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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? What about the second? The third? How many genes should be patentable before closing the window?

No one would allow you to patent the wheel today, unless you provided a new, unobvious improvement of it. Then…another story. And so it should be.

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10. Nick Henriquez on May 26, 2004 11:43 AM writes...

Hi SRC, I agree things are geting more specified. Although I would like tobe as thorough as you time constraints prohibit this at the moment. I will do my best:

"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."

One problem is they use their patent to threaten others with lawsuits. They also use it to block others (usually even less well versed in patent law than I am) from either using their invention freely and/or from actually filing a patent themselves. In the rich countries we have support systems allowing us to pursue such things. Others are not so lucky, but they are deserving inventors! The only way they can get their patent is often by allowing company X to file on their behalf (for a very fat fee of course). Company X often being (one of) the filer(s) of spurious other related patents.

"Regarding “obviousness,” please see my earlier post about the specialized meaning of this term in patent law."
Precisely one of the reasons patentees are likely to be experienced patent-filers who know/see that what is "obvious" to everyone else isn't to a patent office. Hence, patenting is for insiders and thus "unfair" to many inventors around the world.

"Also, note that it cannot be obvious to test for mutations that are not known."
No, actually it is VERY obvious and the mutations identified by e.g. Myriad were detected precisely because those mutations are exactly what people are trying to find. In fact the whole human genome project was started in order to identify normal and abnormal sequence variations.

"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."
Yes. Problem is that this particular "inventor" wasn't doing something inventive. He/she was simply trying to scoop an ongoing project using resources largely funded by taxes.

"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."
The "people" were pipped to the post, a regular occurrence as scientists have different interests.

What goes wrong is that the patentee is allowed to abuse the power of a patent by preventing free access to certain healthcare.The patent was made possible by tax-funded projects. the patented information would have surfaced relatively short time later if the patentee hadn't messed things up.

"As discussed previously, creativity, insight, effort, etc. don’t come into patenting."

I noticed that. In fact it seems to be perfectly OK to patent information generated by others funded by taxes and then to keep the profit. Don't you agree something is very wrong with that?

"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"

No, my argument derives from the fact that if something is obvious, then it can't be non-obvious. I disagree that the original intention of patent institutes could possibly have been to reinterpret the vocabulary.

I've done some refreshing of my memory and found this definition for INVENTION in the "Inventor's Glossary":

The creation of a new technical idea and of the physical means to accomplish or embody it. The act of inventing through original conception and reducing the concept to practice. An invention described in a patent application must contain, at a minimum, every element found in the patent claim.

I am arguing (and have been throughout) that "detection of (even new) mutations to identify disease risk" is no longer a new technical idea. The application of any (newly discovered) mutation-detection by standard means including the production of a DNA-copy for this purpose should in my opinion fall at the first hurdle. If the patentee simply stumbled upon an aberrant sequence just ahead of a large (tax-funded remember?) pack and did not come up with a novel way of checking for the abberation there are no grounds for allowing a patent in my view.

I will have to sort through our problems on why certain things are "common property" by law and others are not another day.

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11. SRC on May 26, 2004 2:51 PM writes...

[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.]
One problem is they use their patent to threaten others with lawsuits. They also use it to block others (usually even less well versed in patent law than I am) from either using their invention freely and/or from actually filing a patent themselves. In the rich countries we have support systems allowing us to pursue such things. Others are not so lucky, but they are deserving inventors! The only way they can get their patent is often by allowing company X to file on their behalf (for a very fat fee of course). Company X often being (one of) the filer(s) of spurious other related patents.

If the invention is worthless ("negligible added value"), then who cares whether they block others from using their invention? More to the point, why would they waste their time threatening lawsuits to protect something worthless? Who locks up his garbage?

Conversely, if others are put out by not being able to use the invention freely, then presumably the added value of the invention was not negligible after all.

Similarly, if the invention has negligible added value, then why would others want to file patent applications on it? And if they did, wouldn't they come in for the same opprobrium now directed at the first inventor/applicant? Why would the second applicant be a deserving inventor, and the first not?

Basically, either the invention has value or it doesn't. If it does, then the inventor should be entitled to remove the invention from the public domain (i.e., receive a patent) and to enforce his proprietary rights. If it doesn't, he should have exactly the same entitlement (assuming in both cases the invention is novel, etc.), it's just that he'd be a fool to exercise those rights (or to file in the first place).

