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.

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.

60 Minutes

60 Minutes did a great job with their segment, "Patented". It really is worth watching. Kudos to all involved, including Kevin Noonan, with whom I have sparred on the subject, who did a good job standing up for his side. I hope he'll take part in the documentary we are making as well. It is worth noting that the "lies" Noonan accused me of were the same statements made by Morley Safer on the 60 Minutes segment, though he seems a bit more politic in his references to the TV show than to my book (which he hadn't read, by his own admission, at the time).

This summer, Taylor and I should be able to edit something together in time, hopefully, for a couple festivals, perhaps the Rotterdam Film Festival here in Europe would be a good start. Overall, the timing on this subject really has been amazing. Little did I know when writing my book that the ACLU would bring this suit, nor especially that the time-table on the suit would coincide so well with the launch of the book. I'm been privileged to meet so many activists and academics involved in this debate at this critical time, and really am in awe of their commitment. Glad to see such momentum and media attention finally for this critical issue.

Win!

I must remember to take more holidays. Everything truly interesting seems to happen when I'm far from my computer. Of course, the ACLU's suit against Myriad is the big news, with proponents of gene patenting scrambling to find fault, or predicting armageddon as the result of Judge Sweet's well-crafted decision. Essentially, the judge held, as I have argued here and in my book, that the patents granted on gene sequences cover products of nature, which are otherwise not eligible for patent protection. He saw past the cute, lawyerly tricks that have been used to try to argue that "isolation and purification" of a gene result in something, somehow unique, and he found as reason and logic dictate: nature made the patented sequences at issue in the case, not man, and the patents are invalid under Section 101. See also my post "It's the novelty."

Expect a long, hard slog as this case moves up to the Federal Circuit Court of Appeals, and then, obviously, to the Supreme Court. Meanwhile, we may get a clue as to SCOTUS's leanings when they issue a decision in Bilski.

WOW

...on holiday at the moment, and this keyboard is too odd to do a detailed post, but suffice it to say for the moment that I am stunned and thrilled that the District Court ruled against Myriad! Much more soon!

Good News from the District Court

Judge Sweet did the right thing on the defendants' motions to dismiss, refusing to grant those motions, and ensuring this case can go forward on the merits. This is excellent news, and a sound rejoinder to the insistence by the likes of Holman, Noonan, Quinn, and other pro-gene-patent folks that this case was "frivolous." For non-lawyers, the claim of "frivolous" is particularly charged given that, in federal court, a lawyer can be sanctioned for bringing a frivolous claim. Moreover, in federal court, the pleading requirements for a claim are rather liberal, and as long as the claim is colorable, involves some real, federal case or controversy, and plaintiffs have suffered some injury which the court can redress, then the complaint is not frivolous.

I am still reading the decision, but it indicates that the court is certainly aware of the importance of this case, and the necessity of resolving the claims in federal court. Much depends upon it. I am thrilled about this decision since it means the merits will be resolved one way or another. The summary judgment motion is now pending, and has been fully briefed. Now we shall see how the court decides that motion, which would go to the merits of the claims, and then watch this baby go on up to appeal... eventually, to SCOTUS.

Doing Philosophy in Public

Lately, I feel that the ivory tower is crumbling. Or at least it is developing some stress fractures. This is a good thing. For too long, the academic world and the real world have been at odds. Academics, intent on fulfilling the career goals, and standardized path of academic achievement, have helped to perpetuate the lay-public's view that academics are isolated, uninvolved, and mostly irrelevant. Academic disputes might be heated, emotionally charged, and the may make or break academic careers, but rarely do these disputes matter to the world at large. As the link above notes, Henry Kissinger correctly noted that the bitterness of academic disputes "is in inverse proportion to the importance of the subject." Indeed, among academics the currency of the trade has often been to find an opponent, attack, and if possible, destroy. But does any of this intellectual parrying matter to anyone, and must this be the future model of the academy -- to provide a sort of Punch and Judy show as occasional tidbits to a bemused public already wary of the goings-on in university halls? Simply put, no. It doesn't need to be like that.

