Philosophy and Public Policy: Metaphysics Matters!

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

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

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

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

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

From "Frivolous" to the Supreme Court

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 Who Owns You? The Corporate Gold Rush to Patent Your Genes (Wiley-Blackwell 2009). A few months after it was released, the ACLU helped spearhead a lawsuit 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, I took a lot of heat. 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 "frivolous," 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, both scientists and lawyers, including patent attorneys, have chimed in on the side of the ACLU, but no matter.

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 Supreme Court will now grapple with it. It is important, it seems, to the highest court in the U.S.

At the time I found myself defending my work against those who resorted (and still do) to attacking me rather than countering my arguments, I had no clue what motivated the vitriol and attempts to personally smear me. I made the mistake of lashing out. 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 amicus (friend of the court) briefs will be submitted by parties on various sides. In the past couple years, in cases like Bilski and Prometheus, 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 Supreme Court is simply not qualified 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.

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.

May reason prevail.

Myths 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 ad absurdium, 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."

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 March 2002.

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 nature of the commons, not about utilitarian concerns over the effects 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 Prometheus 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.

Lies, desperation and the death throes of gene patenting

The 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 previous post. One of my old adversaries, Chris Holman, whose incompetent review and attempt to discredit me I refuted here (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 Mike Daisey 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 Who Owns You? 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 his comments section, 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 suggest that the Supreme Court is unqualified 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.

So the patent-industrial complex, which always profits from the mere act of patenting (by fees on filing patents, costly patent-law seminars, 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 preserve the scientific commons against monopolization, 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 logic itself. The Supreme Court seems to agree, and has altered the law. The Court of Appeals, Federal Circuit (CAFC) has been overturned. Its decision in Prometheus 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 Myriad 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 Prometheus decision's reasoning makes the Myriad product patents even more questionable than those at issue in Prometheus, which at least involved "methods" in which the laws of nature monopolized were couched. Four of the claims challenged in the Myriad case are claims over merely "isolated," unmodified gene sequences with no method or process involved.

The CAFC panel on Prometheus which was overturned unanimously by the Supreme Court unanimously approved of the now invalid patents. The CAFC panel in the Myriad case was not unanimous. As I explained last year, some of the method claims at issue in Myriad 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 Myriad court consisted of Lourie, Bryson, and Moore, the Prometheus 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 Prometheus appeal, that she ought not to stubbornly side with the losers as Rader did in the Prometheus 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 certiorari to the Supreme Court. If the CAFC does the right thing and reverses its previous decision in light of the Prometheus decision, then the Supreme Court is unlikely to take it up on cert, feeling that their Prometheus reasoning is correctly applied to overturning Myriad. If the CAFC decides to try to weasel around the Prometheus ruling it will still be a split panel, and SCOTUS would likely hear the Myriad 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 Myriad 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.

In the meantime, expect the rhetoric and public wailing 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, why not the sun itself? 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 Myriad 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.

New Issue of GeneWatch Magazine

My Article: Naturally Occurring Genes and the Commons by Necessity appears in the latest issue of GeneWatch Magazine, a publication of the Council for Responsible Genetics. There is an impressive line-up of authors for this issue, including Chris Holman, Kevin Noonan, Robert Cook-Deegan, and interviews with Daniel Ravicher and Sandra Park. Most of these arguments are the usual, utilitarian sort on both sides of the issue. I tried to be clear in my article about the deontological, ethical necessity of not patenting unmodified parts of nature, expanding and clarifying, I hope, the arguments I began to make in my book. I have yet to see a decent reply to these deontological arguments beyond the usual utilitarian pleas. The whole issue is worth reading to see the various perspectives and arguments. I am proud to be among the authors, and thankful to the editors.

