The Perils of Pure Positivism

The dominant paradigm among law schools training young students to be lawyers is to indoctrinate them into accepting the truth of legal positivism. This trend continues the once fashionable school of Critical Legal Theory (in which law is politics, pure and simple), which went out of fashion, at least as a term, with the collapse of the allegedly Marxist states. In "pure" legal positivism, there is a complete disconnect between law and morality, and the validity of enactments derives from the fact of their enactment (to simplify greatly). In law school, I too read Austin and Hart, and modern proponents like Dworkin, I just never bought them. Legal positivism is the legal equivalent of moral relativism, and leaves open the door to too many hypothetical conditions under which we would be forced to accept the justice of clearly unjust enactments. As a believer in Justice, I maintained my allegiance to the classical, liberal underpinnings of the US Constitution, grounded as it is in a form of natural law theory.

Yet, in the current debate over gene patents, I can see that the grip of legal positivism on lawyers, especially patent attorneys it seems, is tenacious. As I have argued, intellectual property is not derived from natural law, and is thus a set of purely positive enactments. If there were no conflicts with natural law, then all its enactments would be "just," or at least acceptable. It is clear that a number of patent attorneys arguing for the continuation of gene patents either see no truth to natural law theory at all, or cannot grasp the necessity that positive enactments may not justly contradict natural law. It seems most likely, from my recent debates with gene patent proponents, that embracing pure legal positivism is a convenient way in general for lawyers to avoid cognitive dissonance, as there is never the threat that one might have to defend a stance that is, by nature, unjust.

And so, my continuing call to recognize that law must be naturally constrained from granting ownership to things that, by nature, cannot be exclusively possessed, that belong to what I term a "commons by necessity" continues to be misconstrued as a utilitarian call to recognize common rights for some other purpose. Rather, it is a recognition of a simple, necessary law of being, much like that which requires 2+2 to equal 4. Some things, like natural laws, cannot be possessed to the exclusion of anyone. Naturally occurring genes fall into this category too, as a matter of natural law. Positivists who fail to grasp this, or who refuse to recognize this, are persuaded that this is but a matter of choice. To them, I would ask, have you forgotten your Orwell?

"In a time of universal deceit - telling the truth is a revolutionary act."

— George Orwell

Save Money and Paper

Who Owns You? The Corporate Gold Rush to Patent Your Genes is available for the Kindle reader. I think I need to get me one of those gadgets soon! I also have the pdf of the book, which I found on a torrent site (irony of ironies). Let me know if you want it ;-)

There is a 4-part interview with me done in The Netherlands that has just been added to YouTube.

Finally, my talk at Cardozo Law School, Oct 22, 2009, regarding ethics and intellectual property (including some in-depth about the issue of gene patents) is also on YouTube now.

Who Owns You: Review in Choice

(this review made it into this month's "Editors' Picks" as well)

Koepsell, David. Who owns you?: The corporate gold-rush to patent your genes. Wiley-Blackwell, 2009. 187p index afp; ISBN 9781405187312, $79.95; ISBN 9781405187305 pbk, $24.95. Reviewed in 2009 dec CHOICE.

Via reflective consideration of secondary sources, attorney and philosopher Koepsell (Technology Univ. of Delft, The Netherlands) explores economic, ethical, legal, and scientific questions raised by the patenting of one-fifth of the human genome. After two chapters that provide a usefully comprehensive introduction, subsequent chapters address his ontologically informed ethical approach; the evolution of genetic and genomic research; the role of DNA in distinctions among species and individuals; and the legal evolution of patents regarding genes and other natural substances. Koepsell advocates a more limited scope for genome-related patents on the basis of intellectual property case law. He argues against the existing state of genome patent law, and further argues that existing genome patent protections harm science and economic innovation. This readable book covers a lot of ground, but it could benefit from greater incorporation of existing economic, legal, and philosophical inquiry. Recent legal decisions in Europe and North America suggest that Koepsell's emphasis on the demonstration of both an innovation and a commercial use ultimately may prove central to future jurisprudence in cases involving these patents. Koepsell's timely book is highly recommended for all reading levels. Summing Up: Highly recommended. All readership levels. -- C. H. Blake, James Madison University

Reprinted with permission from CHOICE http://www.cro2.org/, copyright by the American Library Association.

Stop Lying about the Myriad Patents on BRCA 1 and 2

Numerous defenders of Myriad often claim that the patents do not cover naturally-occurring genes, but rather only "methods" created by humans, or "isolated and purified" genes, which they allege can only be created by man. After all, they claim, isolated genes do not appear in nature, and it takes the work of humans to create them. This is, of course, hogwash. Isolating a gene is accomplished in nature in the process of cellular metabolism. Protein synthesis is accomplished without human intervention, much less, human invention, because various forms of RNA read the beginnings and ends of genes, omit the introns, and construct proteins from the remaining (exon) codons. So, merely finding the beginning and end of a gene is, as I have analogized in my book and elsewhere, equivalent to reading a map, and noting a geographical feature therein. Nature made the feature, and defined its borders, and we simply find it and model it. So that's the "isolation" and it doesn't warrant patent.

The "purification" part is part of nature's bag of tricks too, as mRNA skips the introns (the non-protein coding regions), and in fact some laboratory methods for creating cDNA (thus "purifying" DNA) use mRNA to accomplish this. Again, nothing at all inventive.

Finally, the Myriad patents on BRCA1 and 2 claim un-modified genes -- mutations in the BRCA1 and 2 gene that occur naturally. Their sole inventive claim is "isolation." See the patent yourself, and look at the claims (pp. 153-156). Look specifically at this:

"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."

Now, note: these are not method claims, they are not claims for cDNA, but rather over naturally-occurring mutations to naturally-occurring genes. As I discuss above, and in my book, and elsewhere in this blog, this is not inventive at all. Rewarding for discovery of laws of nature goes beyond the scope of patent, and it inhibits research, and access to the "commons by necessity" that is the human genome and laws of nature in general.

It is like saying that since detached bird wings do not exist in nature, one ought to be able to patent detached bird wings. It's madness, and everyone except patent lawyers and others getting wealthy off this insanity can see that.

Good News from the District Court

Judge Sweet did the right thing on the defendants' motions to dismiss, refusing to grant those motions, and ensuring this case can go forward on the merits. This is excellent news, and a sound rejoinder to the insistence by the likes of Holman, Noonan, Quinn, and other pro-gene-patent folks that this case was "frivolous." For non-lawyers, the claim of "frivolous" is particularly charged given that, in federal court, a lawyer can be sanctioned for bringing a frivolous claim. Moreover, in federal court, the pleading requirements for a claim are rather liberal, and as long as the claim is colorable, involves some real, federal case or controversy, and plaintiffs have suffered some injury which the court can redress, then the complaint is not frivolous.

I am still reading the decision, but it indicates that the court is certainly aware of the importance of this case, and the necessity of resolving the claims in federal court. Much depends upon it. I am thrilled about this decision since it means the merits will be resolved one way or another. The summary judgment motion is now pending, and has been fully briefed. Now we shall see how the court decides that motion, which would go to the merits of the claims, and then watch this baby go on up to appeal... eventually, to SCOTUS.

Doing Philosophy in Public

Lately, I feel that the ivory tower is crumbling. Or at least it is developing some stress fractures. This is a good thing. For too long, the academic world and the real world have been at odds. Academics, intent on fulfilling the career goals, and standardized path of academic achievement, have helped to perpetuate the lay-public's view that academics are isolated, uninvolved, and mostly irrelevant. Academic disputes might be heated, emotionally charged, and the may make or break academic careers, but rarely do these disputes matter to the world at large. As the link above notes, Henry Kissinger correctly noted that the bitterness of academic disputes "is in inverse proportion to the importance of the subject." Indeed, among academics the currency of the trade has often been to find an opponent, attack, and if possible, destroy. But does any of this intellectual parrying matter to anyone, and must this be the future model of the academy -- to provide a sort of Punch and Judy show as occasional tidbits to a bemused public already wary of the goings-on in university halls? Simply put, no. It doesn't need to be like that.

Sometimes, we can step outside this model, seek not only positive collaborations between the academy and the "real" world, but also work to make ourselves relevant to the public in broader ways. This is part of the virtue of applied ethics, and one reason I have been thrilled to be at TU Delft. Here, engagement in the world is part of the goal. Applied ethics means nothing without a world to apply it to, and projects and researchers working on applied ethics in the Dutch technical universities are not only training engineers to think ethically, but also engaged in projects involving policies affecting hundreds of thousands of people. This is as it should be. Never before have I felt more at home in striving for public policy changes based upon my research. Where once my goals to take my research and do something with it might have been met with scorn by entrenched academic establishments, I am now encouraged by an atmosphere that accepts and even embraces the next logical step: change.

