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!

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.

Myriad case, Federal Circuit decision - reason for hope

No one can be terribly surprised that the Federal Circuit ruled essentially to continue the practice of gene patents yesterday. But there are some surprising tidbits in the various, lengthy, and somewhat contrary decisions of the three panel judges. One disappointment for gene patent proponents was the ruling on standing, which held that indeed there was standing for the plaintiffs to bring a declaratory judgment action as they did. Some hoped that the Federal Circuit would drop-kick the case on standing and never have to reach the substantive issues. Those hopes were dashed when the court concluded that there was at least one plaintiff with standing to sue based on an ongoing harm.

More surprising is the holding regarding the method claims relating to comparing or analyzing sequences, which the court struck down unanimously as unpatentable under Bilski. This is a minor win, and increases the likelihood of continued appeals as no-doubt Myriad will want to have either the en banc circuit review this, or the Supreme Court (perhaps both will happen eventually).

Unsurprising is that the court ultimately upheld their reasoning that X sometimes does not equal X. Violating the logical law of identity has been the underlying reasoning behind such ridiculous decisions as Parke-Davis (cited by the court) which established the "isolated and purified" notion by which a number of patent attorneys now are forced to argue that sometimes two morphologically identical molecules are nonetheless not identical. In continuing to strain logic, the majority decision holds that the sequence claims cover patent-eligible compositions of matter. But the silver lining is that there is division on the court, and the reasoning of the Majority, and concurrence of judge Moore, illustrate just how strained the logic has become. Moore argues that there is some significant chemical distinction between an isolated gene and a gene found in nature because at the ends of the isolated gene are nothing, whereas at the ends of the gene found in nature are more nucleotides. This does not support any claim of morphological difference between the claimed gene or gene parts and the sequence identified as occurring in nature. As I argue in my book, drawing a border does not create, automatically, a new, unique thing, especially where, as here, the information encoded in the string (which directs the functionality of a gene) is nature's own definition of a border.

Finally, Judge Bryson sees clearly the illogic of extending patent eligibility to isolated DNA, and writes a dissent to that part of the majority holding, using arguments I and others have made often.

What this means is surely that this fight is far from over, that it will be appealed, likely, to the en banc Federal Circuit and ultimately to the Supreme Court. Unfortunately, by the time a Supreme Court decision is final, Myriad will have run out the clock, having reaped its billions in profit from their unethical practice before the patent expires.

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!

Stop Lying about the Myriad Patents on BRCA 1 and 2

Numerous defenders of Myriad often claim that the patents do not cover naturally-occurring genes, but rather only "methods" created by humans, or "isolated and purified" genes, which they allege can only be created by man. After all, they claim, isolated genes do not appear in nature, and it takes the work of humans to create them. This is, of course, hogwash. Isolating a gene is accomplished in nature in the process of cellular metabolism. Protein synthesis is accomplished without human intervention, much less, human invention, because various forms of RNA read the beginnings and ends of genes, omit the introns, and construct proteins from the remaining (exon) codons. So, merely finding the beginning and end of a gene is, as I have analogized in my book and elsewhere, equivalent to reading a map, and noting a geographical feature therein. Nature made the feature, and defined its borders, and we simply find it and model it. So that's the "isolation" and it doesn't warrant patent.

The "purification" part is part of nature's bag of tricks too, as mRNA skips the introns (the non-protein coding regions), and in fact some laboratory methods for creating cDNA (thus "purifying" DNA) use mRNA to accomplish this. Again, nothing at all inventive.

Finally, the Myriad patents on BRCA1 and 2 claim un-modified genes -- mutations in the BRCA1 and 2 gene that occur naturally. Their sole inventive claim is "isolation." See the patent yourself, and look at the claims (pp. 153-156). Look specifically at this:

"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."

Now, note: these are not method claims, they are not claims for cDNA, but rather over naturally-occurring mutations to naturally-occurring genes. As I discuss above, and in my book, and elsewhere in this blog, this is not inventive at all. Rewarding for discovery of laws of nature goes beyond the scope of patent, and it inhibits research, and access to the "commons by necessity" that is the human genome and laws of nature in general.

It is like saying that since detached bird wings do not exist in nature, one ought to be able to patent detached bird wings. It's madness, and everyone except patent lawyers and others getting wealthy off this insanity can see that.

A methodical response to Chris Holman's "review"

I will work through as many of his specific citations of error. In general, his allegations of error rely on one disregarding the context of my policy and logical discussion of the law, which includes my dismissal through argument of many of the current law’s assumptions (such as that “isolation and purification” somehow turns a gene into something “new). In re-reading my book in light of Holman's review, I kept thinking maybe he and I read a different book, there's so much he disregards and so little he focuses on. But here are my responses to as many of the alleged errors as possible:

1.) I caught most of my discussions of nucleotides in proofing, but did apparently miss some cases in which I refer to a nucleotide or nucleic acid as an amino acid. mea culpa

2.) My discussion of introns is accurate though not in-depth, but Holman doesn’t specify how I allegedly erred.

