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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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May 19, 2004

All the Myriad Ways

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Posted by Derek

Closely related to the patenting of biochemical pathways is the patenting of genes. I'm not completely thrilled with that, either, but it still makes a bit more sense to me. With these patents, you own the gene and uses for it, but you don't get to claim everything else downstream of it (like the protein it codes for!) In the first genomic gold rush, the USPTO was swamped with gene applications, and granted quite a few of them without too much in the way of defined utility. Since then, they've tightened up, and you're really supposed to spell out what a gene is good for in order to patent it. Generally, that means using the gene as the basis for a diagnostic test.

In that vein, Myriad Genetics holds lucrative patents on the BRCA1 and BRCA2 breast-cancer susceptibility genes (background here), on which it makes plenty of diagnostic revenue. But it's been losing protection in Europe. Earlier this year, they lost their European patent for BRCA2, and now their BRCA1 patent is history, too.

In general, it's harder to get and hold on to such patents with the European Patent Office, but these decisions seem to have been taken on good old prior-art grounds rather than any finer points. It turns out that a British cancer charity research foundation had applied for BRCA2 before Myriad, which would seem to indicate that the latter's patent never should have even been granted. As for BRCA1, New Scientist reports that the Myriad amended their claims for it in 1995, correcting a few base pairs months after their first filing, during which time the sequence was published in the open literature. Whoops! Can't get a patent after that happens.

Myriad seems to have pretty much given up on the European market for these patents some time ago, what with all the legal trouble. But you have to assume that they're going to continue to pump the US market for all it's worth. Meanwhile, Canada (well, Ontario at least) is just ignoring these patents, according to the New York Times.

A question now is whether Myriad's claims are going to hold up over here. If this were a high-level question about the patentability of genes, the arguing could go on for a long time. But if we're just talking prior art, then it just comes down to some relatively simple issues: are their filing dates just as hosed up here, or not? And even if they are, is there anyone motivated enough to challenge them?

Comments (14) + TrackBacks (0) | Category: Cancer | Patents and IP


COMMENTS

1. SRC on May 20, 2004 12:28 PM writes...

Just to clarify, before someone trots out the hardy chestnut about "someone owning our genes," any claims directed to a gene will always specify "an ISOLATED AND SUBSTANTIALLY PURE nucleic acid." Patent law in the US (and elsewhere, generally) excludes claims to things occurring as such in nature. (Neem tree activists please note.) Something _isolated_ from a naturally-occurring substance is another story. It doesn't occur in nature in isolated form ("touched by the hand of man"), and so is patentable. (Willow and Pacific yew trees aren't patentable; aspirin and taxol are.)

So the upshot is that the stuff in your cells is yours. Unless, of course, you isolate and purify your own genes...

Permalink to Comment

2. Derek Lowe on May 20, 2004 1:10 PM writes...

Right you are. Genes are treated in patent law as large and complicated chemical entities, with a defined composition as given by their sequence. Proteins, naturally enough, are handled the same way.

Permalink to Comment

3. Nick Henriquez on May 21, 2004 8:48 AM writes...

Ah, but why should it be patentable to determine that I have (or don't have) gene X. Why indeed would it be possible for me to be FORCED to allow a specific company (in this case Myriad) access to all of my genetic info in order to determine the presence/absence of something? More importantly, if company X subsequently finds something else entirely and patent THAT, why shouldn't they give me (the source of their discovery) royalties? And yet this is how the law currently works.

As for being unable to patent trees, e.g. certain genetic variants of organisms have indeed been patented. There was big hoohah going on (maybe it's been solved lately) with certain mice being used for cancer research as a university had patented their use. Possibly a method-patent, the details are hazy in my mind, but they were trying to make all sorts of institutions pay for using mice to test cancer drugs. Not good for scientific progress, not good at all....

More extreme versions of this occur when companies patent e.g. variants of plants such as rice containing a particular gene (these are in fact patentable under US law it seems ??). In another instance a British company patented a protein from a cactus based on the fact that it suppressed hunger in African Bushmen (who used the cactus for 100s of years).

As neither the Bushmen nor the tribe growing the rice are charged, this doesn't seem such a big deal. Until you realise that the discovery of the (variant) gene/protein was based on centuries of agriculture and/or trial and error by a tribe that will not benefit one jot from the companies' gains. In fact, if they e.g. try to patent what is essentially their centuries-old knowledge this might actually be impossible.

