How Genes Are Like Plutonium
(Neither Should Be Patentable)
SOURCE: USPTO
Patenting unmodified genes rewards discovery, not invention. We must prohibit the process and invalidate all claims to unmodified genes to facilitate more open science. Above: sequence from a patent for BRCA1.
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Until recently, the laws of nature have been understood to be part of the domain of scientific discovery. Science, in turn, was part of the public domain. Not only was most basic science in the last century funded publicly, through institutions such as the NIH and NSF, but the results of publicly-funded research were widely released, published in academic journals, increasing our communal wealth of knowledge. Of course, technologists, engineers, and inventors all have benefited by the steady march of publicly-funded science and its treasure-trove of public-domain knowledge.
Natural laws, once discovered, have been successfully and profitably applied in patented applications to new and useful products and processes. No one would have considered patenting the law of gravity, nor would any patent on gravity serve the purposes of the Patent Act: to encourage innovation in the useful arts. It would, in fact, impede innovation. No one employing the law of gravity in any new device could produce and market their invention without paying whatever fee the patent-holder demands. Similarly, no one would consider patenting hydrogen, or plutonium, nor any element on the periodic table. Yet, parts of nature have now been patented in record numbers. Unmodified genes have been granted patents, and this impedes science. Since the mid 1990s, unmodified gene sequences have been granted patents. Thus, the company that owns the patent for the test for BRCA1 and BRCA2 (related to breast cancer) owns not only the process for detection of the gene (which is inventive and should be patentable), but also the sequence of amino acids in the gene itself. Miami Children’s Hospital owns the patent on the monogenic disease called Canavan’s. These are but two of the more than 8,000 existing gene patents.
Even though the Patent and Trademark Office now requires more “stringent” declared uses for gene patents, the uses need not be truly inventive. All genes have some “use,” but the use was invented by nature, not by man. Genes in their unmodified forms code for proteins, but this is not a “use” in the sense demanded by a patent since nature is non-teleological. That is, claiming a philosophical purpose for a gene only make sense within the framework of Intelligent Design.
Intellectual property laws are bargains between inventors, authors, and the public. We grant to authors and inventors valuable monopolies, limited in time and scope, in the hopes that this will encourage new inventions and art, and benefit us all. When the monopoly expires, the full knowledge that was once monopolized moves back to the public domain. The trick to any bargain, however, is balancing the interests of the bargaining parties, and at some point, a bargain may become “unconscionable” when one party’s benefit far exceeds the perceived benefit to the other party. In contract law, such bargains can be invalidated. In the case of gene patents, the bargain not only contradicts the purposes of patent law, but it is unconscionable.
Patenting unmodified genes rewards discovery, not invention. Would we allow a patent on plutonium? It must be isolated through complex processes (which might, being inventive, be patentable) but patenting plutonium would be as ridiculous as patenting hydrogen or any other element of nature Not only does it contradict a long history of not patenting laws of nature, but it impedes both science and invention. Basic science requires openness. It is the original open-source enterprise. Hypotheses can only be tested if results are published, and scientific progress depends upon rapid and thorough exchange of experimental results and public testing of hypotheses. Patents impede this process, because between filing and granting of a patent, information in the patent remains secret. Furthermore, if granted, patents on unmodified genes complicate the process of discovery for other investigators, requiring patent searches, payments of license fees, or turning away from research on parts of the genome that are patented.
We would not tolerate a patent on any other element or part of nature that is unmodified, non-inventive, and fundamental to basic science. Although Einstein worked in a patent office, he never applied for a patent on the theory of relativity. It wasn’t his invention, after all. Nor are the unmodified genes for which countless patents have already been granted the inventions of the patent holders, although we should be grateful for their discoveries, and some might make useful, patentable inventions based upon these discoveries. It is time to prohibit the process of patenting unmodified genes, and to invalidate, either by legislation or judicial action, all claims to unmodified genes. HR 977, the Genomic Research and Accessibility Act first introduced in 1997 by Rep Xavier Becerra (D-CA) to ban the practice of gene patenting, languishes still in committee, but it’s time to renew this debate. Science demands it.
David Koepsell is the author of Who Owns You: The Corporate Gold Rush to Patent Your Genes (Wiley-Blackwell 2009). He has a law degree and a PhD in philosophy from the University of Buffalo, and teaches Ethics and Technology at the Delft University of Technology in the Netherlands.
Comments on this article
How can I help get this legislation passed: HR 977, the Genomic Research and Accessibility Act first introduced in 1997 by Rep Xavier Becerra (D-CA) to ban the practice of gene patenting.
April 14th, 2009 at 4:51 amFortunately, I have health insurance through my employer. My health insurance company agreed to pay for my BRCA genetic test. Result: I have the BRCA2 6174delT. My daughters also have health insurance and are able to access this expensive MYRIAD Genetics test. One daughter is negative. We are awaiting the results for the other. I have just had risk reducing salpingo-oophorectomy surgery.
AS you so clearly state: “Patenting unmodified genes rewards discovery, not invention.” The process can be patented, but not the gene itself. Perhaps someone can find another unique, less expensive process to sequence the gene. Why have such unethical patents been allowed. I just received an email from an Israeli researcher. He states that in Israel the patent on the BRCA genes is NOT accepted. He will help anyone get the test through an Israeli lab for $60.
An Israeli cancer genetics researcher stated in an email to mt on April 11, 2009:
April 14th, 2009 at 4:56 am“>With regard to what you call the Myriad monopoly, as far as I know they do
>not have a patent on mutations in both genes but maybe only on one of them.
