tag:blogger.com,1999:blog-60018136379714004892024-02-27T11:10:47.679+01:00Who Owns You?Occasional musings on Gene Patents and IP law.Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.comBlogger97125tag:blogger.com,1999:blog-6001813637971400489.post-5817568406216302672015-10-07T15:02:00.001+02:002015-10-07T15:02:04.338+02:00Final nail in the coffin<div dir="ltr" style="text-align: left;" trbidi="on">
In a final blow to Myriad, who had won in two lower courts in Australia upholding its patents there, the <a href="http://www.smh.com.au/national/health/landmark-high-court-ruling-on-brca1-gene-patent-as-pensioner-wins-legal-case-20151006-gk2wvu.html" target="_blank">High Court just ruled </a>that their patents are invalid, citing reasoning echoing the US Supreme Court and that I argued in my book <a href="http://www.amazon.com/Who-Owns-You-Innovation-Philosophy-ebook/dp/B00WUCT4AI/ref=sr_1_1?ie=UTF8&qid=1444222881&sr=8-1&keywords=who+owns+you+koepsell" target="_blank">Who Owns You</a>. The rest is now history. Reason once again prevails in one small area of patent law.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-31473924636706581272015-05-29T19:26:00.002+02:002015-05-29T19:26:26.054+02:00Foreword and Preface, for free!<div dir="ltr" style="text-align: left;" trbidi="on">
Thanks to Wiley (my publisher) and PatentDocs (the very popular and excellent website on patents) you can read the Foreword (by Dr. Kevin Noonan) and the Preface (by myself) <a href="http://www.patentdocs.org/2015/05/koepsell-and-noonan-on-gene-patenting.html" target="_blank">online</a>.<br />
<br />
In other news, today the book hit #1 in the Patents, Trademarks, and Copyright New Releases section of <a href="http://www.amazon.com/gp/new-releases/books/10960/ref=zg_b_hnr_10960_1" target="_blank">Amazon</a>!</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-65802017793735253692015-05-26T17:26:00.000+02:002015-05-26T17:26:11.602+02:00What's New in the Second Edition?<div dir="ltr" style="text-align: left;" trbidi="on">
Addressing some criticisms from reviews for the first edition, I have corrected technical errors throughout. Moreover, I have added a significant amount of material in the wake of the <i>Myriad </i>decision. A full new chapter discusses the decision itself and its reasoning. An expanded version of the "Science" chapter, now co-authored with Vanessa Gonzalez, PhD, a pharmacogenomics expert, includes illustrations and some new material as the science has advanced. I have added a chapter describing a complete ontology of invention and discovery that coalesces the reasoning behind my arguments into guidance for future issues where the distinctions between the two are likely to be called into question and pose issues for patent law, science, and innovation. As well, Kevin Noonan (a critic of my arguments) wrote a lengthy and informative foreword in which he offers the utilitarian arguments in favor of gene patents.<div>
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The work now should stand as a more complete record of my arguments, the legal status of gene patents, and an epoch of sorts that has come to a close, even as some questions linger, and new ones loom for future consideration.</div>
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I hope you enjoy it.</div>
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David Koepsell,</div>
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Mexico, D.F. 2015</div>
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Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-17379531761737600672015-05-20T18:14:00.000+02:002015-05-20T18:14:06.493+02:00Who Owns You, 2d Edition<div dir="ltr" style="text-align: left;" trbidi="on">
The 2d Edition is already available as a Kindle download, and the hardcopies will be in stores and available for order in a few weeks, depending on your location.<br />
<br />
The issue of gene patenting is not settled worldwide, and our interpretation of the changing law will impact our approach to new and emerging technologies in biology and beyond. I hope you'll consider carefully my arguments, my attempt to devise a coherent ontological scheme to innovation vs. discovery that can avoid some of the pitfalls of the past, as well as my attempt to describe and reason through the Supreme Court's rulings in the area of gene patents and related cases. Here is the link to the book on Amazon.<br />
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<a href="http://www.amazon.com/Who-Owns-You-Innovation-Philosophy/dp/1118948505/ref=sr_1_1?ie=UTF8&qid=1432138077&sr=8-1&keywords=david+koepsell" target="_blank">http://www.amazon.com/Who-Owns-You-Innovation-Philosophy/dp/1118948505/ref=sr_1_1?ie=UTF8&qid=1432138077&sr=8-1&keywords=david+koepsell</a><br />
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Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-84822412313747366702015-05-15T13:52:00.002+02:002015-05-26T00:29:40.185+02:00Thank you (Again) Brian Leiter<div dir="ltr" style="text-align: left;" trbidi="on">
There's a JD/PhD working at University of Chicago Law School named <a href="http://en.wikipedia.org/wiki/Brian_Leiter" target="_blank">Brian Leiter</a>. He specializes in philosophy of law and Nietzsche, and for a while was a sort of gatekeeper for the Philosophy field due to his <a href="http://chronicle.com/article/The-Man-Who-Ranks-Philosophy/149007/" target="_blank">ratings of </a>philosophy departments. While his <a href="http://dailynous.com/2014/10/10/leiter-to-step-down-from-pgr-the-new-consensus/" target="_blank">importance in that role has recently declined</a>, he also has a long history of <a href="https://files.nyu.edu/dv26/public/Statement_of_Concern.html" target="_blank">internet</a> belligerence and <a href="http://dailynous.com/2014/12/24/leiter-threatens-jenkins-ichikawa-with-legal-action/" target="_blank">public dustups</a>. He may be why you are here visiting my blog since he has lately focused some of his anger on me and has twice mentioned my name in the last few months. I won't bother trying to psychoanalyze his obsessions, nor to document his <a href="http://abovethelaw.com/2014/09/everyone-hates-this-poor-law-professor/" target="_blank">issues</a> and <a href="http://www.readmorewritemorethinkmorebemore.com/2014/09/archive-of-meltdown.html" target="_blank">disagreements</a> (all of which can be gleaned from some of the links in this post, and by a casual search of the web) but simply take this opportunity <a href="http://whoownsyou-drkoepsell.blogspot.mx/2010/08/thank-you-brian-leiter.html" target="_blank">to thank you Brian Leiter</a>, for helping to bring some <a href="http://whoownsyou-drkoepsell.blogspot.mx/2010/08/thank-you-brian-leiter.html" target="_blank">notice to my web pages and work in philosophy -- again</a>, especially now that the <a href="http://www.amazon.com/Who-Owns-You-Innovation-Philosophy/dp/1118948505/ref=sr_1_1?ie=UTF8&qid=1431689567&sr=8-1&keywords=david+koepsell" target="_blank">2d Edition of Who Owns You is available on Amazon</a>, iTunes, and soon in bookstores near you.<br />
<br />
I've noticed a fair amount of increased interest in my personal web page and this blog (probably by people looking to confirm an un-cited-to claim about <a href="https://twitter.com/drkoepsell/status/598993373412790272" target="_blank">my stand on an issue</a> relevant to a professor in philosophy - <a href="https://twitter.com/drkoepsell/status/598993669971054592" target="_blank">a stand I never took</a>, as I merely tried to correct some misperceptions about the nature of tenure given I worked in that area of the law when I was employed in the <a href="http://openjurist.org/18/f3d/1005" target="_blank">NY Attorney General'</a>s office). Doubtless those who searched out my statements on that case are puzzled as to why Leiter would mention me by name - <a href="https://twitter.com/drkoepsell/status/598453698335940608" target="_blank">I did muse on his own stand on the case</a>. I have no answer for that other than the guy seems <a href="http://rgheck.blogspot.mx/2014/11/did-i-misrepresent-leiters-threats.html" target="_blank">obsessed and consumed by vendettas.</a> He has been proven wrong in his judgment about my foresight and abilities of <a href="http://whoownsyou-drkoepsell.blogspot.mx/2014/12/myriad-is-finished.html" target="_blank">analysis of the justice of gene patents</a>, I was more or less <a href="http://whoownsyou-drkoepsell.blogspot.ca/2013/06/philosophy-and-public-policy.html" target="_blank">vindicated by a sweeping change in the law</a>, and the rest is history. The Second Edition documents the arguments I made, their applicability to the current legal scheme, and the errors of t<a href="https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=9&cad=rja&uact=8&ved=0CFQQFjAI&url=http%3A%2F%2Flaw.umkc.edu%2Fpdfs%2Fvitas%2Fholman.pdf&ei=9tpVVYfxOIXQtQXRsoDgBg&usg=AFQjCNHTXSajMrW4BygXXsCkg3omTOtj0w&sig2=GXOX71XQCnlw80Zkefa4qQ&bvm=bv.93564037,d.b2w" target="_blank">hose who for so long supported</a> a practice which I am glad to see stopped in the USA.<br />
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In the new edition, which includes a <a href="https://books.google.com.mx/books?id=hIG4CAAAQBAJ&pg=PT8&dq=david+koepsell+who+owns+you+second+edition&hl=en&sa=X&ei=PdtVVafaJorIsAWn6oGoBg&ved=0CBsQ6AEwAA#v=onepage&q=david%20koepsell%20who%20owns%20you%20second%20edition&f=false" target="_blank">foreword by Kevin Noonan</a> of http://www.patentdocs.org (who is a friendly and an honest critic of my arguments even now), I elaborate on the <a href="http://whoownsyou-drkoepsell.blogspot.mx/2012/03/patent-religion-suffers-blow-reading.html" target="_blank">Myriad</a> case, which began after the first edition was published, and offered an exciting opportunity to track the relevance of public philosophical debate. The case surprised <a href="http://www.ipwatchdog.com/2013/07/14/why-scotus-myriad-ruling-overrules-chakrabarty/id=43249/" target="_blank">many in the patent bar</a>, but anyone who pays attention to the logical arguments about the nature of "isolated" genes vs. those that are part of the genome would not be surprised. The unanimous Supreme Court decision was entirely <a href="http://whoownsyou-drkoepsell.blogspot.mx/2013/06/logic-prevails.html" target="_blank">logical</a>, the legal landscape has been made more logical and predictable, and in this edition I added some materials proposing a general ontology of discovery and invention that helps to make sense of the new state of the law for applicability in the future.<br />
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I'll have a lot more to say in the near future on <a href="https://www.publicknowledge.org/issues/patent-reform" target="_blank">patent reform</a> in general which I think is at a critical crossroads, but in the meantime, and <a href="http://whoownsyou-drkoepsell.blogspot.mx/2010/08/thank-you-brian-leiter.html" target="_blank">once again, thank you Brian Leiter</a>, for keeping my name in the blogosphere, and helping to draw attention to my work. Keep it up and I may feel obliged to give you a cut of the royalties. </div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-59541128268164996682015-02-13T16:39:00.004+01:002015-02-13T16:39:58.677+01:002d edition coming soon!<div dir="ltr" style="text-align: left;" trbidi="on">
The book is in press now, due out in May. Expanded with discussion of the Myriad case which pretty much established what I argued for as the law of the land, as well as including a foreword by Kevin Noonan of Patentdocs, the blog that once attacked the book, this edition is intended to be a definitive edition.<br />
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Here's a link at Wiley: <a href="http://au.wiley.com/WileyCDA/WileyTitle/productCd-1118948505.html">http://au.wiley.com/WileyCDA/WileyTitle/productCd-1118948505.html</a></div>
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Many thanks to all who contributed.</div>
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-David</div>
