Other people's bodies: a fresh perspective

Admittedly, I have scrupulously avoided making arguments based upon ethical perspectives that are grounded in religious beliefs when discussing gene patents or bioethics in general. This is largely because I am completely non-religious. I also think religious arguments do little to convince those who don't happen to share your beliefs. Nonetheless, Arthur Gershman's book Other People's Bodies offers a fresh perspective on issues in bioethics, with some special relevance to the gene patenting debate. Gershman is himself a registered patent attorney who has weighed in against gene patenting online, and in a number of other fora and media. His blog is here and includes a recent column from the Jewish Daily that opines against gene patents in relation to the Myriad case.

Gershman's short book is chock full of interesting and enlightening essays relating to bioethics in general, and educating the reader about the perspectives offered by Jewish thinkers and theologians. While I am not personally convinced by religious or even culturally-based arguments about the ethics of various biological studies or commercial actions regarding our tissues, bodies, or genes, I think it worth pointing out that the BRCA1 and 2 mutations, as with a number of monogenic mutations, disproportionately affect the Jewish population, just like Canavan's and Tay-Sachs, Ashkenazi Jews appear to have higher percentages of these diseases than other populations, as far as we know. I think that this gives us an obligation to recognize and respect to some degree a Jewish perspective, inasmuch as it offers a unique approach to the ethics of biological materials, bodies, and property emerging from this tradition, and take account of it in our political responses to issues like gene patents. I am happy that Gershman's book gives us this valuable perspective and recommend it to everyone dealing with this issue.

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.

Next Monday, I Like

This has been a big week leading up to an even bigger Monday. That's the day the Supreme Court finally hears the AMP v. Myriad appeal, and I'll be listening. But this past week I had the opportunity to revisit the issue in a number of venues. One was as a guest lecture for an honors class taught by Robert Zwijnenberg at Leiden University. His class is called "Who Owns Life?" and I was invited to discuss my views on gene patents from my book, Who Owns You. There I gave this talk: "Nature, Genes, and the Commons" with a great reception from the students and faculty. The questions were challenging and the discussion wide-ranging.

Later that same day, I appeared on The Forum, a show on KQED, the National Public Radio affiliate in San Francisco. The panel discussion entitled "Who Owns Your Genes" included: Lauren Sommer, science and environment reporter for KQED Public Radio, Karuna Jaggar, executive director of Breast Cancer Action, Jeffrey Lefstin, professor at UC Hastings College of Law, and myself. Again, this discussion was civil, interesting, in depth, and revealed the fundamental disagreements and agreements in anticipation of the Supreme Court's oral argument next Monday.

Finally, my friend Joanna Rudnick's great film, "In The Family" is being re-released. This film is an important view on the scientific and social role of the BRCA1 and 2 tests that Myriad monopolizes, and features the only taped discussion of those patents from Mark Skolnick, the founder of Myriad. Here is an excerpt from the press release, I urge everyone to watch the documentary online:

"As Supreme Court debates gene patenting linked to hereditary breast and ovarian cancer, POV and Kartemquin release In the Family free online

Emmy-nominated 2008 film by Joanna Rudnick features revelatory video interview with Myriad Genetics, defendant in the SCOTUS case.

Chicago – On April 15, 2013, the Supreme Court of the United States will hear a landmark case on the patentability of genes linked to hereditary breast and ovarian cancer.

To raise public awareness on the issues involved, the documentary In the Family – which helped spark the original case – will be streamed online for free to coincide with the hearing. In the film director/producer Joanna Rudnick tells her story of discovering she carries the BRCA gene mutation. She interviews other cancer “pre-vivors,” and in doing so is led to Myriad Genetics, sole patent holder of the BRCA genes and sole provider of genetic testing for mutations in the genes.

In the Family will be exclusively streamed online at http://www.pbs.org/pov/inthefamily, launching with the Supreme Court hearing of the ACLU’s challenge to the BRCA genes on April 15, 2013 for 30 days (through May 15, 2013), followed by a second streaming window of 30 days around when the verdict is announced.

Rudnick’s exposing video interview with Myriad’s founder Mark Skolnick – in which she questions why the cost of the test is going up despite advances in technology – remains the only on-camera comment Myriad has given on these issues since the case was launched."

On Monday, of course, we'll have some new material to review as the court's arguments become available online. 

stay tuned!