Sometimes, we can step outside this model, seek not only positive collaborations between the academy and the "real" world, but also work to make ourselves relevant to the public in broader ways. This is part of the virtue of applied ethics, and one reason I have been thrilled to be at TU Delft. Here, engagement in the world is part of the goal. Applied ethics means nothing without a world to apply it to, and projects and researchers working on applied ethics in the Dutch technical universities are not only training engineers to think ethically, but also engaged in projects involving policies affecting hundreds of thousands of people. This is as it should be. Never before have I felt more at home in striving for public policy changes based upon my research. Where once my goals to take my research and do something with it might have been met with scorn by entrenched academic establishments, I am now encouraged by an atmosphere that accepts and even embraces the next logical step: change.

Three years ago, when I began to approach the issue of gene patenting, it was more or less just an academic question to me. Yes I felt viscerally that this was an important issue, but I never realized the extent to which it impacted the lives of hundreds of thousands of people around the world (if not more), or the extent to which others were moved to finally act on the issue. When, two months after my book came out, the ACLU sued Myriad on this very issue, and now with the US dept of Health and Human Services making some progress in suggesting significantly altering gene patenting, I can see that applied ethics must naturally reach out as an academic field into the real world of activism.

I had the great fortune last week to be where the rubber meets the road on this issue, in what could legitimately be called "gene patent week" in New York City. There, I met with the attorneys for the ACLU, as well as a patent attorney who has been a harsh critic of my work, calling me, the ACLU, and other opponents of gene patenting "liars"(though, even now, he admits not having read my book). I met with Luigi Palombi, whose book Gene Cartels came out just recently, and does for the legal case against gene patents what mine does for the ethical case. I met the director of the film "In The Family," Joanna Rudnick, who possesses the BRCA1 mutation that makes her susceptible to breast and ovarian cancer, and who discovered in documenting her experiences that the patent that Myriad Genetics owns for that gene prevents her and many others from accessing information about their own bodies, from getting second opinions about her tests, and for many women, the prohibitive price of the test prevents even getting the test done in the first place. I met clinicians and researchers, like Debra Leonard and Ellen Matloff, each of whom has personal experience with how gene patents prevent doctors, researchers, and patients from getting access to information that is not only vitally needed, but part of nature, a natural law, and thus not properly owned. I met with Tania Simoncelli and Sandra Park, of the ACLU, who have striven each in her own way to actually end the process of gene patenting. Tania's background is in science, and she has fought for years to get a suit started, and Sandra is an attorney who is fighting valiantly in the courts. I met Dan Ravicher and Chris Hansen, of the Public Patent Foundation and the ACLU, each of whom has staked his organization's reputations on bringing this courageous and necessary suit.

These people humbled me. What began for me as an academic issue is now personal, and a matter of activism. This is not academia, and the rhetoric around the edges of the debate, the name calling, insinuation, and arguing about the meanings of terms and legal rulings must be put into perspective. People are being hurt, and these harms are not academic. They are wrong. Public policy must change. Never before has it been clearer to me that this is not just an issue for debate, but the cusp of something big.

I had the great fortune to meet and interview James Watson, co-discoverer of the structure of DNA, and I asked him about gene patenting. He opposes it, and he says his opposition was why he was "fired" from the Human Genome Project. He stated in our 45 minute on-camera interview that "something has to give" and that gene patenting cannot continue. It is harming too many people. I value his judgment as a scientist, and his concern as a person came through when he expressed his disdain for the costs associated with a non-inventive test that has been given an exclusive monopoly through patent.

I particularly value the energy, commitment, and involvement of academics, lawyers, clinicians, and counselors -- all those named above and many more unmentioned, who have moved beyond the academic issues involved and sought to change the world because they know that their cause is just. They have staked their reputations, their careers, money, relationships, and futures on pursuing this change, and their commitment should embolden us all. It gives me strength, and makes me thankful that here, applied philosophy means involvement in the world, unashamedly pursuing the good, and making philosophy relevant once again.