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Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com1tag:blogger.com,1999:blog-6001813637971400489.post-80198561650375900312014-12-17T17:14:00.002+01:002014-12-17T21:05:37.918+01:00Myriad is Finished<div dir="ltr" style="text-align: left;" trbidi="on">
BREAKING NEWS!<br />
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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, <a href="http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1361.Opinion.12-15-2014.1.PDF" target="_blank">who today rejected their claims on appeal</a>. This fight is done.<br />
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Echoing reasoning I have advocated, the court held:<br />
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"Contrary to Myriad’s argument, it makes no difference<br />
that the identified gene sequences are synthetically<br />
replicated. As the Supreme Court made clear, neither<br />
naturally occurring compositions of matter, nor synthetically<br />
created compositions that are structurally identical<br />
to the naturally occurring compositions, are patent eligible.<br />
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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.<br />
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UPDATE: it's particularly good timing as the second edition of <a href="http://www.wiley.com/WileyCDA/WileyTitle/productCd-1118948505.html" target="_blank">Who Owns You</a> 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 <a href="https://prezi.com/gtxihzkwj-9n/nature-and-the-commons/" target="_blank">this</a>.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com1tag:blogger.com,1999:blog-6001813637971400489.post-31780502156832676952014-03-14T08:02:00.003+01:002014-03-14T08:02:47.127+01:00More Stuff Happens with the BRCA genes<div dir="ltr" style="text-align: left;" trbidi="on">
So <a href="http://www.nytimes.com/2014/03/11/business/patentholder-on-breast-cancer-tests-denied-injunction-in-lawsuit.html?_r=0" target="_blank">there's still activity in the Myriad case</a>, and also a second edition of my book <i>Who Owns You</i> 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. <a href="https://ecf.utd.uscourts.gov/cgi-bin/show_public_doc?214md2510-7" target="_blank">In a 100+ page opinion</a>, the court in <i>Myriad v. Ambry</i> 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. <br />
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Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com2tag:blogger.com,1999:blog-6001813637971400489.post-74587501315205221902013-06-19T17:16:00.000+02:002013-06-19T17:47:46.775+02:00Philosophy and Public Policy: Metaphysics Matters!<div dir="ltr" style="text-align: left;" trbidi="on">
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.<br />
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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 <em>Who Owns You</em> 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. <br />
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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.<br />
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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 <em>intention</em> of creating the product and the <em>design</em> of the product must come from <em>minds</em>. 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.<br />
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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 <em>Myriad</em> 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.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com3tag:blogger.com,1999:blog-6001813637971400489.post-19092526193732488462013-06-14T19:56:00.001+02:002013-06-14T20:53:55.085+02:00looking back and preserving history<div dir="ltr" style="text-align: left;" trbidi="on">
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Strangely, in the wake of the recent <a href="http://www.cnn.com/2013/pdf/12-398_8njq.pdf" target="_blank">Supreme Court decision in Myriad</a>, one of my very my very first public<i> </i>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<i>. </i>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.</div>
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"<br />
The Case Against Gene Patents</div>
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Written by David Koepsell</div>
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Posted: June 13, 2009 @ 5:35 pm</div>
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I favor innovation, and am interested in ensuring that science and<br />
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?"</div>
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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.</div>
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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<br />
that are being patented.</div>
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The first public altercations over gene patents came from groups<br />
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<br />
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.</div>
<div dir="ltr">
<br /></div>
<div dir="ltr">
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<br />
this sort of thing.</div>
<div dir="ltr">
<br /></div>
<div dir="ltr">
In Gottschalk v. Benson, the Supreme Court stated: "the patent would<br />
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<br />
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.</div>
<div dir="ltr">
<br /></div>
<div dir="ltr">
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<br />
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. </div>
<div dir="ltr">
<br /></div>
<div dir="ltr">
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<br />
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.</div>
<div dir="ltr">
<br /></div>
<div dir="ltr">
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."</div>
<div dir="ltr">
<br /></div>
<div dir="ltr">
About the Author</div>
<div dir="ltr">
David Koepsell is an author, philosopher, and attorney whose recent<br />
research focuses on the nexus of science, technology, ethics and public<br />
policy. He is an Assistant Professor at the Delft University of<br />
Technology, Faculty of Technology, Policy, and Management, Philosophy<br />
Section, and he blogs at Who Owns You?</div>
</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com2tag:blogger.com,1999:blog-6001813637971400489.post-86006654518703108142013-06-13T19:50:00.001+02:002013-06-13T19:50:19.604+02:00Logic Prevails!Read it and weep, IP-maximalists: <div><a href="http://www.cnn.com/2013/06/13/politics/scotus-genes/index.html?c=mobile-homepage-t">http://www.cnn.com/2013/06/13/politics/scotus-genes/index.html?c=mobile-homepage-t</a><div><br></div></div>Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-53648456364415778502013-04-21T10:20:00.001+02:002013-04-21T16:42:11.909+02:00Other people's bodies: a fresh perspective<div dir="ltr" style="text-align: left;" trbidi="on">
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 <a href="http://www.amazon.com/Other-Peoples-Bodies-Arthur-Gershman/dp/1257826700" target="_blank">Other People's Bodies</a> 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 <a href="http://koshergoldfish.blogspot.nl/2013/04/the-jewish-daily-forward-weighs-in.html" target="_blank">here</a> and includes a recent column from the Jewish Daily that opines against gene patents in relation to the Myriad case.<br />
<br />
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. </div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com1tag:blogger.com,1999:blog-6001813637971400489.post-70376135212265847762013-04-16T09:50:00.001+02:002013-04-16T09:50:42.424+02:00JUSTICE KAGAN: "And the PTO seems very patent happy" <div dir="ltr" style="text-align: left;" trbidi="on">
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 <i>ought </i>to be the case. They are "patent happy." (see, e.g., the <a href="http://www.google.com/patents/US6004596" target="_blank">Peanut Butter Sandwich patent</a>).<br />
<br />
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 <i>changing </i>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 <a href="http://whoownsyou-drkoepsell.blogspot.nl/2012/03/patent-religion-suffers-blow-reading.html" target="_blank"><i>Prometheus</i></a>.<br />
<br />
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 <i>Myriad </i>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 <a href="http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398-amc7.pdf" target="_blank">here</a>. Also, I am providing links to some excellent in-depth and plain English analyses here, at <a href="http://www.patentlyo.com/patent/2013/04/amp-v-myriad-gene-patenting-oral-arguments.html" target="_blank">Patently-O</a> and at <a href="http://www.scotusblog.com/2013/04/justices-debate-gene-patenting-issues-in-plain-english/" target="_blank">ScotusBlog</a>. What I wish to do here is highlight sections from my <a href="http://www.amazon.com/Who-Owns-You-Corporate-Philosophy/dp/1405187301/ref=sr_1_1?ie=UTF8&s=books&qid=1242896619&sr=1-1" target="_blank">book </a>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:<br />
<br />
<blockquote class="tr_bq">
"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." (<i>Who Owns You? </i>p. 111-12)</blockquote>
<blockquote class="tr_bq">
"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)." (<i>Ibid</i>, p. 112)</blockquote>
<blockquote class="tr_bq">
"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.” (<i>Ibid</i>, p. 113)</blockquote>
<blockquote class="tr_bq">
"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." (<i>Ibid</i>, p. 114)</blockquote>
<blockquote class="tr_bq">
"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." (<i>Ibid</i>., p. 115)</blockquote>
<br />
I quote these sections because they show that the arguments I made anticipated the same ones made in the <i>Myriad </i>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 <a href="http://whoownsyou-drkoepsell.blogspot.nl/2012/04/myths-about-who-owns-you.html" target="_blank">Myths About Who Owns You </a>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.<br />
<br />
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.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com2tag:blogger.com,1999:blog-6001813637971400489.post-50978466206082064832013-04-13T09:35:00.003+02:002013-04-13T09:38:11.636+02:00Next Monday, I Like<div dir="ltr" style="text-align: left;" trbidi="on">
This has been a big week leading up to an even bigger Monday. That's the day the Supreme Court finally hears the <i>AMP v. Myriad</i> 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, <a href="http://www.amazon.com/Who-Owns-You-Corporate-Patent/dp/1405187301/ref=sr_1_2?ie=UTF8&qid=1365838307&sr=8-2&keywords=david+koepsell" target="_blank">Who Owns You</a>. There I gave this talk: "<a href="http://prezi.com/yzwld1xci2tc/nature-genes-and-the-commons-who-owns-you/" target="_blank">Nature, Genes, and the Commons</a>" with a great reception from the students and faculty. The questions were challenging and the discussion wide-ranging.<br />
<br />
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 "<a href="http://www.kqed.org/a/forum/R201304120900" target="_blank">Who Owns Your Genes</a>" 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.<br />
<br />
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:<br />
<br />
<div align="center" class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2195" style="text-align: center;">
<b><u>"As Supreme Court debates gene patenting linked to hereditary breast
and ovarian cancer, POV and Kartemquin release <i>In the Family</i> free online</u></b></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2196">
<br /></div>
<div align="center" class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2197" style="text-align: center;">
<span style="color: red;">Emmy-nominated 2008 film by Joanna Rudnick features revelatory
