Move to Outlaw Gene Patenting
A bi-partisan bill is being introduced in the House of Representatives to outlaw the patenting of human genes. It doesn't have a number yet. Here is what it states: "Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies."
More when I know more about its potential impact and what it might achieve.
posted by Wesley J. Smith @ 8:46 PM
16 Comments
16 Comments:
Medical advancement and the promise that tomorrow we might fix the problems that kill people today.
Rest In Peace
5000 BC - 2007
Royale: I was hoping you would write. While your comment is clear hyperbole--it's not as if medical research will stop if this bill passes--I will look into your concerns. In fact, if you would send me your private e-mail address, I would appreciate it.
No, of course not. But with our economic system, such curtailment of patent rights will have a very drastic effect in medical advancement.
Actually, this hypothetical might be a very good law review article for me to write. I was looking for a new topic.
Please share the results of your offline conversation and / or a summary of your law review article.
First, would you fear this would restrict drug research? This will remain the key to biomedical advances far more than direct genetic manipulation. I don't see how it would, though perhaps the phrasing of "natural occurring products" should be changed. That's because the drugs developed could be structurally and certainly functionally equivalent to the "natural" human product. I think what should be meant is that no direct human product should be used (that is for profit and without consent) - e.g. blood products and eggs and organs should NOT ONLY not be patented but ALSO should not become commodities in the commercial sense.
The more important sense is that specific genes are NOT patented. Without that, human exceptionalism will become human exceptions, with the law twisted always in favor of the commercial use. At some point, especially with umbilical cord and amniotic fluid now in storage, there may need to be an agency to regulate the consent and usage in research and development. Also access to the genetic testing, clinical trials and treatments should be fair. Certainly a patent system designed basically for the promotion of the exploitation of inanimate and nonhuman objects CANNOT be the basis of advanced medical research, just like the children resulting from artifical techniques SHOULD NOT dealt with in the legal system as Property Law first (Chain of title) and then Family Law (BUT isn't that the way it's becoming)
Robert B,
Those are good questions. But I think most, if not all your concerns, are best addressed by the FDA and NOT the patent system. The FDA is in a much better position to regulate the ethics of research and medicine than either the PTO or federal courts hearing patent cases.
Isn't that the point?
The patent court decides who the "inventor" is. The FDA in case of drugs (and genetic manipulation treatments?) regulates its use.
Again analogy to the test tube baby. First part of case, who owns the baby? Second part of case, who and how of the child rearing?
The protest to this on human rights grounds is profound. There can be NO valid claim to OWN a human being or components of same.
Therefore FDA regulation or something beyond that is required to preserve human rights and acheive some sort of equity in the utilization of the results of genetic research. Just like a family court judge should look after the interests of the child always and not the "process" from which he/she was derived.
The patenting part should indeed be disallowed.
I'm with Wesley for a change.
Patents are supposed to be for inventions, not discoveries. A naturally occurring gene sequence was not invented by anyone and should not be patentable. If somebody develops a treatment based on that sequence, the treatment is still a patentable invention.
I don't think there are really human rights issues here. It's a question of how intellectual property works, and what things are properly thought of as part of the knowledge commons and which are privately ownable.
How would this bill affect genes that are already patented? This has been going on for quite some time.
Robert B,
Tell your objections to the anemia and diabetic patients who rely on human genes placed into microbes to create EPO and insulin.
Without patents for such, what's the incentive?
This takes the money out of drug research and places into the hands of generic drug companies.
My point and that of most of the human exceptionalists here is decidedly NOT strictly bio-Luddites.
Along with conceding that drugs and the methodology of treatments derived from genetic knowledge are patentable, we do NOT concede that the direct human components and the nature of the gene itself should be patentable.
Human genes or blood products or adult stem cells provide treatments. Some of these may be natural human donations, subsequent manipulations, or synthetic or animal derivation of the DNA sequence or the human products such as proteins, enzymes, etc.