Three years ago, when I began to approach the issue of gene patenting, it was more or less just an academic question to me. Yes I felt viscerally that this was an important issue, but I never realized the extent to which it impacted the lives of hundreds of thousands of people around the world (if not more), or the extent to which others were moved to finally act on the issue. When, two months after my book came out, the ACLU sued Myriad on this very issue, and now with the US dept of Health and Human Services making some progress in suggesting significantly altering gene patenting, I can see that applied ethics must naturally reach out as an academic field into the real world of activism.

I had the great fortune last week to be where the rubber meets the road on this issue, in what could legitimately be called "gene patent week" in New York City. There, I met with the attorneys for the ACLU, as well as a patent attorney who has been a harsh critic of my work, calling me, the ACLU, and other opponents of gene patenting "liars"(though, even now, he admits not having read my book). I met with Luigi Palombi, whose book Gene Cartels came out just recently, and does for the legal case against gene patents what mine does for the ethical case. I met the director of the film "In The Family," Joanna Rudnick, who possesses the BRCA1 mutation that makes her susceptible to breast and ovarian cancer, and who discovered in documenting her experiences that the patent that Myriad Genetics owns for that gene prevents her and many others from accessing information about their own bodies, from getting second opinions about her tests, and for many women, the prohibitive price of the test prevents even getting the test done in the first place. I met clinicians and researchers, like Debra Leonard and Ellen Matloff, each of whom has personal experience with how gene patents prevent doctors, researchers, and patients from getting access to information that is not only vitally needed, but part of nature, a natural law, and thus not properly owned. I met with Tania Simoncelli and Sandra Park, of the ACLU, who have striven each in her own way to actually end the process of gene patenting. Tania's background is in science, and she has fought for years to get a suit started, and Sandra is an attorney who is fighting valiantly in the courts. I met Dan Ravicher and Chris Hansen, of the Public Patent Foundation and the ACLU, each of whom has staked his organization's reputations on bringing this courageous and necessary suit.

These people humbled me. What began for me as an academic issue is now personal, and a matter of activism. This is not academia, and the rhetoric around the edges of the debate, the name calling, insinuation, and arguing about the meanings of terms and legal rulings must be put into perspective. People are being hurt, and these harms are not academic. They are wrong. Public policy must change. Never before has it been clearer to me that this is not just an issue for debate, but the cusp of something big.

I had the great fortune to meet and interview James Watson, co-discoverer of the structure of DNA, and I asked him about gene patenting. He opposes it, and he says his opposition was why he was "fired" from the Human Genome Project. He stated in our 45 minute on-camera interview that "something has to give" and that gene patenting cannot continue. It is harming too many people. I value his judgment as a scientist, and his concern as a person came through when he expressed his disdain for the costs associated with a non-inventive test that has been given an exclusive monopoly through patent.

I particularly value the energy, commitment, and involvement of academics, lawyers, clinicians, and counselors -- all those named above and many more unmentioned, who have moved beyond the academic issues involved and sought to change the world because they know that their cause is just. They have staked their reputations, their careers, money, relationships, and futures on pursuing this change, and their commitment should embolden us all. It gives me strength, and makes me thankful that here, applied philosophy means involvement in the world, unashamedly pursuing the good, and making philosophy relevant once again.

Summary of recent events at Biopolitical Times

The good people at the Center for Genetics and Society offer an excellent recap of recent events in the battle over gene patenting. It encapsulates some of the major recent developments I have blogged about here, and includes a link to the GRITtv debate with Quinn and me. There's momentum, there's interest, and very soon, there will start to be decisions one way or another. Stay tuned!

Aaron Fellmeth review in Bioethical Inquiry

Although Fellmeth finds the book insufficiently academic, and bemoans my failure to tie up the loose ends of all of the questions raised by gene patenting, he gives some praise:

"Judging by its provocative yet rhetorical title,
informal tone, and modest number of citations to the
work of others, Who Owns You? is clearly not
addressed to the academic or research communities;
nonetheless, it contains a good deal of helpful
information for the lay public relating to the relevant
(and some irrelevant) biology and biochemistry,
intellectual property law, and ethics of gene patenting.
Koepsell’s gift of conversational writing facilitates
communication of complex ideas to the uninitiated.
On the whole, the book explains much of its subject
matter well."

I did set out to write an accessible general introduction to the topic, and I find that people who have read the book are pleased with its style and tone, as well as interested in a topic they knew little about before reading the book. Moreover, I do admit quite clearly near the end of the book that many of the issues raised, including the link between genes and individuals, remain unanswered and outside the scope of the book.

Finally, Fellmeth's review points to a recurring issue, and that is that lawyers and legal scholars who read my arguments generally miss the point I make in elucidating a new theory of the commons, the "commons by necessity," and this is likely due to the positivist trend in legal scholarship. Steven Poole's review in The Guardian at least notes my "quirky" approach to natural law, which is at the heart to my conclusions about the genome being a "commons by necessity." Overall, I am happy with Fellmeth's review because unlike Holman, he is honest and comprehensive about the whole of the work. He approaches the whole book and not just parts of it, and his differences with my conclusions and approach are honest and not apparently tinged with any conflicting interests. Nonetheless, he takes issue with things that are arguable, and alleges that, for instance, patents on DNA cover something sufficiently "altered" to make them patentable. Here, it is clear we disagree, though like Holman, he calls this my "error."

I'm in touch with Fellmeth, and thanked him for the review. As I said to him, my books have met with reviews that range all over the map, but somehow, over time, the ideas I am working on developing, regarding the nature of ideas, property, the commons, and innovation, have benefited from good, honest, open debate. Judging from the positive response I received last week in NYC, and my interactions with the community of people both affected by gene patents personally, and working to eradicate them, I feel good about the future, and my contributions to changing the law.

Appearance and debate on Gene Patents, GritTV, Oct 26

That was the Week that Was

I have hope. And I have evidence now that hope is worthwhile. This week has been nothing short of amazing. Somehow, everything seems to be happening at once, and now I feel as though the prospects for action to stop gene patenting are good. There is clear momentum, and public support, and a growing group of disparate activists and academics who have somehow begun to convene. In sum, here's what has happened this week:

Monday: I met with Luigi Palombi (see previous posts) and things are in the works now to take this movement international, with real backing and strength. We then attended a screening of Joanna Rudnick's film "In The Family" at Cardozo Law School, and met Dan Ravicher of the Public Patent Foundation. I also met Kevin Noonan, who was the lone voice on the other side of the issue, and who is a some-time foil, having critiqued my book (before reading it) on his website -- Patentdocs. He was a gentleman, though, and I hope he'll take part in our film and offer the reasoning behind gene patents.

Tuesday: Taylor Roesch and I interviewed James Watson for our documentary. He delivered some extraordinary sound bites in opposition to gene patenting, and provides unparalleled scientific credibility on the subject given his connection with the human genome's discovery and mapping. Later that evening, we went to another screening of "In The Family" at the Tribeca Cinema, where we were able to film a panel discussion on the legal implications of gene patenting and the ACLU vs. Myriad lawsuit.

Wednesday: I gave my talk at Cardozo Law School, entitled "The Ethical Case Against IP," which we also filmed for the movie. We then went to Harlem where we filmed an excellent interview with Luigi.

Thursday (today): Taylor interviewed me for the documentary. We shot in Central Park, which was brilliant, crisp, and sunny, and the leaves are beginning to turn. It was good to be in the park, even if we were working. I then headed downtown and did a live interview on the Leonard Lopate Show. There's a link to the interview (and all similar press) from my homepage, under "press."

Tomorrow and Monday: I have a call-in interview for WBAI Evening News, and then, perhaps, a moment to breathe. Then Monday, I will debate Gene Quinn on the issue of patents and innovation, and then tape an interview with Laura Flanders of Grit TV.

*UPDATE* here's the GritTV spot, I think it went very nicely.

In sum, the ACLU lawsuit, Luigi's activism in Australia and elsewhere, the recent HHS draft report, and the public's overwhelming support of the movement to eradicate gene patents (when they learn it is happening) give me courage, hope, and strength to continue this work, and seek real and lasting change.