video interview with Myriad Genetics, defendant in the SCOTUS case.</span></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2198">
<br /></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2212">
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. </div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2211">
<br /></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2210">
To raise public awareness on the issues involved, the documentary
<a href="http://www.inthefamilyfilm.com/" rel="nofollow" target="_blank"><i>In
the Family</i></a> – 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.</div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2224">
<br /></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2208">
<i>In the Family</i> will
be exclusively streamed online at <a href="http://www.pbs.org/pov/inthefamily" id="yui_3_7_2_1_1365838542802_2209" rel="nofollow" target="_blank">http://www.pbs.org/pov/inthefamily</a>,
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.</div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2207">
<br /></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2225">
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."</div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2225">
<br /></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2225">
On Monday, of course, we'll have some new material to review as the court's arguments become available online. </div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2225">
<br /></div>
<div class="yiv1694706387" id="yui_3_7_2_1_1365838542802_2225">
stay tuned! </div>
<b></b><br />
<br /></div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-10226117703182363852013-03-20T13:51:00.000+01:002013-03-20T15:11:51.419+01:00Pro-Patent Panic and Hyperbole While Waiting for Myriad<div dir="ltr" style="text-align: left;" trbidi="on">
Over at <a href="http://www.ipwatchdog.com/2013/03/19/st-jude-childrens-research-hospital-gets-patent-for-genetically-modified-human-immune-cells-for-cancer-therapy/id=37741/#comments">IPWatchdog</a>, where I have been banned as have most others who dare to challenge Gene Quinn's point of view, the panic in the air is palpable. So much so that he (and those who are afraid that the Supreme Court will do the right thing and narrow the scope of patenting genes to fit the exclusion for products of nature) has committed perhaps more fallacies in a single post than even he has ever done. Bravo for that, it would be a singular accomplishment! Let's analyze just a couple:<br />
<br />
<i>Straw Man Fallacy</i>: This is one of Gene's favorites. He posts this particular tirade using as his excuse a patent described thusly -" <a href="http://www.freepatentsonline.com/8399645.html">U.S. Patent No. 8,399,645</a> — was issued to <a href="http://www.ipwatchdog.com/2013/03/19/st-jude-childrens-research-hospital-gets-patent-for-genetically-modified-human-immune-cells-for-cancer-therapy/id=37741/www.stjude.org/">St. Jude Children’s Research Hospital</a>. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults." Note that the patent relates to genetically modifying human immune cells. He then inexplicably makes this move and then mentions the upcoming <i>Myriad </i>argument in the Supreme Court: "It seems unthinkable that the Supreme Court could issue a ruling that would call into question the patent eligibility of an innovation that has the potential for curing cancer, but that is what is at stake." Finally, admitting that a ruling in <i>Myriad </i>won't likely affect this patent, he concludes this section with "if the Supreme Court says that human genes are not patentable then what is to stop the march toward a ruling that says genetic modifications are likewise not patentable?" Wow, that was a fast one. How he got from A to B is an enormous mystery, suggesting that somehow a decision that holds that the BRCA1 and 2 patents are invalid under Section 101 because (presumably) they are products of nature has any relation to his nightmare scenario. In fact, there is no relation. He has raised a spectre which is unrelated to Myriad so that he can knock it down. Classic straw man. Raise up an argument that is not the argument in question, knock it down, and pretend you won the day. The patents in the St. Jude filing are not on isolated human genes, they cover instead genetically modified human immune cells. As even Eric Guttag notes in his comment to Gene (only true believers are allowed to comment there) modifying an organism in some way (not counting mere isolation) is inventive under the doctrine of <i>Chakrabarthy </i>which we have discussed here many times, mostly because that case also raises clearly the exclusions of products of nature. <br />
<br />
Another straw man (and appeal to emotion) is this beauty: "By any measure St. Jude has been enormously successful. And those who think that government shouldn’t be funding research that results in the issuance of patents will absolutely hate the fact that the government and grants have played a role, together with the patent system, to provide the incentive and funding necessary to achieve this remarkable advance." Well, now, who thinks that? I think that this basic research ought to be funded, but that patenting it robs from the taxpayer, who has already subsidized the research, and who now has to pay monopolistic prices to access the fruits of their investment. But this is a very different position than that which Gene Quinn weaves out of whole straw.<br />
<br />
<i>Non-sequitor</i>: Gene's entire point of the article seems to be to raise a red flag somehow suggesting that those who oppose patenting certain things will somehow prevent the cure for cancer. Here's his alarmist question: "How strange would it be if the cure for cancer has been achieved only for society to take the position that it is not patentable? If innovations of this importance are not patent eligible then why would anyone spend the amount of time and money necessary to bring them into being?" But earlier he noted that the research was done under an NIH grant. So the means to do the research was not venture capital fronted on the basis of the possibility of some return. It was basic research conducted as part of the government's major public granting system. Why would a research hospital doing basic research using funds given by the government try to come up with cures for cancer? My guess is: they want to cure cancer, and the government has given them the means. The patent incentive is utterly unnecessary in this case. It is now a nice extra double reward that the hospital will realize, and we could quibble with the justice of that, but his alarmist question bears no relation to the case, it is a complete non-sequitor.<br />
<br />
<i>Equivocation</i>: one way to screw up an argument is to use a word or phrase in two different senses to try to make them appear equal when they are not. Gene does that here with the following: quoting the claim he includes "3. An isolated host cell comprising a polynucleotide encoding a chimeric receptor comprising: (a) an extracellular ligand-binding domain comprising an anti-CD19 single chain variable fragment (scFv) domain; (b) a transmembrane domain; and (c) a cytoplasmic domain comprising a 4-1BB signaling domain and a CD3? signaling domain.""" then Gene goes on ..." As you can see, the isolated host cell claim, claim 3, could be on a very slippery slope if the Supreme Court decides that the isolation step in the Myriad patent is insufficient to establish patent eligibility." And so, don't you see, because some of us claim that an isolated unmodified <i>gene </i>is not inventive, and remains a product of nature, then of course so too would the isolated host cell in this case, and so the cure for cancer would not be patent eligible and people like me all want to stop the research that leads to the cure for cancer. Don't you see? But wait, what he apparently hopes you don't notice is that in the St. Jude patent, the isolated host cell is chimeric. It has been modified. It isn't a product of nature. Which destroys his whole chain of reasoning. Oops.<br />
<br />
<i>Appeals to emotion</i>: Quinn's rhetoric is always geared toward dangling red meat to raise the ire of his true believers, and those who don't dig too deeply into his faulty "arguments." This post is replete with pointless appeals to emotion, including the following, which also is an appeal to tradition "St. Jude Children’s Research Hospital is internationally recognized for its pioneering research and treatment of children with cancer and other life-threatening diseases. The hospital’s research has helped push overall survival rates for childhood cancer from less than 20 percent when the institution opened to almost 80 percent today. The research that led to this patent was supported in part by a grant from the National Institutes of Health. The patent issued today increased St. Jude’s patent portfolio to more than 100 issued United States patents" And so? Clearly, those of us who want to stop the patenting of unmodified and merely isolated genes are trying to destroy a wonderful organization!! Well, except we're not, obviously. Then there's this one, which really needs no further comment: "The anti-patent zealots will be remembered in history in the same way that we today view those who persecuted the likes of Galileo. Standing in the way of scientific advance and innovation is regressive, shortsighted and irresponsible. Only those with a special phobia against science and innovation, as well as a healthy disregard for reality, would ever stand in the way of the march of health related innovations." Except, oh man.<br />
<br />
<b>An so in sum</b><br />
<br />
Let's get serious. A ruling for petitioners will <b>not </b>bring the biotech industry to a screeching halt as Quinn and his ilk want you and the Supreme Court to believe. Appealing to fear is the only hope they have in this case, since logic indicates that isolating something, as I have argued extensively, that is not the design and intention of some person does not make the isolated product of nature (like our famous O2 example) somehow inventive. We might have legitimate disagreements about whether isolation of something found in nature from its natural substrate ought to make it inventive, but the sort of panicky pronouncements, poor argumentation, and inflammatory rhetoric used in this post simply calls attention to the fear that patent-expansionists face whenever the Supreme Court starts reining them in. It's the same panic they exhibited when my book first came out, in which I took a very moderate position, the same position that the Solicitor General has taken that cDNA is patentable, but merely isolated genes are not.It's the same position the Supreme Court should take, and it's perfectly moderate and logical.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-69557965992293144332012-12-22T01:28:00.000+01:002012-12-22T01:28:55.038+01:00From "Frivolous" to the Supreme Court<div dir="ltr" style="text-align: left;" trbidi="on">
A few years ago I got lucky, in a way. In 2006 I worked as a fellow at the Yale Center for Bioethics and wrote what came to be published as <a href="http://www.amazon.com/Who-Owns-You-Corporate-Philosophy/dp/1405187301/ref=sr_1_1?ie=UTF8&qid=1356135606&sr=8-1&keywords=who+owns+you" target="_blank"><i>Who Owns You? The Corporate Gold Rush to Patent Your Genes</i> (Wiley-Blackwell 2009)</a>. A few months after it was released, the ACLU helped spearhead a <a href="http://en.wikipedia.org/wiki/Association_for_Molecular_Pathology_v._Myriad_Genetics" target="_blank">lawsuit</a> against Myriad Genetics for their patents over the BRCA1 and 2 genes. My incredibly lucky timing catapulted me into an important international debate about the patent-eligibility of isolated but otherwise unmodified genes in a way I never anticipated. In the process, <a href="http://www.patentdocs.org/2009/06/falsehoods-distortions-and-outright-lies-in-the-gene-patenting-debate.html" target="_blank">I took a lot of heat</a>. Everyone who has spoken up against the practice of seeking and granting patents on genes has taken heat from IP-maximalists, typically patent attorneys, for whom the unimpeded expectation of being able to apply for a patent on nearly everything is an important source of income. Looking back on the headlines in those blogs that decried the lawsuit and books and articles like mine is telling. The lawsuit was called "<a href="http://www.ipwatchdog.com/2009/05/14/aclu-files-frivolous-lawsuit-challenging-patents/id=3417/" target="_blank">frivolous</a>," a heady charge for attorneys who can be sanctioned personally for taking part in cases that have no merit. I was called a liar, as have others. We were alleged to neither understand the law nor understand the science. Since then, <a href="http://www.aclu.org/free-speech-womens-rights/aclu-challenges-patents-breast-cancer-genes-0" target="_blank">both scientists and lawyers, including patent attorneys</a>, have chimed in on the side of the ACLU, but no matter.<br />