[Regarding “obviousness,” please see my earlier post about the specialized meaning of this term in patent law.]
Precisely one of the reasons patentees are likely to be experienced patent-filers who know/see that what is “obvious” to everyone else isn’t to a patent office. Hence, patenting is for insiders and thus “unfair” to many inventors around the world.

Drawing up a patent application (as distinct from inventing) is a job for those who know what they're doing, but that's true of most home plumbing and electrical work too. That's why most inventors have recourse to patent attorneys, but they are not required to do so. I don't see the unfairness here.

[Also, note that it cannot be obvious to test for mutations that are not known.”]
No, actually it is VERY obvious and the mutations identified by e.g. Myriad were detected precisely because those mutations are exactly what people are trying to find. In fact the whole human genome project was started in order to identify normal and abnormal sequence variations.

The operative phrase here is "trying to find." Yes, many were trying to find the mutations, but whoever actually did find them should be entitled to a patent. No prizes for placing or showing – got to be first. The fact that others were trying to do the same thing proves that the inventor did something others considered valuable, because they were trying to do it too.

Regarding obviousness, let me try again. It would be obvious to test for mutations linked to disease if you actually knew which mutations those were, but it's not obvious which mutations you need to test for. Put another way, was it obvious to test whether codon 1541 had changed from GAG to TAG? I doubt it.

In similar vein, it's obvious that a compound that kills only malignant cells and has no toxicity for normal ones would be useful in cancer therapy. So, what compound would that be? Ah, there's the rub, because that's not obvious at all.

[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.]
Yes. Problem is that this particular “inventor” wasn’t doing something inventive. He/she was simply trying to scoop an ongoing project using resources largely funded by taxes.

So…if someone is working on a project, everyone else should step aside and leave them to it? What if Myriad started trying to identify these mutations before the human genome project did? Should the human genome project back off?

Actually, the backers of the human genome project should be (and probably are) pleased by identification of cancer-related mutations – a major rationale for the project was to provide the technical infrastructure to allow identification of disease-related genes.

[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.]
The “people” were pipped to the post, a regular occurrence as scientists have different interests.

Which people are we talking about? Aren't scientists people too? Or are we using "the people" in the Berkeleyesque sense? Whoever they are, if they want to avoid being pipped at the post, they need to move faster than their competitors if they want to be first.

What goes wrong is that the patentee is allowed to abuse the power of a patent by preventing free access to certain healthcare.The patent was made possible by tax-funded projects. the patented information would have surfaced relatively short time later if the patentee hadn’t messed things up.

Free access?? Air is free; everything else you pay for. If you live in a country with national health care, don't for a minute think that you get "free" health care – check your pay stubs to figure out just how much you pay for, e.g., in the UK, national insurance. Healthcare is never free; it's just that for some of it, you don't pay at the time of service because you've already paid.

So the invention was made possible by tax-funded projects. Suppose those projects didn't exist, but that the inventors drove to work over a tax-funded road. Or the inventors received their education(s) at tax-supported universities. You could still argue that tax funding "made the invention possible" – and you'd be right.

Making the invention possible is not the same thing as creating the invention.

[As discussed previously, creativity, insight, effort, etc. don’t come into patenting.]
I noticed that. In fact it seems to be perfectly OK to patent information generated by others funded by taxes and then to keep the profit. Don’t you agree something is very wrong with that?

No, I don't. Quite the contrary; it's a major purpose of tax subvention of research, at least in the US, to provide the requisite technical infrastructure that will ultimately improve health care. Most in the US see the government's proper role as tackling those jobs that are too big (e.g., building roads and dams) and/or those for which the benefit is so far off in time, or so widely distributed over the population (supporting basic research; defending the country) that no private organization is likely to perform that function.

In fact, the Bayh-Dole Act requires American universities to attempt to commercialize tax-funded inventions by licensing them to for-profit companies (and further requires universities to share revenue from such licensing with the inventors). So far from being an outrage, the government (here, at least) insists that tax-funded research be turned into some private company's profit, if at all possible.

(Also note the Small Business Innovative Research (SBIR) program in the US, where the whole idea is to give nascent small businesses tax-derived assistance ultimately to become profitable later.)