Review in The Guardian, UK

A rather nice review from Steven Poole's "Etcetera non-fiction roundup," Oct 17, 2009, in The Guardian:

"Who Owns You? The Corporate Gold Rush to Patent Your Genes, by David Koepsell (Wiley-Blackwell, £14.99)

Despite the protester-friendly subtitle, this isn't exactly a gosh-wow exposé of the gene-patenting business, but a tersely polemical investigation of the philosophical, scientific and legal issues. Should biotech companies be able to patent genetic sequences taken from sick individuals and monopolise the profit from them? Can you be said to "own" your genes, and to what extent are they part of you as a person? Some companies have acquired patents on genes that we all share, prompting Koepsell to observe: "The only thing the inventor has done is to point out, as if on a map, where that gene lies in nature."

The author insists at moments on a slightly quirky general account of "natural law", but one doesn't need to buy that to appreciate his fruitful detours into discussions of copyright history or "open source". He finally returns to the analogy with land, arguing that ought to be our shared "commons", and that the patent-rush constitutes a new enclosure."

NYC Media and talks

I'll be in NYC from Oct 18-26, and have a number of media appearances and talks scheduled. I am excited too to be getting together with Luigi Palombi, of Australia, the author of Gene Cartels which makes the legal case against gene patenting and is the most comprehensive work on the legal aspects of the subject I have read. Finally, Taylor Roesch and I will do some filming for the documentary we are producing about the issue. It will be a busy and exciting week!

In addition to the media listed below, I will be speaking at Cardozo Law School on Oct 21, at noon, room 205 on "The Ethical Case Against IP" and then debating my friend Gene Quinn of IPWatchdog.com on the the issue "Patents: Competing views of Innovation" at noon on Oct 26 also at Cardozo. Both events will be open to the public.


Thursday October 22 – IN-STUDIO at WNYC NEW YORK PUBLIC RADIO
“Leonard Lopate”
Interview Time: 1:00 PM – 2:00 PM LIVE
http://www.wnyc.org/shows/lopate/


Friday October 23 – BY PHONE –WBAI-FM
“WBAI Evening News with Andrea Sears”
http://www.wbai.org/


Monday October 26 –IN STUDIO at Grit TV (Free Speech TV)
“Grit TV with Laura Flanders”
Nationally Syndicated TV / Radio
Interview time: 1:30 PM – 2:00 PM
http://www.lauraflanders.com/

Great report from US-DHHS

So, it seems that the US Dept. of Health and Human Services will recommend de-fanging almost completely gene patents as they are presently granted in the US. Essentially, they have reached the same conclusions that I reach in my book regarding the nature and utility of gene patents and effects in creating patent thickets. Because the report is not available yet, I cannot say whether they address any of the ethical issues involved. Here's part of the conclusion reported at IPWatchdog, where my friend Gene Quinn is naturally quite alarmed by what I consider to be a fantastic step forward:

"For the most part, patents covering genetic tests and related licensing practices do not appear to be causing wide or lasting barriers to patient access. However, the case studies and public comments documented several situations in which patient access to genetic tests has been impeded for segments of the population—especially indigent patients—when these tests are offered by an exclusive provider or a limited number of providers, a practice directly enabled by current patenting and licensing practices."

I look forward to reading the final report and hoping that Congress acts as recommended.

Patents: tools of state socialism

the following reasoning is met with deafening silence at IP Watchdog, where clueless patent attorneys accuse me of socialism, communism, etc...

How are patents a free market device? Shouldn’t capitalism embrace free markets? My love for free markets is what drives me to hate patents, since they skew markets, are a state-granted privilege accorded for no better reason than beating someone else to filing something with bureaucrats, and inhibit free, unfettered competition, which is what capitalism ought to encourage rather than hinder.

Patents are more socialist than capitalist. They get the state into the business of marketplaces, of determining what technologies ought to succeed or fail, of boosting patented tech over non-patented tech, rather than encouraging the market to select for the best products and drive pricing. It’s a lot closer to five-year plans than what I envision, which is a market without any state involvement at all.

and now, the film version... and Australia

We are in the development stage right now, but will begin filming for a documentary on the subject of gene patents later this autumn.

Luigi Palombi and I are also planning a workshop in Canberra on the issue of gene patenting to coincide with the Australian Senate's decision due late November, early December. We hope to get some interviews for the documentary while we are there as well.

Citation in Brief for Amici Curiae

I notice that Who Owns You and this blog are cited and quoted in a recent court filing in the ACLU v. Myriad case. The references occur in the BRIEF FOR AMICI CURIAE IN SUPPORT OF PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS AND IN SUPPORT OF PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT for the National Women's Health Network, Asian Communities for Reproductive Justice, Center for Genetics and Society, Generations Ahead and the Pro-Choice Alliance for Responsible Research at p. 18. Quoting now the brief:

"The consequences of such attempts to assert exclusionary rights to our common heritage often involve harms to others. Attorney and philosopher David Koepsell asks us to “[i]magine a tax on air, or a levy on sunlight, or some corporation claiming ownership of the open seas and demanding royalties for their use. Imagine a world where ideas could be owned, and thinking ideas held by others was prohibited or subject to fees, taxes or royalties.” David Koepsell, Who Owns You?, Wiley-Blackwell at 133 (2009). He points out that the “human genome is a constantly evolving object that involves every member of the species” and that “[g]ranting exclusionary rights to discoverers of genes that are part of that genome interferes with our common rights as beneficiaries and possessors of parts of the human genome.” http://whoownsyou-drkoepsell.blogspot.com (Aug. 21, 2009 posting; last accessed Aug. 27, 2009)."

I am pleased to see this used in the brief, and I am quite honored.

Good review in NL

A favorable review of Who Owns You? appeared in De Ingenieur 21 August 2009 (I have scanned it and it can be read here, but it's in Dutch.) A shorter, English version by the same author is at amazon.uk.

Meanwhile, I am reading and can recommend Luigi Palombi's Gene Cartels which does with the legal argument against gene patents what I have tried with the ontological/ethical argument. Palombi methodically examines the case law and statues, making the case that gene patents violate both the spirit and letter of patent law. I urge you to read this book if you want to see why the legal arguments made by proponents of gene patents are nonsensical.

Correspondence with Lawrence Lessig

Lessig is one of my heroes. This is from his bio at his web site:

"Lawrence Lessig is a Professor of Law at Stanford Law School and founder of the school's Center for Internet and Society. Prior to joining the Stanford faculty, he was the Berkman Professor of Law at Harvard Law School, and a Professor at the University of Chicago. He clerked for Judge Richard Posner on the 7th Circuit Court of Appeals and Justice Antonin Scalia on the United States Supreme Court."

Now I'm no Lessig, and haven't got his credentials nor reputation, but when someone of his caliber is attacked with basically the same accusations as those leveled against me, it certainly makes one wonder. Kudos in that case to Stephan Kinsella for being a stand-out among the patent lawyer crowd, and rising to his defense, as he did to mine.

Their tactics haven't changed. He too was accused of "misunderstanding" patent law, or the following -- "the trouble is he knows nothing of patent law, like most (but not all) law professors."

Here's what I wrote to Lessig:

"Dear Prof. Lessig,

I recently joined the ranks of those who are attacked by patent lawyers for treading on their turf, and saw that one of my patent attorney defenders defended you against similar attacks in the past. http://www.lewrockwell.com/orig/kinsella7.html#corppat

My sin was commenting on gene patenting policy, from an ethical perspective. My book Who Owns You? The Corporate Gold Rush to Patent Your Genes (Wiley-Blackwell 2009) was trashed in a scathing review by a patent attorney with a biotech startup firm employment history (who appears not to have read critical parts of the book, but merely commented on the few cases I reference). http://ndpr.nd.edu/review.cfm?id=17005 My response to his "review" is at my blog, http://whoownsyou-drkoepsell.blogspot.com/2009/08/methodical-response-to-chris-holmans.html where Mr. Kinsella also chimes in in my defense.

Anyway, seeing that you went through this too made me feel much better. I'm in excellent company.

best,
David Koepsell"

UPDATE

I received this quick response from Prof. Lessig:

"Congratulations! The hysteria of the patent bar shows we're onto something here. I look forward to the book."

A patent attorney who gets it!

Many kudos to Stephan Kinsella, who is a patent attorney who writes at the againstmonopoly.org blog. He posts a nice rebuke to Randall Mayes, and makes the case that patents in general are not necessarily efficient in encouraging innovation, and are de facto usurpations of property rights (making all my statements about the scope and effect of gene patents true, not fiction). His post can be read here. He also lends his support to my responses to Chris Holman, writing here. I have added his blog to my blogroll too, and will be following it diligently.