One the one hand they are prevented to patent their own discoveries, on the other hand there's no prior art. Consequently anyone else is free to patent something because tribe X wasn't in the habit of writing such things down 100-400 years ago.

This is in fact a type of occurrence which has made many indigenous peoples wary of outsiders sticking their noses into their heritage. I can't blame them.

As for the bushmen, I do believe they are getting something back now after great efforts from a South-African lawyer forced the company to pay into a foundation to handle the money. The rice issue was still a bone of contention between the Indian government and the US patent office last time I looked.

Permalink to Comment

4. Nick Henriquez on May 24, 2004 3:55 AM writes...

Hi Qetzal,

You're absolutely right so my explanation must have been obscure and I thank you for clarifying things. I probably shouldn't have "mixed"the issues I brought up.

Of course as you state, neither tribe would be prevented from using their plants for their original purposes. However, they are prevented from patenting what is essentially their invention. Furthermore they are not legally entitled to compensation which is ethically ridiculous under the circumstances.In both cases the only reason companies got on the trail of these patentable facts was the previous discovery of unique traits by the tribes.

As for the determination of genetic info. In order to determine whether I have gene X I need to give a company/person access to my whole genome. There simply is no other way to do the assay as I can't give access to one gene only. As a consequence I don't have control over what further assays are performed. This would even be the case if I get a statement from the person/company that they only will perform one assay, there's absolutely no way to control what happens to my DNA. These are private companies which give no access to their proprietary handling methods, I hear of cases where you actually sign away any rights you might have.

One instance of this is the entry of e.g. your DNA profile into security databases. Your info is never removed even after you are found innocent or are excluded from a particlular investigation.

What Myriad patented was pretty broad (though I don't have acces to the precise text anymore) and prevented other companies and even academic institutes from performing the necessary sequencing. Hence they were (and still are in the US) the only ones legally able to check for these genes.

As this is a health issue I think it is wrong to allow the patent in a case like this and again I apparently did not state that point clearly enough, I can only hope this is clearer now.

There are other reasons not to allow such genetic patents, there is no creativity involved (anymore) in sequencing. The fact that certain genes are associated with a disease is also not a very creative discovery and usually based on "open source" database information.

Even where it isn't I can guarantee that the patients who originally provided their DNA for science never intended others to be restricted in using the benefits of discoveries made from it.

On the whole then this type of DNA patent should not be allowed in my view.

Permalink to Comment

5. SRC on May 24, 2004 2:34 PM writes...

Nick,

A number of issues are being conflated here, resolution of which I think will allay concerns.

"Of course ... neither tribe would be prevented from using their plants for their original purposes. However, they are prevented from patenting what is essentially their invention."

The plant never was patentable to them, or to anyone else, because it was found as such in nature – they hadn't changed it. You can't patent iron ore; you can patent steel. See the post above.

Furthermore they are not legally entitled to compensation which is ethically ridiculous under the circumstances. In both cases the only reason companies got on the trail of these patentable facts was the previous discovery of unique traits by the tribes.

This confuses law with ethics – not the same thing. There's a lot of daylight between what's legal and what's nice, or charitable. The tribes provided a clue – no more than that – that the plant may contain an active agent. (Those who protest that characterization should bear in mind that many tribes believe in magic and witchcraft, so their technical insights shouldn't generally be taken as read. The fact that they think something works should be regarded as an invitation to research, not as received truth.) The operative phrase here is "on the trail of." Would it be nice to compensate them? Yes. Is one ethically obliged to do so? Maybe. Is one legally obliged? No.

"As a consequence I don’t have control over what further assays are performed. This would even be the case if I get a statement from the person/company that they only will perform one assay, there’s absolutely no way to control what happens to my DNA. These are private companies which give no access to their proprietary handling methods, I hear of cases where you actually sign away any rights you might have."

This mixes together privacy issues with patent law. The issue here is whether a given genetic assay should be patentable. What people do with the information from the assay, or what other assays they run, is a privacy issue, and has no relation to the patentability issue regarding the original assay. To see this, note that if the assay were made unpatentable (i.e., put in the public domain), then anybody who was so inclined could use that assay to invade your privacy as you're now concerned about the patentee doing. Making the invention unpatentable would not address the (legitimate) privacy concern. Patentability and privacy are two distinct issues.

