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.

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