JUSTICE KAGAN: "And the PTO seems very patent happy"

I love that quote from Justice Kagan because it pinpoints the root of the issue. She said it when Myriad's attorney tried to justify the practice of patenting isolated genes by referring to the Patent and Trademark Office's past practice of doing so. She is right, and that office, run as it is by patent attorneys, much like the CAFC is dominated by them, is a poor guide for what ought to be the case. They are "patent happy." (see, e.g., the Peanut Butter Sandwich patent).

One should never try to predict what the Supreme Court will do in any given situation. Nonetheless, a brief analysis of the transcript of the oral argument in the Myriad case is revealing. The Justices seem inclined to hold in a way that readers of this blog will be familiar with: isolation of a gene is not enough, only changing the gene suffices to make it patentable. The questioning from the Court right from the start revealed their discomfort with the current "isolation" regime, which is unsurprising in light of their recent decision in Prometheus.

Mr. Hansen did an excellent job in his argument, under some difficult questioning, steering the discussion back to the question of whether a product of nature, merely isolated, should be eligible under Section 101. He cited all the best examples, arguments, and precedent. He also conceded as he should that recombinant DNA is eligible, and that the patents at issue in the Myriad case are not recombinant. He also left the door open for the Justices to do as they seem inclined to do, and follow the lead of the Solicitor General, ruling that the isolated genes alone are ineligible subject matter but that cDNA is. This is also the position I have maintained all along in my book and since. The attorney for Myriad had a tougher time of it, and the questioning of the Justices seemed to have him in a corner a couple times. Instead of recapping the arguments, I urge you read them yourself here. Also, I am providing links to some excellent in-depth and plain English analyses here, at Patently-O and at ScotusBlog. What I wish to do here is highlight sections from my book that made the same argument that seems likely to win the day, a conservative position I have maintained all along, arguing that mere isolation is insufficient to warrant patent, that some degree of intention (and design) is necessary to make something inventive, and that while engineered genes ought to be patent eligible, isolated genes alone ought not to be. Here are some relevant passages:

"Each instance of the un-engineered human genome is a naturally occurring object. Its existence as an abstracted ideal which is instantiated in you, me, and every other human, in its present form has no element of the type of expression described above. There is no mixing of labor with any present human genome’s form, nor is there any human intention involved." (Who Owns You? p. 111-12)

"All copyrightable and patentable objects are intentionally produced man-made objects and they are not merely ideas. Your DNA, or mine, or any other non-engineered being, is not an expression according to this description of intellectual property, and neither is any naturally-occurring subset of a genome (such as a gene or a SNP)." (Ibid, p. 112)

"Chemical formulas, for example, or natural laws, cannot be copyrighted or patented. The seminal Supreme Court case Diamond v. Diehr, specifically excluded from patentability “laws of nature, natural phenomenon and abstract ideas.” (Ibid, p. 113)

"Many gene patents are perfectly valid both legally and ethically. All valid patents use products of nature in some form, but they do not extend to protect the naturally-occurring parts of the invention. Most patents on new chemicals involve not just a patent on the new compound, but also a patent on the process of synthesizing the compound.These sorts of patents provide guidance for how gene patents can legally issue and still also promote innovation. New genes could of course be patented if they are man-made. New combinations of genes can also be patented if they are the products of human intention." (Ibid, p. 114)

"Many gene patents issue now in which the current use of the gene is in merely finding the same gene. This is quite absurd. It is like patenting the element iron, and then claiming that the use of iron is in finding iron, or patenting the Rock of Gibraltar and then claiming that the utility of the patent is in locating the Rock of Gibraltar." (Ibid., p. 115)

I quote these sections because they show that the arguments I made anticipated the same ones made in the Myriad case which began a couple months after my book was published. These same arguments have been to a large degree echoed by the questioning of the Justices. Together with Myths About Who Owns You the past year at least has demonstrated just how conservative my arguments have been and how they echo the thinking of at least some Supreme Court Justices as well as precedent, and that perhaps initial claims about how wildly inaccurate, off-base, or whacky my arguments were, were themselves wildly inaccurate, whacky and off-base, or perhaps merely ideologically-motivated.

Now of course, the Court may still rule that all gene patents are just fine, but at least I take comfort in having my arguments made in public court, in language and with examples similar to that I used in 2006 when I first confronted these issues from a philosophical perspective. I'm comforted that now my arguments seem firmly in the mainstream and persuasive to many if not all.

ACLU petitions for certiorari to the U.S. Supreme Court.

As predicted, the plaintiffs have petitioned the Supreme Court to review the CAFC decision reported here . The grounds for the petition include the failure of the CAFC to properly apply the decision in Mayo to the facts of the Myriad case. Given the split in the CAFC, and the Supreme Court's own admonition that the CAFC ought to have reconsidered their decision in light of Mayo, it would be highly surprising if they don't decide to take this up next term. Expect more posturing and puffery from those who promote patenting products of nature as the Supreme Court considers the petition and opposing submissions. The fact is, patent attorneys who have made profits by helping corporations to monopolize what cannot justly be monopolized are terrified that the Supreme Court might do the right thing and finally end this practice. I think their fears are justified. A careful reading of Mayo and recent decisions by the Supreme Court on patent matters seems to show a trend against those who contend that one can patent anything simply by drawing artful claims.

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 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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