"One instance of this is the entry of e.g. your DNA profile into security databases. Your info is never removed even after you are found innocent or are excluded from a particlular investigation."

As above. Nothing to do with patentability.

"What Myriad patented was pretty broad (though I don’t have acces to the precise text anymore) and prevented other companies and even academic institutes from performing the necessary sequencing. Hence they were (and still are in the US) the only ones legally able to check for these genes."

Actually, their patent (I assume we're talking about US 5,693,473 and US 5,709,999) is directed to alteredBRCA1 genes, not the genes per se, probes that hybridize to them, and methods of detecting them. If they (but see below) found alterations that are linked to breast and ovarian cancer, and invented ways of detecting such alterations, why shouldn't they benefit from that contribution?

"There are other reasons not to allow such genetic patents, there is no creativity involved (anymore) in sequencing. The fact that certain genes are associated with a disease is also not a very creative discovery and usually based on “open source” database information."

Patent law doesn't require an inventor to be wildly creative – just to provide something new, not obvious in view of what is known, and useful. To see this, look at mechanical patents, most of which are new little wrinkles on existing gizmos. Few flashes of creative insight, no new parts, just new combinations of gears, levers, screws, etc. (all "open source") that work a bit better than earlier combinations. The whole idea of patent law is to encourage public disclosure of better ways of doing things (hence the term "patent", i.e., "open"), as opposed to keeping such improvements as trade secrets (as in the craft guilds of the Hanseatic League). There is no judgment of effort, creativity, or worthiness – just novelty, unobviousness (used in a specialized field-specific, rather than colloquial, sense), and utility.

"Even where it isn’t I can guarantee that the patients who originally provided their DNA for science never intended others to be restricted in using the benefits of discoveries made from it."

On the other hand, I'm sure they also didn't intend for someone who invents a medically useful test not to be rewarded for doing so, because then no one would bother inventing further ones. Because we have no way of knowing what the invention is worth, we let the market determine the reward, that is, what other people are willing to pay for it, by giving the inventor a time-delimited right to exclude others from using his invention. Any restrictions on use of such inventions (as opposed to discoveries; discovery + utility = invention) expire with the patent.

Having said all this, as Derek points out, there is apparently a substantial issue of patentability but on practical grounds (lack of novelty) rather than philosophical ones. The above comments all address the principle of patentability assuming that the invention is novel and unobvious, not the specifics of this case.

Permalink to Comment

6. Nick Henriquez on May 24, 2004 4:09 PM writes...

Uhmm, yep we are talking about the same things here. No, I'm not confused but my explanation seems to keep wrong-footing people. I don't agree with the premise on which patent LAW is based because despite stating the reverse it has allowed the patenting of the obvious and non-novel, often even to the detriment of the actual discoverers.

So we can agree that you're very likely right about the law and (hopefully) that I'm right about the lack of justice contained in the process.

As for the specifics of the (rice and cactus) plant issues, I'll look them up and get back to them in my own blog so have a look there if you wish to continue (e.g. get there via my homepage www.alifeinscience.com or email me).

The one point which I do want to re-iterate here is that if I "generate" a genetic duplicate of something which lives in the wild, technically this organism is my invention. As such it is patentable under current law. If the patent were granted then every identical plant would fall under the patent. Theoretically then the wild plants would also be covered unless someone can PROVE that it was already there.

What classic culture does is mix strains. What GM does is add certain genes to a single strain. The results can be and sometimes are almost indistinguishable from eachother. Proving that a plant has been generated through culture is very difficult for a small farmer (no documentation etc.). Thus if rich multinationals start suing small farmers for breach of patent, they might even be correct in their assessment. But regardless the farmers wouldn't have the money to defend themselves. This is a problem of patent law and I'm sorry but patenting is part of patent law...

Now for the meat on the bone of contention in my view. The case of the patent on assays for mutated BRCA genes.
1. someone finds out that the genes are related to mammary cancer.
2. someone ELSE patents the use of detecting mutations by various commonly used techniques.

Was the technique novel? Nope.

Was the application non-obvious? Nope.

