In this weekend's reading in The Immortal Life Of Henrietta Lacks we read about the first legal fights over the control, and ownership, of human cellular material. Court battles like these that took place in the early 1970s must seem like old history to you. 1973? The Beatles had broken up, Richard Nixon was President, and Disco was just beginning to define the decade. These are old battles. Surely they must be over, decisions must have been made - legal precedents and business models must have been established. Don't you think?How ironic then, to read about a case going before a federal courthouse in Washington D.C. tomorrow as in April 4, 2011 to settle the same fundamental questions as the ones we read of this weekend: are isolated human genes, and their respective sequences of bases - of As-Ts-Cs and Gs - patentable? More specifically, if a company analyzes and sequences two genes responsible for a percentage of the incidence of breast cancer in patients - and perform research to identify and analyze those genes in patients' cells - can they patent their product?
That is the central argument going before the court tomorrow in the case of Association of Molecular Pathology, et al. v United States Patent and Trademark Office. At stake is a profit potential of billions of dollars.
The company, Myriad Genetics, has sought a patent for a the BRCA1 and BRCA2 gene (Breast Cancer Susceptibililty Gene 1 and 2). The BRCA genes only account for 10-15% of all instances of breast cancer, but 80-90% of those women who have this gene do go on to develop breast cancer. Myriad Genetics discovered and has patented the genes. Only now, an appeals court is asking the federal court to determine if these genes can be patently or not - based on the the argument we read about in TILOHL, that "products of nature" cannot be patented.
Now, what about a "molecular diagnostic product"? Myriad Genetics, claiming a patent on the genes, has developed a product to determine if a woman has either BRCA1 or 2. It's called BRACAnalysis. Clever, huh? Here's the pitch:
"BRACAnalysis® assesses a woman's risk of developing breast or ovarian cancer based on detection of mutations in the BRCA1 and BRCA2 genes. This test has become the standard of care in identification of individuals with hereditary breast and ovarian cancer and is reimbursed by insurance."
Having discovered these genes, Myriad Genetics was awarded a patent on BRCA1 and 2. In 2010, a judge ruled that the BRCA 1 & 2 genes were unpatentable products of nature - and that BRACAnalysis, an offshoot of that illegal patent, resulted from exclusive research that Myriad Genetics did based on that patent. So - the product should not be allowed to be brought to market based on Myriad's "exclusive" rights to research, and develop products from, the BRCA genes.
Confusing? It is confusing to me, too - legal arguments can get pretty dense. Here's some backround.
In late 2009 a group of physicians, patients, and the ACLU, filed a lawsuit against Myriad, claiming that their exclusive patent on genomic information kept knowledge, research, and testing from populations of patients who could possibly benefit from them. In the case of the new test, women who are at a higher genetic risk of having the BRCA genes would be prohibited from testing for it unless they used the Myriad BRACAnalysis product.
The US Patent and Trademark Office countered with an argument defending its decision to award the patent, stating that Myriad had invented something truly beyond anything found as a "product of nature", and as such, was worth protecting with a patent certifying ownership.
In 2010 a judged tossed out the decision, saying that isolated, individual segments (genes) of DNA were no different - just segments - of the whole molecule found in nature. Therefore, he ruled that the patent office was wrong in their decision to award Myriad a patent in the first place.
One analyst viewed this reasoned decision as a reflection of the increasing knowledge and awareness of DNA in our society - that an isolated part is not really different from the whole. It is still a "product of nature". Looking at genes in isolation is representative of our information age. We view things in bits and bytes. Genes are bytes of genetic information.
Monday's decision will determine the availability of this test (and perhaps billions of dollars in profits) to perhaps millions of people around the globe. What do you think? Can we - should we - be able to own/patent genetic information? If not - if we remove the incentive to make a profit from such research, why should companies bother to conduct the research? Is less knowledge, less technology, fewer diagnoses, fewer treatment - the price we ultimately pay for this? Or should we allow Myriad Genomic, and others like them, the right to patent the essence of what it means to be human?
(Don't worry about either side of the argument - chances are it will go to the Supreme Court!)
