Genes cannot be patented, says US court.
A court ruling has overturned a patent held by Myriad Genetics, a Utah-based laboratory, on two genes involved in breast and ovarian cancer. Until now, patients were required to pay a substantial amount for the test and could not repeat it elsewhere.
Legal Consultant - The US Supreme Court has ruled that human genes cannot be patented. The court agreed with "legions of scientists — and cancer patients — that companies cannot patent what belongs to nature and human beings," in a lawsuit filed by the American Civil Liberties Union (ACLU) against Myriad Genetics Inc., according to reports in Popular Science and LifeNews on Tuesday (March 27).
A laboratory in Salt Lake City, Utah, has patented two genes involved in breast and ovarian cancer. Carriers of the BCRA-1 and BCRA-2 genes are more susceptible to developing these hereditary types of cancer. Men also carry these genes, which increase the risk of prostate, pancreatic, and other types of cancer. Therefore, if a patient needs to be tested to find out if they carry these genes, "they—or their health insurance company—will have to pay a substantial amount to Myriad Genetics," says Popular Science. If the result is positive, but the patient wants to confirm it at another laboratory before undergoing complex and expensive surgery, they cannot do so because the test to identify these genes is patented by the laboratory, unless it is done in another country not covered by the patent.
In its defense, the laboratory argued that genetic research is expensive and difficult and that its work should be protected against misuse by others who did not share the risks and costs of research and development. The company claimed that the patent is a reward for years of research, which is expensive but advances science. But the Supreme Court upheld a district court's decision that the laboratory's work was "to discover the gene, not to create it." And the court repeated the terms of another decision, given a year ago: "The laws of nature cannot be patented," understanding "laws of nature" to mean everything that belongs to it or that governs the functioning of the universe.
This earlier decision, delivered by the Supreme Court last week, overturned the patent granted to Prometheus Laboratories for a test that establishes medication dosages in the treatment of autoimmune diseases, such as Crohn's disease. In the case of Myriad Genetics, in 2010 a federal court judge, Robert Sweet, invalidated the patent. "DNA existing in an isolated form does not lose its fundamental quality, that existing in the body, nor the information it encodes." Myriad appealed and, in 2011, a "divided" appeals court understood differently: "DNA isolated from the body for testing has a different chemical structure than DNA found in the body."
The Supreme Court, in turn, overturned that decision and sent the case back to the lower courts for further proceedings, so that the scientific community can discuss the issue with the legal community. The decision is of great importance to patients with various types of cancer, to healthcare institutions, to physicians involved in personalized medicine, to providers of laboratory tests, and especially to the entire scientific community that conducts cancer research or is involved in the human genome project.
If the ban becomes permanent, it will create a revolution in the country: the US Patent and Trademark Office has been granting patents on human genes for almost 30 years. Most scientists argue that, if the process continues, companies will gradually begin to claim patents and, consequently, ownership of parts of the human body, which can then be commercialized. The laboratories that own the genes may no longer conduct research on them, but they can prevent other scientists from doing so. The scientists heard by the courts believe that the results of all genetic research should be shared with the scientific community worldwide. (João Ozorio de Melo)