Pro-Patent Panic and Hyperbole While Waiting for Myriad

Over at IPWatchdog, where I have been banned as have most others who dare to challenge Gene Quinn's point of view, the panic in the air is palpable. So much so that he (and those who are afraid that the Supreme Court will do the right thing and narrow the scope of patenting genes to fit the exclusion for products of nature) has committed perhaps more fallacies in a single post than even he has ever done. Bravo for that, it would be a singular accomplishment! Let's analyze just a couple:

Straw Man Fallacy: This is one of Gene's favorites. He posts this particular tirade using as his excuse a patent described thusly -" U.S. Patent No. 8,399,645 — was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults." Note that the patent relates to genetically modifying human immune cells. He then inexplicably makes this move and then mentions the upcoming Myriad argument in the Supreme Court: "It seems unthinkable that the Supreme Court could issue a ruling that would call into question the patent eligibility of an innovation that has the potential for curing cancer, but that is what is at stake." Finally, admitting that a ruling in Myriad won't likely affect this patent, he concludes this section with "if the Supreme Court says that human genes are not patentable then what is to stop the march toward a ruling that says genetic modifications are likewise not patentable?" Wow, that was a fast one. How he got from A to B is an enormous mystery, suggesting that somehow a decision that holds that the BRCA1 and 2 patents are invalid under Section 101 because (presumably) they are products of nature has any relation to his nightmare scenario. In fact, there is no relation. He has raised a spectre which is unrelated to Myriad so that he can knock it down. Classic straw man. Raise up an argument that is not the argument in question, knock it down, and pretend you won the day. The patents in the St. Jude filing are not on isolated human genes, they cover instead genetically modified human immune cells. As even Eric Guttag notes in his comment to Gene (only true believers are allowed to comment there) modifying an organism in some way (not counting mere isolation) is inventive under the doctrine of Chakrabarthy which we have discussed here many times, mostly because that case also raises clearly the exclusions of products of nature.

Another straw man (and appeal to emotion) is this beauty: "By any measure St. Jude has been enormously successful. And those who think that government shouldn’t be funding research that results in the issuance of patents will absolutely hate the fact that the government and grants have played a role, together with the patent system, to provide the incentive and funding necessary to achieve this remarkable advance." Well, now, who thinks that? I think that this basic research ought to be funded, but that patenting it robs from the taxpayer, who has already subsidized the research, and who now has to pay monopolistic prices to access the fruits of their investment. But this is a very different position than that which Gene Quinn weaves out of whole straw.

Non-sequitor: Gene's entire point of the article seems to be to raise a red flag somehow suggesting that those who oppose patenting certain things will somehow prevent the cure for cancer. Here's his alarmist question: "How strange would it be if the cure for cancer has been achieved only for society to take the position that it is not patentable? If innovations of this importance are not patent eligible then why would anyone spend the amount of time and money necessary to bring them into being?" But earlier he noted that the research was done under an NIH grant. So the means to do the research was not venture capital fronted on the basis of the possibility of some return. It was basic research conducted as part of the government's major public granting system. Why would a research hospital doing basic research using funds given by the government try to come up with cures for cancer? My guess is: they want to cure cancer, and the government has given them the means. The patent incentive is utterly unnecessary in this case. It is now a nice extra double reward that the hospital will realize, and we could quibble with the justice of that, but his alarmist question bears no relation to the case, it is a complete non-sequitor.

Equivocation: one way to screw up an argument is to use a word or phrase in two different senses to try to make them appear equal when they are not. Gene does that here with the following: quoting the claim he includes "3. An isolated host cell comprising a polynucleotide encoding a chimeric receptor comprising: (a) an extracellular ligand-binding domain comprising an anti-CD19 single chain variable fragment (scFv) domain; (b) a transmembrane domain; and (c) a cytoplasmic domain comprising a 4-1BB signaling domain and a CD3? signaling domain.""" then Gene goes on ..." As you can see, the isolated host cell claim, claim 3, could be on a very slippery slope if the Supreme Court decides that the isolation step in the Myriad patent is insufficient to establish patent eligibility." And so, don't you see, because some of us claim that an isolated unmodified gene is not inventive, and remains a product of nature, then of course so too would the isolated host cell in this case, and so the cure for cancer would not be patent eligible and people like me all want to stop the research that leads to the cure for cancer. Don't you see? But wait, what he apparently hopes you don't notice is that in the St. Jude patent, the isolated host cell is chimeric. It has been modified. It isn't a product of nature. Which destroys his whole chain of reasoning. Oops.