So I have no problem with a company building on tax-derived information to make a profit (on which the company would pay corporate income taxes, and from which the company would pay employees and stockholders, who would in turn pay individual income taxes). The government – and I – would call that a laudable outlay of tax funds, because it improves health care and builds the economy at the same time.

I am arguing (and have been throughout) that “detection of (even new) mutations to identify disease risk” is no longer a new technical idea. The application of any (newly discovered) mutation-detection by standard means including the production of a DNA-copy for this purpose should in my opinion fall at the first hurdle.

So…if detection of such mutations is not a new technical idea, then it's not publishable, right? If applying standard means to grind out yet another mutation provides no conceptual advance, then there's no point cluttering the primary literature with it. We should stop funding such work and fire all the researchers who've been wasting their time on it. We wouldn't publish papers on, say, combustion analyses of organic compounds, nor would we fund grants to perform such analyses, because they too provide no conceptual advance.

I disagree with this. I think that detecting each new such mutation is a new technical idea. Detecting such mutations as a generic notion is not new, granted, but each such specific mutation is.

(Novels and films are not new, either, although specific instances of them are, which is why they can receive a copyright.)

If the patentee simply stumbled upon an aberrant sequence just ahead of a large (tax-funded remember?) pack and did not come up with a novel way of checking for the abberation there are no grounds for allowing a patent in my view.

"Just ahead of a large pack"? How far ahead of the pack does someone have to be before his application should have merit? How large does the pack have to be?

I would argue that he did come up with a novel way of checking for the aberration; he devised a probe to find it. Sure, lots of other probes already exist, but they don't find this aberration. This particular probe is novel, and as such provides a novel way of checking for the aberration. As above, the generic notion of a probe is not new, but this specific example of a probe is.

So I would consider whoever did this first fully justified in receiving a patent for his contribution.

Permalink to Comment

12. Nick Henriquez on May 27, 2004 11:59 AM writes...

Thanks SRC,

There remain many things which we'll have to agree to disagree on. You're better-versed in certain details than I am others I'll come back to below. (By the way, how do you get the italics, I can only manage simple text in these comments).

When the US-government requires institutes to licence (if possible) then I assume the institute benefits as well right? So we can agree this is a good thing, both parties benefit. In such a setting tax-dollars are used not only for the profit of a company but also for the profit of the institute/department that put in the original work. A very important point to me.

My problems usually develop when a clear (re)search direction is indicated by a "natural mutant" developed e.g. in the third world and then the preliminary inventor doesn't get ANY compensation from a first-world patentee. Sure the patentee may have had to clean up the data, however in case of university-lincencees surely further development was required as well.

This also covers your tax-subvention point by the way. We can agree that is IS OK to use tax-dollars for profit. However, with (on my part) the proviso that the tax-funded institute that made the original investment should be co-beneficiary of said profits.

You make a decent point with your "trying to find" section. First come first served. However, as I understand it patenting is meant to facilitate/enhance progress in UNCHARTED or HIGH-RISK areas. There is no point in giving breaks to people/companies for things which are easy after all. Me-too research can be very lucrative, but in my view we shouldn't encourage the vultures. The efforts made possible by patenting should indeed be concentrated on "making the impossible possible".

So this bring me back to the theme that what patenting should do it doesn't. What it does manage is to enhance the position of rich patentees, even just by the expense of applying for one.

As for your "stepping aside point", no of course others can also do similar research. However, as these "others" didn't come up with the idea themselves, credit/benefits ought to extend to the "originals" as indeed usually happens in science.
We all know of examples where we're sure someone "stole" an idea. In science, such people usually are avoided like the plague once caught, in business it seems such people are often called "entrepreneurial" and celebrated for stealing other people's creative ideas.

Problem with patenting is not so much that it's first-come-first-serve but that it's prohibitively expensive to try and prove that actually, the patentee was NOT the first to discover something. Especially if the patentee is a big company. By the way, this goes in support of my point that patenting is NOT a level playing field and certainly doesn't favour inventive people.

Coming back to the guy stumbling ahead of the pack etc. My view is that genes are not patentable, period. Not even the first one. But by definition only, the discovery of the first gene did involve true creativeness etc. My reasons for not wanting it to be patentable are simply that parts of nature should not be patentable in any way, shape or form.
Like you stated at some point, if you synthesise ferric oxide this doesn't allow you to patent rust. Great, so we agree, but why should a DNA construct be patentable then?

