Public pressure forced the licensee of the patent to allow labs to test for the genes for free in Australia. He ruled that genes are no different outside of the body than they are inside the body. Trending Latest Video Free. Will health insurance cover the costs of genetic testing?
What are the benefits of genetic testing? What are the risks and limitations of genetic testing? What is genetic discrimination? How are genetic screening tests different from genetic diagnostic tests?
How does genetic testing in a research setting differ from clinical genetic testing? What are whole exome sequencing and whole genome sequencing? What are secondary findings from genetic testing? The court's ruling leaves open the use of cDNA for various purposes. Although most test developers have maintained that cDNA is not critical to providing genetic testing as the technology has advanced, synthetic DNA is still critical to the drug development process.
Harry Ostrer, a medical geneticist at Albert Einstein College of Medicine and a plaintiff in the case, said during a call hosted by the ACLU that now with gene patents invalidated, labs will be able to openly compete to provide testing for BRCA1 and BRCA2 gene mutations, and this will bring down the cost of testing.
Ostrer said that the ruling essentially eliminates sole-source providers for genetic tests, and enables other labs to improve upon existing testing methods. For one of the plaintiffs, the American College of Medical Genetics and Genomics, however, the ruling didn't go far enough.
On behalf of both patients and genetics health professionals, we applaud the decision that human genes are not patentable and hope that this will eventually include cDNA also. But, according to Biotechnology Industry Organization President and CEO Jim Greenwood, the ruling is "a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences.
In addition, the Court's decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions," he said in a statement.
Reasoning that isolated gene sequences were products of nature, he invalidated those claims, noting that the information of interest in terms of diagnosing disease contained in isolated DNA is exactly the same as the information in native DNA. This contributed to the gene patent rush as the human genome project gathered pace in the s and gene discoveries became almost a weekly event.
There are now an estimated 4, gene patents in the United States. The US Supreme Court ruling against gene patents hinged on a decision that isolating a human gene or part of a human gene is not an act of invention, reversing the traditional patent office practice. The decision allows for synthetically produced DNA sequences to be patented.
Commercial genetic testing has been a contentious issue and few companies undertake testing for single gene disorders. This gives them a monopoly and they can set whatever price they like for the test.
This is clearly not a desirable outcome for society because it means we fail to protect vulnerable people who fear they have an illness from exploitation.
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