Wednesday, June 24, 2009

It's the novelty...

So, what it comes down to is this: those who argue that the gene patents they so dearly protect are valid and justifiable must argue two things:

1) that "isolation and purification" as it is being conducted are sufficiently inventive to warrant patent protection, and that what is created in the process is something somehow new, and

2) that we must somehow provide the incentive of patents for gene sequences in order to realize beneficial products from new knowledge about our genes.

Of course, I dispute both claims.

"Isolation and purification"" of genes from a naturally-occurring genome is not inventive, and doesn't create anything new. The science argues in my favor, as does logic. The body "isolates and purifies" genes to the same extent as researchers simply by using mRNA to do the work of the gene. mRNA only reads the exons, skips the introns, and makes a protein, determining by the logic of our natural processes where to begin, and what codons to read to create the final protein. Now let's reason once again by analogy. Imagine creating an artificial heart (which has been done a few times). Clearly, the artificial heart itself is patentable as something new, useful, and non-obvious. But is the process of pumping blood patentable? In the case of gene sequences, the sequence is the process, whereas the final protein is the product. In the body, the processes and products are naturally-occurring, and thus any attempt to replicate them, or realize them synthetically, might result in a new, patentable process, but the genes themselves will not be new, nor will the products that result by patentable if they are naturally-occurring. This conflicts with the current interpretation of what is patentable since things like Epogen are patentable products even though they are analogues of naturally-occurring proteins. My argument hinges upon realizing that this is an over-broad application of the patent law, as are patents on gene sequences.

Let's look again at an analogy. Gravity may be used in perhaps infinite mechanisms that might be used to lift or lower things. Cranes, elevators, etc., all might be designed in nearly limitless ways (even if certain designs are most practical). The device as a whole, which utilizes the force of gravity, is patentable even though gravity is not because it lacks the novelty requirement. Similarly, the process of creating a naturally-occurring product, or part of nature, may be new even though the product has long existed. My example of a water-synthesis machine is on-point. There might be many hundreds of devices we could build that could synthesize water out of hydrogen and oxygen, each of which should be patentable if it meets the criteria for patentability, but the molecule H2O could never be patentable. Neither should the product "Epogen" nor any patent claim on existing human genes. They have long-existed, have been doing exactly what they do that makes them useful to us for many eons, are not the result of our inventive behaviors, and should not be patentable. Isolating them is less complex and less arbitrary than, say, drawing lines on a map simply due to the fact that nature has figured out how to isolate them itself, devising mechanisms for beginning transcription and ending transcription at the natural start and end of the genes. Purification? That too is being done as the mRNA reads only the exons. So where's the inventive step? Why reward anyone for finding these natural things? Better we should reward those who discover new means to create new, useful products like therapies and drugs. If stem cells are successfully used to grow new organs, would anyone seriously argue that the final organs are patentable products rather than just the process by which they are grown?

Take again the example of gravity: if patents were granted on gravity itself, rather than its application in new devices for lifting and lowering things, then the range of inventions available for inventors to produce during the patent term shrinks significantly.

So why the clamor to save these claims on gene sequences? Perhaps it's as Venter said in the article I posted last: because it made patent lawyers rich.

Sunday, June 21, 2009

Worth revisiting/New media

When even Craig Venter agrees that gene sequence patent stifle research, you know you're onto something. While he cites one drug that was made possible by patenting the sequence, he notes it is an exception, and that, for the most part, drugs will not come from the sequences themselves. No, the patents that have emerged, and have proven profitable, are those like Myriad's, whose test incorporates the BRCA1 and 2 sequences necessarily, but which encompasses essentially little that is new or inventive. As I have argued, if they developed a new, better means of screening for the presence of a gene, then by all means, patent it. But the sequences themselves are not new, they are devised by nature. Would scientists have discovered the BRCA1 and 2 genes without financial incentive? I'd say, pretty much assuredly. Breast cancer is a huge social concern, and the efforts to discover disease genes have been motivated by public health and scientific concerns, as much as by profits motives (actually, let's hope, more so). How should scientists looking for disease genes be compensated? By increasing federal funding for basic research. Scientists love grants, believe me. In the end, I wholeheartedly believe that there will be more patentable, downstream innovations by freeing up the upstream research, and enabling it through increased funding. It's not like there isn't market demand for new, better treatments and drugs. Of course, that market would also expand with universal health coverage (not necessarily single payer -- here in NL, we have mandatory health insurance, but we each pay, though the costs are affordable). But that's a whole 'nother matter.

As for media, I did a nice interview at Changesurfer Radio, with my friend Dr. J. Give it a listen, we covered some new ground.


Wednesday, June 17, 2009

The problem with public debate

Most people seem to now immediately fall into the Crossfire version of debate. God bless Jon Stewart for his demolition of Crossfire. It really is what's wrong with our culture. Issues are often complex, too complex to be reduced to just two opposing viewpoints. I know liberals and conservatives are both guilty of this, but it really impedes solving real issues. I am dealing with this on the blog wars I have launched myself into on both and . There, the comments tend to always devolve into an unbridgeable divide, whereas I have argued for a moderate approach to gene patenting. While I have suggested at times that innovation and profits can come without strong Intellectual Property regimes, in my book I argue that there is plenty of room for downstream, patentable innovation without granting patents to gene sequences found in nature.

But apparently, for a certain type of person, by suggesting that something in the world cannot or should not be owned, one becomes simply "ill-informed" or the author of a "screed," part of the "anti-patent crowd" or worse. Suddenly, by suggesting that something ought not to be patented, the fact that you later suggest that there will actually be more patents on real inventions as a result matters not. Neither does the recent evidence that innovation and profits can come from open science and open source matter. What seems to matter is the creed of patent, but let us not forget patents are a means, not an end. And the end is innovation. Innovation, and its fruits, are what we want. What can we do to achieve it? Is there only one course, are there alternate models, and can we accept that various means are worthwhile and available? It's much harder to chart the middle course, but sometimes we should try.

