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Squatting On Life
Andy Smith writes "An investigation by The Guardian newspaper has exposed the extent of human and non-human gene patenting by private firms, universities and charities. What stands out about this investigation is that many of these organisations are 'gene-squatting', ie: patenting genes that they do not yet understand. There are currently over 160,000 patent applications for whole or partial human genes, with more than 20% being from one company, Genset."
From the Human Genome Project's website:
The patentability of inventions under U.S. law is determined by the Patent and Trademark Office (USPTO) in the Department of Commerce. A patent application is judged on four criteria. The invention must be "useful" in a practical sense (the inventor must identify some useful purpose for it), "novel" (i.e., not known or used before the filing), and "nonobvious" (i.e., not an improvement easily made by someone trained in the relevant area). The invention also must be described in sufficient detail to enable one skilled in the field to use it for the stated purpose (sometimes called the "enablement" criterion).
In general, raw products of nature are not patentable. It's usually when these DNA products have been isolated, purified, or modified to produce a unique form not found in nature that they become patentable.
For the rest of the explanation, go to:
http://www.ornl.gov/hgmis/elsi/patents.html
The Human Genome Project's web page is at:
http://www.ornl.gov/hgmis/
Hopefully this will clarify things for people who don't understand what is meant by "patenting genes"
These patents are here to protect the investments of the genetics companies who have been researching into genetic engineering and gene therapy. It doesn't come cheap, why shouldn't they patent their findings?
No, you'll actually find that companies are patenting particular sequences without knowing what they do. Patents are not there to give someone a monopoly for the hell of it, patents are meant to add knowledge to the public domain, by offering the the inventor a limited monopoly for it. If they want a monopoly, they should have to tell us what the genes do first. This is just typical of how corrupt the patent system has become; companies expect to get outright monopolies based on overbroad patent applications. The idea of 'inventing' something and having that protected has long gone. I would go so far as to say this is a good thing in many ways. It stops unscrupulous cowboy genetic's companies messing around with a set of genes in say, maize, and creating some sort of super-weed. At least this way, only the people who actually know what they are doing can apply their findings to genetic engineering.
More rot. Only governments can demand scientists stop messing with genetics. A patent doesn't stop you from doing something, it just passes control to the patent holder, Mr Drug Company. Do you think they give a rat's ass about gene splicing? Not if they can make money off it.
The other bit I don't like is that these patent monopolies will destroy the research community. It's no longer collaborative research within the scientific community, it's private hands-off-this-is-mine greed driven research.
Does my bum look big in this?
You've always been permitted to patent discoveries. The majority of chemical compounds for which patents have been issued have been isolated from nature (and, often, subsequent patents issued on chemical modifications thereof). The notion is that it's patentable because the "inventor" may not have initially created the compound, but he did recognize it, isolate it, and determine a use for it. Strange but true. In fact, very few patents issued in the past 100 years (in any country) cover something entirely novel -- just novel uses for existing things or modifications of existing things.
As for gene patents, there is a wide range of them. The majority of genes (patented or otherwise), have a known (or likely) function assigned to them -- in part because it's hard to make the argument that something is a gene without providing evidence that it is (in fact, in the US you can't make such a claim without presenting the evidence). All of the actual genes patented have a known function with one notable exception: cDNA sequences (expressed sequence tags).
ESTs are, by virtue of experimental design, known to be sequences of expressed genes (at least transcribed DNA). About 3/4 of the ESTs you can produce for a given organism will be readily assignable a putative function as well as info about tissues where the gene is expressed, conditions where the expression occurs, subcellular localization, often times it can even be assigned a place in a particular biochemical pathway. The value lies in the fact that the ESTs can be subsequently used to find tremendous amounts of information regarding regulatory pathways, co-expression, and eve, if you are clever, where the other 1/4 of uncharacterized ESTs come into the equiation. ESTs can also be used as the basis of a slew of technologies that permit researches to visualize the differential activity of all genes in an organism in response to environmental and developmental factors. ESTs themselves can even produce simple drug targets. This type of information and the systems built up around it are probably justifiably patentable.
That said, many corporations patent large collections of genomic sequences as well as ESTs. This is raw DNA from the organism that has been sequenced in tiny pieces and the tiny pieces assembled into large chunks. Why? Well, not every gene is expressed in high enough levels to be readibly detectable in EST libraries and if you want to find them, you need the genomic sequence. The genomic sequence also gives you information about the spatial arrangement of genes, large scale structure of information storage including synteny (where a huge chunk of one genome appears in another genome but rearrangements), colocation of genes (genes in similar pathways tend to congregate), mapping mutations, etc. Genomic information can, if properly handled, also be used to contribute to gene discovery and the whole-genome profiling of gene expression.
I suppose the question is whether or not the inherent an immediate utility of sequence information to molecular biologists and bioinformaticists meets the minimal requirements for patentability. I would say that in the US the answer would be yes, since the information represents an act of discovery (the sequences) and creation (all the sequences are man-made constructs derived from natural sources and annotated in machine-readable form) for which there exists a working model (the constructed libraries and subsequent information derived tehre from) and a definable utility (sometimes a target for drug discovery, but predominantly the utility is for conducting sequence-based research).
That said... I also beleive that there are many technical grounds upon which someone can essentially generate a parallel set of libraries and information and claim they have something new, and defense against that might be tricky. I'm not sure whether spending the cash to patent all of this information is worth while. Though I'm certain it's beneficial to the consumer since the information becomes public knowledge through the patent process rather than allow companies to conduct genetic entirely out of public view.
Several Things:
I think patents, in this case, are a good thing. For example, Genentech patented EPO, and on the basis of this patent produced drugs (recombinant EPO). The time line for drug production, clinical trials, etc... is around 10-15 years, with a price tage or many millions. WHY, without protection from other people piggybacking on your work, would you do this? It is fine to claim that people are blindly patenting, but from a personal perspective of actually being one of those evil people, I think that this is an incorrect statement. We, and everyone else that does this DOES HAVE SOME IDEA. Does that mean that we have all the answers? NO, but to get those answers takes years and dollars, and not insignificant numbers of either of them. Without patent protection, drug companies will not get within a million miles of the gene. All that can be produced with non-patented genes are generic drugs, on which drug companies do not make money. You can argue they make too much money, but there is a reason that the US is at the forefront of the medical world, and money is a pretty good explanation. I do beleive selfish motivation produces the drugs, as that produces the money, and gets you the recognition. This is not like a software problem, where it will be solved by next year. Each gene WILL take years and millions of $, and with a failure rate (defined as not usefull for making a drug out of) at around 80%, you need some protection for the ones that work or you will never make any money.
EST patents are still under question, with no defense of them being mounted, but I would agree that they suck. You have no function on them at all, so patents on them are wrong. For whole genes, function is a lot more clear (although real far from crystal clear).
On a related note: If you get govenment grants (majority of researchers in US) you are required to patent, or otherwise protect your work BY LAW. Failure to do so will get you, and your university, in trouble.
Gavin Fischer