A methodical response to Chris Holman's "review"

I will work through as many of his specific citations of error. In general, his allegations of error rely on one disregarding the context of my policy and logical discussion of the law, which includes my dismissal through argument of many of the current law’s assumptions (such as that “isolation and purification” somehow turns a gene into something “new). In re-reading my book in light of Holman's review, I kept thinking maybe he and I read a different book, there's so much he disregards and so little he focuses on. But here are my responses to as many of the alleged errors as possible:

1.) I caught most of my discussions of nucleotides in proofing, but did apparently miss some cases in which I refer to a nucleotide or nucleic acid as an amino acid. mea culpa

2.) My discussion of introns is accurate though not in-depth, but Holman doesn’t specify how I allegedly erred.

3.) Patent law does apply to discoveries, but they must be “new.” Now, this does not include discoveries of natural things that have long existed, which are not “new” and the case law is clear on this. The only “discoveries” that can then be logically patentable are those that are somehow inventive, which I argue genes are not, even in their “isolated and purified” state. Once again, this is an instance of Holman taking the conclusion of an argument I make out of the context of the argument itself, claiming it is an error rather than explaining the line of reasoning that leads me to my conclusion, and then saying I am merely wrong. We disagree, and I state my reasons in the book.

4.) As I state in the book, US patents do effect other jurisdictions thanks to the WTO and TRIPS agreements. Europe and Japan do not allow “gene patents” on unmodified genes, specifically, they disallow patents over the sequences, although they allow patents on genes used in some new process or product involving an “inventive step,” which helped, for a time, prevent the BRCA1 and 2 patents in Europe, though they are now allowed (to a degree). I argue that new products incorporating laws of nature or natural parts are patentable as a whole. The BRCA1 and 2 patents allowed in Europe are closer to what I would consider to be proper, though I have ethical issues with them as well. This is a point made in The American Interest article as well.

5.) I argue in my book that the yeast and adrenaline patents were erroneous. The adrenaline patent, if it protected the compound adrenaline, could not have protected its naturally-occurring analogue, so what more could it have logically protected other than the process of synthesis? I think I could have done a better job making this logical dispute with those patents explicit. An analogy would be water. If one developed “isolated and purified” water, synthesized it from scratch, and patented it, then in what logical sense could it also protect the molecule H2O? It couldn’t, so it would only be a process patent, no matter what the claims state. As for a patent on a representation of a gene, this was presented as a hypothetical that would accord with my overall theory of IP law, and not as an example of how patents are actually issued. My general theory of intellectual property states that all man-made expressions, intentionally-produced are potentially protectable, in which case so would representations of genes be protectable. Except, I conclude in the case of existing genes that they belong to a commons by necessity which can never be enclosed.

6.) I do discuss Moore at length, I do point out it is a state case, and put it in the historical context that helped convince Celera’s attorneys to begin patenting genes. It is a well-known, historically important case in the development of the law regarding ownership issues in products of human tissues. I put it in that context explicitly in the book.

7.) Patents do include a right to enjoin, I don’t see that leaving that out is a "serious misstatement" about patent rights, which I do mention include the rights to royalties and fees. In fact, the injunction right makes gene patents worse, so thanks to Holman for mentioning this as well. US patents have extra-jurisdictional effect, as mentioned before, through WTO and TRIPS. As I argue, US IP law has a powerful influence on other jurisdictions.

8.) The next long criticism relies on buying Holman’s and other patent attorneys' argument that “isolation and purification” creates something new, which I argue at length in the book it does not. Thus his conclusion “All of these scenarios would indeed raise serious ethical concerns if they had any basis in reality, but in fact all are mere figments of the author's imagination resulting from his profound misunderstanding of patent law,” does not take into account my lengthy argument about isolation and purification, and all the scenarios I mention are thus technically true (under my interpretation of the logic involved), and not at all fiction. What Holman calls a “misunderstanding” of patent law is part of my central disagreement over the scope and effect of gene patents (not a misunderstanding) because of my arguments about the ontological status of genes, both “isolated and purified” and otherwise. This point is crucial to an understanding of my ethical arguments which he completely misses as a result.

9.) I have referenced Murray’s studies about the chilling effect of gene patents. There is certainly room for dispute, and more evidence is needed. Ultimately, my conclusion is based on the ethics, not the practical effect.

10.) I do summarize arguments made by others and cite to as many as I had considered, but I also break new ground which Holman ignores or possibly misses. For instance, his characterization and dismissal of my central argument in Chapter 7, which he calls a rehash of the anti-commons arguments of others. It is not, I don't even use the term "anticommons," and no one who has actually read the chapter could conclude that it relates in any way to any anticommons argument at all (which is a utilitarian argument, while mine is not). That chapter makes the ontological argument which supports my ethical conclusion, regarding the existence of certain things which I call “commons by necessity” and which I conclude DNA belongs to.

11.) The rest of the review basically defends the practice of gene patenting, making this more clearly an advocacy piece, and less a book review.

All told, Holman’s review focuses on about 10 pages of my book, in which I discuss law and cases, and leaves out the bulk of it. In writing this response, I went back and carefully re-read my book and was amazed at just how much of my discussion is completely ignored, and how little of what I write about is actually referenced. It seems that those who disagree with my conclusions have done their best to turn points of contention and disagreement over policy into allegations of “error” where in fact, there is plenty of argument to be made on either side. My book makes one argument, but let’s not pretend that the arguments on the other side are “fact” when they are simply arguments which I have taken care to dispute in making my own.


http://www.typepad.com/services/trackback/6a00d8341c659b53ef0120a55f3734970c

New article in The American Interest

This is a nice primer on the issues, and has a brief plug of my book:

Source: http://www.the-american-interest.com/article-bd.cfm?piece=653

April 12, 1955 was a day of celebration. Across the United States, church bells rang, sirens blew, and people poured into the streets singing and dancing. The rejoicing was a spontaneous response to news that field trials of Jonas Salk’s vaccine against the dread polio virus had been successful... {click here to continue reading}

A summary of the ethical argument

1.) I argue property rights over land and moveables are grounded in brute facts of possession

2.) I argue that IP rights are not grounded, and so we can generally alter them at will except where they may conflict with grounded rights

3.) I explain that patents protect expressions (manifesting a type in some way in the world of tokens) of a type, not the type itself. They are exclusionary, not possessive rights, giving the patent holder the right to exclude another from reproduction or practice of his or her type

4.) A gene is the arrangement of nucleotides that codes for a protein. Its action involves the creation of proteins by mRNA, which as it creates the proteins, reads the beginning and end of the gene, and leaves out the introns. This is the same mechanism employed by humans when we make cDNA.

5.) A patent on cDNA, I argue, is not different than the patent on the gene itself as there is nothing new about the cDNA. Nature devised long ago the methods of reading genes and making proteins. cDNA is thus not novel and not properly patentable. (ultimately, though, my commons argument trumps all of this).

6.) Newly created genes, not otherwise found in nature but assembled from intentional action by humans are properly patentable.

7.) The human genome is a constantly evolving object that involves every member of the species, and is, I argue, a commons by necessity, like outer space, the atmosphere, sunlight, and radio spectra. Discovering its nature, replicating its processes and using them to our benefit cannot ethically be done to the exclusion of others. Granting exclusionary rights to discoverers of genes that are part of that genome interferes with our common rights as beneficiaries and possessors of parts of the human genome.

8.) Myriad, for instance, when it uses its patent on the BRCA1 and 2 genes that are linked to breast cancer, prohibits meanwhile the replication by others of the genes themselves. It has sent cease and desist letters to scientists who were doing lab work on those genes. I argue that it is our right in common to explore and investigate our individual genomes, as well as the human genome, unhindered by claims of others. What Myriad "owns" is a right to stop you from doing that, and they have exercized that right to the our common detriment.

9.) Miami Children's Hospital has done the same thing with the Canavan's disease gene, and while their right is not one of standard, possessory ownership, it is the right to exclude others from doing research on that disease. This is, I claim, an unethical usurpation of the commons of DNA.

10.) My argument differs from what lawyers know as an "anti-commons" argument, which I do discuss in my book, but which my argument does not rely upon. Anti-commons are created where over-patenting has hindered research. This may well be happening, as the Murray article tends to point that way, but my argument about the commons and DNA is a totally new, totally different argument founded on my ontology of commons by necessity.

