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.

In Myriad and More, Metaphysics Matters

This past week, the Federal Circuit Court of Appeals heard oral arguments in the AMP v. Myriad "breast cancer genes" case. You'll recall that following its decision in Prometheus v. Mayo, in which, to the shock and horror of patent attorneys everywhere, certain diagnostic methods were considered ineligible for patent under Section 101 as being too close to natural laws or phenomena, the Supreme Court then vacated and remanded the Myriad appeal back to the CAFC for reconsideration in light of Prometheus. The fact that the decision of the CAFC was vacated and remanded, and that the court was asked to reconsider it in light of Prometheus, ought to be a clue that SCOTUS believes that there is some relevance between the two cases, and in fact there is. Both cases have to do with the distinction between the "natural" and the "artificial" or "man-made," as the Chakrabarthy case we have discussed here, and in my book, makes such a distinction for patent eligibility. Namely, "laws of nature, natural phenomena, and abstract ideas" are all explicitly not eligible for patents according to the Supreme Court, even though patent lawyers like to remind us that the Patent Act makes "discoveries" patentable. Sure they are, as long as they are not discoveries of "natural phenomena, laws of nature, or abstract ideas."

This is where lawyers are no longer the most competent experts, though many assume that they are. The distinction between "laws of nature, natural phenomena, and abstract ideas" and everything else is a metaphysical question. Metaphysics and ontology are primarily the expertise of philosophers, not lawyers. So while patent attorneys like to pretend that they are the sole, or at least best arbiters of what ought to be considered patentable, I beg to differ. This is where philosophers are best suited to offer their expertise, because drawing distinctions, applying logic and metaphysics to the world and its objects is in fact what we are trained to do. Lawyers draw distinctions among legal objects, but not sui generis. Rather, they apply precedent and statutes to determine whether objects, acts, or omissions fall into pre-existing legal categories. Their tools are not metaphysical, and when new objects emerge, close analogies, or new statutes are typically necessary to deal with them. But as I have long argued, sometimes the law is ill-suited to solve new problems, or its categories are mistaken from the start on a metaphysical level.

I have never claimed to be an expert in patent law, but as a metaphysician and ontologist, I am a competent critic of its application to the world and its objects. In the case of gene patents, which often include claims over things that are metaphysically best described as "natural" despite their "isolation," courts ought to pay some heed to the underlying categories involved, and what philosophers have to say about them. Philosophers can disagree, of course, and arguments might be made about the boundary between what is natural and what is not, and I look forward to hearing those arguments and engaging with them. But I claim still, as I have all along, that mere isolation of some molecule does not create something "man-made," and I have provided countless examples, including my favorite, isolated O2. Nothing about its structure, even when isolated, is the product of man's design or intention, just as in Prometheus, nothing about the laws governing the interaction of a drug with a person's metabolism is the product of man's design or intention, even if the drug itself was entirely the product of both. The analogies between these two cases are clear, and when one understands the significance of the metaphysics behind Prometheus, it is clear that if the CAFC were to act responsibly and honestly, they would now have to find Myriad's BRAC1 and 2 patents ineligible. But probably we will have to wait for the Supreme Court to do this, just as they did with Prometheus. Or maybe not; hope springs eternal.

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.