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?

Next Monday, I Like

This has been a big week leading up to an even bigger Monday. That's the day the Supreme Court finally hears the AMP v. Myriad appeal, and I'll be listening. But this past week I had the opportunity to revisit the issue in a number of venues. One was as a guest lecture for an honors class taught by Robert Zwijnenberg at Leiden University. His class is called "Who Owns Life?" and I was invited to discuss my views on gene patents from my book, Who Owns You. There I gave this talk: "Nature, Genes, and the Commons" with a great reception from the students and faculty. The questions were challenging and the discussion wide-ranging.

Later that same day, I appeared on The Forum, a show on KQED, the National Public Radio affiliate in San Francisco. The panel discussion entitled "Who Owns Your Genes" included: Lauren Sommer, science and environment reporter for KQED Public Radio, Karuna Jaggar, executive director of Breast Cancer Action, Jeffrey Lefstin, professor at UC Hastings College of Law, and myself. Again, this discussion was civil, interesting, in depth, and revealed the fundamental disagreements and agreements in anticipation of the Supreme Court's oral argument next Monday.

Finally, my friend Joanna Rudnick's great film, "In The Family" is being re-released. This film is an important view on the scientific and social role of the BRCA1 and 2 tests that Myriad monopolizes, and features the only taped discussion of those patents from Mark Skolnick, the founder of Myriad. Here is an excerpt from the press release, I urge everyone to watch the documentary online:

"As Supreme Court debates gene patenting linked to hereditary breast and ovarian cancer, POV and Kartemquin release In the Family free online

Emmy-nominated 2008 film by Joanna Rudnick features revelatory video interview with Myriad Genetics, defendant in the SCOTUS case.

Chicago – On April 15, 2013, the Supreme Court of the United States will hear a landmark case on the patentability of genes linked to hereditary breast and ovarian cancer.

To raise public awareness on the issues involved, the documentary In the Family – which helped spark the original case – will be streamed online for free to coincide with the hearing. In the film director/producer Joanna Rudnick tells her story of discovering she carries the BRCA gene mutation. She interviews other cancer “pre-vivors,” and in doing so is led to Myriad Genetics, sole patent holder of the BRCA genes and sole provider of genetic testing for mutations in the genes.

In the Family will be exclusively streamed online at http://www.pbs.org/pov/inthefamily, launching with the Supreme Court hearing of the ACLU’s challenge to the BRCA genes on April 15, 2013 for 30 days (through May 15, 2013), followed by a second streaming window of 30 days around when the verdict is announced.

Rudnick’s exposing video interview with Myriad’s founder Mark Skolnick – in which she questions why the cost of the test is going up despite advances in technology – remains the only on-camera comment Myriad has given on these issues since the case was launched."

On Monday, of course, we'll have some new material to review as the court's arguments become available online. 

stay tuned!

ACLU petitions for certiorari to the U.S. Supreme Court.

As predicted, the plaintiffs have petitioned the Supreme Court to review the CAFC decision reported here . The grounds for the petition include the failure of the CAFC to properly apply the decision in Mayo to the facts of the Myriad case. Given the split in the CAFC, and the Supreme Court's own admonition that the CAFC ought to have reconsidered their decision in light of Mayo, it would be highly surprising if they don't decide to take this up next term. Expect more posturing and puffery from those who promote patenting products of nature as the Supreme Court considers the petition and opposing submissions. The fact is, patent attorneys who have made profits by helping corporations to monopolize what cannot justly be monopolized are terrified that the Supreme Court might do the right thing and finally end this practice. I think their fears are justified. A careful reading of Mayo and recent decisions by the Supreme Court on patent matters seems to show a trend against those who contend that one can patent anything simply by drawing artful claims.

In Myriad and More, Metaphysics Matters

This past week, the Federal Circuit Court of Appeals heard oral arguments in the AMP v. Myriad "breast cancer genes" case. You'll recall that following its decision in Prometheus v. Mayo, in which, to the shock and horror of patent attorneys everywhere, certain diagnostic methods were considered ineligible for patent under Section 101 as being too close to natural laws or phenomena, the Supreme Court then vacated and remanded the Myriad appeal back to the CAFC for reconsideration in light of Prometheus. The fact that the decision of the CAFC was vacated and remanded, and that the court was asked to reconsider it in light of Prometheus, ought to be a clue that SCOTUS believes that there is some relevance between the two cases, and in fact there is. Both cases have to do with the distinction between the "natural" and the "artificial" or "man-made," as the Chakrabarthy case we have discussed here, and in my book, makes such a distinction for patent eligibility. Namely, "laws of nature, natural phenomena, and abstract ideas" are all explicitly not eligible for patents according to the Supreme Court, even though patent lawyers like to remind us that the Patent Act makes "discoveries" patentable. Sure they are, as long as they are not discoveries of "natural phenomena, laws of nature, or abstract ideas."

