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How Genes Are Like Plutonium

(Neither Should Be Patentable)

excerpt from the sequence listing in a patent for BRCA1 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.

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.

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