At least it seems extremely obvious to me that if BRCA protects against cancer, then mutations in these genes could be related to cancer. In fact the patent as I read it (currently) even protects the company against anyone using untested mutations with unknown consequences in the genes.

Was the patent granted? Yep.

To add insult to injury, in order to be tested I have to allow an (in my view) unethical institute access to my private info. If I do the test myself (which I could) I am theoretically in breach of the law or at least I was until the EPO ditched the patent.

The fact that patent-holders can abuse the information people are forced to give them may have nothing to do with patenting in your view. It does however have very much to do with what I feel is wrong with patent LAW as it apparently does nothing to address socio-ethical concerns.

As a set of rules intended to facilitate progress I think patenting law should take notice of what the effect of a patent is on society, quite apart of the possible novelty issues etc. Scientists have had to learn that what they do affects people and change their ways accordingly. Patenting is long overdue for such an overhaul in my view. I hope this explains my conerns and objections better.

Permalink to Comment

7. SRC on May 24, 2004 8:20 PM writes...

"The one point which I do want to re-iterate here is that if I “generate” a genetic duplicate of something which lives in the wild, technically this organism is my invention. As such it is patentable under current law."

No, it isn't. Trust me.

To follow on the example above, one could synthesize ferric oxide in the lab too, but that doesn't mean one could then patent iron ore.

What classic culture does is mix strains. What GM does is add certain genes to a single strain. The results can be and sometimes are almost indistinguishable from eachother. Proving that a plant has been generated through culture is very difficult for a small farmer (no documentation etc.).

The burden of proof (at least in the US) is on the patentee to establish infringement, not the accused infringer to prove he didn't infringe.

Now for the meat on the bone of contention in my view. The case of the patent on assays for mutated BRCA genes.
1. someone finds out that the genes are related to mammary cancer.
2. someone ELSE patents the use of detecting mutations by various commonly used techniques.

As indicated previously, the earlier comments were directed to the principle of whether subject matter like this should be patentable, not to the specifics of this particular case (where it would seem the facts as reported militate strongly against patentability). That is, suppose someone found mutations linked to a disease, and devised an assay to find such mutations. So, for present purposes, let's use the facts of this case, but suppose that there were no question of invalidation by prior art, specifically let's suppose that Myriad had found that the genes are related to mammary cancer. Whether they did or not is, of course, another question, but beside the present point.

The critical point here is #2, the detection of specific, well-defined mutations in a given gene that were found by the patentee (as opposed to a general indication that some unidentified mutations somewhere on a chromosome may have some relation to the incidence of cancer.

Was the application non-obvious? Nope.

At least it seems extremely obvious to me that if BRCA protects against cancer, then mutations in these genes could be related to cancer.

The point is which mutations exactly would you look for? How could you construct a hybridization probe to find mutations until you knew what the mutations were? Myriad's US 5,693,473 patent says the BRCA1 gene was previously localized to within 8 million base pairs (I have no idea whether that is true or not). So not only (according to Myriad) were the mutations not nailed down, neither was the gene itself. Myriad asserted that one of the cancer-linked mutations was a change in codon 1541 from GAG to TAG. Clear, specific, immediately apparent how and what to test for.

"Could be related" underscores the second point – uncertainty. "X could be related to Y" is an invitation to research, not an invention. Turn the reasoning around; with the insight that some as yet unidentified mutations somewhere in BRCA1 could be related to cancer, how exactly would you find out which patients were at risk?

Also, as indicated above, "obviousness" in patent law has a specific meaning. It doesn't mean obvious in the colloquial sense (because the patentee would inevitably argue that nothing is obvious, the accused infringer just as inevitably would argue that everything is obvious). To avoid playground-style "is so"/"isn't either" arguments, obviousness determinations rely on an operational standard: in an invention comprising two parts A+B (certain BRCA mutations and hybridization probes, for example), does a written document that suggests combining the two. So establishing obviousness here would require finding a reference that discloses the specific BRCA1 mutations listed by Myriad, AND suggests constructing hybridization probes to find them.

In fact the patent as I read it (currently) even protects the company against anyone using untested mutations with unknown consequences in the genes.

