Myths about "Who Owns You?"

In some of the more critical reviews of my book, a particular alleged "error" on my part is repeated, specifically that I claim that sexual reproduction results in patent infringement of genes. I use this as an example ad absurdium, extending the logic of patent law, which gives reproduction rights over tokens of patented types, but I explicitly state that when we reproduce, we are in no danger of literally violating the patent law, here, on page 92: "Although the PTO has claimed that gene patents do not encompass genes in their natural state, they do just that for all intents and purposes. We might feel a bit relieved to know that when we reproduce we aren’t violating anyone’s patent, but any scientist wishing to explore scientifically that gene sequence does so at his or her own risk because it is now legally bounded territory."

Others have criticized it for having a provocative title, because it suggests that I conclude that patents on genes mean that someone "owns" you. I do not so claim, and the title is provocative, but was the same title of a Scientific American story regarding gene patents in March 2002.

In fact, most of the critical claims leveled against the book fall apart when the book is read in its entirety. Some critical reviews repeated the lie that I made an "anti-commons" argument in the book. I do not. My argument is, ultimately, about the nature of the commons, not about utilitarian concerns over the effects of monopolies. What remains unchallenged is my argument about the nature of the "commons by (logical/material) necessity," in which I describe the nature of the scientific commons, which has recently been effectively upheld in the Prometheus decision in the US Supreme Court, and upon which my entire ethical argument against gene patents hinges. Perhaps at the end of the day, sniping about non-issues has failed to deflate the larger issues at stake (though I feared early on that it might), and only serve now to reveal that those early attempts to try to distract the public from the real ethical problem with allowing monopolies over natural products, laws, and phenomena will fail even as justice prevails.

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.

The Patent Religion suffers a blow: reading tea leaves on AMP v Myriad in the Mayo v. Prometheus decision by SCOTUS

The Patent Religion's believers think that "anything under the sun made by man" is patent-eligible, even where nature made it first. This is the liturgy to which they appeal when challenged about patenting "isolated" or "synthesized" natural products. They think it means that even scientific discoveries, if properly couched in some "transformative" phrasing, are sometimes man-made. This was the case in the Mayo v. Prometheus case in which the patented claims included the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity. These correlations were discovered through empirical research, they were not created. But the unfortunate wording of the Patent Act in the US, which makes patentable any new invention or "discovery" has enabled the patent lawyers to continue to argue that there is essentially no boundary between science and technology. Fortunately, the Supreme Court just burst their bubble. The Court's decision can be found here and should be read by one and all. Justice Breyer, a long-time skeptic of IP-lawyers' rhetorical tricks, pokes through the claims to look at the underlying subject matter. He does an ontologist proud.

While the unanimous decision makes worthy policy arguments about the negative effects on innovation of granting monopolies too far upstream, it also goes a fair way in describing the distinction between laws of nature, and something inventive and patent-eligible. From the decision's syllabus, the following language says it all:

"Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable,the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims. The 'administering' step simply identifies a group of people who will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders. Doctors had been using these drugs for this purpose long before these patents existed ... The 'wherein' clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions ... The 'determining' step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor wishes to use."

Patenting is not a game. Simply trying to squeeze square pegs into round holes using magical phrases will not do. There is a reality that must be observed, and rhetorical tricks aside, the claimed "inventions" were merely scientific discoveries about facts of nature. In this case, the Supreme Court has made both a logical and ontologically-grounded decision, recognizing that even where a claimed invention might be "man-made" it is not created by humans. Where a claim encompasses something that nature created, it cannot be eligible for patent, and fails under section 101.

Already, the patent lawyers have gone apoplectic, claiming that the Supreme Court is not qualified to make such decisions. The wailing and gnashing of teeth is certain to grow before it fades. Industry will not come to a halt, but science can flourish a little less hesitantly, secure in exploring nature and her truths without impinging upon some governmentally-created monopoly.

So what does this mean for gene patents, and the much anticipated AMP v. Myriad, Supreme Court showdown? Notably, Myriad had submitted an amicus brief in the case for the losing side. They know the implications of this decision for their practices and patents. Of course, I think the writing is on the wall. Breyer's language is sufficiently broad and suggestive in the Mayo v. Prometheus decision to indicate that they will be very skeptical of claims by Myriad that "isolated" sequences, not created by man, but identified as existing in nature, are patent-eligible. Procedurally, the case is interesting because in late February everyone expected SCOTUS to either accept the appeal on certiorari, and reconsider the case, or reject the cert petition and let the CAFC decision stand. But nothing happened. Some speculated that they were booting it over to the Solicitor General, who had put in an amicus brief opposing Myriad, to change his mind. But perhaps there is a clue here as to what's going on from the procedural history of Mayo. After the Bilski decision, SCOTUS kicked Prometheus back to the appellate court to reconsider the case in light of Bilski. They did that, and did so wrongly, upholding their previous decision, only to get overturned by a unanimous Supreme Court. Could SCOTUS now do the same with the Myriad case, and if they do, will the Federal Circuit once again ignore SCOTUS, make the wrong decision, only to get overturned, or will they actually try to apply the law of the land? Time will tell.

