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.

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.

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.

Amicus Brief in support of certiorari to the US Supreme Court

The ACLU website links to a pdf of an amicus brief I helped draft in support of the petition for certiorari. We should find out soon, perhaps by March, if the US Supreme Court intends to hear the appeal. Fingers crossed! Many thanks to Luigi Palombi who spearheaded this particular brief and included me in the drafting.

Myriad case, Federal Circuit decision - reason for hope

No one can be terribly surprised that the Federal Circuit ruled essentially to continue the practice of gene patents yesterday. But there are some surprising tidbits in the various, lengthy, and somewhat contrary decisions of the three panel judges. One disappointment for gene patent proponents was the ruling on standing, which held that indeed there was standing for the plaintiffs to bring a declaratory judgment action as they did. Some hoped that the Federal Circuit would drop-kick the case on standing and never have to reach the substantive issues. Those hopes were dashed when the court concluded that there was at least one plaintiff with standing to sue based on an ongoing harm.

More surprising is the holding regarding the method claims relating to comparing or analyzing sequences, which the court struck down unanimously as unpatentable under Bilski. This is a minor win, and increases the likelihood of continued appeals as no-doubt Myriad will want to have either the en banc circuit review this, or the Supreme Court (perhaps both will happen eventually).

Unsurprising is that the court ultimately upheld their reasoning that X sometimes does not equal X. Violating the logical law of identity has been the underlying reasoning behind such ridiculous decisions as Parke-Davis (cited by the court) which established the "isolated and purified" notion by which a number of patent attorneys now are forced to argue that sometimes two morphologically identical molecules are nonetheless not identical. In continuing to strain logic, the majority decision holds that the sequence claims cover patent-eligible compositions of matter. But the silver lining is that there is division on the court, and the reasoning of the Majority, and concurrence of judge Moore, illustrate just how strained the logic has become. Moore argues that there is some significant chemical distinction between an isolated gene and a gene found in nature because at the ends of the isolated gene are nothing, whereas at the ends of the gene found in nature are more nucleotides. This does not support any claim of morphological difference between the claimed gene or gene parts and the sequence identified as occurring in nature. As I argue in my book, drawing a border does not create, automatically, a new, unique thing, especially where, as here, the information encoded in the string (which directs the functionality of a gene) is nature's own definition of a border.

Finally, Judge Bryson sees clearly the illogic of extending patent eligibility to isolated DNA, and writes a dissent to that part of the majority holding, using arguments I and others have made often.

What this means is surely that this fight is far from over, that it will be appealed, likely, to the en banc Federal Circuit and ultimately to the Supreme Court. Unfortunately, by the time a Supreme Court decision is final, Myriad will have run out the clock, having reaped its billions in profit from their unethical practice before the patent expires.