<br />
At the time I was taken aback. I had expressed a point of view that was backed, I felt and argued, by both the law and reason. I believed and argued that claims (the part of the patent that specifies what is monopolized) encompassed parts of nature, despite the allegations by patent professionals and a string of case dictum that "isolation" equaled invention. The arguments in both the court case and my book, and popping up regularly in articles and now other books, were not lies. They were points of view based upon reasoned arguments. The lawsuit, it turns out, was not frivolous. In fact, the <a href="http://www.patentlyo.com/patent/2012/11/supreme-court-has-granted-cert-in-the-myriad-case-question-are-human-genes-patentable.html" target="_blank">Supreme Court will now grapple with it</a>. It is important, it seems, to the highest court in the U.S.<br />
<br />
At the time I found myself defending my work against those who resorted (and still do) to attacking <i>me</i> rather than countering my arguments, I had no clue what motivated the vitriol and attempts to personally smear me. I made the mistake of <a href="http://ieet.org/index.php/IEET/more/koepsell20090816/" target="_blank">lashing out</a>. I should have been more patient. Time, it seems, and the strength of good reason is also a powerful weapon. The principals at the ACLU and the named plaintiffs in the case have taken much abuse too, and they have a personal stake in the lawsuit. Soon, the Supreme Court will hear and consider arguments, and <i>amicus</i> (friend of the court) briefs will be submitted by parties on various sides. In the past couple years, in cases like <i>Bilski</i> and <i>Prometheus</i>, similar vitriol has been lobbed at the Supreme Court for reining in the IP-maximalists, and limiting the realm of patentability in rational ways. Recently, some have argued that the <a href="http://hallingblog.com/supreme-court-agrees-to-hear-so-called-gene-patenting-case-myriads-stock-falls-9/" target="_blank">Supreme Court is simply not qualified</a> to deal with the issue of patents. This by the same people who like to remind us that intellectual property laws have some basis in the Constitution. The highest constitutional court is, of course, the Supreme Court, and their role is to interpret all our federal laws in light of the Constitution.<br />
<br />
I don't know what the Supreme Court will do, but it is heartening to know that there are others who believe this is an important issue, grounded in real logical and legal concerns, with room for argument, and compelling and uncertain enough to warrant the Supreme Court's attention and decision. My heartfelt thanks go to those who have fought the actual hard fight, and got the case as far as it has gone, and have endured worse attacks, steadfastly promoted arguments that many of us feel are correct, and sought real change. I am honored to be in good company, and now bear no ill will toward any of those who have sought to diminish me or my arguments. What matters is commitment, and honesty, and what will decide the day in the courts will be some sort of reason. Whichever side does not prevail should be held in no contempt. We must recognize that those on both sides (or perhaps there is a spectrum since I originally argued for a very moderate view, in my opinion, in which cDNA, for instance, was patent eligible), should be honored for making fair arguments, based on precedent and reason, for honest purposes.<br />
<br />
May reason prevail.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-32410047721684926182012-12-12T21:18:00.001+01:002012-12-12T21:26:32.188+01:00Artificially produced natural products, SCOTUS in the Nineteenth Century got it right<div dir="ltr" style="text-align: left;" trbidi="on">
H/T to Douglas Rogers who dared speak reason at IPWatchdog regarding the Myriad case, and who referenced an interesting Supreme Court case from 1884 -<br />
<h1>
<i><span style="font-weight: normal;"><span style="font-size: small;">Cochrane v. Badische Anilin & Soda Fabrik - 111 U.S. 293 (1884)</span></span></i></h1>
That case involved a challenge to a patent on an artificially produced chemical otherwise found in nature, and stated in relevant part:<br />
<br />
<div style="text-align: left;">
"<span class="headertext">There is another view of the case. According
to the description in No. 95,465, and in No. 4,321, and the evidence,
the article produced by the process described was the alizarine of
madder, having the chemical formula C14H8O4. It was an old article.
While a new process for producing it was patentable, the product itself
could not be patented, even though it was a product made artificially
for the first time, in contradistinction to being eliminated from the
madder root. Calling it artificial alizarine did not make it a new
composition of matter, and patentable as such, by reason of its having
been prepared artificially, for the first time, from anthracine, if it
was set forth as alizarine, a well known substance. <i><span class="l-italics"><a href="http://supreme.justia.com/cases/federal/us/90/566/case.html">Wood Paper Patent,</a></span></i> 23 Wall. 566, <span class="l-normaldigitafter"><a href="http://supreme.justia.com/cases/federal/us/90/566/case.html#593">90 U. S. 593</a></span>."</span></div>
<br />
<span class="headertext">By this reasoning, those who argue that O2, when artificially produced, is suddenly not a product of nature, and thus patent-eligible under Sec 101 are simply wrong. O2 is not new, we didn't design it. Nor are the strings of nucleotides claimed in the <i>Myriad</i> case, despite those who allege the claims encompass "new molecules." As we have noted here before, what makes a gene a gene is its part in producing proteins, the mechanism of which is coded into the gene with stop and promoter codons. Isolating that gene from its surrounding substrate, the genome as a whole, does nothing to make it a new "molecule." Unlike other molecules, the role and use of a gene is informational, and nothing done while isolating the gene from the surrounding genome alters its informational role, we simply use the information for a new purpose. It is mere sophistry to allege this creates a new thing worthy of protection under patent. </span></div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-24428808664224319442012-11-20T12:58:00.003+01:002012-11-30T22:46:10.947+01:00Myriad's Ways - in SCOTUS's sights<div dir="ltr" style="text-align: left;" trbidi="on">
The Supreme Court has been collecting <i>amicus </i>(friend of the court) briefs and has put the matter of the AMP v. Myriad appeal on its calendar for a conference. This means that they will consider the request by AMP and the other plaintiffs/petitioners for review of the decision of the CAFC (the appellate court that most recently heard and decided the case). We should therefore know in December or at the latest early in the new year whether they will listen to an appeal.<br />
<br />
One brief, by the <a href="http://patentdocs.typepad.com/files/brief-of-amici-curiae-cancer-council-et-al..pdf" target="_blank">Cancer Council of Australia</a>, includes language I helped draft, as well as a reference to my book. While no one can predict with certainty what the Supreme Court will do, I have a strong suspicion they will choose to listen to the case, both due to its importance regarding medicine, but also because it serves as a good follow-up case to the <i>Mayo</i> case we have discussed here, which involved patentability of laws of nature. The <i>Myriad</i> appeal will give the Supreme Court a chance to make clear their position on <i>products </i>of nature as well. My friends at Patent Docs have collected links to all the briefs <a href="http://www.patentdocs.org/2012/11/amp-v-myriad-briefed-and-distributed-for-conference-update.html" target="_blank">here</a>.<br />
<br />
<b>** UPDATE** The <a href="http://www.patentlyo.com/patent/2012/11/supreme-court-has-granted-cert-in-the-myriad-case-question-are-human-genes-patentable.html" target="_blank">Supreme Court had granted the petition</a> for certiorari, which means it will hear the appeal!</b> </div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-58295252644172910812012-10-02T06:14:00.000+02:002012-10-03T07:09:53.933+02:00In the Meantime...<div dir="ltr" style="text-align: left;" trbidi="on">
I decided while we wait for things to happen in the <i>Myriad</i> appeal to post the selection below, a Foreword I wrote for the upcoming book <a href="http://www.amazon.com/Question-Mark-Above-Sun-Surrounding/dp/0983740550/ref=sr_1_12?ie=UTF8&qid=1349153003&sr=8-12&keywords=david+koepsell"><i>A Question Mark Above the Sun</i></a> by Kent Johnson, to be released in the next few weeks by Starcherone Books. Because the question of "creation" is vital to my argument about rights of inventors over sequences they didn't write, but merely found and copied, I thought readers of this blog might see the nexus between authorship, creativity, and ownership in other media. I loved writing this, and hope you'll enjoy, and I urge you to support Kent Johnson by buying his book, because it's great:<br />
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<br />
<div class="western" style="margin-bottom: 0in;">
A Question of
Authorship?
</div>
<div class="western" style="margin-bottom: 0in;">
David Koepsell</div>
<div class="western" style="margin-bottom: 0in;">
<br /></div>
<div class="western" style="margin-bottom: 0in;">
The relations between
authors and texts are as complicated as any human relationships –
perhaps even more so. Who counts as an author, and what connects the
author and a text once written are much debated, and long have been.
Academic arguments, for instance, about the “true” author of
Shakespeare’s work rage still, many hundreds of years after the
canon was written. Arguments<i> in</i> academia often focus about who
counts as an author, and who should be so named on journal articles.
Credit for authorship is a much older, established right for which
duties might be owed than, for instance, the relatively modern
institution of copyright. But the connection between author and work
has always been tentative, and theories of literary criticism have
wavered between those who insist upon authorship’s critical
importance and others who maintain the absolute irrelevance of
questions of authorship or author’s intention. Simply put: should
we care who wrote something, really? Does it ultimately matter? And
to what extent are authors really <i>responsible</i> for a text, or
owed some duty of attribution? Finally, are “errors” of
attribution harmful? These are deeply philosophical questions of
ethical import raised intriguingly in the following pages by Kent
Johnson. But before we get to “his” text, I’d like to address
the fundamental, metaphysical and ethical issues underlying both his
work and the controversy around which it dances so eloquently.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
For almost two decades
now I have turned my attention to the metaphysics of expressions.