The probe we were discussing isn't novel. It's a copy of something that's out there in nature. The idea for using it for detection isn't novel either, at least not as a principle. The first vacuum cleaner was patentable (and likely has been patented at the time). To patent a second one you have to come up with new/better parts. Where are the new parts in this DNA sequence? Where is the new methodology? This is a point where we're likely to have to disagree. I'll have just this one more go:
New books have copyrights and that's as it should be. DNA on the other hand shouldn't be copyrighted. In fact it can't be, because that would cause uncounted organisms to be liable for infringement of copyrigt just whilst reproducing or multiplying some cells. Why? Precisely because DNA (fragments) are NOT new inventions, they are (copies of) naturally occurring products.

As for publishing. That's a different kettle of fish. I can publish a new bird variety when I see it. Even an old bird variety in a weird location has novelty value. What I cannot do is prevent others from looking at the bird or mentioning that it can be seen somewhere. When people later mention the bird it would be nice if they also mentioned I saw it first, but I can't sue if they don't. This is how I think new DNA sequences should be handled as well.

So when I find a new mutation I could publish I found an odd sequence. I could perhaps mention that, by the way, those with the sequence are more/less likely to have a certain disease (so doctors take note!). Certainly not a patent in my view, at this point it's no more than a mediocre publication. To make it a good one I have to show WHY the DNA-variant has this effect. Even then it is unlikely that I will find something novel enough to patent, but as you pointed out others have a different opinion.

Last but not least, benefits to healthcare. We're both all for those I believe. But I doubt the US government is very happy about the COST of healthcare brought on by patenting which I have been arguing to be excessive. If more was done to increase the returns for institutions from tax-funded research-patents (as encouraged by licencing) maybe things could improve.

In fact I even believe that the US goverment has threatened to do just that (some act that NIH funded work can be used to overturn patents?).

Every country wants and deserves a reasonable quality of healthcare. Where patenting is most rampant, this healthcare is most expensive and many people simply miss out due to the cost of insurance. Excessive cost (brought on by over-chrging patentees) thus is detrimental to healthcare.

Funnily enough, as discussed elsewhere in this blog, the big companies holding the patents are NOT the best innovators. So even whether patenting helps innovation is becoming moot.....

Permalink to Comment

13. Nick Henriquez on May 27, 2004 12:50 PM writes...

One more point I forgot:

Writers get copyrights. When does a book become a new book? Surely you wouldn't argue that they can get copyrights by printing the same book, but with ONE SPECIFIC misprint (even one altering the meaning of a sentence)? When the book gets translated the writer still receives the copyrights, not the translator. If a writer COPIES words that were already "out in the open" he gets no copyrights. Even if no living person but he/she knew about the words that were there before (at least not unless he/she manages to keep that part secret).

So here we have a different type of book. Written by nature and freely copied by all life on earth. Now why would we start paying copyrights just because someone has worked out the precise (mis)spelling of a particular word? I still don't see it...

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14. SRC on May 27, 2004 1:45 PM writes...

Nick,

I think we've passed beyond the point of productivity in discussion, and will have to agree to disagree a bit. It's been a stimulating discussion, and as indicated earlier, a civil one, which I very much appreciate.

I'd only make one last comment regarding health care costs. Health costs are high in the US not so much because of patents, but because American consumers pay virtually the entire cost of R&D for new drugs.

By the time a drug is approved drug manufacturers typically have about five years of patent exclusivity in which to recoup their sunk costs before having to compete on an equal basis with generic manufacturers. Recovering 10+ years worth of R&D expenses in five years of sales, and concentrating that cost recovery in one country, means that country's price for the drug will be sky-high.

The rest of the world, by setting drug prices artificially low (most other countries constituting monopsonies by virtue of their national health care organizations), essentially get a free ride on the backs of Americans (who not only pay for the cost of finding and developing the drugs, but also pay for much if not most of the basic research that enabled the drugs – e.g., the human genome project you cited).

It's grossly unfair for wealthy developed nations to dictate low prices in this way, but they get away with it because it's easier for American politicians to demonize drug companies than to point this out. (Drug companies are not in danger of beatification, of course, but while they're profitable, they're not outrageously so, and they have the stock prices to prove it.)

High health care costs in the US therefore result largely from the manipulation of the market (and consequent exploitation of the US) by the other G7 countries, not to patents (which those countries also have).

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