Most people think they own their DNA – “My genes, my body.” Well of course you do. Except when it comes to analyzing those genes. Right now companies own patents on about 2,000 of your genes. Typically they make equipment and/or procedures to analyze them. So far, this is legal in the United States, which is why in the U.S. the Patent and Trademark Office has been granting those patents. Now, in what has shocked some lawyers, a federal judge has ruled against gene patents.
Specifics: Federal District Court of Southern New York, Judge Robert W. Sweet. The case is, technically, Association for Molecular Pathology v. US Patent and Trademark Office. More practically, it’s the American Civil Liberties Union (ACLU) and others versus the University of Utah, the patent holder, and Myriad Genetics, Inc. (Utah, USA) a licensee of the patent. Myriad Genetics holds the patents on two human genes, BRCA1 and BRCA2, both associated with breast and ovarian cancer. The company has developed a diagnostic procedure to detect heritable cancer using these genes. On Monday March 29, 2010 in a 128 page ruling the judge voided the University of Utah/Myriad Genetics patents.
As a matter of precedent, most lawyers and analysts believed that Myriad Genetics owned the exclusive rights to the gene patents and would continue to do so. Voiding the patents changes attitudes, as in inserting a note of fear into the genetics industry, although not necessarily very much else. The ruling will be appealed. An excellent overview of the ruling is provided by John Conley and Dan Vorhaus at Genomics Law Report.
From a judicial point of view – and this judge was definitely aware of the importance of the case and the long-term legal issues that will dog genetic research – one thing stands out: This was a summary judgment meaning that one side’s case was so evidently correct that without a valid protest on the facts by the other side, the judge could immediately draw a conclusion – a summary judgment. This does not happen very often. It is, of course, a bigger than normal win for those in favor of disallowing patents on human genes. In this case, it seems a part of the judge’s deliberate reversal, not necessarily of legal precedent, but of preceding sentiment.
I think for most people who understand the importance of their DNA, their genes, there is a gut reaction: How can someone patent a gene? It’s a building block of everyone’s life? The lawyers would be happy to augment that with a hypothetical situation: What if your family had a number of breast cancer cases, and you wanted to take a test that would reveal if you had the genes for that cancer? And what if the only company in the world that can do the test (because it owns the patents on the genes that cause the cancer), happens to be in [pick your country] and is not allowed selling that test in your country?
This is law and lawyering folks, things are never as simple as they seem. Lawyers love to parse things, sorting them into different categories. Why? Because it’s the details that can separate one case from another, or bluntly, separate winning argument from losing argument. When it comes to genes, there is a lot to parse. For example, patent law usually distinguishes between the original of something (the original genes in this case) and what a process does to the thing. For example, start with a bucket of corn (maize). The corn itself cannot be patented because it is a product of nature. However, grind the corn, mix in some solvents and enzymes, and extract the result (ethanol or some such hydrocarbon), and that process can be patented. As the judge noted, a long history of cases forbids patent claims on laws of nature, abstract ideas, and natural phenomena, which include products of nature.
On the other side, the lawyers in favor of gene patenting say that genes are merely chemicals. The fact that they carry the blueprint of life – their inherent information – is not relevant to a patent. When a diagnostic process uses a gene it uses it in isolation as a chemical – as such, it can’t be considered a product of nature. This argument has already been accepted by the U.S. Patent and Trademark Office and the patent court of appeals (a Federal Circuit court). Judge Sweet now says, no, genes are not just chemicals. They carry information that is vital to everyone. If it were not for that information the diagnostic process (including treating the gene as a chemical) would have no meaning. Furthermore, Myriad did not show that the gene used in their diagnostics was different enough from the original (natural) gene to claim that it was no longer the product of nature.
You see where the parsing gets this? It’s gone from a problem most people would perceive with allowing commercial interests (in fact, one company) to have sole patent on something that is found in all humanity, to an argument about whether the thing in question (a gene) has been processed in such a way that it has little or no connection to the original. One senses there are a lot more arguments to come.
This is one case, in one federal court of the United States and absolutely not the end of judicial line. Still, for the rest of the world, this is an important test case bound to be repeated in many courts in many lands. Despite variations in laws between countries, there are some fundamental points in this issue, which no doubt are covered (one way or another) in the laws of most countries. The idea that articles of nature (air, water, blood) are not patentable is almost universal. Of course, interpretations of what is ‘natural’ will vary – as they do in the United States.
Update: An interesting point is the inevitable collision of two types of genetic analysis over the patent issue. One type, such as Myriad Genetics does their diagnosis on individual or small groups of genes. These companies wish to hold patents on the genes to support their patent on their diagnostic process. The other type of company does a broad genetic analysis, sometimes including the entire genome. These companies, such as Counsyl (California, USA), do genetic screening that will often include genes that are patented. Legally, they would not be permitted to report findings on those genes. There is a utilitarian argument about gene patenting that without it, entrepreneurial research will be unprofitable. Here is a situation where the question has to be ‘unprofitable for whom?’
