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.

SCOTUS, Here We Come

So, the Court of Appeals for the Federal Circuit, in reconsidering on remand their decision in the Myriad case has agreed with itself. No big surprise, though I did suggest that, if they wanted to preserve as much gene patenting as possible, they would craft a narrow enough decision, hewing to the Supreme Court's reasoning in Mayo, to withstand scrutiny on the inevitable appeal. They did not. They doubled-down, offering no new substantial reasoning, and basically reiterating their previous arguments. Bryson too stuck to his guns, the ones that will prevail in the Supreme Court, as he dissented and found the claims to the BRCA1 and 2 mutation sequences to be claims over ineligible subject matter. He stated it plainly, thus:

"Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature."

So the majority once again believed that the process of "extraction" of the nucleotide sequences devised by nature from the adjoining nucleotides was sufficient, even under Mayo, to be eligible subject matter under §101. Bryson once again disagreed, and now it's up to the Supreme Court. Let's recall that in Mayo, the decision of the CAFC was unanimously in favor of patent eligibility of a diagnostic method. This is not the case here, Bryson dissented. Let's also recall that the Supreme Court unanimously overturned the CAFC in Mayo, finding that the patents over methods of dosing based upon measuring metabolites were effectively claims over laws of nature. Man didn't make those relationships. Man didn't make the sequences in the Myriad case either, and odds are good that the Supreme Court will side with Bryson on this score. But one never knows, they could find some relevant difference between the cases. I don't see it. As he points out,

"Just as a patent involving a law of nature must have an 'inventive concept' that does 'significantly more than simply describe . . .natural relations' *** a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product."

To conclude, I see in Bryson's dissent a glimmer of the test I have been arguing for to divide the natural from the man-made. My test is: is the thing claimed dependent upon human intention and design? Bryson states:

"In that setting,  man has defined the parts that are to be retained and the parts that are to be discarded, and he has molded the retained portion into a product that bears little resemblance to that which occurs naturally."

He then correctly points out that genes are in fact defined by nature, with stop and promoter codons, and this is what allows them to function in protein synthesis. Man didn't create these boundaries, we merely identify them. So, I still hope that the Supreme Court will draw the bright line I am arguing exists between nature and artifact: the necessary and sufficient conditions for not being natural are: the intention and design of man. I look forward to hearing from those who disagree with a solid counterexample.

Meanwhile, it ain't over 'till the Supremes sing.

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.

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.