Wednesday, December 17, 2014

Myriad is Finished


Last year, following their loss in the Supreme Court, Myriad sought to block competition in a last ditch effort by suing Ambry and others who would offer BRCA testing. They lost a motion for a preliminary injunction, which would have prevented their competitors from offering tests while the suit was pending, then they appealed that to the CAFC, who today rejected their claims on appeal. This fight is done.

Echoing reasoning I have advocated, the court held:

"Contrary to Myriad’s argument, it makes no difference
that the identified gene sequences are synthetically
replicated. As the Supreme Court made clear, neither
naturally occurring compositions of matter, nor synthetically
created compositions that are structurally identical
to the naturally occurring compositions, are patent eligible.

Myriad has lost all the way, and the BRCA genes and technologies and methods associated with their detection are where they belong: in the commons.

UPDATE: it's particularly good timing as the second edition of Who Owns You is in production and due out in May, including a section about the Myriad case which started after my book was first published. For a recent presentation regarding my theory of the commons and how it relates to the current status of the case law, you might want to scroll through this.

Friday, March 14, 2014

More Stuff Happens with the BRCA genes

So there's still activity in the Myriad case, and also a second edition of my book Who Owns You is now under contract with Wiley. My draft is due in August so I'll be writing this summer to update and revise in light of the significantly different legal landscape since the first edition was published. That landscape is active, but so far stable since the Supreme Court case. When Myriad lost in the Supreme Court, as I indicated they would, they sought to vigorously defend what remained of their patents, including by suing those who used the decision as an argument to compete in the BRCA testing arena. Myriad used the aggressive move of asking for a preliminary injunction in a lawsuit against one of those competitors, which turned out to be a big mistake. To win an injunction like that, before the merits of a case are reached, you need, among other things, to demonstrate a likelihood of success on the merits. In a 100+ page opinion, the court in Myriad v. Ambry denied the injunction, using the opportunity to expound on the merits and concluding that Myriad has no such likelihood. This is an early blow that won't help their stock price, and moreover, gives a pretty good early clue as to how the case will go. With the opinion's clear language, other companies are now entering the testing market and competing with Myriad, taking their chances and betting on the likelihood that in fact Myriad cannot monopolize the isolated DNA segments that the Supreme Court already said they cannot monopolize.

Wednesday, June 19, 2013

Philosophy and Public Policy: Metaphysics Matters!

It has been nearly a week now since I received word about the outcome of the Myriad case. I was travelling at the time and suddenly started getting congratualtory emails and Facebook messages, so I went online via free wifi at the coffee shop I was at in the US, and quickly found the news that the Supreme Court had unanimously rejected Myriad's arguments. I was so excited I hit my best friend in the chest... sorry Justin. Now that a week has passed, and the airwaves and blogosphere have been awash with a plethora of incriminations, congratulations, and musings about what it all means, I want to address what is to me a central lesson: philosophy matters.

Sure, some will claim this decision was a legal one, having no relation to philosophy, but such claims betray a complete ignorance about what philosophy is. My book and the writing and speaking I have done on the subject of gene patents ever since have focused upon the ontology of the underlying objects. I have long felt that before we can approach ethical questions we need to clarifying what we are dealing with. I did this first for software, then genes, then nanotehnology. While I have taught medical and bio-ethics, the thesis of Who Owns You is not guided by standard bioethical principles, but rather founded upon uncovering the nature of the objects involved in the debate. Thus, my arguments about the nature of the "commons-by-necessity" and the status of genes as part of that commons confused some who expected typical applied ethics arguments, or legal anti-commons claims. For the past four years, what I have tried to do is show by recourse to basic ontological concepts, that unmodified but merely isolated genes are not different in kind from the genes claimed by Myriad and others as found in nature.

In the course of these arguments, the illogic of those who pursued the course of maintaining gene patents as they existed was laid bare, perhaps never more clearly than in debates about the nature of another naturally-occurring product: O2. When it became clear through those arguments that patent attorneys and others who supported gene patenting must also endorse patenting O2, the necessity of ontology was also revealed. Despite their claims otherwise, a world in which individual O2 molecules are distinguished from each other based upon their origins makes little sense ontologically, forget the ethics. One needs to confuse process with product, a basic ontological error, to support such a view. The Supreme Court, whether they realized it or not, sided with sound ontology. Although lacking the language that philosphers use when engaging in ontology, the Supreme Court's opinion makes both logical and ontological sense.

