Myriad possesses seven patents covering two genes associated with an increased risk for breast and ovarian cancer, termed BRCA1 and BRCA2.
Myriad is the only producer of tests designed to detect these genes. According to the April 4th latimes.com article, ''Myriad Genetics: Is it legal to patent a gene?'', the plaintiffs argue that ''Myriad's corner on the market is bad for patients, among other reasons, because it makes it harder for a woman to get a second opinion or analysis on her test results.''
The patent office and Myriad have asked the court to dismiss the case, saying, ''But for the prospect of the patent exclusivity, Myriad Genetics would not have been established and funded by investors'', according to the same article. They also argue ''that the protections offered by patents create incentives for researchers and companies to put in the effort it takes to come up with groundbreaking tests such as the BRCA screens in the first place.''
To split this dicey hair further, what the judges must decide is whether or not it's legal to patent an isolated segment of DNA.
According to the April 5th sltrib.com article, ''Myriad gene patent appeal draws crowd, stirs judges'', a U.S. government attorney posed the following scenario to the three judges: envision a ''magic microscope that would allow them to gaze into and through everything in nature, arguing that no company can legally claim ownership over anything seen though such a lens.''
Essentially, should the judges adopt this ''magic microscope'' school of thought, it would negate Myriad's BRCA1 and BRCA2 patents, and, in the process, overturn nearly two decades of established patent law.
An in depth look at each side of the issue is presented in the April 12th, 2010 latimes.com article, ''Are patients misserved by patents on human genes?''
A plaintiff in the lawsuit, David Ledbetter is director of the division of medical genetics at Emory University School of Medicine. He was quoted as saying: ''I oppose gene patents because I don't believe that any one laboratory should hold a monopoly on a diagnostic test. That prevents normal quality-control procedures and limits patient access to tests.''
''Monopolies prevent patients from getting a second opinion. It is also impossible to evaluate a lab's performance if you can't compare that performance with other labs. Having only a single laboratory provide tests also creates obstacles to innovation and quality improvement.''
''Legally, I also think there are flaws with patenting genes, which are substances that occur in nature. One purpose of the patent system is to stimulate people to invent in areas not covered by patents that already exist. However, it is not possible to invent an alternative to a gene because there is no alternative substance. This suggests to me that it is something fundamental in nature and that it shouldn't be patented.''
An intellectual property attorney at Nixon Peabody specializing in biotechnology, Ronald Eisenstein weighed in on the issue.
"One of the things that has happened in terms of gene patents as the law and the science have evolved is: It's actually pretty hard to get such patents. The human genome has been mapped, and a basic gene patent is quite rare. The heyday when people were getting these patents was 10 years ago.''
''Increasingly, diagnosis is based on correlations with a large number of genes. You need a company like Myriad to spend money to show that it is accurate. The U.S. government is not paying for that. How much money would any company put into validation if anyone could come along and run the test without paying for it? Instead of having more tests available in the absence of patent protection, we are going to have fewer tests.''
Although the judges' decision is not expected for months, no matter the outcome, the issue will undoubtedly play out again, in another courtroom, and society, as the battle of what some see as humanity versus progress rages on.