I'm not sure what you mean by this. The claims specify BRCA genes with certain specific mutations, set out in various tables in the patent, that are linked with increased incidence of breast and ovarian cancer. The patentee doesn't have to test every single possibility covered by the claims, but must test enough to make a convincing argument that most of the possibilities work (i.e., are enabled). Put another way, what is the value of assaying for mutations with unknown consequences?

"To add insult to injury, in order to be tested I have to allow an (in my view) unethical institute access to my private info.

Easy. Don't get tested. You're no worse off than you were before the assay was developed. Or only go to ethical institutes.

In any case, as pointed out above, any intrusion into your private information has nothing to do with patenting the assay. In this particular case, the EPO invalidated Myriad's patent in Europe; how does that help address your privacy concerns? I don't see any connection.

The fact that patent-holders can abuse the information people are forced to give them may have nothing to do with patenting in your view. It does however have very much to do with what I feel is wrong with patent LAW as it apparently does nothing to address socio-ethical concerns.

This baffles me. How are patent holders forcing people to give them information? No one is forcing people to have the test. How would abrogating the patent holders' rights stop abuse of any information they do get? How do the privacy issues here differ from those arising from, say, public domain STD tests? I don't see how patent law comes into this at all. One doesn't need a patent on a test to abuse information derived from its use.

"As a set of rules intended to facilitate progress I think patenting law should take notice of what the effect of a patent is on society, quite apart of the possible novelty issues etc."

To restate the point above another way, how exactly would you change patent law to promote privacy? How does one "take notice" of the effect of a patent on society, assuming one could reliably assess such effect in advance of the patent's issuance?

Privacy aspects are a red herring here. The operative question is the level of disclosure, the accuracy (how many sequencing errors should be allowed, and how distributed?), and the utility necessary to support patenting a gene, and what scope of coverage should be granted.

Permalink to Comment

8. Nick Henriquez on May 25, 2004 5:04 AM writes...

Hi SRC,

More and more clarification, especially for myself as to what precisely bugs me. But then that's often the way of discussions.

I agree that you SHOULD be right on your first two points. But consider the following:
1. People have indeed patented organisms, even though their added value was negligable from a genetic perspective.
2. The burden of proof of infringement may be on the patentee as you say. Trouble is by the time it GETS to court the individuals I was going on would likely have gone bankrupt or worse. We're not talking about farmers in the US with all sorts of legal protection. We're talking about the third world. Some of these people do actually live on the very edge of starvation/bankruptcy. They can't allow things to go that far and must therefore cave in to the stronger/richer patentee. There are whole hordes of people who will rather plea bargain than let things get to court even in the US and The Netherlands. Imagine how a third world farmer feels when a group of policemen come to arrest him, or even just to serve papers!

This is not a problem of the law per se, granted. This is a problem of it's application to people who literally cannot defend themselves. But this is exactly what would need to be remedied BEFORE patent law can be applied properly worldwide. History, even very recent history, clearly shows that humans will always find ways to abuse power over others.

I agree with SRC that this is strictly speaking the subject of a different discussion on ethics, not on patenting. However, at the time I was clarfying what was wrong about patenting (genes) in my view. Especially when the gene(s) in question are found out based on work performed by people living in third-world countries.

When we find oil in Ingeria everyone will agree that the Nigerians own the oil. A company will come in and get it out of the ground, but the Nigerians have an undeliable right to the bulk of the proceeds. The company will of course only come if it can make a profit. In my view this is how patenting "inventions" should work as well.

Now we get back to the "meat":
Lets keep things broad and ignore BRCA and go for the broad gene patenting business. Lets assume there's a list of mutations claimed to be linked to a disease. This list has been discovered by the patentee. The prospective patentee has devised a set of probes to detect these mutations and thus to test for an increased/decreased chance of the disease.

What has the patentee actually done? He (or she)has taken data from the human genome project, or at best performed a lot of sequencing himself. Using techniques devised over two decades ago he then statistically analysed a group of mutations with epidemiological data COLLATED BY OTHERS. In this way he found out that a certain disease is linked to a certain (set of) mutations.
Coming to the nowadays OBVIOUS conclusion that testing for these mutations can help assess risk of developing this disease he then goes one step further. Using STANDARD PROGRAMS he "designs" a set of nucleotides able to detect the mutation(s) efficiently.
Using STANDARD SOFTWARE he applies for a patent.

As the finding that disease X is linked to particular mutations the patent is granted.