Specifically, I have been interested in what counts as an expression,
and how expressions differ from other sorts of things. In that time I
have mostly concentrated upon the legal category we call
“intellectual property,” which most of us know as copyrights,
patents, and trademarks. In the course of this work I’ve come to a
theory of expression that has implications broader than IP law, which
concerns legal monopolies to profit from expressions. My work has led
me to critique the foundations of IP law for various reasons that are
not relevant to this text. But the broader implication of what I have
come to believe is, namely: expressions, once expressed, do not
belong to the author. To get to this point, and its obvious
implications for the remarkable events behind <i>A Question Mark
Above the Sun</i>, let’s look at what it means to be an author, and
what an expression is, stripped down to their elemental forms, and
without worrying for the moment about what we think <i>ought</i> to
be the case.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
An expression is the
extension of some idea into the “real” world. Ideas exist as
thoughts in minds until they are expressed, and then they take on
lives of their own. In fact, this is why modern intellectual property
(IP) laws were created: because once an expression “leaves” the
author, it is simply no longer physically (and maybe morally) beyond
the realm of his or her dominion. The expression is free for all to
adopt, appropriate, alter, or re-express. So we should be skeptical
of claims about any “exact” connection between an author and an
expression. This is certainly true for expressions that have been
around a long time. The works of Homer, for instance. Homer’s works
were recited for ages before they were written down as poems and
songs that were part of an oral tradition that predated modern,
mass-produced copies of either. Whose expression is “The Illiad”?
even assuming a largely mythical Homer did exist, “his” epic
poetry was told and re-told many thousands of times, doubtless
changing over time, with new riffs and tweaks added by balladeers
over the ages before someone first published a written copy, or
before a standard Homeric canon was created some centuries later.
Then translated, the meanings and nuances added or lost are the
result of the translators. Whose voice remains? Is it Homer?</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Of course Homer’s
works are no longer truly Homer’s, and may never have been. In a
very real sense, they ceased to be Homer’s (or the author(s)?) once
released into the wild. There they took on new forms, and their
current iteration, while still attributed to some author we call
“Homer” (or someone, the joke goes, not Homer but with the same
name) is a text whose authorship is very much literally doubtful. It
is the work of legions, now, unnamed and unimportant in the grand
scale of literature. Works such as Homer’s, like the Bible, for
example, historically remote and oft-changed, altered and translated
over millennia, are most clearly distinct from the expressions of
their “original” authors. These sorts of works raise not just
metaphysical, but ethical questions about the <i>role</i> and
<i>importance</i> of authorship to a particular text. Does it matter,
for instance, if Homer did not write, originally some particular
verse or phrase, or for that matter, Homer’s works in their
entirety? Is there some right or duty relating to the first
expression of some idea, and its ultimate fortune?
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
While we may be
responsible for our expressions when they are made, the root of that
responsibility is in the <i>choice</i> of making the expression and
in its initial content. It is a terrible risk to express an idea, one
imbued with more chance of failure, ridicule, and numerous other
potential liabilities than with “success.” Success generally
means finding an audience that appreciates or at least acknowledges
the expression. Most expressions drift away into the winds, never to
be remembered. This is often thought of as the worst sort of failure
for an author. But is this sort of failure linked to the fate of the
expression, or the fate of the expression’s linkage to the author?
The answer to this, which is in many ways the question underlying
Kent Johnson’s musings and research, depends on what is <i>important</i>
to the author as much as what is appreciated by an audience. What if
there is no one “Homer” or what if Shakespeare either didn’t
write some or all of Shakespeare’s works? What does this mean for
us, as an audience, the worth of the works, and the value of Homer or
Shakespeare as poets?
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Most authors want to
be connected to their works. Their expressions are personal, and this
is the great risk of authorship. The courage to express means also
accepting the great risks of expressing. Oblivion, ridicule,
criticism, and obscurity are one’s most likely fates, but all
authors dream of making some lasting impact on the world through
their expression in some medium. Sculptors and architects do so with
real, lasting monuments, and those who write attempt to do so with
materials more ephemeral. Balladeers’ and dancers’ mediums of
expressing are more fleeting still. Some people believe that taking
the risk of expressing an idea in some medium requires that the
community of potential observers and appreciators acknowledge that
risk through such things as attribution and more recently,
monopolies. Some authors (and clearly, I am using this term very
loosely because I view expressions as occurring in many types of
media, at the hands of a range of artists and even inventors) choose
to produce their expressions anonymously, or care little for their
attribution. Their reasons may be many and varied. Perhaps they fear
the potential risks, or maybe they see the expression itself as being
more important than attribution.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
The question for us,
if we are concerned with the ethics involved in “proper”
attribution, is: is attribution of expression to author a moral
requirement? Improper attribution can be a moral wrong where an
expression is harmful, somehow. Attributing a libelous expression
falsely is clearly wrong, as it passes off a responsibility for harm
to an innocent party. Attribution, or the naming of the original
author, is not only often imprecise (because as we saw above,
expressions are changed over time, and may accumulate numerous
authors) but is <i>not morally required</i>. Authors might wish to be
associated with their expressions, but we are under <i>no positive
duty</i> to ensure they are.<br />
<br />
Part
of the risk of expression is that the thing expressed lives a life of
its own, flitting off into the wild, morphing over time, affecting
audiences in any number of unpredictable and unintended ways. An
author could no more ethically take credit for unintended good
effects than for unintended bad ones. Once “free” of the author
(once expressed) the expression and author are related only
tangentially, as a perhaps interesting story about a particular
expression’s origin, but little more. Our expressions live on,
populating the world, replicating, thriving without us, and we should
be glad of this. Just as with children, for whom we might be proud as
they grow, thrive, develop, and go about their lives; our expressions
live on, thrive, die, or remain unknown despite our hedonistic wishes
for immortality. Children are not their parents, and their successes
or failures speak only partially to our success or failure as
parents. Authors and parents want to claim credit for the successes
of their expressions or children, but allowing them to succeed (or
fail) without the necessity of taking that credit represents a
greater moral choice.
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
In fact, this is the
realization of much modern literary criticism and its disentangling
of author, intention, and expression. The work speaks for itself, and
while we might very much enjoy trying to discern the author’s
intention, doing so is epistemologically impossible, perhaps even for
the author at the time of expressing. Kent Johnson takes this to its
logical and moral extreme, questioning the rights, duties, and nature
of authorship and attribution in general. He does so from firm
ground. Authors have long toyed with the nature of their own
authorship, and created personae and pseudonyms to make their
expressions on their behalf, implicitly acknowledging the absurdity
of any firm connection between expression and author. Araki Yasusda,
who may or may not have been a Japanese poet whom Johnson translated,
is but one example, and the story Johnson weaves to make his
political and moral case about “O’Hara’s” poem is both
serious philosophical inquiry and wrenching satire.
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Modern political
economy and the nature of profits in the publishing world have
encouraged adopting a myth about the relation of author to work. This
myth, destroyed effectively by Johnson, and undermined by the
historical examples I have noted above, is that expressions are the
author’s and that we must somehow acknowledge their conception to
them and their profits. We <i>choose</i> to do so now for complex
reasons, and in so doing may very well undermine the moral worth of
creative expression. Blockbuster authors are now often industries
around which publishing empires rise and fall. For instance,
Bloomsbury, which published one of my books, has made a fortune and
grown significantly propelled by the profits of <i>Harry Potter</i>.
J.K Rowling is now inextricably associated with the <i>Harry Potter</i>
volumes and movies. Rowling is as much a brand as the books
themselves, expertly crafting a persona and canon that will, for the
foreseeable future be known both as her and hers. How does <i>Harry
Potter</i> stack up to <i>Beowulf</i>?
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
I’ll take a great
risk and suggest that in the next thousand years or so, if humans
remain, and English is still read, <i>Beowulf</i> will continue to
have an important role in our culture and <i>Harry Potter</i> will
not. J.K. Rowling may well be regarded as a successful author in her
time, and <i>Harry Potter</i> valued for introducing a generation of
kids to long-form fiction reading, but as great literature whose
impact on a culture is historically important and meaningful,
<i>Beowulf</i>, whose author is unknown, is a monument unlike most
modern works. Were I the author of <i>Beowulf</i>, if indeed there
was a single author, I’d prefer that sort of legacy to Rowling’s.
While works of greatness uncoupled with fame or fortune do not pay
the bills, they are the <i>reason</i> most good authors take the risk
of authorship to begin with. But there are few truly good authors,
and fame and fortune are the current gods to which we worship. Now
here comes the proselytizing, and forgive me, I am not <i>primarily</i>
a fiction author (though I have dabbled). Authors should strive
neither for fame nor profit. Thus, attribution ought not to be an
author’s primary concern (or even a concern at all), but rather the
expression itself ought to be an end in itself, rather than a means
to some other end. The author’s primary duty overrides claims of
obligations owed by others, beyond the duty not to falsely attribute.
If the author’s duty <i>not</i> to claim rights to expressions is
true, as I claim it is, then there is no harm in even false
attribution where there’s no harm. Yes, some artists want to be
known for their works, but more often than not, true artists want
their <i>works</i> to be known.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Consider Banksy.
Banksy is famous for his works, iconoclastic stencils that began as
graffiti, but are known and sought the world over as art. But Banksy
is a pseudonym, and the ongoing power of his work stems in part from
his carefully crafted and preserved anonymity. In the film <i>Exit
Through the Gift Shop</i>, we see Banksy’s hooded figure, and
marvel at the rise of an obsessive-compulsive documentarian of
graffiti art’s own rise to the heights of artistic success, trading
on the <i>modus operandi</i> of Banksy, but without so much talent.
Of course the joke may well be on us, as the whole “documentary”
seems ultimately to have been a charade of sorts, making fun of the
art world, fame, glory, money, and the role and importance of critics
in turning the previously banal into gold. This film, like Orson
Welles’ <i>F For Fake</i>, uncovers the ludicrous extent to
which we attach names and histories to expressions, and how this
turns something into a treasured piece of “art.” Welles’ “film
essay” (as he called it) itself plays with notions of authenticity
and authorship, focusing on famous fakers such as Elmyr de Hory, one
of the twentieth century’s most successful art forgers. News that
many of the forgeries that de Hory had sold ended up in famous
galleries throughout the world both enraged collectors and urged them
to be silent. So many “authentic” Matisse’s and Picasso’s,
all suddenly called to question. The value of each as a <i>market</i>
commodity must now be forever in doubt, even if the artistic value of
any of them might be unscathed.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
What is it after all
that makes a particular Vermeer valuable? Han van Meegeren, who faked
and forged dozens of Vermeers, sold them successfully to educated
collectors and museums before he was caught. Was it the signature
that made the painting a worthy piece of art? Was it the art itself?
