By GARRETT BAIRD
4:58 PM AKDT, May 11, 2011
A judge’s ruling in the court case ACLU v. Myriad could have a substantial impact on the future of gene patenting in the United States. In March 2010, Judge Robert Sweet ruled that Myriad Genetics did not have the right to patent the BRCA1 and BRCA2 genes because they were products of nature, not inventions. In his decision he said, “Therefore, the patents at issue directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.”
The case ACLU v. Myriad was brought forth on May 12, 2009 when the ACLU and the Public Patent Foundation filed a lawsuit against Myriad Genetics on behalf of more than 150,000 geneticists, pathologists, laboratory professionals, individual researches, breast cancer and women’s health groups, genetic counselors and individual women. Although the main contention the plaintiffs were arguing was that genes are products of nature, not inventions, there are several other issues with gene patenting that make them so controversial.
The first is their interference with research. Gene patents give the right to the patent holder to exclude others from making, using, and selling the invention for the 20 year time period following the issuing of the patent. Anyone who uses a patented gene without permission of the patent holder, regardless of commercial or noncommercial purposes, commits patent infringement and may be sued by the patent holder. This discourages many researchers from doing any research at all in order to avoid patent infringement issues.
A survey in 2003 asked all leading laboratory directors in the United States whether gene patents had prohibited their research or studies. The survey found that 53 percent had “decided not to develop or perform a test/service for clinical or research purposes because of a patent.” Other scientists also share this belief as they fear the rise of an “anticommons” effect, in which scientists would simply avoid research on genes so they don’t have to go through long and expensive negotiations with the many patent holders on a gene.
“I think that gene patents are definitely slowing research down,” said Pamela Diesel, biology teacher at Somerset Area School District. “It ultimately limits the amount of work being done.”
Regis Kelly, executive vice chancellor at the University of California at San Francisco, also weighed in on the matter when he said, “The proliferation of gene patents does create something of a mine field that could inhibit the commercial development of new medicine.”
The second issue with gene patenting is that they create monopolies that inhibit development and charge exorbitantly high prices. In 2005, the average worldwide price for anti-retroviral combination therapies (ARVs) that treat HIV/AIDS cost was about $10,000 per patient. When critical patents for those therapies expired though, the cost decreased to about $168 per patient. This is due to the fact that the patent holders hold the exclusive right to these genes and they therefore can charge whatever price they choose and in the end force many to be denied a treatment or therapy because of the cost.
These two issues, along with the issue that genes are products of nature and therefore cannot be patented under patent law, are evident in the case ACLU v. Myriad. Jan A. Nowak, president of the Association for Molecular Pathology and one of the plaintiffs in the case explains the logic behind why gene should not be patented when she said, “You can’t patent my DNA, any more than you can patent my right arm, or patent my blood.” The other issues in the case is that Myriad Genetics charges over $3,000 for the genetic testing done on the BRCA1 and BRCA2 genes and at one time there was a 12% false negative rate on the testing.
These two issues are a result of the monopoly Myriad Genetics has been granted over the BRCA1 and BRCA2 genes. Myriad can charge whatever price they want and can control which companies can do they testing. In this case, they prohibit any other company from doing the testing and therefore slow development on the testing. This also excludes second opinions from being done, forcing several patients to make rash medical decisions based on one test. Many other patients are denied treatment because they cannot afford the high price or their insurance won’t cover the test.
All of these reasons and issues have resulted in ACLU v. Myriad and the decision by Judge Robert Sweet. The decision to end gene patenting creates much controversy though as many can see the reasons in favor of gene patenting. Diesel says, “I can see why they exist, companies put so much time and money into developing the genes and want some kind of reward for their work but yet at the same time gene patents are beginning to get out of control.”
Although many scientists agree with Diesel that gene patents should be kept in place, the Justice Department has backed up Judge Robert Sweet’s ruling but Myriad Genetics is currently appealing his decision. If the decision is upheld through the appeals process though, the future of gene patenting could very well be at risk.
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