As I noted before, the DNA itself or the knowledge of it cannot be owned. Its utilization though can be regulated under stewardship guided by democratic principles of justice and preservation of human rights. If Teddy Roosevelt felt at the beginning of the 20th century that our natural heritage should be preserved, so in the 21st century, we should preserve our human nature. In neither case can mindless consumerism or hucksters of false promises or pompous barons of capital get in the way of balancing human needs to forge true progress by honoring heritage and human values.
I think right now, the balance is fine.
Under 35 USC 101, you cannot patent natural processes. To the extent that the knowledge of the human genome is a natural process, no patents.
However, each of the following are currently patentable and should remain so
1. figuring out what genes/ proteins do
2. splicing them out of the human genome and
3. medical applications thereof, including putting them into microbes
If any of those are disrupted, medical advancement will suffer.
Royale: In your example, the process used should be patentable because that is an invention. But the company should not be able to prevent a different company from using the same gene in a different process through obtaining a patent on the gene. Or, would the other company be able to use the same gene in a different process?
Short answer - maybe, as it depends on the scope of the patents.
With DNA, biotech companies aren't interested in actual human gene, what they want is cDNA (complementary DNA).
Normally, human DNA has lots of "junk" or non-coding regions that are of no use. So, biotech companies cut out the useful portions and put that into microbes.
In a sense, it's kind of like taking crude oil and making octane. Sure, the octane was naturally present in crude oil, but there is a lot of stuff in crude oil that you don't want in your car.
So, if the patent covered this process, then the competitor would probably not be able to use this portion.
But that's just theoretical.
In reality, gene splicing is so routine that any new patents will probably be just for the uses of a gene and not the DNA sequences themselves. This is because new inventions cannot be obvious to people who do this and gene splicing is pretty obvious now.
Y'know - I can never figure out if I'm supposed to capitalize "Mtraven" or leave it "mtraven."
Anyway, he nailed it.
"Patents are supposed to be for inventions, not discoveries. A naturally occurring gene sequence was not invented by anyone and should not be patentable. If somebody develops a treatment based on that sequence, the treatment is still a patentable invention."
EXACTLY! And that person *should* patent the treatment he invents, but owning a patent on the gene itself?
My problem - patenting a gene means that nobody else can do work on that gene, meaning that there's a shortage of healthy competition that will make treatments more affordable to everybody.
Royal:
"Tell your objections to the anemia and diabetic patients who rely on human genes placed into microbes to create EPO and insulin.
Without patents for such, what's the incentive?"
Competition. Healthy competition that gives various companies the right to try new treatments using the same gene. One company can do X - another company does Y. Process Y is cheaper than Process X, and therefore the Y company makes a profit because more people will flock to Y company. X company then must stay competative, so it works harder to find a cheaper alternative that is just as effective, and then you have more avenues being explored, more developments being delved into, and the consumer wins in the long run because there's no monopoly to force them to pay through the nose for whatever treatments only one company comes up with.
I love a good debate, I love a good argument, and I love good, healthy competition. You don't get results until you get many people arguing over the same thing trying to come up with the best possible answer.
TE Fine wrote:
"My problem - patenting a gene means that nobody else can do work on that gene, meaning that there's a shortage of healthy competition that will make treatments more affordable to everybody."
That is why Congress enacted exceptions to patent infingement, including research.
See for yourself: 35 USC 271(e)(1)
To everybody,
If I may be as presumptuous to assume that everyone commenting represent the "lay" understanding of how biotech patents work, then let me assure, all your objections and perspectives are already incorporated into the law. So, I find it hard to fathom why Congress would want to outlaw patents except for a misunderstanding/ lack of education.
Royale: That wouldn't be the first time Congress acted in ignorance. As I have said, when I find out more about this and the reasons why, I plan to write something about it. I appreciate Royale's contributions to this discussion very much because it raises good questions for me to ask. Thanks, Royale!
Sure, no problem!
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