Orson Welles’ great works were fakes of a kind as well, under the
guise of which he could more successfully treat delicate subject
matters, like the story of William Randolph Hearst under the very
thin guise of <i>Citizen Kane</i>. Clifford Irving, who wrote the
book <i>Fake!</i> About de Hory, became Welles’ subject in <i>F for Fake</i> when his attempt to publish an official “biography”
of Howard Hughes becomes exposed as a fraud. And around and around we
go. Author, work, truth, fake, art, critic… the lines are forever
blurred when we begin to grapple with the metaphysical natures of
each, and the ethical duties of author and audience.
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Johnson upends and
dispels all the traditional notions of authorship and its role in
creation, scandalizing many in the process. This is what happens when
the <i>status quo</i>, by which the current <i>business</i> of
publishing continues and profits some, is challenged at its very
base. It is a final deconstruction, of sorts, to claim as he does
through the thin veneer of fiction, that there is some sort of
conspiracy at work protecting the origin of a great poem. There is a
conspiracy at work. There are several, in fact, including the twin
conspiracies of convention and commerce, according to which authors
are the <i>inventors</i> of the works they create and, like Thomas
Edison, should profit through a state-supported monopoly over their
“creations,” as well as some social-institutional monopoly over
its essence. To pretend there is some sort of strict tie, some
ownership, some moral right to protect and defend an expression once
expressed is a form of authorial authoritarianism. It is the
antithesis of free thought. Ideas don’t want to be free, they just
are. Part of the risk of expression involves the loss of control.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
But authors who aspire
to Homer’s fate take that risk and launch their works into the
winds and hope. Hope is the thing with feathers, and great works take
flight without legal institutions, critics, or conventions to buoy or
defend them against history. The freedom of expression is perhaps our
most basic right, because it intercedes at the barrier between the
mind and the body, where we choose to bring ideas into the world, but
it comes with a certain responsibility too. “Our” ideas are only
genuinely ours to the extent that we keep them trapped in our minds,
and even so, they are likely not just ours. More often than not, they
come from somewhere and someone else. Great ideas turn up
historically in numerous places at once. Newton, who (may or may not
have actually) said he stood on the shoulders of giants, quarreled
with Leibniz for years about the origins of calculus. Their
approaches to the problems of calculus were different, but solved the
same problems using differing methods. Today, both Leibniz and Newton
are celebrated, and calculus (whoever “created” it) helps propel
rockets to the planets and beyond. Newton, and Leibniz, and every
other scientist before and since <i>has</i> stood on the shoulders of
giants: their peers, and their betters, who preceded them. Science is
an evolving narrative, constantly refined but never perfected, a
cycle of observation, hypothesis, synthesis, theory, observation,
falsification, hypothesis, and so on.
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Literature too is an
evolving system, a dialogue of sorts among authors and <i>voices
</i>within a tradition (sometimes encompassing numerous languages)
over time. <i>Ulysses</i> is Joyce’s homage to the epic, borrowing
from and imitating various styles, merging fiction, politics,
religion, and culture in a new tapestry, the parts of which are
neither new nor original. <i>Ulysses</i> is <i>Odysseus</i>, and
Joyce plays Homer, wrapping an ordinary Dublin day in the cloak of
epic. It was scandalous too, for different reasons, daring to elevate
the bodily and the base, and insert them into epic. Since its
original publication, <i>Ulysses</i> has changed, and the version
that many of us grew up with as the “official” version has been
replaced by a work alleged to be more closely aligned with Joyce’s
own intention. Are there two <i>Ulysses</i>? Which is the real one?
And who wrote each? <i>Ulysses</i> evolves, even as the Homeric epics
have. Like all expressions, it is susceptible to revision and change,
and Joyce’s intentions are both unknowable and irrelevant. Only a
certain cult-like adherence to the myth of some strong link remaining
between author and expression will defy this inevitable tendency. To
defy this is to deny the true status of expression and to insist on
some morbid, unnatural stasis in our culture and its artifacts.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
And so what if? What
if Johnson’s story is “true” to the extent that Koch wrote
O’Hara’s haunting, prescient poem as an homage, an act of
beneficence, the selfless act of an author who recognizes the
overarching <i>duty to express</i> free of any egotistical desire for
attribution? Is positing such an act of friendship, honor, and beauty
a crime? Is it even just ethically wrong or suspect? I think it’s a
lovely idea, and Johnson takes the risk as any author does of
expressing his idea in a creative way. In so doing, he enriches the
culture with literature, raises important philosophical questions, as
is his wont, about the nature, duty, and obligations of authorship,
and provokes further inquiry and wonder about a literary moment. It
is interesting to ponder. It would be, as Johnson suggests, a truly
supererogatory act if true. It is useful to consider the nature of
acts through fiction and non-fiction. Ethicists do this all the time.
We posit trains, and multiple tracks, and sacrificing 1 person versus
5, we compose outrageous hypothetical situations so that we can
consider the ethical issues at play. These narratives are sometimes
ridiculous and disturbing (as in the various “trolley” examples,
involving choices between killing numbers and types of bystanders who
happen to be stuck on railroad tracks) and even scandalous
(cannibalism on lifeboats, etc.). But these stories are meant to
provide insight into values by forcing us to consider what roles
intentions and consequences mean for ethical decision-making.<br />
Philosophers exchange, comment upon, revise, and embellish
hypothetical examples used in ethics research. The history of
philosophy in general, as in all scientific research, is a history of
footnotes, critique, and revision of ideas whose geneses are often
now obscure – standing on the shoulders of giants. Claims of
originality must be looked at skeptically.
</div>
<div class="western" style="margin-bottom: 0in;">
<br />
Johnson crafts a
fictional account (a hypothesis of sorts) as a means of inquiry, as
scientists do, as philosophers do, to examine a possibility. Like
good science fiction and good science as well, it is founded upon
entirely plausible circumstances, with some interesting and unlikely
drama thrown into the mix from literary license. Like good
literature, it launches itself as an expression into the winds of
history and opens itself up for our use as we see fit. The laws these
days still allow this sort of supposition, though we should be
mindful about trends that could silence it. Laws are constantly
refined to benefit the monopolists of expressions. Science itself is
becoming monopolized by desperate academic presses intent on placing
profit over the ethos of science, which has hitherto been open and
free. Copyrights have been extended time and again, having begun with
terms of 14 years, and now thanks to the late Sonny Bono’s famous
lobbying for an extension of the copyright term just before Disney’s
Mickey Mouse was due to lapse into the public domain, the monopoly
for expressions is now the entire lifetime of an author plus an
addition 70 years. The public domain, those expressions that are our
not only morally but legally to do with as we will, is shrinking by
degrees.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
The world of free
expression must push back against both the tyranny of conformity and
the authority of the law. Law that seeks to constrict our free
expression must be especially distrusted. Threats to free expression,
and the freedom of expressions, come both from attempts to
monopolize, and from those who seek to squelch criticism. Expanding
notions of libel or slander, reputation and celebrity rights, and
other attempts to prohibit the use of that which ought to remain in
the public domain, all undermine authors’ moral dignity, and the
duty to express. Anything that constrains an author from expressing
is suspect. Expressions, except when they are truly libelous (false
claims that harm a reputation), are risks for both the author and
audience. The author takes the risks described above, that they will
succeed and live on unencumbered by the author, or dissipate and die,
unknown and unheard. The audience takes a risk that the expressions
they consume will change them somehow, and affect them in some deep
way that stays with them forever.</div>
<div class="western" style="margin-bottom: 0in;">
<br />
The (morally) best
authors (and inventors) embrace a radical view of free expression,
where they recognize the risks and rewards of creation. God took such
a risk, in the Judeo-Christian tradition, creating humanity and
giving us “free will.” Because Adam and Eve chose the path
offered to them via free will, and consumed of the tree of the
knowledge of good and evil, we are here. It was God-as-author’s
risk in creating a free expression that humanity would act beyond His
control, His command, and become creators too.<br />
<br />
Our
free will embodies a moral imperative to speak what we believe is the
truth, or important, despite the consequences. The corpus of
expressions created since the beginning of time are a testament to
man’s role as creator, channeling ideas into the world upon which
each new generation of creators builds. Who is the author of our
culture, or the entire history of human expression? No one person is,
but our culture is the sum of all. It is the collective consciousness
made manifest in every medium conceivable, told by a litany of
voices, creating an orchestra of ideas, a symphony of words,
pictures, stories, poems, statues, and science. No greater monument
to humanity exists. We cannot bottle it up or create ties binding any
one work to any one author.<br />
<br />
Homer,
Joyce, Yasusda, God, Shakespeare, Johnson, they are all only the
genesis, but creation is now beyond their control. Expressions live
on their separate lives, unchained and free, evolving and uncredited,
and this demonstrates the dignity, duty, and the courage of being a
creator. Let us celebrate then the risk of creation, and the duty to
let go, the allow our expressions their separate lives, and build a
common culture of communication through our evolving media, content
that there are expressions -- these supremely human, flawed, and most
permanent cultural artifacts. They will survive, like the words on
Ozymandias’s fallen statue, which survive even while a culture and
its king’s visage lie in dust. They will speak of us long after we
are gone, and speak well only if we let them.<br />
<br />
Johnson’s
book celebrates the unbound word, our Promethean glory as creators
free of the debt of credit. His own act of creation, obscured as
truths wrapped in fictions, touches upon the duty and ethos of the
author and audience, spinning together, weaving something beautiful,
and alive, new, and unchained. Somehow and somewhere, beneath or
because of the cognizable expressions, imperfectly capturing our
ideas, the truth will eventually be known. We are lucky if we get
glimpses, and good authors, when they are <i>especially</i> fortunate
or particularly talented, may give us those glimpses.
