In 1980 the U.S. Supreme Court ruled that genetically engineered, human-made products were eligible for patent protection. A decade later, the U.S. Patent and Trademark Office (USPTO) was awarding protection on not only synthetic and engineered segments of DNA but also unchanged DNA that had been isolated from cells. The ability of researchers to patent isolated, unaltered DNA has been a major source of criticism in patent law. And so it is with much controversy that this issue has been opened for another round of discussion in a recent amicus brief issued by the U.S. government.
The brief, which concludes that unaltered DNA should not be eligible for patent protection, was prompted by multiple lawsuits that have been filed in the United States and Australia against patents held on the genes BRCA1 and BRCA2, which are associated with breast cancer and ovarian cancer. Patents on these genes, which are held in several countries by the biotech company Myriad Genetics, have been highly controversial. In 2004 in Europe, for example, opposition to Myriad’s BRCA patents resulted in revocation, on the basis that the patents were too broad and thus hindered freedom of research and medical care. The patents were restored in 2008.
Earlier this year, the Myriad patents fell under fire again, when a New York district court ruled that claims were invalid in seven patents filed by Myriad and the University of Utah Research Foundation (UURF). The patents were filed on a genetic test for susceptibility to hereditary breast and ovarian cancer, based on the detection of mutations in BRCA1 and BRCA2.
The court’s ruling against Myriad and UURF was unsettling for the biotech industry, which in recent years has made a living on gene patents, particularly since 2001, when the USPTO added Utility Examination Guidelines to the patent process. These guidelines essentially justified all patents on unaltered genes, removing them from the debate about whether such genes, when isolated from cells, are still considered products of nature or are somehow different, which would render them patentable.
The recent litigation and amicus brief have renewed long-standing debates in bioethics, particularly about where the line should be drawn for patent protection on living entities. The challenge lies in balancing profitability for biotech companies with the recognition that genetic material makes life possible and is common to all species. The brief suggests that attributing “ownership” of human genes to single companies does not represent the best possible scenario for research or medicine and could force an extensive reexamination and subsequent overhaul of current gene patent law.
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