That was the Week that Was

I have hope. And I have evidence now that hope is worthwhile. This week has been nothing short of amazing. Somehow, everything seems to be happening at once, and now I feel as though the prospects for action to stop gene patenting are good. There is clear momentum, and public support, and a growing group of disparate activists and academics who have somehow begun to convene. In sum, here's what has happened this week:

Monday: I met with Luigi Palombi (see previous posts) and things are in the works now to take this movement international, with real backing and strength. We then attended a screening of Joanna Rudnick's film "In The Family" at Cardozo Law School, and met Dan Ravicher of the Public Patent Foundation. I also met Kevin Noonan, who was the lone voice on the other side of the issue, and who is a some-time foil, having critiqued my book (before reading it) on his website -- Patentdocs. He was a gentleman, though, and I hope he'll take part in our film and offer the reasoning behind gene patents.

Tuesday: Taylor Roesch and I interviewed James Watson for our documentary. He delivered some extraordinary sound bites in opposition to gene patenting, and provides unparalleled scientific credibility on the subject given his connection with the human genome's discovery and mapping. Later that evening, we went to another screening of "In The Family" at the Tribeca Cinema, where we were able to film a panel discussion on the legal implications of gene patenting and the ACLU vs. Myriad lawsuit.

Wednesday: I gave my talk at Cardozo Law School, entitled "The Ethical Case Against IP," which we also filmed for the movie. We then went to Harlem where we filmed an excellent interview with Luigi.

Thursday (today): Taylor interviewed me for the documentary. We shot in Central Park, which was brilliant, crisp, and sunny, and the leaves are beginning to turn. It was good to be in the park, even if we were working. I then headed downtown and did a live interview on the Leonard Lopate Show. There's a link to the interview (and all similar press) from my homepage, under "press."

Tomorrow and Monday: I have a call-in interview for WBAI Evening News, and then, perhaps, a moment to breathe. Then Monday, I will debate Gene Quinn on the issue of patents and innovation, and then tape an interview with Laura Flanders of Grit TV.

*UPDATE* here's the GritTV spot, I think it went very nicely.

In sum, the ACLU lawsuit, Luigi's activism in Australia and elsewhere, the recent HHS draft report, and the public's overwhelming support of the movement to eradicate gene patents (when they learn it is happening) give me courage, hope, and strength to continue this work, and seek real and lasting change.

Citation in Brief for Amici Curiae

I notice that Who Owns You and this blog are cited and quoted in a recent court filing in the ACLU v. Myriad case. The references occur in the BRIEF FOR AMICI CURIAE IN SUPPORT OF PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS AND IN SUPPORT OF PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT for the National Women's Health Network, Asian Communities for Reproductive Justice, Center for Genetics and Society, Generations Ahead and the Pro-Choice Alliance for Responsible Research at p. 18. Quoting now the brief:

"The consequences of such attempts to assert exclusionary rights to our common heritage often involve harms to others. Attorney and philosopher David Koepsell asks us to “[i]magine a tax on air, or a levy on sunlight, or some corporation claiming ownership of the open seas and demanding royalties for their use. Imagine a world where ideas could be owned, and thinking ideas held by others was prohibited or subject to fees, taxes or royalties.” David Koepsell, Who Owns You?, Wiley-Blackwell at 133 (2009). He points out that the “human genome is a constantly evolving object that involves every member of the species” and that “[g]ranting exclusionary rights to discoverers of genes that are part of that genome interferes with our common rights as beneficiaries and possessors of parts of the human genome.” http://whoownsyou-drkoepsell.blogspot.com (Aug. 21, 2009 posting; last accessed Aug. 27, 2009)."

I am pleased to see this used in the brief, and I am quite honored.