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.

Lies, desperation and the death throes of gene patenting

The recent Prometheus decision has the patent-industrial complex up in arms. The Supreme Court's unanimous decision overturned patents on medical methods that amounted to patents on laws of nature, as I describe more fully in my previous post. One of my old adversaries, Chris Holman, whose incompetent review and attempt to discredit me I refuted here (a refutation he has never acknowledged or challenged), lashed out at me personally, and others (by extension) who disapprove of gene patents, by comparing me with Mike Daisey whose This American Life story on Apple factory conditions was recently retracted. Holman's analogy was faulty, and upon my request he retracted a lie in his post in which he stated that I claimed in Who Owns You? to be "an intellectual property attorney." Because I have never claimed to be so, and certainly not in my book, he retracted his lie upon my request, while explaining that he vaguely recalled it, though he obviously never attempted to verify his recollection by finding the alleged claim in my book. There is of course a certain irony that he had to retract his error (lie) in his own attempt to portray me as a liar. The irony seems to be lost on him, and although his analogy falls apart completely in light of all of the omitted context of my book, as opposed to Daisey's story, which I point out fully in his comments section, his attempt to slur me personally served his purposes anyway. Mainly, proponents of the broadest possible patent regime seek to discredit anyone who opposes them as being "wrong" and "failing to understand the patent system." They wish to be the only experts, and thus the only credible commentators on what can or ought to be patent-eligible. They even suggest that the Supreme Court is unqualified to make law regarding what should be patented. But the Supreme Court in the US is the ultimate arbiter of all US laws, including patent law, having itself created the explicit exceptions to Section 101 patent-eligibility for "laws of nature, natural phenomena, and abstract ideas." Like it or not, the Supreme Court is the final source of authority for what those exceptions encompass, not patent lawyers or even the Federal Circuit.

So the patent-industrial complex, which always profits from the mere act of patenting (by fees on filing patents, costly patent-law seminars, etc.), and which thus seeks to keep as broad as possible the domain of patent-eligibility, is struck with fear and trembling. They are looking to blame those of us who are not part of the system, who have no economic stake in the patent system, and who seek only to preserve the scientific commons against monopolization, and accuse us of meddling in their realm. As I have argued all along, the law is open to debate, and subject to change, and in the case of gene patenting I believe it ought to be changed because it neither reflects the spirit of the purpose of patent law, nor logic itself. The Supreme Court seems to agree, and has altered the law. The Court of Appeals, Federal Circuit (CAFC) has been overturned. Its decision in Prometheus was completely overruled, and the types of method patents at issue in that case are no longer to be tolerated. That is the law of the land. Moreover, it vacated and remanded the CAFC's opinion in the Myriad case about the BRCA 1 and 2 patents. This bodes ill for gene patent proponents, despite their attempts to try to distinguish the two cases. In fact, the Prometheus decision's reasoning makes the Myriad product patents even more questionable than those at issue in Prometheus, which at least involved "methods" in which the laws of nature monopolized were couched. Four of the claims challenged in the Myriad case are claims over merely "isolated," unmodified gene sequences with no method or process involved.

The CAFC panel on Prometheus which was overturned unanimously by the Supreme Court unanimously approved of the now invalid patents. The CAFC panel in the Myriad case was not unanimous. As I explained last year, some of the method claims at issue in Myriad were already struck down, and there was a dissenting opinion by one of the three panel members, Judge Bryson, who wrote that the product claims at issue were also invalid as products of nature. It is unlikely that Bryson will change his mind, and it is unlikely that Judge Lourie will change his mind (the Myriad court consisted of Lourie, Bryson, and Moore, the Prometheus court was Lourie, Rader, and Bryson). The wild card is Judge Moore. Will Bryson convince Moore, who filed a concurrence in the Myriad case and who did not sit on the overturned Prometheus appeal, that she ought not to stubbornly side with the losers as Rader did in the Prometheus case? Justice Breyer's decision gives plenty of ammunition to Moore and Bryson to write a majority opinion overturning the Myriad patents as amounting to claims over products of nature. In any case, whatever the CAFC decides to do, there will again be a petition for certiorari to the Supreme Court. If the CAFC does the right thing and reverses its previous decision in light of the Prometheus decision, then the Supreme Court is unlikely to take it up on cert, feeling that their Prometheus reasoning is correctly applied to overturning Myriad. If the CAFC decides to try to weasel around the Prometheus ruling it will still be a split panel, and SCOTUS would likely hear the Myriad appeal eventually. The CAFC may wish to write a narrow ruling overturning the Myriad patents, but leaving the door open enough for similar patents, and avoiding the sort of broad restriction that the Supreme Court could craft. Or they may decide to do what they did before and drop kick it to SCOTUS for some final ruling. Patent attorneys who are thinking far enough into the future ought to hope that the CAFC overturns their previous Myriad reasoning on some sort of narrow grounds, invalidates the Myriad patents and leaves the door open somehow for other sorts of gene patents (like those on cDNA), rather than allow this to finally be determined by the Supreme Court which seems hostile in general to the rhetorical cuteness of claim-drafters.

In the meantime, expect the rhetoric and public wailing to swell in an effort to influence the public's perception of what horrible fate might befall us all if patent attorneys cannot patent everything under the sun, and what the hell, why not the sun itself? I and others who oppose gene patents have withstood a lot of public abuse, but the reasoning we have employed has survived, and so far is winning the day. The law of the Myriad case is now the district court's decision, until the CAFC issues a new one, and that means the Myriad gene patents are invalid, for now. Let's see what happens next. In the long arc of history, I do believe that justice ultimately prevails.