Surprise verdict in U.S. gene patent case
Most people think they own their DNA – “My genes, my body.” Well of course you do. Except when it comes to analyzing those genes. Right now companies own patents on about 2,000 of your genes. Typically they make equipment and/or procedures to analyze them. So far, this is legal in the United States, which is why in the U.S. the Patent and Trademark Office has been granting those patents. Now, in what has shocked some lawyers, a federal judge has ruled against gene patents.
Specifics: Federal District Court of Southern New York, Judge Robert W. Sweet. The case is, technically, Association for Molecular Pathology v. US Patent and Trademark Office. More practically, it’s the American Civil Liberties Union (ACLU) and others versus the University of Utah, the patent holder, and Myriad Genetics, Inc. (Utah, USA) a licensee of the patent. Myriad Genetics holds the patents on two human genes, BRCA1 and BRCA2, both associated with breast and ovarian cancer. The company has developed a diagnostic procedure to detect heritable cancer using these genes. On Monday March 29, 2010 in a 128 page ruling the judge voided the University of Utah/Myriad Genetics patents.
As a matter of precedent, most lawyers and analysts believed that Myriad Genetics owned the exclusive rights to the gene patents and would continue to do so. Voiding the patents changes attitudes, as in inserting a note of fear into the genetics industry, although not necessarily very much else. The ruling will be appealed. An excellent overview of the ruling is provided by John Conley and Dan Vorhaus at Genomics Law Report.
From a judicial point of view – and this judge was definitely aware of the importance of the case and the long-term legal issues that will dog genetic research – one thing stands out: This was a summary judgment meaning that one side’s case was so evidently correct that without a valid protest on the facts by the other side, the judge could immediately draw a conclusion – a summary judgment. This does not happen very often. It is, of course, a bigger than normal win for those in favor of disallowing patents on human genes. In this case, it seems a part of the judge’s deliberate reversal, not necessarily of legal precedent, but of preceding sentiment.
I think for most people who understand the importance of their DNA, their genes, there is a gut reaction: How can someone patent a gene? It’s a building block of everyone’s life? The lawyers would be happy to augment that with a hypothetical situation: What if your family had a number of breast cancer cases, and you wanted to take a test that would reveal if you had the genes for that cancer? And what if the only company in the world that can do the test (because it owns the patents on the genes that cause the cancer), happens to be in [pick your country] and is not allowed selling that test in your country?
This is law and lawyering folks, things are never as simple as they seem. Lawyers love to parse things, sorting them into different categories. Why? Because it’s the details that can separate one case from another, or bluntly, separate winning argument from losing argument. When it comes to genes, there is a lot to parse. For example, patent law usually distinguishes between the original of something (the original genes in this case) and what a process does to the thing. For example, start with a bucket of corn (maize). The corn itself cannot be patented because it is a product of nature. However, grind the corn, mix in some solvents and enzymes, and extract the result (ethanol or some such hydrocarbon), and that process can be patented. As the judge noted, a long history of cases forbids patent claims on laws of nature, abstract ideas, and natural phenomena, which include products of nature.
On the other side, the lawyers in favor of gene patenting say that genes are merely chemicals. The fact that they carry the blueprint of life – their inherent information – is not relevant to a patent. When a diagnostic process uses a gene it uses it in isolation as a chemical – as such, it can’t be considered a product of nature. This argument has already been accepted by the U.S. Patent and Trademark Office and the patent court of appeals (a Federal Circuit court). Judge Sweet now says, no, genes are not just chemicals. They carry information that is vital to everyone. If it were not for that information the diagnostic process (including treating the gene as a chemical) would have no meaning. Furthermore, Myriad did not show that the gene used in their diagnostics was different enough from the original (natural) gene to claim that it was no longer the product of nature.
You see where the parsing gets this? It’s gone from a problem most people would perceive with allowing commercial interests (in fact, one company) to have sole patent on something that is found in all humanity, to an argument about whether the thing in question (a gene) has been processed in such a way that it has little or no connection to the original. One senses there are a lot more arguments to come.
This is one case, in one federal court of the United States and absolutely not the end of judicial line. Still, for the rest of the world, this is an important test case bound to be repeated in many courts in many lands. Despite variations in laws between countries, there are some fundamental points in this issue, which no doubt are covered (one way or another) in the laws of most countries. The idea that articles of nature (air, water, blood) are not patentable is almost universal. Of course, interpretations of what is ‘natural’ will vary – as they do in the United States.
Update: An interesting point is the inevitable collision of two types of genetic analysis over the patent issue. One type, such as Myriad Genetics does their diagnosis on individual or small groups of genes. These companies wish to hold patents on the genes to support their patent on their diagnostic process. The other type of company does a broad genetic analysis, sometimes including the entire genome. These companies, such as Counsyl (California, USA), do genetic screening that will often include genes that are patented. Legally, they would not be permitted to report findings on those genes. There is a utilitarian argument about gene patenting that without it, entrepreneurial research will be unprofitable. Here is a situation where the question has to be ‘unprofitable for whom?’