Appeals to emotion: Quinn's rhetoric is always geared toward dangling red meat to raise the ire of his true believers, and those who don't dig too deeply into his faulty "arguments." This post is replete with pointless appeals to emotion, including the following, which also is an appeal to tradition "St. Jude Children’s Research Hospital is internationally recognized for its pioneering research and treatment of children with cancer and other life-threatening diseases. The hospital’s research has helped push overall survival rates for childhood cancer from less than 20 percent when the institution opened to almost 80 percent today. The research that led to this patent was supported in part by a grant from the National Institutes of Health. The patent issued today increased St. Jude’s patent portfolio to more than 100 issued United States patents" And so? Clearly, those of us who want to stop the patenting of unmodified and merely isolated genes are trying to destroy a wonderful organization!! Well, except we're not, obviously. Then there's this one, which really needs no further comment: "The anti-patent zealots will be remembered in history in the same way that we today view those who persecuted the likes of Galileo. Standing in the way of scientific advance and innovation is regressive, shortsighted and irresponsible. Only those with a special phobia against science and innovation, as well as a healthy disregard for reality, would ever stand in the way of the march of health related innovations." Except, oh man.

An so in sum

Let's get serious. A ruling for petitioners will not bring the biotech industry to a screeching halt as Quinn and his ilk want you and the Supreme Court to believe. Appealing to fear is the only hope they have in this case, since logic indicates that isolating something, as I have argued extensively, that is not the design and intention of some person does not make the isolated product of nature (like our famous O2 example) somehow inventive. We might have legitimate disagreements about whether isolation of something found in nature from its natural substrate ought to make it inventive, but the sort of panicky pronouncements, poor argumentation, and inflammatory rhetoric used in this post simply calls attention to the fear that patent-expansionists face whenever the Supreme Court starts reining them in. It's the same panic they exhibited when my book first came out, in which I took a very moderate position, the same position that the Solicitor General has taken that cDNA is patentable, but merely isolated genes are not.It's the same position the Supreme Court should take, and it's perfectly moderate and logical.

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.

Artificially produced natural products, SCOTUS in the Nineteenth Century got it right

H/T to Douglas Rogers who dared speak reason at IPWatchdog regarding the Myriad case, and who referenced an interesting Supreme Court case from 1884 -

Cochrane v. Badische Anilin & Soda Fabrik - 111 U.S. 293 (1884)

That case involved a challenge to a patent on an artificially produced chemical otherwise found in nature, and stated in relevant part:

"There is another view of the case. According to the description in No. 95,465, and in No. 4,321, and the evidence, the article produced by the process described was the alizarine of madder, having the chemical formula C14H8O4. It was an old article. While a new process for producing it was patentable, the product itself could not be patented, even though it was a product made artificially for the first time, in contradistinction to being eliminated from the madder root. Calling it artificial alizarine did not make it a new composition of matter, and patentable as such, by reason of its having been prepared artificially, for the first time, from anthracine, if it was set forth as alizarine, a well known substance. Wood Paper Patent, 23 Wall. 566, 90 U. S. 593."

By this reasoning, those who argue that O2, when artificially produced, is suddenly not a product of nature, and thus patent-eligible under Sec 101 are simply wrong. O2 is not new, we didn't design it. Nor are the strings of nucleotides claimed in the Myriad case, despite those who allege the claims encompass "new molecules." As we have noted here before, what makes a gene a gene is its part in producing proteins, the mechanism of which is coded into the gene with stop and promoter codons. Isolating that gene from its surrounding substrate, the genome as a whole, does nothing to make it a new "molecule." Unlike other molecules, the role and use of a gene is informational, and nothing done while isolating the gene from the surrounding genome alters its informational role, we simply use the information for a new purpose. It is mere sophistry to allege this creates a new thing worthy of protection under patent.

Myriad's Ways - in SCOTUS's sights

The Supreme Court has been collecting amicus (friend of the court) briefs and has put the matter of the AMP v. Myriad appeal on its calendar for a conference. This means that they will consider the request by AMP and the other plaintiffs/petitioners for review of the decision of the CAFC (the appellate court that most recently heard and decided the case). We should therefore know in December or at the latest early in the new year whether they will listen to an appeal.

One brief, by the Cancer Council of Australia, includes language I helped draft, as well as a reference to my book. While no one can predict with certainty what the Supreme Court will do, I have a strong suspicion they will choose to listen to the case, both due to its importance regarding medicine, but also because it serves as a good follow-up case to the Mayo case we have discussed here, which involved patentability of laws of nature. The Myriad appeal will give the Supreme Court a chance to make clear their position on products of nature as well. My friends at Patent Docs have collected links to all the briefs here.

** UPDATE** The Supreme Court had granted the petition for certiorari, which means it will hear the appeal!