. Other labs that wanted to offer the test could do so only if they paid a very high royalty to Myriad, which would increase their costs dramatically. Dr. King’s BRCA test cost her about $300 in equipment, reagents and staff. Myriad was charging over $3000 for the same test! She was understandably quite angry about this!
2)I am of Ashkenazi Jewish descent and had the targeted genetic test for the 3 “Ashkenazi Jewish mutations” done about 6 years ago. Happily the results were normal. My physicians said it was not necessary, but a genetic counselor colleague said it was indicated, and ordered the test for me. We had to fight with my health insurance company for months to get them to partially pay for the test, and it still wound up costing me several hundred dollars. The total cost charged by Myriad was close to $1000 (This was cheaper because they only did targeted mutation analysis for the three mutations, rather than sequencing the entire two genes)
The NY article quotes: “This will raise questions among Ashkenazi Jewish women and men about what they should do personally, and that’s a very difficult question to answer,” Dr. Lichtenfeld said. “People who think they should be tested really need to be appropriately counseled about the potential benefits and the potential risks.” This was my argument against the direct-to-consumer genetic testing is offered by 23andMe for carrier status for certain genetic diseases, since genetic counseling is not included in their service. And unfortunately, most physicians do not have the training to provide adequate information about these tests. I asked two of my physicians whether I should have the test done, and both said it was not necessary.
Roberta, thanks for sharing both your professional and personal experiences with the patenting of human genes, reinforcing the author's first and third points. I too have an issue with tax payer funded research benefiting for-profit companies at the expense of the tax payers that paid for that research. It's a pretty sad state of affairs too, when the original researcher is also constrained from further research to protect that intellectual property sale of tax payer funded research. Hopefully universities will get smarter at finding ways to commercialise research that returns dividends to the original investors - the tax payers. Sadly it does seem that for profit start-ups are better at commercialising new discoveries than publicly funded employees.
John Liddicoat, Research Fellow and Dianne Nicol, Professor of Law, both at the University of Tasmania have provided an update on the status of gene patenting in Australia, referencing what's been happening in Canada and the United States -
Gene patents may sound scary but soon they may no longer matter:
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