3.) Patent law does apply to discoveries, but they must be “new.” Now, this does not include discoveries of natural things that have long existed, which are not “new” and the case law is clear on this. The only “discoveries” that can then be logically patentable are those that are somehow inventive, which I argue genes are not, even in their “isolated and purified” state. Once again, this is an instance of Holman taking the conclusion of an argument I make out of the context of the argument itself, claiming it is an error rather than explaining the line of reasoning that leads me to my conclusion, and then saying I am merely wrong. We disagree, and I state my reasons in the book.

4.) As I state in the book, US patents do effect other jurisdictions thanks to the WTO and TRIPS agreements. Europe and Japan do not allow “gene patents” on unmodified genes, specifically, they disallow patents over the sequences, although they allow patents on genes used in some new process or product involving an “inventive step,” which helped, for a time, prevent the BRCA1 and 2 patents in Europe, though they are now allowed (to a degree). I argue that new products incorporating laws of nature or natural parts are patentable as a whole. The BRCA1 and 2 patents allowed in Europe are closer to what I would consider to be proper, though I have ethical issues with them as well. This is a point made in The American Interest article as well.

5.) I argue in my book that the yeast and adrenaline patents were erroneous. The adrenaline patent, if it protected the compound adrenaline, could not have protected its naturally-occurring analogue, so what more could it have logically protected other than the process of synthesis? I think I could have done a better job making this logical dispute with those patents explicit. An analogy would be water. If one developed “isolated and purified” water, synthesized it from scratch, and patented it, then in what logical sense could it also protect the molecule H2O? It couldn’t, so it would only be a process patent, no matter what the claims state. As for a patent on a representation of a gene, this was presented as a hypothetical that would accord with my overall theory of IP law, and not as an example of how patents are actually issued. My general theory of intellectual property states that all man-made expressions, intentionally-produced are potentially protectable, in which case so would representations of genes be protectable. Except, I conclude in the case of existing genes that they belong to a commons by necessity which can never be enclosed.

6.) I do discuss Moore at length, I do point out it is a state case, and put it in the historical context that helped convince Celera’s attorneys to begin patenting genes. It is a well-known, historically important case in the development of the law regarding ownership issues in products of human tissues. I put it in that context explicitly in the book.

7.) Patents do include a right to enjoin, I don’t see that leaving that out is a "serious misstatement" about patent rights, which I do mention include the rights to royalties and fees. In fact, the injunction right makes gene patents worse, so thanks to Holman for mentioning this as well. US patents have extra-jurisdictional effect, as mentioned before, through WTO and TRIPS. As I argue, US IP law has a powerful influence on other jurisdictions.

8.) The next long criticism relies on buying Holman’s and other patent attorneys' argument that “isolation and purification” creates something new, which I argue at length in the book it does not. Thus his conclusion “All of these scenarios would indeed raise serious ethical concerns if they had any basis in reality, but in fact all are mere figments of the author's imagination resulting from his profound misunderstanding of patent law,” does not take into account my lengthy argument about isolation and purification, and all the scenarios I mention are thus technically true (under my interpretation of the logic involved), and not at all fiction. What Holman calls a “misunderstanding” of patent law is part of my central disagreement over the scope and effect of gene patents (not a misunderstanding) because of my arguments about the ontological status of genes, both “isolated and purified” and otherwise. This point is crucial to an understanding of my ethical arguments which he completely misses as a result.

9.) I have referenced Murray’s studies about the chilling effect of gene patents. There is certainly room for dispute, and more evidence is needed. Ultimately, my conclusion is based on the ethics, not the practical effect.

10.) I do summarize arguments made by others and cite to as many as I had considered, but I also break new ground which Holman ignores or possibly misses. For instance, his characterization and dismissal of my central argument in Chapter 7, which he calls a rehash of the anti-commons arguments of others. It is not, I don't even use the term "anticommons," and no one who has actually read the chapter could conclude that it relates in any way to any anticommons argument at all (which is a utilitarian argument, while mine is not). That chapter makes the ontological argument which supports my ethical conclusion, regarding the existence of certain things which I call “commons by necessity” and which I conclude DNA belongs to.

11.) The rest of the review basically defends the practice of gene patenting, making this more clearly an advocacy piece, and less a book review.

All told, Holman’s review focuses on about 10 pages of my book, in which I discuss law and cases, and leaves out the bulk of it. In writing this response, I went back and carefully re-read my book and was amazed at just how much of my discussion is completely ignored, and how little of what I write about is actually referenced. It seems that those who disagree with my conclusions have done their best to turn points of contention and disagreement over policy into allegations of “error” where in fact, there is plenty of argument to be made on either side. My book makes one argument, but let’s not pretend that the arguments on the other side are “fact” when they are simply arguments which I have taken care to dispute in making my own.


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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