I hope this clears up my arguments a bit. In a bit, I will also point out how I believe Holman and others have distorted my discussions of the law (as I begin to discuss above in justifying my discussion of Moore based on its use by Celera's attorneys). I have also tried to point out, in relation to Holman's lengthy selection accusing me of creating "fictions," that my position on these issues is correct if you don't buy (as I don't, and argue against) the "isolation and purification" argument, which I argue is a fiction.

I find it still very strange that Holman's review cites my chapter 7 as a re-hash of the anti-commons arguments of others, when nowhere in that chapter do I ever make anything like that argument.

But I see all that discussion as a distraction, and my book spends about 10 out of its 200 pages discussing cases, none of which are determinative of the argument or conclusions.

Why the lawyers just don't get it

"It is difficult to get a man to understand something
when his salary depends upon his not understanding it."
-- Upton Sinclair

(Full disclosure, in response to the anonymous commenter, when all is said and done, I will have made roughly half the billable hours of a single patent application from the advance and royalties from my book. I have also spent nearly as much of my own money on travel and expenses. Such is the nature of academic publishing)

Central to my argument is the notion that DNA is what I call a "commons by necessity" which I make a detailed ontological argument regarding. Thus, my chapter 7 is critical, and is not at all an anti-commons argument of which IP lawyers are familiar, but a metaphysical/ontological argument about the underlying objects. Despite any differences lawyers might have with me regarding the present nature and effect of gene patents, my critical ethical argument, the central thesis of the book, hinges not on the law but on this ontological argument about the nature of certain things in the world that I claim simply cannot be ethically enclosed by any claim whatsoever.

I see the legal arguments attorneys want to raise as being utterly orthogonal then to my argument, which despite our disagreements about the nature and effects of the current patent regime, brings unmodified genes out of the range of any property scheme for ontological reasons. If you grasp this point, then you'll understand my frustration that quibbling over the current state of the law doesn't get around my central thesis.

Thus, the attorneys defend their turf by claiming I know nothing about patent law (I know a fair amount) and its practice in regards to genes. They claim, for instance, that there are no patents on unmodified genes, I claim that the allegations of "isolation and purification" somehow modifying genes is utterly illogical, and provide numerous analogies to back this argument up. They go after my legal analysis, although it ultimately does not affect my conclusion, even were I totally uninformed about the present nature and extent of gene patents. My philosophical argument implies that any patent on genes would nonetheless be unethical. This critical point, the ontological argument, remains unassailed in any review or critique.

More hate from the lawyers...

Below is a letter I sent to Brian Leiter in response to his piling on in defense of Holman, who I still contend is out of his league in reviewing a book on public policy, and then focusing only on his legal disagreements and characterizing them as me being "wrong." In many ways, this event reminds me of the town hall meetings going on back in the US. When faced with the potential of losing a monopoly on a questionable practice that has earned patent attorneys millions in fees, they resort to invective, threats, attacks, ad hominem, etc. Always skirting the central policy arguments and rationale, they seek to destroy reputations, to allege lies, deceit, and to claim their worldview is privileged. In many ways it is. Corporations hold the reins, and purse strings, and anyone challenging their primacy and modus operandi is open game. I never thought it would be an easy fight, but I never realized it would get so ugly.

It's a shame, I think if Leiter would read my book, and saw the naturalistic arguments I make about the nature and ontology of law, he'd be more sympathetic. Instead, he is defending his vetting of the reviewer (though he didn't select him), who really was nonetheless not an appropriate person to review my book. While accusing me of digging in, he digs in. Too bad. Instead he accuses me of "incompetence" ... it's a shame. It all hinges on accepting Holman's and other's interpetation of the "isolation and purification" smokescreen, which I dispel in my book and have done so numerous times, in numerous analogies, since then. If one doesn't accept that "isolation and purification" creates anything new and thus patentable, then all of the claims I make, characterized by Holman and now Leiter as "figments of the author's imagination resulting from his profound misunderstanding of patent law" are not at all, but rather real concerns.

I note that there are critical reviews of Leiter's books out there too, but I would never leap to the conclusion that any of them were "bad" books and that he should simply own up to that fact. It's a shame he does so, so very publicly, and without an opportunity for me to set the record straight on his blog:


----
Hey Brian,

Hardly was a "smear campaign," as I think asking about his industry ties is certainly appropriate.

"Mr. Koepsell protests that his book was really about ethics and policy, not law, so apparently his complete misunderstanding of patent law doesn't matter."

Actually, Holman admits it is a book on ethics and policy, not law. It is part of a series devoted to public policy, and was never marketed as a legal primer to gene patents. Moreover, I don't think it's fair to say I have a "complete misunderstanding of patent law." Holman and I disagree about the nature and effect of gene patents, and if you read my book, I lay out a logical argument and arguments by analogy challenging the "isolation and purification" notion. Obviously, well-intentioned attorneys and jurists disagree. The current suit against Myriad for the BRCA1 and 2 gene patents shows that at least some attorneys agree with my perceptions about the nature and effects of these sorts of patents. Since you lack a comments section to your blog, which really is quite harsh and rather offensive given that the book has in fact been received positively by others, I am posting this to my blog, along with a link to your blog.

I find it odd that you claim also: "Koepsell spews forth a series of ad hominem allegations against the reviewer, disputes no actual point of substance, and tries to explain away his other mistakes as "proofreading" errors (yeah, right)"

What "series" of ad hominems are you speaking of? I raised a legitimate concern given Holman's past positions and potential vested stake in the outcome of this debate. I see nothing else that could be characterized as an ad hominem. Please enlighten me?

Not sure why even legal scholars like yourself must resort to vitriol. My aims and goals are to change public policy about gene patenting. My arguments and understandings of the current state of gene patenting accord with those of many other legal scholars and philosophers, and my methods have always been the use of logic, ontology, and argument rather than personal attacks. This issue seems to have raised the ire of patent attorneys especially, even as scientists and progressive-minded lawyers have rallied to the cause.

All my best,
David

Tide is turning in Australia?

An ongoing inquiry and effort in the Australian Senate looks to be heading toward a ban there on gene patents. Let's hope it sets the stage for similar moves in other countries and regions.

Some responses to recent critiques

Just posted at Ethical Technology's blog:

http://ieet.org/index.php/IEET/more/koepsell20090816/

We're all commoners now

A major argument I make in my book, Who owns You? is about the nature of the natural genome as a "commons." It seems to me utterly clear and uncontroversial that that there are some things that simply cannot be claimed by any individual as their "property" in any meaningful sense of the term. The strongest analogy I make is to radio spectra, which can be monopolized only over short distances as long as someone else has a transmitter of identical strength. Brute force cannot make one the king of the radio waves, as long as others have the same potential force, in which case we end up with the classic tragedy of the commons, where a certain frequency ultimately becomes worthless as whomever wishes to and has the means tries in vain to monopolize something that cannot be enclosed. In many ways, this is the story of the encroachment by corporations in general over the domain of science.

Scientists deal in the natural world. They seek understanding, prediction, and ultimately control over natural laws. This cannot be accomplished without a community of scientists undertaking the tried and true methods of science, which depend in large part upon open critique and judgment of hypotheses, theories, and results of experiments by a community of peers. The domain of science is nature and its laws, and these can best be delved into, and nature's riddles best solved, with open and free exchange of information. All of which clearly annoys the powers that be who want as much as possible to cordon off vital knowledge so it can be put to use in profit-making. I am not, in general opposed to making profits, nor am I opposed to people being rewarded for inventiveness, except where the commons makes better sense, or in some cases, is a matter of justice.

We choose to make certain commons (which I call "commons by choice"). Thus, while land can be enclosed, and trains can be privately owned and possessed to the exclusion of others, in some cases we deem it in everyone's best interests to make certain resources freely available, or at least be heavily subsidized (as in the case of national parks and public transportation.) In other cases, like in the case of radio spectra, we allow the government to regulate an otherwise unencloseable space (what I call a "commons by necessity"), doling out monopolies to bidders at public auctions in order to prevent the breakdown of that commons. In some cases, nations negotiate to regulate commons (like the atmosphere) to prevent the collapse or ruination of an unencloseable space that benefits all. In the case of genes, an unencloseable, evolving, utterly natural and necessary commons has been parceled out to the first to file their bogus claims of invention where they are merely drawing lines on a landscape that nature drew long ago. Lots of money is now at stake, and there are entrenched interests, shares, and stakeholders who will fight tooth and claw to hold onto what they never should have gotten. But the commons are ours. Always have been. No property right can be taken where none ever truly existed, and as a classical liberal about property (in the A. Smith sense), I am perfectly comfortable that no right will be denied when we repeal the practice of gene patenting, and once again require invention, innovation, usefulness, and human need to drive the market rather than greed and the desire for bulging patent portfolios.

