Friday, June 14, 2013

looking back and preserving history

Strangely, in the wake of the recent Supreme Court decision in Myriad, one of my very my very first public posts on the subject of gene patents, made at the invitation of Gene Quinn at ipwatchdog.com, seems to have disappeared from his archives. Meanwhile, he is claiming as others have done that my original statements and arguments went far beyond what the Supreme Court did. In the interests of preserving history, I'm reposting my article so you can judge for yourself the extent to which the Court has essentially restated my arguments. I believe they have.
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The Case Against Gene Patents
Written by David Koepsell
Posted: June 13, 2009 @ 5:35 pm
I favor innovation, and am interested in ensuring that science and
technology work hand in hand to both better our standard of living, and enrich those who create new and useful works. But it is not necessarily true that current intellectual property laws always accomplish this. Nor is it so that everything under the sun is subject to intellectual property protection. When Jonas Salk developed his vaccine for polio, he was asked by Edward R. Murrow who owned the patent on the vaccine. His famous reply was "well, the people, I would say. There is no patent. Could you patent the sun?"

Since the mid 1990s, patents have been granted for human genes. Although now they are supposedly limited only to "isolated and purified" genes, this is a limitation of no consequence at all. It merely means marking the beginning and end point of the gene, and perhaps leaving out a few introns (which are meaningless junk that doesn't do anything to the functioning of the genes, and that remains as a byproduct of evolution." I argue that this is as ""inventive" as marking the boudaries of natural features, like mountains, on a map. It gives the mapmaker no right to the mountain, nor to preclude others from depicting that mountain.

The practice of patenting genes began during the progress of the Human Genome Project, which was a world-wide publicly funded scientific endeavor to map the human genome. While the HGP released the data it found into the public domain, it left open the option of "downstream" patents for new, inventive innovations, treatments, etc., that might come from the research. Meanwhile, Celera began to patent an unspecified number of sequences it found in its private attempt to map the genome. It's "shotgun" approach to sequencing remains a vital, patentable innovation that has changed the way gene sequencing is done. It was new, inventive, useful, and non-obvious. But this is not true of human genes
that are being patented.

The first public altercations over gene patents came from groups
representing those who suffer from genetic diseases. Canavan's Disease is a monogenic disease (it is carried by one gene only) that strikes a disproportionately among people of Ashkenazi Jewish heritage. When Miami Children's Hospital acquired a patent for the gene, a group representing families suffering from Canavan's Disease sued under tort law. They claimed that based on the patent, he Miami Children's Hospital was unjustly enriched when they not only collected royalties but restricted the number of labs that could offer testing for the disease and charged a fee beyond the cost of the test. Because of the restrictive licensing, many labs stopped offering the test. The case settled, and the legality of gene patenting remains unchallenged in court. It has so far been
based only upon the PTO's interpretation of regulations it has promulgated. Recently, the ACLU's suit against Myriad over its tests for the "breast cancer genes" has brought this issue back to the spotlight.

I argue in my book - Who Owns You? - that gene patents violate the patent law because what they claim as patentable is a part of nature, and thus neither new nor non-obvious. Awarding patents to non-new discoveries does not encourage innovation, and sitting on what are essentially laws of nature, so far upstream, actually stifles downstream innovation. Moreover, There are certain things that we have regarded both culturally and legally as belonging to a commons, and thus not subject to private ownership. I argue that unmodified genes are exactly
this sort of thing.

In Gottschalk v. Benson, the Supreme Court stated: "the patent would
wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." That would amount to patenting an abstract idea, contrary to long established precedent. Laws of nature are inherent in nature. We do not invent them, they are part of the fabric of everything. Gravity is an example, the laws of evolution are another, as are the laws of relativity. Scientists devise explanations for these laws that we call "theories", and attempt to confirm or falsify them through experiment. As we acquire a better understanding of natural processes and products, we become better equipped to manipulate our world, create new things that nature never made, and bring our inventiveness to bear on nature to make our lives better. This is, in sum, the purpose of intellectual property law: to further the progress of the useful arts and sciences. But if we try to do so by allowing governmentally-sponsored monopolies (as intellectual property ultimately is not a free-market device) we must be careful to not stifle innovation by granting monopolistic rights over laws of nature. Instead, we should grant rights only to those things that are the products of human thought
and creativity. The application, for instance, of the laws of gravity to some specific way of moving people up and down between floors. The splicing of a genetic segment into a creature in such a way that nature never devised to make an entirely new creature that might, for instance, eat oil, is inventive. Finding a gene that has evolved over millenia is not.

Finally, I argue that the genome is a commons. There are parts of the world that cannot be owned in any practical sense. Radio spectra are my favorite example. There's no way to exert ownership over a particular band. I can exert my ownership over my possessions and my land, but the only means of trying to control a band on the radio spectrum is to broadcast over it. But along comes my neighbor who does the same thing, and cranks up the wattage. There is no winner. It is the classic tragedy of the commons. I argue that genes, which are, after all, parts of what Richard Dawkins calls "the river of life flowing out of Eden" are simply unencloseable. Parents all over the world are reproducing patented genes, technically violating the patents on those genes because they
haven't sought permission and aren't paying royalties. The idea is absurd, of course. This is why the practice is absurd. Unmodified genes simply cannot be owned, nor should they be. 

But there's plenty of room for innovation. As I mentioned, Celera deserves the fruits of its invention in developing new, useful, non-obvious technologies for rapidly sequencing genes. When new methods of testing are developed, they ought to be rewarded. A number of corporations agree with the thesis that patenting too far upstream actually stifles innovation, and the SNP (single nucleotide polymorphisms) Consortium is a prime example. The Consortium itself is a not-for-profit organization made up of the Wellcome Trust, a number of
leading academic centers, and thirteen pharmaceutical and technological companies. These members have joined efforts to discover the roughly 300,000 SNPs thought to exist in the human genome, and to release this information into the public domain, while securing for each member IP rights over real innovations developed both along the way, and as a result of the effort. The same is true of the HapMap project which includes private companies, academic centers, and public and private research institutes. These efforts underscore the role of public science in profitable enterprise, and the recognition by corporations of the role of each in spurring innovation. None of the private corporations involved in these efforts could be accused of being wild-eyed anarchists seeking to undo private property rights. They simply realize that not everything should be patented, and that upstream patents can stifle downstream innovation, slowing the progress of the useful arts and sciences, and undermining the purposes for which patents were invented in the first place.

My book is certain to cause disagreements, as there is room for reasonable people to debate my assumptions about the role of intellectual property in innovation, as well as the nature of genes and genomes. But this is an issue that requires public debate, and legal challenge. Whether the courts or legislators ultimately change the way that genes are now being patented remains up in the air, which is why now is a perfect time to decide for yourself, and make your arguments, and be heard on this vital issue."

About the Author
David Koepsell is an author, philosopher, and attorney whose recent
research focuses on the nexus of science, technology, ethics and public
policy. He is an Assistant Professor at the Delft University of
Technology, Faculty of Technology, Policy, and Management, Philosophy
Section, and he blogs at Who Owns You?

2 comments:

Arthur Gershman said...

When it comes to posting on a "gene happy" blog [such as described by Justice Ginsburg in oral arguments] you just can't win. They don't ply fair and will delete any post they don't like. A similar thing happened to me in a post of the Patentdocs blog. We will just have to rely on our blogs to get the truth out.

David Koepsell said...

It's a tremedous act of cowardice for Quinn to have removed my invited guest post now, and to try then to mischaracterise the nature of my original arguments. I have reposted it here so that history is preserved.