** UPDATE **

The Supreme Court has scheduled a meeting on the Myriad case for Friday, Mar 23. It seems likely, based on the Mayo v. Prometheus ruling that they will remand to the appellate court, or take the case up on cert. It seems highly unlikely that they would refuse cert outright. We should know by Monday.


** UPDATE **

The Supreme Court vacated and remanded the appellate court judgment for further consideration in light of their reasoning in Prometheus. This makes the district court's ruling current law of the case (with no precedential effect), and means we must hold our breath until the CAFC makes a ruling (which might, if they apply Prometheus honestly, find the product patents invalid). Let's hope!

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.

Laws of logic apparently off limits in the law

Recently, I was banned from IPWatchdog.com by its founder, Gene Quinn. At one time, I had posted there as a guest contributor on the issue of gene patents, but it became clear quickly that any amount of questioning or imposing even some logical limits on the reach of patent law was blasphemy to members of the IP-industrial complex. A careful scan of the materials there over time shows that anyone questioning the unbridled patentability of basically anything becomes a pariah. The entire debate for me, over the past few years, has illustrated most depressingly for me that the law has no room for logic, and expedience, profits, and power are what win the day. Let's look carefully at the current state of the debate, and why the law in this instance contradicts the most basic laws of logic.

The Law of Identity

This is one of the three basic laws of thought known since the Greeks, and understood by all rational people to be necessarily agreed upon for reasoned discourse. A=A, in all cases, without exception. As I pointed out in the ongoing discussion about the BRCA1 and 2 patents, this is a logical law disregarded in the courts through cases that allow for the patenting of "isolated" chemicals, molecules, or elements. The response of the patent professionals is "X" becomes somehow "different" when it is isolated from some substrate or complex. This is the reasoning used by those who claim that Priestley's isolation of O2 from Mercuric Oxide would result not just in a patent-eligible process for making pure O2 (which I did not contest) but also result in a patent-eligible product, namely: O2. So, let's get this straight. O2 molecules produced through photosynthesis, as opposed to those produced by the Priestley process, or perhaps the the process of electrolysis from water, are not identical. This clearly violates the law of identity, because morphologically, although completely the same, O2 does not equal O2 if and only if the process for creating them is not identical. But this violates at least two other ontological principles: sparsity, and the distinction between product and process. It unnecessarily multiplies entities (so that O2 created by electrolysis is ontologically distinct from O2 created by photosynthesis, etc.) based upon the method of creation of the particular molecules.

I posed some counterexamples that show why this chain of reasoning fails. Consider, for instance, a person created through IVF. The person remains a product of nature despite his or her method of creation. None of the attributes of that person, excepting his or her existence itself, differ from the attributes of any other person. The intention of the creator of something to create something does not itself make the object an artifact. Rather, the intention must extend to the particular form. A genetically-engineered creature, by which a specific intention to alter the natural state of the creature created is expressed, counts for creating a non-natural thing. O2 created by electrolysis has no new form, and human intention is not responsible for its form, only its origin. Believing that this is enough to create an artificial thing, worthy of the status "invention" means believing that IVF is enough to create an "artificial" human.

Let's take an example more similar to DNA and genes, and one I use in my book: a string of letters. the following string contains a sub-string:

ddkkghfooocnnnmadhatterkkkggoodiiannnd

Taking seriously the claims of the patent-professionals who support gene patenting, "madhatter" as it appears in the string is qualitatively different than "madhatter" as an "isolated" string. Assigning a variable to the string X=madhatter , they seriously argue that X does not equal X once isolated. It becomes somehow "different." This is really wonderland.

Too far upstream

This is a critical issue for new technologies, specifically in nanotech, where molecules themselves are often parts of the essential building blocks of technologies, and where the threat of patenting too far "upstream" such as in gene patents, may hinder an entire industry. The law has no bright line distinctions to draw in measuring what is too far "upstream" and ignores, once again, logic. The limitation is often cited as being a limit on patenting "abstract ideas," but this is a pleonasm. As I have argued, all ideas are abstract. The only relevant inquiry is: is it a product of nature, or is it a new, man-made artifact or process.

Which law rules?
Unfortunately, the courts and attorneys who fail to abide by basic principles of logic, or choose to ignore them when they do not suit their needs, will win unless reined in by the Supreme Court, or by legislatures. There is no separate logic for the law, or for any particular field. We cannot as a civilization engage in reasoned progress unless we agree on certain axioms, including the laws of logic. But more and more, it seems that raw power, expedience, and money win over reason, and that policy is shaped to suit the powerful, logic be damned. But still, I hope.

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.

Moving on from this blog

I have really enjoyed, benefited from, and hopefully contributed to the discussion of gene patents with both my book and this blog, but I am moving ahead. My new book comes out in the next month or so, and I will be focusing my academic work more broadly on questions pertaining to meta-ethics, normative ethics, and justice. Thank you all for participating in this discussion, and for your interest in this important topic. Here's a draft cover of my new book (click on it to enlarge):

I will be updating about my future research soon. If you're interested, you can find me on Twitter.