The commons is reemerging in many spheres, as a vital natural forum for both competition and cooperation. After all, the commons once devised under British common law were available for commoners, who had no other property or wealth, to eek out a living through their hard labor and a common agreement that some spaces were to be used for all. If one was productive, frugal, and lucky, one could rise above one's squalor and save, and even, eventually, become a tenant farmer (because then, the sovereign owned everything thanks to God). Recognizing the role and use of the commons was both a democratic and a market innovation, encouraging class mobility. The oceans are another example, rich with resources claimed by no one, the bravest and best, or the luckiest could garner wealth. The commons is a source of capital for anyone who uses it best. Intellectual capital, innovation, guts, grit, and fortitude, combined with a well-maintained commons, is not only right, it is just.

Speech rights and innovation

I am working on a paper for a special issue of The Monist, forcing myself to refine and expound on themes I have developed in the past about artifice and expression. In the course of it, I have come to see the strength of the ACLU's arguments about free speech. They are quite technically right, and we should acknowledge that intellectual property is a governmental interference with speech rights. It might well be one we are willing to endure, like so many other speech rights we have chosen to let the government curtail, but it is simply a governmental restriction on speech. If you own the copyright of a song, you are granted a monopoly, by the grace of the sovereign, over that song for an obscene (see above) period of time. During that time, I cannot record your song, even with my own creative arrangement of instruments or voices, or editing of the lyrics, without paying you for that pleasure. So, my speech has been restricted. If we take the court's current, small "l" liberal interpretation of what constitutes speech then I'd argue that building a machine, which after all expresses an idea (brings an idea into the physical world outside of a mind) is as much a matter of free expression as sculpting a statue could be argued to be. Patents limit my right to express certain ideas, just as do copyrights. One way to get beyond the implications of these restrictions is to make IP all a matter of private contract: agreements between authors/inventors and end users, without the institutional necessities of government (except, maybe, the courts in case of breach). This is precisely what is going on with the use of copyleft, creative commons, open source, and other forms of licensing that avoid traditional IP laws. Seems to me that this sort of private alternative to big government bureaucracy ought to appeal to conservatives... if there are any left.

It's the novelty...

So, what it comes down to is this: those who argue that the gene patents they so dearly protect are valid and justifiable must argue two things:

1) that "isolation and purification" as it is being conducted are sufficiently inventive to warrant patent protection, and that what is created in the process is something somehow new, and

2) that we must somehow provide the incentive of patents for gene sequences in order to realize beneficial products from new knowledge about our genes.

Of course, I dispute both claims.

"Isolation and purification"" of genes from a naturally-occurring genome is not inventive, and doesn't create anything new. The science argues in my favor, as does logic. The body "isolates and purifies" genes to the same extent as researchers simply by using mRNA to do the work of the gene. mRNA only reads the exons, skips the introns, and makes a protein, determining by the logic of our natural processes where to begin, and what codons to read to create the final protein. Now let's reason once again by analogy. Imagine creating an artificial heart (which has been done a few times). Clearly, the artificial heart itself is patentable as something new, useful, and non-obvious. But is the process of pumping blood patentable? In the case of gene sequences, the sequence is the process, whereas the final protein is the product. In the body, the processes and products are naturally-occurring, and thus any attempt to replicate them, or realize them synthetically, might result in a new, patentable process, but the genes themselves will not be new, nor will the products that result by patentable if they are naturally-occurring. This conflicts with the current interpretation of what is patentable since things like Epogen are patentable products even though they are analogues of naturally-occurring proteins. My argument hinges upon realizing that this is an over-broad application of the patent law, as are patents on gene sequences.

Let's look again at an analogy. Gravity may be used in perhaps infinite mechanisms that might be used to lift or lower things. Cranes, elevators, etc., all might be designed in nearly limitless ways (even if certain designs are most practical). The device as a whole, which utilizes the force of gravity, is patentable even though gravity is not because it lacks the novelty requirement. Similarly, the process of creating a naturally-occurring product, or part of nature, may be new even though the product has long existed. My example of a water-synthesis machine is on-point. There might be many hundreds of devices we could build that could synthesize water out of hydrogen and oxygen, each of which should be patentable if it meets the criteria for patentability, but the molecule H2O could never be patentable. Neither should the product "Epogen" nor any patent claim on existing human genes. They have long-existed, have been doing exactly what they do that makes them useful to us for many eons, are not the result of our inventive behaviors, and should not be patentable. Isolating them is less complex and less arbitrary than, say, drawing lines on a map simply due to the fact that nature has figured out how to isolate them itself, devising mechanisms for beginning transcription and ending transcription at the natural start and end of the genes. Purification? That too is being done as the mRNA reads only the exons. So where's the inventive step? Why reward anyone for finding these natural things? Better we should reward those who discover new means to create new, useful products like therapies and drugs. If stem cells are successfully used to grow new organs, would anyone seriously argue that the final organs are patentable products rather than just the process by which they are grown?

Take again the example of gravity: if patents were granted on gravity itself, rather than its application in new devices for lifting and lowering things, then the range of inventions available for inventors to produce during the patent term shrinks significantly.

So why the clamor to save these claims on gene sequences? Perhaps it's as Venter said in the article I posted last: because it made patent lawyers rich.

Worth revisiting/New media

When even Craig Venter agrees that gene sequence patent stifle research, you know you're onto something. While he cites one drug that was made possible by patenting the sequence, he notes it is an exception, and that, for the most part, drugs will not come from the sequences themselves. No, the patents that have emerged, and have proven profitable, are those like Myriad's, whose test incorporates the BRCA1 and 2 sequences necessarily, but which encompasses essentially little that is new or inventive. As I have argued, if they developed a new, better means of screening for the presence of a gene, then by all means, patent it. But the sequences themselves are not new, they are devised by nature. Would scientists have discovered the BRCA1 and 2 genes without financial incentive? I'd say, pretty much assuredly. Breast cancer is a huge social concern, and the efforts to discover disease genes have been motivated by public health and scientific concerns, as much as by profits motives (actually, let's hope, more so). How should scientists looking for disease genes be compensated? By increasing federal funding for basic research. Scientists love grants, believe me. In the end, I wholeheartedly believe that there will be more patentable, downstream innovations by freeing up the upstream research, and enabling it through increased funding. It's not like there isn't market demand for new, better treatments and drugs. Of course, that market would also expand with universal health coverage (not necessarily single payer -- here in NL, we have mandatory health insurance, but we each pay, though the costs are affordable). But that's a whole 'nother matter.

As for media, I did a nice interview at Changesurfer Radio, with my friend Dr. J. Give it a listen, we covered some new ground.

-d

The problem with public debate

Most people seem to now immediately fall into the Crossfire version of debate. God bless Jon Stewart for his demolition of Crossfire. It really is what's wrong with our culture. Issues are often complex, too complex to be reduced to just two opposing viewpoints. I know liberals and conservatives are both guilty of this, but it really impedes solving real issues. I am dealing with this on the blog wars I have launched myself into on both IPWatchdog.com and Patentdocs.org . There, the comments tend to always devolve into an unbridgeable divide, whereas I have argued for a moderate approach to gene patenting. While I have suggested at times that innovation and profits can come without strong Intellectual Property regimes, in my book I argue that there is plenty of room for downstream, patentable innovation without granting patents to gene sequences found in nature.

But apparently, for a certain type of person, by suggesting that something in the world cannot or should not be owned, one becomes simply "ill-informed" or the author of a "screed," part of the "anti-patent crowd" or worse. Suddenly, by suggesting that something ought not to be patented, the fact that you later suggest that there will actually be more patents on real inventions as a result matters not. Neither does the recent evidence that innovation and profits can come from open science and open source matter. What seems to matter is the creed of patent, but let us not forget patents are a means, not an end. And the end is innovation. Innovation, and its fruits, are what we want. What can we do to achieve it? Is there only one course, are there alternate models, and can we accept that various means are worthwhile and available? It's much harder to chart the middle course, but sometimes we should try.

I am happy to take the insults, if only someone also occasionally gets the message. The message is this: science can be impeded when patents are granted on naturally-occurring things, like laws of nature, genes, etc. We ought to fund and free up the basic science side, and see the innovations that come out of this. This was the model of the the NSF and NIH in the 50s and 60s, and we have abandoned it, and I believe it has been to our detriment. The US is losing its pre-eminence as a bastion for science and technology, we are losing our best and brightest to nations where there is a better balance between public funding of science and corporate profits and spin-offs. This has worked before, and we can go back.

