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.

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.