Thank You, Brian Leiter

Last summer, I was horrified when I read a scathing review of my book by Chris Holman. I drafted a hasty response on the invitation of James Hughes at the IEET Blog in which I questioned Holman's reading of my book (as he appeared to address only a few pages of it) as well as his objectivity, due to his long-term connections with the biotech industry. To this day, and to my knowledge, he does not deny consulting or otherwise working on behalf of BIO (he is certainly well-known by BIO), although he says he owns no shares in any biotechs using gene patents. My questioning of his motives and neutrality earned me a rebuke from Brian Leiter, who is a law school professor and author of a well-known blog, as well as a J.D./Ph.D. in philosophy like me (although he teaches in a law school, and not a philosophy department). Leiter is known by philosophers mostly for his Gourmet Report which ranks philosophy departments. Although Mr. Leiter had clearly not read my book, he gleefully publicized Holman's review, and publicly rebuked my response (for features he himself has employed), ignoring my pleas for him to pay attention to the substance of my arguments, and Holman's lack of substance in his review (and even Leiter calls for such potential conflicts to be disclosed when he is the subject of criticism).

Despondent that Mr. Leiter's gossipy coverage might tarnish my reputation, I sought the advice of my mentor, a philosopher of long-standing, international reputation. I was advised to relax. Leiter was not that important in philosophical circles (beyond his rankings, which departments do pay attention to), nor his blog that important. "all publicity is good publicity," I was told. And in fact, my mentor was right.

Stephan Kinsella (a patent attorney whom I have since befriended) read about me through Leiter's blog and came to my public defense, bolstering my arguments frequently with his perspective as a patent attorney. And since Holman's review, the majority of reviews of my book, including in Choice, The Guardian, The Yale Journal of Biology and Medicine, The Journal of High Technology Law, Metapsychology Online Reviews, Ethical Perspectives, and elsewhere, have been quite positive. Patent attorneys have tended to be negative, just as they have been critical of the ACLU's claims in the AMP v. Myriad case. But even more importantly than any review, the issue has gained terrific traction this year, the public is becoming aware, and there is the real possibility of changing public policy.

I will never fully understand Mr. Leiter's motivations (although he was on the board of the publication that solicited Holman's review, and did personally peruse and clear the review before publication), nor the delight of some in the scandal-sheet style attacks on my claims (or maybe just on me). My arguments have stood the test, and moreover, the same reasoning is motivating courts and institutions to change the law. This is much more than I hoped for. I am happy to withstand the attacks of academics and patent attorneys, as long as the word gets out, and these arguments get heard. Most people understand well that natural products and laws of nature ought not to be monopolized, as Judge Sweet held, and that the end of gene patents will be a step toward justice. I have had the great good fortune this past year to meet courageous people who have stepped beyond the theory, and sought to change things. I have mentioned them in this blog, including Luigi Palombi, the ACLU and its attorneys, plaintiffs in the AMP v. Myriad case, and others. I am thankful for their commitment to this important issue. Finally, I should thank you, Brian Leiter, for helping to make this a phenomenal year for justice and for helping to connect me with so many wonderful activists, working to change the system.

UPDATE: Indeed, justice has fully prevailed. The Supreme Court adopted the reasoning I advocated and invalidated most gene patents, and a 2d edition of my book is coming out in May 2015, with a chapter devoted to the Myriad case which set the new precedent.http://whoownsyou-drkoepsell.blogspot.ca/

Win!

I must remember to take more holidays. Everything truly interesting seems to happen when I'm far from my computer. Of course, the ACLU's suit against Myriad is the big news, with proponents of gene patenting scrambling to find fault, or predicting armageddon as the result of Judge Sweet's well-crafted decision. Essentially, the judge held, as I have argued here and in my book, that the patents granted on gene sequences cover products of nature, which are otherwise not eligible for patent protection. He saw past the cute, lawyerly tricks that have been used to try to argue that "isolation and purification" of a gene result in something, somehow unique, and he found as reason and logic dictate: nature made the patented sequences at issue in the case, not man, and the patents are invalid under Section 101. See also my post "It's the novelty."

Expect a long, hard slog as this case moves up to the Federal Circuit Court of Appeals, and then, obviously, to the Supreme Court. Meanwhile, we may get a clue as to SCOTUS's leanings when they issue a decision in Bilski.

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

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.

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.


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