The Court has reasoned that the BRCA mutations claimed in Myriad's patents, even though "isolated" from the surrounding genome, remain "natural phenomena." An explanation for how this is so resides in ontology. In each case, the molecules described by the nucleotide sequences identified are not the result of man's design. They are nature's own products. Similarly, even when synthesized, O2 is never the product of man's design.  The process of creating isolated BRCA mutations in the lab may well be man-made, but will never result in anything other than a natural product because the product is one designed by evolution, not human ingenuity. We could call lab-made O2 or BRCA genes "synthetic natural products," and explain this by understanding that the process of making something cannot be confused with the resulting product. To be non-natural, both the intention of creating the product and the design of the product must come from minds. This is why I am more or less comfortable with the court's holding that cDNA is patent-eligible, because in producing cDNA (when, as the Court notes it does not exactly mirror sequences found in nature), one must combine intention with design.

At one of my recent talks, someone asked why in making my arguments I relied on ontology rather than ethics. My response was that courts are typically unmoved by ethics. This may be suprising, but it is true. The Court's decision in Myriad is about the nature of the underlying objects, not about what is right or wrong. Perhaps there is an ethical dimension to the general prohibition against patenting abstract ideas, natural phenomena, and laws of nature. Or perhaps not. Perhaps this restriction is about the nature of the objects too, as I have claimed when I argue they are simply materially and logically (and thus maybe also ethically) "unencloseable." But the Court's decision is guided, whether knowingly or not, but an ontology, and one which is coherent if understood as I am describing it. It provides guidance for those who conduct basic research, and those who wish to commercialize inventions. It offers some clarity where the law had deviated from logic. It illustrates that philosophy is not divorced from other subjects, and can indeed be relevant in numerous spheres. Indeed, metaphysics matters a great deal, and we engage in its practice every day to greater or lesser degrees, and sometimes public policy is significantly affected by its improper or proper uses. Philosophers would do well to point out the role of philosophy, as illustrated by the Myriad case and its implications, in the real world, and those who fail to see this as an implementation of philosophical reasoning should review the role and nature of philosophy historically. It really is the meta-science.

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, 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.
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?

Sunday, April 21, 2013

Other people's bodies: a fresh perspective

Admittedly, I have scrupulously avoided making arguments based upon ethical perspectives that are grounded in religious beliefs when discussing gene patents or bioethics in general. This is largely because I am completely non-religious. I also think religious arguments do little to convince those who don't happen to share your beliefs. Nonetheless, Arthur Gershman's book Other People's Bodies offers a fresh perspective on issues in bioethics, with some special relevance to the gene patenting debate. Gershman is himself a registered patent attorney who has weighed in against gene patenting online, and in a number of other fora and media. His blog is here and includes a recent column from the Jewish Daily that opines against gene patents in relation to the Myriad case.

Gershman's short book is chock full of interesting and enlightening essays relating to bioethics in general, and educating the reader about the perspectives offered by Jewish thinkers and theologians. While I am not personally convinced by religious or even culturally-based arguments about the ethics of various biological studies or commercial actions regarding our tissues, bodies, or genes, I think it worth pointing out that the BRCA1 and 2 mutations, as with a number of monogenic mutations, disproportionately affect the Jewish population, just like Canavan's and Tay-Sachs, Ashkenazi Jews appear to have higher percentages of these diseases than other populations, as far as we know. I think that this gives us an obligation to recognize and respect to some degree a Jewish perspective, inasmuch as it offers a unique approach to the ethics of biological materials, bodies, and property emerging from this tradition, and take account of it in our political responses to issues like gene patents. I am happy that Gershman's book gives us this valuable perspective and recommend it to everyone dealing with this issue.

Tuesday, April 16, 2013

JUSTICE KAGAN: "And the PTO seems very patent happy"

I love that quote from Justice Kagan because it pinpoints the root of the issue. She said it when Myriad's attorney tried to justify the practice of patenting isolated genes by referring to the Patent and Trademark Office's past practice of doing so. She is right, and that office, run as it is by patent attorneys, much like the CAFC is dominated by them, is a poor guide for what ought to be the case. They are "patent happy." (see, e.g., the Peanut Butter Sandwich patent).