</div>
<div class="western" style="margin-bottom: 0in;">
</div>
</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com6tag:blogger.com,1999:blog-6001813637971400489.post-80588863151408172762012-09-26T10:57:00.001+02:002012-09-26T10:58:44.560+02:00ACLU petitions for certiorari to the U.S. Supreme Court.<div dir="ltr" style="text-align: left;" trbidi="on">
As predicted, the plaintiffs have <a href="http://patentdocs.typepad.com/files/petition-for-certiorari.pdf">petitioned </a>the Supreme Court to review the CAFC decision reported <a href="http://whoownsyou-drkoepsell.blogspot.nl/2012/08/scotus-here-we-come.html">here</a> . The grounds for the petition include the failure of the CAFC to properly apply the decision in <a href="http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf">Mayo</a> to the facts of the <i>Myriad </i>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 <i>Mayo</i>, it would be highly surprising if they don't decide to take this up next term. Expect more <a href="http://www.patentdocs.org/2012/09/plaintiffs-again-file-certiorari-petition-in-myriad-case.html">posturing</a> and <a href="http://holmansbiotechipblog.blogspot.nl/">puffery</a> 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 <i>Mayo</i> 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.</div>
Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-31102221139184485982012-08-16T19:47:00.004+02:002012-08-17T07:25:17.160+02:00SCOTUS, Here We Come<div dir="ltr" style="text-align: left;" trbidi="on">So, the Court of Appeals for the Federal Circuit, in reconsidering on remand their decision in the Myriad case <a href="http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf">has agreed with itself</a>. No big surprise, though I<a href="http://whoownsyou-drkoepsell.blogspot.nl/2012/03/patent-religion-suffers-blow-reading.html"> did suggest that</a>, if they wanted to preserve as much gene patenting as possible, they would craft a narrow enough decision, hewing to the Supreme Court's reasoning in <a href="http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf">Mayo</a>, to withstand scrutiny on the inevitable appeal. They did not. They doubled-down, offering no new substantial reasoning, and basically reiterating their previous arguments. Bryson too stuck to his guns, the ones that will prevail in the Supreme Court, as he dissented and found the claims to the BRCA1 and 2 mutation sequences to be claims over ineligible subject matter. He stated it plainly, thus:<br />
<br />
<blockquote class="tr_bq">"Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature."</blockquote><br />
So the majority once again believed that the process of "extraction" of the nucleotide sequences devised by nature from the adjoining nucleotides was sufficient, even under <i>Mayo</i>, to be eligible subject matter under §101. Bryson once again disagreed, and now it's up to the Supreme Court. Let's recall that in <i>Mayo</i>, the decision of the CAFC was <i>unanimously in favor</i> of patent eligibility of a diagnostic method. This is not the case here, Bryson dissented. Let's also recall that the Supreme Court unanimously overturned the CAFC in <i>Mayo</i>, finding that the patents over methods of dosing based upon measuring metabolites were effectively claims over laws of nature. Man didn't make those relationships. Man didn't make the sequences in the Myriad case either, and odds are good that the Supreme Court will side with Bryson on this score. But one never knows, they could find some <i>relevant</i> difference between the cases. I don't see it. As he points out,<br />
<br />
<blockquote class="tr_bq">"Just as a patent involving a law of nature must have an 'inventive concept' that does 'significantly more than simply describe . . .natural relations' *** a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product." </blockquote><br />
To conclude, I see in Bryson's dissent a glimmer of the test I have been arguing for to divide the natural from the man-made. My test is: is the thing claimed <i>dependent upon</i> <i>human intention and design</i>? Bryson states:<br />
<br />
<blockquote class="tr_bq">"In that setting, man has defined the parts that are to be retained and the parts that are to be discarded, and he has molded the retained portion into a product that bears little resemblance to that which occurs naturally."</blockquote><br />
He then correctly points out that genes are in fact defined by nature, with stop and promoter codons, and this is what allows them to function in protein synthesis. Man didn't create these boundaries, we merely identify them. So, I still hope that the Supreme Court will draw the bright line I am arguing exists between nature and artifact: the necessary and sufficient conditions for not being natural are: the intention and design of man. I look forward to hearing from those who disagree with a solid counterexample.<br />
<br />
Meanwhile, it ain't over 'till the Supremes sing.</div>Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-32109499095724824222012-07-24T08:09:00.000+02:002012-07-24T10:14:07.288+02:00In Myriad and More, Metaphysics Matters<div dir="ltr" style="text-align: left;" trbidi="on">
This past week, the Federal Circuit Court of Appeals heard oral arguments in the <i>AMP v. Myriad</i> "breast cancer genes" case. You'll recall that following its decision in <a href="http://whoownsyou-drkoepsell.blogspot.nl/2012/03/lies-desperation-and-death-throes-of.html"><i>Prometheus v. Mayo</i></a>, 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 <i>Myriad </i>appeal back to the CAFC for reconsideration in light of <i>Prometheus</i>. The fact that the decision of the CAFC was vacated and remanded, and that the court was asked to reconsider it in light of <i>Prometheus</i>, 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 <i>Chakrabarthy</i> 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 <b>not eligible</b> 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."<br />
<br />
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 <b>everything else</b> is a <i>metaphysical</i> 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 <b>philosophers are best suited</b> 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 <i>sui generis</i>. 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 <a href="http://www.amazon.com/The-Ontology-Cyberspace-Philosophy-Intellectual/dp/0812695372/ref=sr_1_2?ie=UTF8&qid=1343117353&sr=8-2&keywords=ontology+of+cyberspace" target="_blank">I have long argued,</a> sometimes the law is ill-suited to solve new problems, or its categories are mistaken from the start on a metaphysical level.<br />
<br />
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, <a href="http://whoownsyou-drkoepsell.blogspot.nl/2009/06/its-novelty.html">isolated O2</a>. Nothing about its structure, even when isolated, is the product of man's design or intention, just as in <i>Prometheus</i>, 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 <i>Prometheus</i>, 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, <a href="http://whoownsyou-drkoepsell.blogspot.nl/2012/03/patent-religion-suffers-blow-reading.html">just as they did with <i>Prometheus</i></a>. Or maybe not; hope springs eternal.</div>Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com2tag:blogger.com,1999:blog-6001813637971400489.post-77332630703723685892012-04-11T17:24:00.002+02:002012-04-11T19:40:55.753+02:00Myths about "Who Owns You?"In some of the more critical reviews of my book, a particular alleged "error" on my part is repeated, specifically that I claim that sexual reproduction results in patent infringement of genes. I use this as an example <i>ad absurdium</i>, extending the logic of patent law, which gives reproduction rights over tokens of patented types, but I explicitly state that when we reproduce, we are in no danger of literally violating the patent law, here, on page 92: "Although the PTO has claimed that gene patents do not encompass genes in their natural state, they do just that for all intents and purposes. We might feel a bit relieved to know that when we reproduce we aren’t violating anyone’s patent, but any scientist wishing to explore scientifically that gene sequence does so at his or her own risk because it is now legally bounded territory." <br />
<br />
Others have criticized it for having a provocative title, because it suggests that I conclude that patents on genes mean that someone "owns" you. I do not so claim, and the title is provocative, but was the same title of a Scientific American story regarding gene patents in <a href="http://www.scientificamerican.com/article.cfm?id=who-owns-you">March 2002</a>.<br />
<br />
In fact, most of the critical claims leveled against the book fall apart when the book is read in its entirety. Some critical reviews repeated the lie that I made an "anti-commons" argument in the book. I do not. My argument is, ultimately, about the <i>nature</i> of the commons, not about utilitarian concerns over the<i> effects</i> of monopolies. What remains unchallenged is my argument about the nature of the "commons by (logical/material) necessity," in which I describe the nature of the scientific commons, which has recently been effectively upheld in the <i>Prometheus</i> decision in the US Supreme Court, and upon which my entire ethical argument against gene patents hinges. Perhaps at the end of the day, sniping about non-issues has failed to deflate the larger issues at stake (though I feared early on that it might), and only serve now to reveal that those early attempts to try to distract the public from the real ethical problem with allowing monopolies over natural products, laws, and phenomena will fail even as justice prevails.Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com0tag:blogger.com,1999:blog-6001813637971400489.post-78528590490722659842012-03-29T10:12:00.003+02:002012-03-30T10:12:00.967+02:00Lies, desperation and the death throes of gene patentingThe recent Prometheus decision has the patent-industrial complex up in arms. The Supreme Court's unanimous decision overturned patents on medical methods that amounted to patents on laws of nature, as I describe more fully in my <a href="http://whoownsyou-drkoepsell.blogspot.com/2012/03/patent-religion-suffers-blow-reading.html">previous post</a>. One of my old adversaries, Chris Holman, whose incompetent review and attempt to discredit me I refuted <a href="http://whoownsyou-drkoepsell.blogspot.com/2009/08/methodical-response-to-chris-holmans.html">here</a> (a refutation he has never acknowledged or challenged), lashed out at me personally, and others (by extension) who disapprove of gene patents, by comparing me with <a href="http://holmansbiotechipblog.blogspot.com/2012/03/npr-retraction-of-story-on-apple.html">Mike Daisey</a> whose This American Life story on Apple factory conditions was recently retracted. Holman's analogy was faulty, and upon my request he retracted a lie in his post in which he stated that I claimed in <i>Who Owns You?</i> to be "an intellectual property attorney." Because I have never claimed to be so, and certainly not in my book, he retracted his lie upon my request, while explaining that he vaguely recalled it, though he obviously never attempted to verify his recollection by finding the alleged claim in my book. There is of course a certain irony that he had to retract his error (lie) in his own attempt to portray me as a liar. The irony seems to be lost on him, and although his analogy falls apart completely in light of all of the omitted context of my book, as opposed to Daisey's story, which I point out fully in <a href="http://holmansbiotechipblog.blogspot.com/2012/03/npr-retraction-of-story-on-apple.html?showComment=1332834619759#c3962820225471688856">his comments section</a>, his attempt to slur me personally served his purposes anyway. Mainly, proponents of the broadest possible patent regime seek to discredit anyone who opposes them as being "wrong" and "failing to understand the patent system." They wish to be the only experts, and thus the only credible commentators on what can or ought to be patent-eligible. They even <a href="http://www.ipwatchdog.com/2012/03/28/selective-precedent-amnesia-mayo-prometheus/id=23653/">suggest that the Supreme Court is unqualified</a> to make law regarding what should be patented. But the Supreme Court in the US is the ultimate arbiter of all US laws, including patent law, having itself created the explicit exceptions to Section 101 patent-eligibility for "laws of nature, natural phenomena, and abstract ideas." Like it or not, the Supreme Court is the final source of authority for what those exceptions encompass, not patent lawyers or even the Federal Circuit. <br />
