The Justice department issued an appeals court briefing last Friday that has the potential to change the face of patent law and reshape the biotech industry as we know it. After a lower court ruling in March, which overturned several decades of gene patenting policy, Myriad Genetics corporation has appealed the decision, asking the higher court to recognize its supposed right to patent a sequence of the human genome. If the decision is upheld, the biotech industry mainstay of patenting not only isolated human genes, but plant genes as well, could be a thing of the past.
Last year, a conglomeration of medical societies, civil rights groups, researchers and patients sued Myriad and its research foundation at the University of Utah, claiming that the biotech firm's patents on two genes BRCA1 and BRCA2 are unconstitutional and outside the scope of intellectual property rights. The company sells a test for about $3,000 that detects mutations in these genes which signal a high risk of breast or ovarian cancer. In March, United States District Court Judge Robert W. Sweet invalidated the patents.
The case is now being appealed and if the “friend of the court” briefing offered by the Justice Department is any indication, Judge Sweet's decision will be upheld. Their amicus curiae holds that:
"The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth..."
While those within the biotech industry decried the ruling, saying that it will retard progress in the medical field, many researchers feel just the opposite. Without licensing fees from gene patents hampering the process, some experts feel genome sequencing technology can become so inexpensive that anyone could scan hundreds of their own genes for mutations, for the price Myriad charges for two.
Those in and outside the research sphere who oppose gene patenting have observed the draconian policies biotech firms such as Monsanto already exercise in the agricultural field and fear that ownership, in part or in whole, of human genes by international corporations will conflict with their natural rights. Considering that 20 percent of the human genome is already patented, the scenario of companies charging royalties for a couple to reproduce is not that far-fetched.
Myriad argued in its brief to the appellate court that the plaintiffs did not have standing to sue because they were not being accused of copyright infringement. The lower court rejected those arguments, but they could still be used to throw the case out without a legal review of the merits of gene patenting.
If the ruling is upheld, its not clear how (or if) it will be enforced, at least in the short term. According to the New York Times, “The patent office said in a statement that it would not immediately put the policy into effect and would not start denying patents on genes because of pending litigation.” A spokesman further stated the office will “maintain the status quo while this matter is pending resolution by the Federal Circuit Court of Appeals.”