This is where lawyers are no longer the most competent experts, though many assume that they are. The distinction between "laws of nature, natural phenomena, and abstract ideas" and everything else is a metaphysical question. Metaphysics and ontology are primarily the expertise of philosophers, not lawyers. So while patent attorneys like to pretend that they are the sole, or at least best arbiters of what ought to be considered patentable, I beg to differ. This is where philosophers are best suited to offer their expertise, because drawing distinctions, applying logic and metaphysics to the world and its objects is in fact what we are trained to do. Lawyers draw distinctions among legal objects, but not sui generis. Rather, they apply precedent and statutes to determine whether objects, acts, or omissions fall into pre-existing legal categories. Their tools are not metaphysical, and when new objects emerge, close analogies, or new statutes are typically necessary to deal with them. But as I have long argued, sometimes the law is ill-suited to solve new problems, or its categories are mistaken from the start on a metaphysical level.

I have never claimed to be an expert in patent law, but as a metaphysician and ontologist, I am a competent critic of its application to the world and its objects. In the case of gene patents, which often include claims over things that are metaphysically best described as "natural" despite their "isolation," courts ought to pay some heed to the underlying categories involved, and what philosophers have to say about them. Philosophers can disagree, of course, and arguments might be made about the boundary between what is natural and what is not, and I look forward to hearing those arguments and engaging with them. But I claim still, as I have all along, that mere isolation of some molecule does not create something "man-made," and I have provided countless examples, including my favorite, isolated O2. Nothing about its structure, even when isolated, is the product of man's design or intention, just as in Prometheus, nothing about the laws governing the interaction of a drug with a person's metabolism is the product of man's design or intention, even if the drug itself was entirely the product of both. The analogies between these two cases are clear, and when one understands the significance of the metaphysics behind Prometheus, it is clear that if the CAFC were to act responsibly and honestly, they would now have to find Myriad's BRAC1 and 2 patents ineligible. But probably we will have to wait for the Supreme Court to do this, just as they did with Prometheus. Or maybe not; hope springs eternal.

Open Science and Economics

The Open Science Summit (here are my slides) has concluded, and it marks the start of a very important ongoing conversation, including discussions we should continue to have about the practical effects of patents on innovation. My arguments have always been both theoretical and practical. While Ron Bailey at Reason relates "Numerous studies have so far failed to find that gene patents are a big impediment to either research or innovation" in reporting on our session at the Summit, there are also numerous such studies showing that the impact is in fact bigger than some make it out to be. One noteworthy recent addition to the empirical evidence is this article, by Heidi Williams of Harvard University - Department of Economics; National Bureau of Economic Research (NBER), entitled "Intellectual Property Rights and Innovation: Evidence from the Human Genome" which just came out this past month. She sent me the following link, and below I summarize and provide some useful quotes:

Williams tracks the progress of individual discoveries, looking at the research that was conducted on both patented and unpatented genes, and comparing the rate of innovation and commercialization resulting from both. she states, in describing her methodology: "My empirical analysis relies on a newly-constructed data set that traces out the distribution of Celera's IP across the human genome over time, linked to gene-level measures of scientific research and product development outcomes." ... significantly, she finds:

"For each gene, I collect data on publications investigating potential genotype phenotype links, on successfully generated scientific knowledge about genotype-phenotype links, and on the development of gene- based diagnostic tests that are available to consumers. Both the cross-section and panel specifications suggest Celera's IP led to economically and statistically significant reductions in subsequent scientific research and product development outcomes. Celera genes have had 35 percent fewer publications since 2001 (relative to a mean of 1 publication per gene)."

finally, she concludes:

"I estimate a 16 percentage point reduction in the probability of a gene having a known but scientifically uncertain genotype-phenotype link (relative to a mean of 30 percent), and a 2 percentage point reduction in the probability of a gene having a known and scientifically certain genotype-phenotype link (relative to a mean of 4 percent). In terms of product development, Celera genes are 1.5 percentage points less likely to be used in a currently available genetic test (relative to a mean of 3 percent). The panel estimates suggest similarly-sized reductions, on the order of 30 percent. Taken together, these results suggest Celera's short-term IP had persistent negative effects on subsequent innovation relative to a counterfactual of Celera genes having always been in the public domain. The panel estimates measure a transitory effect of Celera's IP, and suggest that innovation on Celera genes increased after Celera's IP was removed. However, the cross-section estimates measure more persistent e ffects and suggest that Celera genes have not 'caught up'"

The evidence is growing more damning all the time. This study cites the Murray study I have previously cited here, and nails the lid in the coffin, as far as I can tell, on the economic effects of gene patents. I hope you'll read this paper. I am thankful that economists like Williams are continuing to blow the lid on the real story of patents, and how they inhibit both science and commerce.