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.

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.

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.

Some updates

I've been having a back-and-forth with Gene Quinn at his site, IPwatchdog. Here's a link to some of our ongoing disagreement abut gene patenting and the ACLU/Myriad suit.

Also, today the TU Delta (my university's newspaper) published an opinion piece I wrote on the subject of the suit, with some references to repercussions for Europe.

Still trying for some more traction in the US media, where this is most relevant, but where there's very little in the way of reasoned analysis. On both sides of the issue, emotions seem to be driving people's opinions, but I am appealing (IMHO) to sound philosophical reasoning, legal precedent, and logic. Always a deadly gambit, I know. So sue me.

Totally pwned, dude

I have attempted to chime in on a few blog debates about the Myriad suit and found two distinctly different takes on the subject. There are those who see the clear irrationality and inconsistency of allowing patents on disease genes, and then there are those who claim that without these patents innovation, and thus cures for diseases, will grind to a halt. The latter, clearly, get my goat.

Let's be clear, basic research flourished for decades (before Bayh-Dole, which I'll explain in a moment), and the corporate world did not suffer in the least. Consider the decades between 1945 and 1975. Corporate growth and wealth in the US was enjoying a rather steady uphill climb, even though at the time much of the basic research that was happening was publicly funded, conducted in universities, with no reward of patent available to university researchers. Somehow, the corporate world benefitted, the economy tended to grow, innovation proceeded apace, and technology improved. In 1980, Birch Bayh and Bob Dole had their bill passed, the Bayh-Dole act mentioned above, which allowed those conducting research with public money (NIH or NSF grants, chiefly) to profit through intellectual property rights to their inventions. This set off a flurry of grabs by universities for potentially profitable, blockbuster patents, like the famous "Harvard Mouse." Before this, of course, basic science was published in journals, made free and open for use by any and all who might innovate, and was often successfully turned into profit and property through actual inventions. But Bayh-Dole changed that, and some (like me, for instance) might argue, not necessarily for the better.

Patents on unmodified genes were another ripe field for plunder, and disease genes especially. These are the nuggets, because that's where the federal funds go: disease research, and if you can claim rights to a disease, you can get all sorts of profitable royalties. In my book, I call attention to Canavan's disease, which is one of those genetic diseases that strikes largely among Ashkenazi Jews, like Tay-Sachs. But while, as I argue, all gene patents (not just on genes) violate the "commons" that is the human genome (and genomes in general), it is the disease patents that are most troubling.

Think back to the 30 years between the creations of the NIH and NSF and the enactment of Bayh-Dole. Was that system stifling research? Did it require appealing to greed somehow to impel or prod along a lazy research community? Have things improved so much since Universities were encouraged to churn out patents to pay for the gaps created by the withdrawal of federal funding? Is it too late to turn back the clock a bit, and see if maybe it wasn't working just fine, before we decided that science required the lure of lucre to do what it had done for ages?

Call me a cockeyed optimist, an idealist, or worse, but I think science and industry had a pretty healthy relationship before the present era. The atomic age, the space age, the computer age, all had their geneses before Bayh Dole. I think we can afford to give that model another go. What say you?

On Gene Patents

The past week's news about the ACLU lawsuit to combat Myriad's patents on two versions of the "breast cancer" gene has prompted me to begin to record my own thoughts and observances on the practice. Of course, I have a book-length treatment of the subject that was recently published by Wiley-Blackwell, appropriately titled: Who Owns You? The Corporate Gold Rush to Patent Your Genes, available now at major booksellers. Ironically, torrents for the book exist and there's little I can do to stop them. So much for my libertarian take on Intellectual Property. No matter, the ideas are what I want to spread, and they center around the nature of property in general, the existence of natural "commons" which cannot be "enclosed" by laws, at least not ethically, and the relations between ethics and nature.

So this is it, rather than try to swat down the misunderstandings and miscommunication about the practice of gene patenting by replying to every erroneous blog post or media article out there, I will summarize my thoughts here. I will also post updates, including news articles, and my own writings on the subject as they may appear.

For starters, here's the New York Times piece on the lawsuit: Cancer Patients Sue Over Breast Cancer Gene Patents

and here's a piece I recently published at Science Progress (before the lawsuit): How Genes are Like Plutonium

Here's an article about my talk at the University of Virginia Law School on the subject