>We, in Israel, are testing freely and not through Myriad (partially because
>we do not think that a commercial company can have a patent on the Jewish
>genome…), and of course the cost of the test in our labs is a fraction of
>the cost in the US (about $60 for the three founder mutations). If in the
>future you wish to test through our system (that has tested for these
>mutations many many times) please fill free to contact me.”
The central thesis of your argument can be summarized in your concise statement, “Unmodified genes have been granted patents, and this impedes science.” The article cites thousands of unmodified gene patents. I challenge you to cite one specific patent claiming an unmodified gene. Only a small bit of research would be required to discover that genes are typically claimed in their isolated or purified form. Further, only a basic understanding of science is required to understand that genes do not exist in nature in their isolated and purified form. Thus, gene patents do not claim a compound found in nature.
The article goes on to suggest that the new PTO guidelines are not stringent enough to exclude those genes with no inventive use from the category of patentable subject matter. Again, even a cursory review of the PTO guidelines would reveal that the purpose of requiring the function of the gene to be known is to avoid granting patents on subject matter that is not useful. However, the “use” need not be inventive unless the patent is on said use. Patents claiming nucleic acids, as chemicals, need only demonstrate the function of the invention as the function of the protein (amino acid). More “use” is required than merely encoding proteins.
The facts cannot be argued, though the policy conclusion of the article can. Patents encourage innovation and reward inventive contributions with limited property rights in the invention for 20 years. Without patents to protect these biotech inventions, private industry would not have incentive to develop therapies and cures for diseases. Thus, engineers and scientists do benefit from these types of patents, assuming they take advantage of modern medicine.
The information in patents is published 18months after the filing of the application as required by statute. Thus it does not remain secret until grant as the article states.
While I disagree with you central thesis, I understand that it is a fundamental belief that many Americans subscribe to, and I respect that. However, I encourage you to do the minimal amount of research necessary to write a factually accurate essay to support your argument. Misstatements of fact do nothing more than undermine your credibility and that of the article.
April 15th, 2009 at 1:29 pmIn response to Logan, clearly you don’t see the ridiculousness of the “isolated and purified form” requirement as made clear by my rather prominent analogy and reference to plutonium, which also requires “isolation and purification.” One can isolate and purify any number of naturally occurring compounds and still never warrant patent protection, because the chemicals or compounds themselves are not created by human invention. One can get a patent on the process, but not the compound, unless it doesn’t pre-exist in nature, despite one’s honest effort in “isolating” it. Many scientists like Church, Sulston, Collins, Dawkins, and others see the smokescreen of the “isolation and purification”requirement and similarly oppose gene patents. I fully support man-made genes (e.g. genetically engineered through intentional intervention) receiving patents, but the evidence is overwhelming that significant numbers of gene patents, such as those specifically referenced in the article, are for discoveries, not inventions. The two examples cited in the article satisfy your challenge, moreover.
April 16th, 2009 at 4:37 amMyra,
Here’s how the Canadian govt and its provinces are responding to the Myriad patents on BCRA1 and 2:
http://www.cancer.ca/Canada-wide/How%20you%20can%20help/Take%20action/Advocacy%20what%20were%20doing/Gene%20patenting/Breast%20cancer%20genes/Background%20on%20the%20patenting%20of%20BRCA1%20and%202%20genes.aspx?sc_lang=en
April 16th, 2009 at 6:33 am…sorry, BRCA1 and 2…
But note, the Europeans have done something a bit more reasonable, allowing the claims on new and inventive processes, but disallowing claims on the sequences themselves:
http://www.phgfoundation.org/news/4412/
April 16th, 2009 at 6:35 amWhile you make many valid points about the misuse of patents, one statement, “…. between filing and granting of a patent, information in the patent remains secret.” is not correct. The patenting process dramatically excellerates the sharing of public knowledge that would almost otherwise be kept a trade secret, even before the document is evaluated for patentability. All patent applications become public documents approximately six months after they enter the utility stage.
April 24th, 2009 at 9:44 amBrian, thanks for the clarification, but the delay between filing and publication can be as much as 18 months, which is still a very significant period in which plenty of valuable research can later turn out to be for naught. See this entry for the current general time-periods between filing and publication in both the US and Europe: http://en.wikipedia.org/wiki/Submarine_patent
April 24th, 2009 at 11:20 amIt’s better than pre-1995, but still, the delay and impact on research is significant.
I think that the plutonium analogy is quite apt. Harrison Brown, one of my professors, supervised the Oak Ridge/Manhattan Project work on isolating plutonium. He and one of his colleagues were granted a patent on their process for isolating plutonium, but not plutonium itself. See: http://www.freepatentsonline.com/2822239.html Moreover, Dr. Brown used money that he received from his research activities to help found the Federation of American Scientists and when he died, he was the editor in chief of the Bulletin of Atomic Scientists. Dr. Brown taught me and many others that scientists and inventors had a responsibility to use their discoveries carefully and make them contributions to world peace and health. (Yes, I know that he helped make the atomic bomb, but he sure tried to make up for it in his later years.) I never discussed gene patents with him, but I think he would find them contrary to the promotion of scientific research. Patents on processes derived from genetic information could be patented, as that is the inventive step, but patents on the DNA sequence itself should never have been granted by the US PTO. The scientists and PTO of Harrison Brown’s time were right not to patent discoveries; we need to go back to that practice.
January 21st, 2010 at 6:16 pm