I am happy to take the insults, if only someone also occasionally gets the message. The message is this: science can be impeded when patents are granted on naturally-occurring things, like laws of nature, genes, etc. We ought to fund and free up the basic science side, and see the innovations that come out of this. This was the model of the the NSF and NIH in the 50s and 60s, and we have abandoned it, and I believe it has been to our detriment. The US is losing its pre-eminence as a bastion for science and technology, we are losing our best and brightest to nations where there is a better balance between public funding of science and corporate profits and spin-offs. This has worked before, and we can go back.

Tuesday, June 16, 2009

Name calling at Patentdocs

So I am being called a liar, for unspecified reasons, at I will have to elaborate here shortly on the whole "isolation and purification" line of argument, that really seems to have the true believers convinced. Meanwhile, I'm doing what I can to be civil and stick to the arguments as opposed to the name calling.

Here's an interesting article that might put it in perspective. Venter himself, in opposing gene patents, notes that the frenzy to patent genes enriched mostly the patent lawyers. Maybe this is why Noonan is frantically trying to reframe the debate, and call those who oppose him "liars."

Thursday, June 11, 2009

Get Your Hands Out of my Genes!

I think it's important to revisit some of the non-legal arguments I and others have made regarding gene patents. A striking feature I note from all my talks on the subject is the visceral reaction many have to learning that human genes are patented. Forget the fact that these patents violate the patent law because they are not of anything remotely new. Forget the argument, which is compelling, that granting these patents violate the US Constitutional grant of authority for patent because they actually hinder the progress of the useful arts and sciences. Forget even that these patents might violate the First Amendment because they interfere with a plausible right to research (especially if one buys that donating money to political campaigns is "free speech," then scientific inquiry into nature better damned well be). No, there's something else to it. Something that underlies the visceral reactions my audiences and readers note. It's invasive. It's theft.

Our genes might be practically open to discovery, there's very little physically I can do to prevent you from acquiring my genes and unraveling my genetic code. But that doesn't mean it wouldn't be disturbing or unethical if you did this. The knowledge you could get about me, and use against me, is just too potentially disruptive to decide that we are not somehow each custodians, and maybe even more properly guardians, of our individual genetic data.

At the same time, the genome we share cannot be cordoned off. To the degree that our genetic information is mostly the same, we should all have access to it. No one should be able to claim that if we want to peek around, learn some more, and do some studies on this common genetic code, we somehow have to pay for this. Our "common genetic heritage" is, I argue, an actual commons like the sky, sunlight, or international waters. We should treat it as such.

The visceral "icky" reaction is based on the intimate relation we each have to our individual genomes, and the common relation we share with the "human genome." Just as no one should profit from your image, and no one legally can without your consciously and knowingly signing away your rights to it, your genes cannot be exploited for private gain without your consent. Nor can a commons that is owned by all be exploited without common consent. Yet this is what is occurring, and this is why we are riled. It's time to take back our common genetic heritage. We have nothing to lose but our double-helical chains!

Thursday, June 4, 2009

Lawful vs. Just

Another newspaper story doesn't quite get it right. Time and again I read stories like this one in the Miami Herald in which gene patents are called "lawful" or proper, or whatnot, tracing their appropriateness to either the Chakrabarty decision or the Moore decision, or both. Simply put, neither case applies to unmodified human genes, which are at the heart of the ACLU case against Myriad. Chakrabarty involved the patentability of an engineered life form, and Moore involved the patentability of a product manufactured out of material extracted from human tissue. The latter turned on the issue of a waiver signed by the patient which gave rights to research and development based on the extraction to the defendant. It did not go the the Supreme Court of the US, just that of California.

Of course, I describe the history in greater depth in my book, and there are a number of excellent books, including The Gene Wars that detail how, using these cases as their precedent, Celera sought patents from the Patent and Trademark Office for human genes discovered in the course of their parallel and private Human Genome Project. The point it, the ACLU case will be one "of first impression" as this sort of legal challenge has not yet been made. The administrative decision of a government agency, including that which allegedly narrowed the applicability of gene patents, is not strictly speaking "law":

The regulation states: "If a patent application discloses only nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. But when the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the ‘‘utility’’ requirement. That is, where the application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene compositionmay be patentable"

This is not "law" because it is simply a regulation, issued as guidelines for PTO examiners, promulgated by an administrative agency. Laws are debated and passed by legislators elected by citizens, while regulations and administrative guidelines might be passed or issued by bureaucrats, either with or without review or comment by the public or elected legislators. Generally, there is a call for public comment, and none is received because so few people ever hear of proposed regs. The point is, just because this regulation or "guideline" exists, doesn't mean it is lawful. Plenty of administrative rules, regulations, and guidelines turn out to be illegal, unconstitutional, or just plain stupid. In this case, I believe this one is all three. As I argue in my book, the "isolation and purification" requirement, if applied to analogous cases, would make the Devils Tower in Wyoming patentable as soon as someone drew an arbitrary border around it, isolating it from the surrounding environment, and stating that by so doing one has developed a use which includes finding the Devils Tower on a map (or any other geographic feature, for that matter).

So, let's get this straight once and for all. The PTO has been acting without legal precedent, and without legal guidance. Determining the legality of these gene patents can be done in only two ways: through legislation specifically making it legal or illegal, or through a court decision, ultimately by the Supreme Court. Unless you're of the school of thought that says whatever the government, or God help us, its bureaucracies, does is legal per se. But I'm sure you're not.