One should never try to predict what the Supreme Court will do in any given situation. Nonetheless, a brief analysis of the transcript of the oral argument in the Myriad case is revealing. The Justices seem inclined to hold in a way that readers of this blog will be familiar with: isolation of a gene is not enough, only changing the gene suffices to make it patentable. The questioning from the Court right from the start revealed their discomfort with the current "isolation" regime, which is unsurprising in light of their recent decision in Prometheus.

Mr. Hansen did an excellent job in his argument, under some difficult questioning, steering the discussion back to the question of whether a product of nature, merely isolated, should be eligible under Section 101. He cited all the best examples, arguments, and precedent. He also conceded as he should that recombinant DNA is eligible, and that the patents at issue in the Myriad case are not recombinant. He also left the door open for the Justices to do as they seem inclined to do, and follow the lead of the Solicitor General, ruling that the isolated genes alone are ineligible subject matter but that cDNA is. This is also the position I have maintained all along in my book and since. The attorney for Myriad had a tougher time of it, and the questioning of the Justices seemed to have him in a corner a couple times. Instead of recapping the arguments, I urge you read them yourself here. Also, I am providing links to some excellent in-depth and plain English analyses here, at Patently-O and at ScotusBlog. What I wish to do here is highlight sections from my book that made the same argument that seems likely to win the day, a conservative position I have maintained all along, arguing that mere isolation is insufficient to warrant patent, that some degree of intention (and design) is necessary to make something inventive, and that while engineered genes ought to be patent eligible, isolated genes alone ought not to be. Here are some relevant passages:

"Each instance of the un-engineered human genome is a naturally occurring object. Its existence as an abstracted ideal which is instantiated in you, me, and every other human, in its present form has no element of the type of expression described above. There is no mixing of labor with any present human genome’s form, nor is there any human intention involved." (Who Owns You? p. 111-12)
"All copyrightable and patentable objects are intentionally produced man-made objects and they are not merely ideas. Your DNA, or mine, or any other non-engineered being, is not an expression according to this description of intellectual property, and neither is any naturally-occurring subset of a genome (such as a gene or a SNP)." (Ibid, p. 112)
"Chemical formulas, for example, or natural laws, cannot be copyrighted or patented. The seminal Supreme Court case Diamond v. Diehr, specifically excluded from patentability “laws of nature, natural phenomenon and abstract ideas.” (Ibid, p. 113)
"Many gene patents are perfectly valid both legally and ethically. All valid patents use products of nature in some form, but they do not extend to protect the naturally-occurring parts of the invention. Most patents on new chemicals involve not just a patent on the new compound, but also a patent on the process of synthesizing the compound.These sorts of patents provide guidance for how gene patents can legally issue and still also promote innovation. New genes could of course be patented if they are man-made. New combinations of genes can also be patented if they are the products of human intention." (Ibid, p. 114)
"Many gene patents issue now in which the current use of the gene is in merely finding the same gene. This is quite absurd. It is like patenting the element iron, and then claiming that the use of iron is in finding iron, or patenting the Rock of Gibraltar and then claiming that the utility of the patent is in locating the Rock of Gibraltar." (Ibid., p. 115)

I quote these sections because they show that the arguments I made anticipated the same ones made in the Myriad case which began a couple months after my book was published. These same arguments have been to a large degree echoed by the questioning of the Justices. Together with Myths About Who Owns You the past year at least has demonstrated just how conservative my arguments have been and how they echo the thinking of at least some Supreme Court Justices as well as precedent, and that perhaps initial claims about how wildly inaccurate, off-base, or whacky my arguments were, were themselves wildly inaccurate, whacky and off-base, or perhaps merely ideologically-motivated.

Now of course, the Court may still rule that all gene patents are just fine, but at least I take comfort in having my arguments made in public court, in language and with examples similar to that I used in 2006 when I first confronted these issues from a philosophical perspective. I'm comforted that now my arguments seem firmly in the mainstream and persuasive to many if not all.