Name calling at Patentdocs

So I am being called a liar, for unspecified reasons, at patentdocs.com. I will have to elaborate here shortly on the whole "isolation and purification" line of argument, that really seems to have the true believers convinced. Meanwhile, I'm doing what I can to be civil and stick to the arguments as opposed to the name calling.

Here's an interesting article that might put it in perspective. Venter himself, in opposing gene patents, notes that the frenzy to patent genes enriched mostly the patent lawyers. Maybe this is why Noonan is frantically trying to reframe the debate, and call those who oppose him "liars."

Thanks to IPwatchdog.com for inviting this post

http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/

Get Your Hands Out of my Genes!

I think it's important to revisit some of the non-legal arguments I and others have made regarding gene patents. A striking feature I note from all my talks on the subject is the visceral reaction many have to learning that human genes are patented. Forget the fact that these patents violate the patent law because they are not of anything remotely new. Forget the argument, which is compelling, that granting these patents violate the US Constitutional grant of authority for patent because they actually hinder the progress of the useful arts and sciences. Forget even that these patents might violate the First Amendment because they interfere with a plausible right to research (especially if one buys that donating money to political campaigns is "free speech," then scientific inquiry into nature better damned well be). No, there's something else to it. Something that underlies the visceral reactions my audiences and readers note. It's invasive. It's theft.

Our genes might be practically open to discovery, there's very little physically I can do to prevent you from acquiring my genes and unraveling my genetic code. But that doesn't mean it wouldn't be disturbing or unethical if you did this. The knowledge you could get about me, and use against me, is just too potentially disruptive to decide that we are not somehow each custodians, and maybe even more properly guardians, of our individual genetic data.

At the same time, the genome we share cannot be cordoned off. To the degree that our genetic information is mostly the same, we should all have access to it. No one should be able to claim that if we want to peek around, learn some more, and do some studies on this common genetic code, we somehow have to pay for this. Our "common genetic heritage" is, I argue, an actual commons like the sky, sunlight, or international waters. We should treat it as such.

The visceral "icky" reaction is based on the intimate relation we each have to our individual genomes, and the common relation we share with the "human genome." Just as no one should profit from your image, and no one legally can without your consciously and knowingly signing away your rights to it, your genes cannot be exploited for private gain without your consent. Nor can a commons that is owned by all be exploited without common consent. Yet this is what is occurring, and this is why we are riled. It's time to take back our common genetic heritage. We have nothing to lose but our double-helical chains!

Podcast on Point of Inquiry

http://www.pointofinquiry.org/david_koepsell_who_owns_you/

Lawful vs. Just

Another newspaper story doesn't quite get it right. Time and again I read stories like this one in the Miami Herald in which gene patents are called "lawful" or proper, or whatnot, tracing their appropriateness to either the Chakrabarty decision or the Moore decision, or both. Simply put, neither case applies to unmodified human genes, which are at the heart of the ACLU case against Myriad. Chakrabarty involved the patentability of an engineered life form, and Moore involved the patentability of a product manufactured out of material extracted from human tissue. The latter turned on the issue of a waiver signed by the patient which gave rights to research and development based on the extraction to the defendant. It did not go the the Supreme Court of the US, just that of California.

Of course, I describe the history in greater depth in my book, and there are a number of excellent books, including The Gene Wars that detail how, using these cases as their precedent, Celera sought patents from the Patent and Trademark Office for human genes discovered in the course of their parallel and private Human Genome Project. The point it, the ACLU case will be one "of first impression" as this sort of legal challenge has not yet been made. The administrative decision of a government agency, including that which allegedly narrowed the applicability of gene patents, is not strictly speaking "law":

The regulation states: "If a patent application discloses only nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. But when the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the ‘‘utility’’ requirement. That is, where the application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene compositionmay be patentable"

This is not "law" because it is simply a regulation, issued as guidelines for PTO examiners, promulgated by an administrative agency. Laws are debated and passed by legislators elected by citizens, while regulations and administrative guidelines might be passed or issued by bureaucrats, either with or without review or comment by the public or elected legislators. Generally, there is a call for public comment, and none is received because so few people ever hear of proposed regs. The point is, just because this regulation or "guideline" exists, doesn't mean it is lawful. Plenty of administrative rules, regulations, and guidelines turn out to be illegal, unconstitutional, or just plain stupid. In this case, I believe this one is all three. As I argue in my book, the "isolation and purification" requirement, if applied to analogous cases, would make the Devils Tower in Wyoming patentable as soon as someone drew an arbitrary border around it, isolating it from the surrounding environment, and stating that by so doing one has developed a use which includes finding the Devils Tower on a map (or any other geographic feature, for that matter).

So, let's get this straight once and for all. The PTO has been acting without legal precedent, and without legal guidance. Determining the legality of these gene patents can be done in only two ways: through legislation specifically making it legal or illegal, or through a court decision, ultimately by the Supreme Court. Unless you're of the school of thought that says whatever the government, or God help us, its bureaucracies, does is legal per se. But I'm sure you're not.

Free Markets and Corporate Welfare

Let's face it: patents are governmentally-sponsored monopolies. So are copyrights and trademarks. I argue that patents are a far larger governmental interference with the free market than copyrights, because there is less of an infrastructure devoted to copyright. Your copyright is instituted by your authorship, and helped a bit by affixing the little copyright symbol. Your copyright is enforced in the courts, rather than through a government bureaucracy. If we had truly free markets, then products would survive by virtue of their relevance to consumers, and consumers' trust in your brand, and their willingness to pay you for what they think the product is worth. Can we conceive of such a marketplace? Indeed. Without the anti-free market devices of corporations, patents, and arcane and expensive bureaucracies and institutions, useful new products would have to prove their value without the crutch of artificially-created monopoly status, and prices would reflect actual values. All of this seems elementary, and economies existed and flourished long before governments became so entangled with corporate interests. Imagine the flood of new innovation that might enter the marketplace without the threat of large, corporate monopolists threatening lawsuits based on questionable patents.

In many ways, there is now a shadow economy that is waging courageous battle with the monopolists. In this week's The Economist (which I diligently read cover to cover each week), they declare the battle over. Open source has won. This is more or less true. Much of the backbone of the interwebz runs on Apache servers, and Sun bought Open Office, and Google is running on mostly open source software, etc., etc.. And somehow, the infrastructure of the internet is benefitting, and companies still make profits, and the products get better more rapidly, and science marches forward. This is because a truly free market, one that involves consumers and producers in a virtuous cycle, works better than providing advantages to corporations through unnatural monopolies. The latter course is inefficient.

Scientists too realize the benefits of keeping some things in the public domain. Some early responses to the potential that some would grab claims to genes included concerted scientific and corporate cooperation to maintain a commons in basic science. People often ask me how we can fight the monopolist impulse, and reclaim our genome. The good news is, there are many who are trying. The ACLU suit is one avenue. But scientists, and those who support open source and open science realize the true value of not just free markets, but openness as a commodity, as a source of value, and as a value in itself.

Some basic ontology of ideas, artifacts, and natural kinds

in response to some more disagreement to a post at IPwatchdog.

Some subtleties bear discussion surrounding the ACLU/Myriad suit, and the general legal prohibition against owning "ideas." As with many legal confrontations, one of the problems involves the unclear use of terms by the courts. Specifically, while the Supreme Court has prohibited patents over laws of nature before because they would "amount to" owning ideas, this is not the real reason why laws of nature cannot be patented. Well, it is, sort of, but let's evaluate the various things and see why we cannot own laws of nature:

Laws of Nature: these are inherent in nature, thus they are not new or inventive. Thus, I cannot claim a monopoly over the phenomenon that attracts bodies to each other. Nor can I try to own the phenomena that causes 2 multiplied by itself to equal 4. Nor can I own the phenomenon that causes energy to be released from hydrogen molecules when they are fused (the sun has been doing this for a long time), nor can I own the phenomenon that makes human females more prone to cancer when they possess a certain string of genes, nor can I lay claim to that string of genes which has been a product of evolution for eons.

Expressions: Expressions are the products of human minds, they are the ways that ideas are transmitted between people. The ideas might be new, for instance, of a unicorn, a steam engine, a warp drive, a new combination of genes not already occurring in nature, etc.. They may be of old things, like the natural processes of evolution, the laws of relativity or gravitation, or of a string of genes that evolution created.