<br />
So the <a href="http://c4sif.org/2010/10/the-ip-industrial-complex-and-how-to-fight-it/">patent-industrial complex</a>, which always profits from the mere act of patenting (by fees on filing patents, <a href="http://www.patentdocs.org/2012/03/confer.html">costly patent-law seminars</a>, etc.), and which thus seeks to keep as broad as possible the domain of patent-eligibility, is struck with fear and trembling. They are looking to blame those of us who are not part of the system, who have no economic stake in the patent system, and who seek only to <a href="http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=305">preserve the scientific commons against monopolization</a>, and accuse us of meddling in their realm. As I have argued all along, the law is open to debate, and subject to change, and in the case of gene patenting I believe it ought to be changed because it neither reflects the spirit of the purpose of patent law, nor <a href="http://whoownsyou-drkoepsell.blogspot.com/2011/09/laws-of-logic-apparently-off-limits-in.html">logic itself</a>. The Supreme Court seems to agree, and has altered the law. The Court of Appeals, Federal Circuit (CAFC) has been overturned. Its decision in <i>Prometheus</i> was completely overruled, and the types of method patents at issue in that case are no longer to be tolerated. That is the law of the land. Moreover, it vacated and remanded the CAFC's opinion in the <i>Myriad</i> case about the BRCA 1 and 2 patents. This bodes ill for gene patent proponents, despite their attempts to try to distinguish the two cases. In fact, the <i>Prometheus</i> decision's reasoning makes the Myriad product patents even more questionable than those at issue in <i>Prometheus</i>, which at least involved "methods" in which the laws of nature monopolized were couched. <a href="http://whoownsyou-drkoepsell.blogspot.com/2009/11/stop-lying-about-myriad-patents-on-brca.html">Four of the claims</a> challenged in the Myriad case are claims over merely "isolated," unmodified gene sequences with no method or process involved. <br />
<br />
The CAFC panel on <i>Prometheus</i> which was overturned unanimously by the Supreme Court unanimously approved of the now invalid patents. The CAFC panel in the <i>Myriad</i> case was not unanimous. As <a href="http://whoownsyou-drkoepsell.blogspot.com/2011/07/myriad-case-federal-circuit-decision.html">I explained last year</a>, some of the method claims at issue in <i>Myriad</i> were already struck down, and there was a dissenting opinion by one of the three panel members, Judge Bryson, who wrote that the product claims at issue were also invalid as products of nature. It is unlikely that Bryson will change his mind, and it is unlikely that Judge Lourie will change his mind (the <i>Myriad</i> court consisted of Lourie, Bryson, and Moore, the <i>Prometheus</i> court was Lourie, Rader, and Bryson). The wild card is Judge Moore. Will Bryson convince Moore, who filed a concurrence in the Myriad case and who did not sit on the overturned <i>Prometheus</i> appeal, that she ought not to stubbornly side with the losers as Rader did in the <i>Prometheus</i> case? Justice Breyer's decision gives plenty of ammunition to Moore and Bryson to write a majority opinion overturning the Myriad patents as amounting to claims over products of nature. In any case, whatever the CAFC decides to do, there will again be a petition for <i>certiorari</i> to the Supreme Court. If the CAFC does the right thing and reverses its previous decision in light of the <i>Prometheus</i> decision, then the Supreme Court is unlikely to take it up on <i>cert</i>, feeling that their <i>Prometheus</i> reasoning is correctly applied to overturning <i>Myriad</i>. If the CAFC decides to try to weasel around the <i>Prometheus</i> ruling it will still be a split panel, and SCOTUS would likely hear the <i>Myriad</i> appeal eventually. The CAFC may wish to write a narrow ruling overturning the Myriad patents, but leaving the door open enough for similar patents, and avoiding the sort of broad restriction that the Supreme Court could craft. Or they may decide to do what they did before and drop kick it to SCOTUS for some final ruling. Patent attorneys who are thinking far enough into the future ought to hope that the CAFC overturns their previous <i>Myriad</i> reasoning on some sort of narrow grounds, invalidates the Myriad patents and leaves the door open somehow for other sorts of gene patents (like those on cDNA), rather than allow this to finally be determined by the Supreme Court which seems hostile in general to the rhetorical cuteness of claim-drafters.<br />
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In the meantime, expect the <a href="http://www.ipwatchdog.com/2012/03/20/supreme-court-mayo-v-prometheus/id=22920/#comments">rhetoric</a> and <a href="http://www.patentdocs.org/2012/03/mayo-collaborative-services-v-prometheus-laboratories-what-the-courts-decision-means.html">public wailing</a> to swell in an effort to influence the public's perception of what horrible fate might befall us all if patent attorneys cannot patent everything under the sun, and what the hell, <a href="http://scienceblogs.com/mikethemadbiologist/2009/05/could_you_patent_the_sun.php">why not the sun itself</a>? I and others who oppose gene patents have withstood a lot of public abuse, but the reasoning we have employed has survived, and so far is winning the day. The law of the <i>Myriad</i> case is now the district court's decision, until the CAFC issues a new one, and that means the Myriad gene patents are invalid, for now. Let's see what happens next. In the long arc of history, I do believe that justice ultimately prevails.<br />
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<script src="http://www.pikk.com/javascripts/widget.js" type="text/javascript"></script>Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com2tag:blogger.com,1999:blog-6001813637971400489.post-26347772086014607732012-03-21T09:52:00.003+01:002012-03-28T22:48:11.272+02:00The Patent Religion suffers a blow: reading tea leaves on AMP v Myriad in the Mayo v. Prometheus decision by SCOTUSThe Patent Religion's believers think that "anything under the sun made by man" is patent-eligible, even where nature made it first. This is the liturgy to which they appeal when challenged about patenting "isolated" or "synthesized" natural products. They think it means that even scientific discoveries, if properly couched in some "transformative" phrasing, are sometimes man-made. This was the case in the <i>Mayo v. Prometheus</i> case in which the patented claims included the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity. These correlations were discovered through empirical research, they were not created. But the unfortunate wording of the Patent Act in the US, which makes patentable any new invention or "discovery" has enabled the patent lawyers to continue to argue that there is essentially no boundary between science and technology. Fortunately, the Supreme Court <a href="http://www.chicagotribune.com/health/sns-rt-us-mayo-prometheus-patentbre82j18i-20120320,0,1586588.story">just burst their bubble</a>. The Court's decision can be found <a href="http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0CDoQFjAC&url=http%3A%2F%2Fwww.supremecourt.gov%2Fopinions%2F11pdf%2F10-1150.pdf&ei=449pT5uWKsS38gO65qnwCA&usg=AFQjCNHCiK9DKC5ljr4nEOabfOK9fWWl7w">here</a> and should be read by one and all. Justice Breyer, a long-time skeptic of IP-lawyers' rhetorical tricks, pokes through the claims to look at the underlying subject matter. He does an ontologist proud. <br />
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While the unanimous decision makes worthy policy arguments about the negative effects on innovation of granting monopolies too far upstream, it also goes a fair way in describing the distinction between laws of nature, and something inventive and patent-eligible. From the decision's syllabus, the following language says it all:<br />
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<blockquote>"Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable,the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims. The 'administering' step simply identifies a group of people who will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders. Doctors had been using these drugs for this purpose long before these patents existed ... The 'wherein' clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions ... The 'determining' step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor wishes to use."</blockquote><br />
Patenting is not a game. Simply trying to squeeze square pegs into round holes using magical phrases will not do. There is a reality that must be observed, and rhetorical tricks aside, the claimed "inventions" were merely scientific discoveries about facts of nature. In this case, the Supreme Court has made both a logical and ontologically-grounded decision, recognizing that even where a claimed invention might be "man-made" it is not <i>created</i> by humans. Where a claim encompasses something that nature created, it cannot be eligible for patent, and fails under section 101. <br />
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Already, the patent lawyers have gone <a href="http://www.ipwatchdog.com/2012/03/20/supreme-court-mayo-v-prometheus/id=22920/">apoplectic</a>, claiming that the Supreme Court is not qualified to make such decisions. The wailing and gnashing of teeth is certain to grow before it fades. Industry will not come to a halt, but science can flourish a little less hesitantly, secure in exploring nature and her truths without impinging upon some governmentally-created monopoly.<br />
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So what does this mean for gene patents, and the much anticipated <i>AMP v. Myriad</i>, Supreme Court showdown? Notably, Myriad had submitted an amicus brief in the case for the losing side. They know the implications of this decision for their practices and patents. Of course, I think the writing is on the wall. Breyer's language is sufficiently broad and suggestive in the <i>Mayo v. Prometheus</i> decision to indicate that they will be very skeptical of claims by Myriad that "isolated" sequences, not created by man, but identified as existing in nature, are patent-eligible. Procedurally, the case is interesting because in late February everyone expected SCOTUS to either accept the appeal on certiorari, and reconsider the case, or reject the cert petition and let the CAFC decision stand. But nothing happened. Some speculated that they were booting it over to the Solicitor General, who had put in an amicus brief opposing Myriad, to change his mind. But perhaps there is a clue here as to what's going on from the procedural history of <i>Mayo</i>. After the <i>Bilski</i> decision, SCOTUS kicked <i>Prometheus</i> back to the appellate court to reconsider the case in light of <i>Bilski</i>. They did that, and did so wrongly, upholding their previous decision, only to get overturned by a unanimous Supreme Court. Could SCOTUS now do the same with the <i>Myriad</i> case, and if they do, will the Federal Circuit once again ignore SCOTUS, make the wrong decision, only to get overturned, or will they actually try to apply the law of the land? Time will tell.<br />
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<b>** UPDATE **<br />
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The Supreme Court has scheduled a meeting on the <i>Myriad</i> case for Friday, Mar 23. It seems likely, based on the <i>Mayo v. Prometheus</i> ruling that they will remand to the appellate court, or take the case up on cert. It seems highly unlikely that they would refuse cert outright. We should know by Monday.<br />
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<b> ** UPDATE **<br />
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The Supreme Court vacated and remanded the appellate court judgment for further consideration in light of their reasoning in Prometheus. This makes the district court's ruling current law of the case (with no precedential effect), and means we must hold our breath until the CAFC makes a ruling (which might, if they apply Prometheus honestly, find the product patents invalid). Let's hope! </b>Davidhttp://www.blogger.com/profile/05018243335902307150noreply@blogger.com1