Despite that the patentee has done only incremental work and not "invented" a single item on the above list we are now unable to perform this test elsewhere without infringing on the patent. This is not helpful to society, nor does it help progress.

Summarising: In my view nowadays gene patenting is wrong because it does not involve any creativity or special insight on the part of the patentee. I liken it to discovering a new well or a mine. Finding it may occasionally give me right to a one-off finders fee though many governments have laws preventing even that. It does not allow me sole access to the proceeds of said well/mine. These proceeds are after all the posession of "the people" who live in a country, not of one or two "discoverers". (And let's keep the discussion clean here and not go into exclusive mining rights forced on some governments by our multinationals).

This situation may have been different when the first gene was discovered, or the first time someone showed that a (set of) mutation(s) was linked to disease. But give it a rest. If I (re)discover the wheel today, no-one should allow me to patent it!

Permalink to Comment

9. SRC on May 25, 2004 2:47 PM writes...

Nick,

We are clarifying the issues. This is a productive discussion, and I very much appreciate its civility.

1. People have indeed patented organisms, even though their added value was negligable from a genetic perspective.

So some inventors have temporarily removed something worthless from the public domain. What's the problem? 99% of all patents (including my own, I'm sad to say) turn out to be worthless.

2. The burden of proof of infringement may be on the patentee as you say. Trouble is by the time it GETS to court the individuals I was going on would likely have gone bankrupt or worse. We’re talking about the third world. Some of these people do actually live on the very edge of starvation/bankruptcy. They can’t allow things to go that far and must therefore cave in to the stronger/richer patentee. There are whole hordes of people who will rather plea bargain than let things get to court even in the US and The Netherlands. Imagine how a third world farmer feels when a group of policemen come to arrest him, or even just to serve papers!

We're a bit unclear on the process. First, patent infringement is a civil matter, not a criminal one. No one does hard time for infringing a patent. No one gets arrested, no policemen are involved. No plea bargaining, no awaiting last minute calls from the governor, no one hanging on prison bars playing a harmonica.

Instead, patent infringement litigation is about money. From that perspective, it's apparent that there isn't much point in suing someone who doesn't have any. The patentee would still have to pay his own lawyer(s), and would have no hope of collecting anything in return – not a good business proposition.

In general, it's not worthwhile to bring an infringement action against individuals, even wealthy ones, because the cost for such a suit is so high (> $0.5 M). Instead, aggrieved patent holders go after whoever supplied, say, a patented article, rather than those who merely used it, much as one chops down a tree rather than pulling off every leaf.

Last, concern about third world farmers overlooks one fact: a US patent has no force overseas. A third world farmer no more has to worry about a US patent than he does US tax law (he catches a break there). Any patent problems he might have would arise from a patent issued by his own government, and not by the US, Japan, or any European country.

In fact, few inventors bother to file patents in third world countries, first because of the money consideration above, and second because third world countries adopt a, shall we say "relaxed," posture toward patent enforcement. So stories of destitute third world farmers broken on the wheel of a first world patent, while highly emotive, are simply not true.

I agree with SRC that this is strictly speaking the subject of a different discussion on ethics, not on patenting. However, at the time I was clarfying what was wrong about patenting (genes) in my view. Especially when the gene(s) in question are found out based on work performed by people living in third-world countries.

When we find oil in Ingeria everyone will agree that the Nigerians own the oil. A company will come in and get it out of the ground, but the Nigerians have an undeliable right to the bulk of the proceeds. The company will of course only come if it can make a profit. In my view this is how patenting “inventions” should work as well.

I don't quite understand how the Nigerian example relates to patenting genes. Could you elaborate a bit?

Lets keep things broad and ignore BRCA and go for the broad gene patenting business. Lets assume there’s a list of mutations claimed to be linked to a disease. This list has been discovered by the patentee. The prospective patentee has devised a set of probes to detect these mutations and thus to test for an increased/decreased chance of the disease.

What has the patentee actually done? He (or she)has taken data from the human genome project, or at best performed a lot of sequencing himself. Using techniques devised over two decades ago he then statistically analysed a group of mutations with epidemiological data COLLATED BY OTHERS. In this way he found out that a certain disease is linked to a certain (set of) mutations.

