Wednesday, August 26, 2009

A patent attorney who gets it!

Many kudos to Stephan Kinsella, who is a patent attorney who writes at the 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.

Saturday, August 22, 2009

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.

New article in The American Interest

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


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}

Friday, August 21, 2009

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.

Thursday, August 20, 2009

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,

Monday, August 17, 2009

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.