In a surprising move, the U.S. Justice Department filed a brief last Friday that declared, for the first time, that the U.S. government does not support the patenting of naturally occurring human genes. This new position is contained in a document filed as part of the ongoing legal challenge to the gene patents on the human breast cancer genes, BRCA1 and BRCA2.
As background: a company called Myriad Genetics has held the patents on these two genes since the late 1990s. They sell diagnostic tests that cost nearly $4,000, and if a woman wants to test her own DNA for any mutations in the BRCA genes, they are required to pay for this very expensive test. The gene patents prevent any competitors from offering the same test without paying Myriad a license fee. Earlier this year, the ACLU challenged these patents in federal court, and the initial court ruling, which came as a surprise to many, invalidated the patents. Myriad appealed, and it seems likely this will end up in the Supreme Court before it is finally settled.
I have a scientific interest in this case, having just published a paper that directly challenges gene patents by providing free software that allows anyone to test their own DNA for mutations in the BRCA genes. Our software requires that you first have your genome sequenced, which (of course) is not feasible for most people today, but which I think will be routine in the not-too-distant future.
It seems absurd that, having your own DNA in hand (on a flash drive, perhaps), you wouldn’t be allowed to check your own genes for mutations without first paying a license fee to a company. Actually, under current law you might have to pay hundreds of license fees, because thousands of human genes have already been patented.
The same government that issued these patents has finally woken up to this absurdity. In their amicus brief, the Justice Department wrote:
“the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a ‘human-made invention.’ Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell – that is, the relationship between genotype and phenotype – is simply a law of nature. 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.”
Rarely have I seen such sensible scientific reasoning from lawyers, and I must say it is very refreshing. Just in case the text quoted above is isn’t clear enough, the brief goes on to point out that “the patent laws do not, however, embrace the products and processes of nature itself.” The reason for the bit about “isolated” DNA is that Myriad’s patents cover DNA that has been “isolated” from the cell, and the Justice Department wanted to make it clear that this distinction should not somehow make the DNA patentable.
The legal implications of my own challenge to the BRCA gene patents were discussed at length at Genomics Law Report, and by Forbes blogger Robert Langreth. It will be interesting to see how this latest filing by the Justice Department changes the picture. The implications go far beyond the BRCA gene patents: if the initial court ruling and the Justice Department’s position hold up, then virtually all gene patents, on human genes and on many other species’ genes, will become invalid.
It’s about time. New genes have been the basis of many exciting discoveries, but they are not inventions. No one should have exclusive rights to a gene that occurs naturally in a human, another animal, a plant, or any other living species.
Great post Steve, I agree with you 100% about the patenting of human genes. But I do have one question- many products of nature are, in fact patented, such as natural molecules derived from plants and microorganisms which are subsequently patented by pharmaceutical companies and used as drugs (this includes many antibiotics and anticancer agents). While a great number of these natural molecules are modified in some way to increase their activity, stability, and "patentability" so to speak, many others have been patented in their natural form over the years. How does this composition of matter differ from a naturally occurring gene?
ReplyDeleteThanks. Great post, and great blog. Keep on fighting the good fight.
Microbial: I'm not an expert on biochemistry, so I can't really answer your question about modified molecules. However, if someone has a patent on an unmodified, naturally occurring compound, that sounds like it too would be covered by the new Justice Department opinion. We'll see if the courts agree - the new opinion is just an amicus brief, not a legal ruling.
ReplyDeleteYou can patent efficient purification or synthesis procedures of the naturlly occurring molecules, but you are not supposed to patent the molecules themselves.
ReplyDeleteA quick update: I wrote an Op/Ed piece in the Baltimore Sun on this topic, which appeared in today's (Nov 10) print edition, and which is online at The Baltimore Sun's website as well.
ReplyDeleteSo what if a company produces a molecule which is later found to occur naturally? If it constitutes some type of prior art, I worry that this decision will kill the economic incentive to preserve and record biodiversity.
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