Every invention builds on work performed by others. No exceptions. The patentee receives protection for his incremental contribution.

As pointed out in an earlier post, the quantity or creativity of the work involved isn't relevant. The only relevant issues are whether the resulting invention is new, not obvious in view of what was known, and useful. If so, then the applicant is allowed to set up a toll booth and try to charge people to pass through it.

As for the age of the techniques, think again about mechanical patents. Look at US 6,530,332 (I haven't figured out how to hyperlink this – sorry), which describes an improved apparatus for plowing a field. Plows go back to prehistory; but this guy figured out how to make one that he says is better in some respects than existing ones. The examiner agreed that his apparatus was novel, unobvious, and of course a plow is useful, so he was allowed to set up his toll booth. He doubtless drew on the work of previous designers of plows, as well as on metallurgists, engineers, agronomists, and who knows who else. But if his plow really is better, why shouldn't he be rewarded for contributing his improvement? If people think his improved plow is valuable, they'll buy it, and he'll be rewarded; if not, not.

Coming to the nowadays OBVIOUS conclusion that testing for these mutations can help assess risk of developing this disease he then goes one step further. Using STANDARD PROGRAMS he “designs” a set of nucleotides able to detect the mutation(s) efficiently.
Using STANDARD SOFTWARE he applies for a patent.

Regarding "obviousness," please see my earlier post about the specialized meaning of this term in patent law. Also, note that it cannot be obvious to test for mutations that are not known. Once the mutations are known, it may be obvious to test for them, but the inventor is the one who made the unobvious contribution of identifying the mutations. Without that contribution, it would not be at all obvious what to test for, or people would have done it – and the invention would not be novel, and therefore not patentable.

Despite that the patentee has done only incremental work and not “invented” a single item on the above list we are now unable to perform this test elsewhere without infringing on the patent. This is not helpful to society, nor does it help progress.

I disagree. Of course he's invented something – he's invented a way of testing for susceptibility to a disease. No one knew how to do that before. Now they do – thanks to the inventor. True, he didn't invent software, or sequence the human genome, or collate epidemiological data, but then he didn't get a patent on them either. He got one for a medically useful test for susceptibility to a disease, which is what he contributed. And I think that very much helps society, and progress. How much he is rewarded depends on how many people use his test, and what they think it is worth to them.

Summarising: In my view nowadays gene patenting is wrong because it does not involve any creativity or special insight on the part of the patentee.

As discussed previously, creativity, insight, effort, etc. don't come into patenting. In essence, that argument derives from Marx's labor theory of value, that the value of something arises from the amount of labor that went into producing it, which on its face is silly. Do we create more value by mowing a lawn with scissors than with a lawn mower? The buyer only cares about the performance and cost of an article relative to the alternatives. He doesn't care how much effort went into producing it.

I liken it to discovering a new well or a mine. Finding it may occasionally give me right to a one-off finders fee though many governments have laws preventing even that. It does not allow me sole access to the proceeds of said well/mine.

These proceeds are after all the posession of “the people” who live in a country, not of one or two “discoverers”.

Why should you receive a finder's fee, or indeed anything, if you merely found something that already belonged to "the people"?

Why is something the possession of "the people" who live in a country? Why not just the people who live around the mine or well? Or, going the other way, the people who live on that continent? Or the people of the earth, generally? What's special about a country? Bear in mind that many third world "countries" are colonial constructs comprising a number of ethnic groups who've been at each others' throats from time immemorial. Residents of such countries would doubtless argue for ethnic group ownership.

And, for that matter, what's special about a well, or a mine? Why not land, or a house, or a car? In essence, that position disputes the right to own any private property, making everything subject to the oft-cited "tragedy of the commons." To put it in terms to which lab workers can relate, what is the worst-maintained equipment in any lab? Answer: the communally-owned equipment, because everyone figures that someone else will take care of it.

Last, digging wells or mines doesn't sound like much fun, especially when some attempts are (inevitably) fruitless. Why would anyone bother engaging in such labor if there were no reward for doing so? I certainly wouldn't.

This situation may have been different when the first gene was discovered, or the first time someone showed that a (set of) mutation(s) was linked to disease. But give it a rest. If I (re)discover the wheel today, no-one should allow me to patent it!

So, it is it only the first gene, the first mutation, that should receive a patent? W