Artifacts: These are a form of expression, specifically objects that endure -- what we might call continuants.

Other expressions: Occurents, like a dance, a speech (if not recorded), and other expressions of ideas that do not last after the event. They occur over a span of time

So far, the law of intellectual property has only been applied to a particular kind of continuant, specifically only those that express ideas not otherwise found in nature - new ideas. So, an expression of the laws of nature is excluded subject matter, not because it is an idea, but because it is an expression that is not of something new. A scientific theory is a good theory if and only if it bears a good correlation to the laws of nature, such that it accurately predicts experimental results.

Is gravity an ""idea"? Yes, inasmuch as the abstract entity -- the law of gravitation has been working on the universe since the universe began, just as the abstract entities of mathematics have been making 2 + 2 = 4 for billions of years before humans figured out that it wasn't just a good idea, it was the law.

open...: Intellectual Monopolies Kill: Two Examples

open...: Intellectual Monopolies Kill: Two Examples

some excellent analysis

Some updates

I've been having a back-and-forth with Gene Quinn at his site, IPwatchdog. Here's a link to some of our ongoing disagreement abut gene patenting and the ACLU/Myriad suit.

Also, today the TU Delta (my university's newspaper) published an opinion piece I wrote on the subject of the suit, with some references to repercussions for Europe.

Still trying for some more traction in the US media, where this is most relevant, but where there's very little in the way of reasoned analysis. On both sides of the issue, emotions seem to be driving people's opinions, but I am appealing (IMHO) to sound philosophical reasoning, legal precedent, and logic. Always a deadly gambit, I know. So sue me.

Totally pwned, dude

I have attempted to chime in on a few blog debates about the Myriad suit and found two distinctly different takes on the subject. There are those who see the clear irrationality and inconsistency of allowing patents on disease genes, and then there are those who claim that without these patents innovation, and thus cures for diseases, will grind to a halt. The latter, clearly, get my goat.

Let's be clear, basic research flourished for decades (before Bayh-Dole, which I'll explain in a moment), and the corporate world did not suffer in the least. Consider the decades between 1945 and 1975. Corporate growth and wealth in the US was enjoying a rather steady uphill climb, even though at the time much of the basic research that was happening was publicly funded, conducted in universities, with no reward of patent available to university researchers. Somehow, the corporate world benefitted, the economy tended to grow, innovation proceeded apace, and technology improved. In 1980, Birch Bayh and Bob Dole had their bill passed, the Bayh-Dole act mentioned above, which allowed those conducting research with public money (NIH or NSF grants, chiefly) to profit through intellectual property rights to their inventions. This set off a flurry of grabs by universities for potentially profitable, blockbuster patents, like the famous "Harvard Mouse." Before this, of course, basic science was published in journals, made free and open for use by any and all who might innovate, and was often successfully turned into profit and property through actual inventions. But Bayh-Dole changed that, and some (like me, for instance) might argue, not necessarily for the better.

Patents on unmodified genes were another ripe field for plunder, and disease genes especially. These are the nuggets, because that's where the federal funds go: disease research, and if you can claim rights to a disease, you can get all sorts of profitable royalties. In my book, I call attention to Canavan's disease, which is one of those genetic diseases that strikes largely among Ashkenazi Jews, like Tay-Sachs. But while, as I argue, all gene patents (not just on genes) violate the "commons" that is the human genome (and genomes in general), it is the disease patents that are most troubling.

Think back to the 30 years between the creations of the NIH and NSF and the enactment of Bayh-Dole. Was that system stifling research? Did it require appealing to greed somehow to impel or prod along a lazy research community? Have things improved so much since Universities were encouraged to churn out patents to pay for the gaps created by the withdrawal of federal funding? Is it too late to turn back the clock a bit, and see if maybe it wasn't working just fine, before we decided that science required the lure of lucre to do what it had done for ages?

Call me a cockeyed optimist, an idealist, or worse, but I think science and industry had a pretty healthy relationship before the present era. The atomic age, the space age, the computer age, all had their geneses before Bayh Dole. I think we can afford to give that model another go. What say you?

Science and the First Amendment

The ACLU lawsuit against Myriad presents a unique and intriguing claim based upon the First Amendment of the US Constitution. I would have never thought of challenging gene patents on these grounds, but it's certainly a "colorable" claim, in my opinion. This means, it sets forth a cause of action, and it should survive a "motion to dismiss" which is Myriad's inevitable reaction to the complaint. So where's the 1st Amendment claim? In the complaint, the cause of action is described:

"all of the challenged claims represent patents on abstract ideas or basic human knowledge and/or thought and as such are unconstitutional under the First and Fourteenth Amendments to the United States Constitution"

So, here's how the First Amendment gets violated: the government prohibits some speech. Now, taking the facts and claims alleged in the complaint as liberally as possible, as the court must do on a motion to dismiss, here's the essence of the First Amendment claim: The government grants a patent, and this patent prohibits certain speech about basic human knowledge or thoughts. If researchers are prevented from doing basic science, investigating breast cancer as the Yale group sought to do until they were harassed by Myriad, then this could be an example. It raises an interesting general problem about science and intellectual property, namely: all monopoly rights to knowledge and its applications are governmental prohibitions on speech. This is not limited to patents that cover "basic human knowledge and/or (ugh) thought." This is literally true. Monopolies stifle speech, and where they are granted by government, they are unconstitutional. Except that I am pretty sure that patent law in general is not about to be overthrown on First Amendment grounds (not that it would necessarily offend me if it were). So this claim is going to be a tough fight. We shall see.

A Certain Irony

When the British crown began to consider expanding its territories and commercial reach, it reached out to a population that even today we associate with violence, thievery, and anarchy: pirates. It was cheaper than starting from scratch and building fleets of vessels, raising a navy, then arming and equipping them. The Pirates had perfected their methods against both Spanish and British vessels, and to cut the losses to British commerce, it seemed best to put them under the Crown's employ. The "Privateers" were born, and Pirates were successfully re-branded. They were used to cut into Spanish stakeholdings along important routes of developing trade, as well as to launch raids on strategic ports along those trade routes. They also continued to commit acts of piracy against foreign vessels and to bring home the booty (some of it) to the Crown.

What does this story have to do with Intellectual Property, you might ask?

The Crown employed these privateers in many cases by using a device still used today. The sovereign extended a monopoly to them in exchange for their loyalty and a share of the proceeds from their raids. Piracy was legitimized, institutionalized, and whole swaths of the new world were acquired by something called "Letters Patent." (This is the one used to employ Francis Drake)

It is from these that the modern institution of patent is partly derived. The grant by a sovereign, for a period of time, of exclusive use of a part of the world or its resources. I argue that these devices owe nothing to natural law, but remain choices of sovereigns, and can be altered as we see fit. Patents must serve pragmatic purposes. Now that we have democracies, the sovereign that benefits ought to be the people represented, not isolated individuals or corporations. The purposes of Patent law are best met when it is crafted to encourage the growth of science, the swift movement of scientific and technical knowledge into the public domain, and innovations are rewarded even while scientific inquiry is encouraged. Over-reaching, as in the case of patents on basic scientific truths (like the sequence of a naturally-occurring gene) serves none of the purposes of patent law, and turns the PTO into an anti-democratic sovereign, and the patent holders into pirates.

On Gene Patents

The past week's news about the ACLU lawsuit to combat Myriad's patents on two versions of the "breast cancer" gene has prompted me to begin to record my own thoughts and observances on the practice. Of course, I have a book-length treatment of the subject that was recently published by Wiley-Blackwell, appropriately titled: Who Owns You? The Corporate Gold Rush to Patent Your Genes, available now at major booksellers. Ironically, torrents for the book exist and there's little I can do to stop them. So much for my libertarian take on Intellectual Property. No matter, the ideas are what I want to spread, and they center around the nature of property in general, the existence of natural "commons" which cannot be "enclosed" by laws, at least not ethically, and the relations between ethics and nature.

So this is it, rather than try to swat down the misunderstandings and miscommunication about the practice of gene patenting by replying to every erroneous blog post or media article out there, I will summarize my thoughts here. I will also post updates, including news articles, and my own writings on the subject as they may appear.

For starters, here's the New York Times piece on the lawsuit: Cancer Patients Sue Over Breast Cancer Gene Patents

and here's a piece I recently published at Science Progress (before the lawsuit): How Genes are Like Plutonium

Here's an article about my talk at the University of Virginia Law School on the subject