An ongoing legal battle regarding gene patents began in 2009 when the ACLU representing numerous clients sued Myriad Genetics and the USPTO. The dispute is over patents on two genes, BRCA1 and BRCA2, discovered in the 1990s which have a correlation to increased rates of breast and ovarian cancer.
The case subsequently went to the Federal Appeals Court that handles biotechnology patents, the Supreme Court, and was earlier this year remanded back to the Federal Appeals Court. On August 16, 2012 the Federal Appeals Court reaffirmed that gene patents are legal. So, why did the activists lose the legal battle?
Whether you are conservative, liberal, or libertarian, or an expert or amateur patent attorney or molecular biologist; the odds are that you have objections to gene patents and made up your mind based on uniformed opinions. The Federal Appeals Court decided that these arguments are misconceptions and consequently were not very convincing. If you are an activist, do you know what a gene patent actually means? Do you know what actually receives patent protection?
In the law suit, the plaintiffs argued that gene patents violate the First Amendment and are therefore invalid and unconstitutional, because genes are products of nature. The court wisely determined everything is a product of nature, but is not always natural. Man derives baseball bats from the wood of ash trees, then carves them in to a desired shape and receives patent protection.
Similarly, isolated BRCA genes are chemically distinct from natural DNA. In nature, BRCA genes are covalently bonded and from a chemist’s perspective they are different molecules than the isolated version. Although the information in both versions of the genes is identical, the patents are on a physical entity. That entity is a molecule, similar to the naturally occurring molecules insulin, EPO, and penicillin produced by man which have also received patent protection.
Activists routinely refer to ownership of genes which they perceive as immoral. In patent law, however, gene patents do not convey ownership of a gene, rather are a property right guaranteed by the Constitution which temporarily excludes others from receiving financial rewards from a patent holder’s work. In addition, the Thirteenth Amendment which abolished slavery prohibits owning genes.
The plaintiffs also argued that the gene patents restrict scientific research. However, the evidence does not support this claim. A National Academy of Sciences study (2003) conducted by Walsh, Arora, and Cohen found:
"Changes in technology and policy over the last several decades have led to concerns that the patent system may be creating difficulties for those trying to perform research in biomedical fields. However, we find that drug discovery has not been substantially impeded by these changes. We also find little evidence that university research has been impeded by concerns about patents on research tools. Rather researchers managed to adopt solutions or work around the problems through licensing, going offshore, using public data, legal action, and infringement."
Furthermore, according to statistics compiled by Bloomberg News more than 18,000 scientists have researched the BRCA genes publishing more than 9,000 research papers.
The second major dispute of the lawsuit alleges that Myriad’s $3000 screening test for mutations on the BRCA genes is too expensive and restricts access to medical care although it is covered by health insurance. However, a study conducted by Duke University researchers found that contrary to expectations, the BRCA screening test is not particularly costly relative to other tests.
The Duke study found that systemic transaction costs that exist within the medical industry are responsible for high medical costs. According to Genomics Law Report, Myriad’s revenues for the diagnostic test reached over $400 million during the company’s most recent fiscal year. Myriad’s BRCA patents are set to expire in 2015.
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