DNA Code - IP or Public Domain?

Anonymous Coward writes "A British trust has warned Celera Genomics that data from Human DNA should remain in the public domain to maximize benefits for medical research. Celera is about to patent DNA structures after decoding about one third of the human genome. The Wellcome Trust is leading moves to stop the information becoming the private property of corporations. " Celera has been brute-forcing structures, enabling them to beat The Human Genome Project to the punch - and are filing for 6000 patents. Please contact the Wellcome Trust to indicate your support of them. Patent attempts like Celera's stifle scientific progress.Update: 10/26 10:00 by H :Thanks to net_shaman for the pointer to a similar article in The Washington Post.

This should not work

DNA IS DATA! Data is NOT patentable, any more than a christmas carol. You can COPYRIGHT data, but you cannot, and should never be able to, patent it.

I know the patent office disagrees, as they freely allow people to patent genes, but that is a clear violation of the patent concept and those people who allowed it should be shown the door. The sad thing is, the only door they're likely to be shown is the one to their new office, as they get to be promoted.

On the religious side (yes, there is an aspect to this that's definitely non-tech), we are approaching the end of the millenium. A flashpoint for several of the world's largest religions, all of which have bloody histories. Patenting something they claim ownership of could be just the trigger we DON'T need. I'd rather NOT be burned at the stake, because some company wanted to cash in on the gene-mapping craze, thank you very much.

Then, it would be an impossible patent to enforce. Yes, you can enforce the means of mapping, but that is VERY different from enforcing the genetic code itself. It'd be impossible to monitor for natural infringement (which WOULD count, as patents count against identical or similar inventions, even when no actual copying took place), and impossible to prove an absence of prior art. (You can't scan the DNA of every living person, let alone everyone who's died in the past 100,000 years.)

US Patents

While I don't agree that pre-existing natural 'source' should be patentable... I did a little research on it...

When you file for a patent in the US for anything including genome maps, you must publicly disclose it entirely within 2 years for patent protection.

Disclosure includes printed publications and/or a publicly accessible database. The US govt is then required to hold the information back for up to 3 years (usually less).

Now unless I'm mistaken, this means that you can go to IBM's little patent server instead of paying them for the information, though this might be considered illegal if you reprint it without permission.

Now in 1992 the NIH (National Institutes of Health) tried to patent several gene fragments and the PTO sent a rejection notice back to them immediately.

In 1997, the PTO said that it would allow expressed sequence tags (ESTs) to be patented. Now, ESTs are DNA sequences made up to a few hundred base pairs in length that can be used to identify the expression of specific genes.

As far as I'm considered, DNA is nothing more than the source code of life and should fall under the same catagory as algorithms when it comes to patents.

Now, patenting the effects of the new DNA is something entirely different. Should you be able to patent the method of replacing a specific sequence of old DNA with your particular new DNA sequences in order to change something, for example to change hair color in humans?

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Oh shoot, do I infringe?

Patenting DNA structures could lead to a whole new form of lawsuit. Since certain aspects of DNA structures are randomly determined (both through mutation and combination during sexual reproduction), it could be possible for anyone to infringe just by living.

I think that's pretty absurd.

"Oh, I'm sorry, we just got the patent on the gene which gives you blue eyes. We felt it was novel because of how it changes the pigment which colors the eye. License the patent or die."

Granted, I doubt that's their intentions. I can see patenting certain processes for building DNA strands, and perhaps even processes for integrating modified DNA within existing tissue. But patenting the DNA patterns themselves is like trying to patent any of nature's creations.

--Joe
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Re:Patent an existing creation?

I'm a scientist, not a patent laywer, so gross oversimplifications follow:
When one files a provisional patent application on a gene, one is not applying for a patent on the gene itself, but rather on a _use_ for that gene. For example, "gene_x for use in treating osteoporosis." You then usually have a year to prove your claims by providing data or at least showing that you are actively working on it rather than just sitting on it. If another company or academic institution finds that gene_x is actually involved in cancer, then they can pursue gene_x for use in treating cancer and you're SOL (shit outta luck).

The key is proving utility and this is why ESTs are unpatentable en masse. The patent office has set a very high threshold for proving utility when it comes to biotech patents; I've personally had to field questions from patent examiners and they can be brutal--for good reason: now that cDNA and sequencing technologies are so ubiquitous, pretty much anyone can generate sequence data, but not everyone can prove utility; proving utility requires time and money and, in most cases, innovation. A provisional application is as they say, "a stake in the ground" showing that you were here first--you identified this gene and you think it is involved in process X. If you can prove this, the patent may be issued to you.

I personally feel that the genome should be open source (and it will be), but I do feel that people who mine the data in clever ways and find interesting things should have legal protection for their discoveries. And let's face it: many drugs on the market are there due to the research of for-profit companies (they have bigger resources, harder timelines, etc. than academia) usually in collaboration with academia. If companies cannot profit on drugs they discover, then I wonder how much the rate of discovery of new drugs for treating diseases will decrease...

As for the whole Celera deal...I don't understand what people are getting so huffy about. I've spoken to Ventner and Celera and they've always planned to release the entire genome to the public, gratis. True, they aren't going to release it as soon as they get it (nor will they release all the work and analysis they've done on it), but the sequence itself will be released. Nothing they do with it will prevent academics from doing research...it may simply limit what other companies can do. It may be a moot point though since Celera at one point did get some DOE funding and this might make the United States Government a co-applicant of these patents. Co-applicants can make any patented claims public domain and the USG is likely to do this depending on how it all works out.

That's my 2 cents on a very complicated issue,
james

Re:It's just not that simple....

Jon Peterson wrote:

A discovery can reasobaly considered IP in some situations, and so can a description.

Yes, but there are three legal forms of IP: patents, trademarks and copyrights. You just can't say "it's valid IP, therefore they can patent it". Trademarks are just plain offtopic here, so I'll talk about the other two.

They could easily justify copyrighting their information packages (and probably are doing so). They charge for the information, and the copyright keeps the people they send it to from redistributing it legally, except for fair use.

They're talking about patenting it. Patenting genes has gone on for a while, particularly in agricultural circles. If you patent a gene, nobody can USE the gene without a license. You buy a bag of genetically altered seed, part of what you are paying for is the license to use the patent on those genes. Here, they are making two big jumps from "mainstream" genetic patents:
* it's human genes now
* it's naturally occuring genes now

People are hopefully going to be more outraged now that we are messing with human genes. On the other hand, it's the second part that makes it more legally outraged. You should never be able to patent a discovery. Patents are for inventions, for novel ways of applying things. I might as well patent the oak tree outside my window, there's a lot of information there, it must be IP.



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What the Patents Do

A lot of people have posted comments to the effect of `Will I have to pay royalties if they`ve patented the gene for blue eyes?`. That`s not what the patents are for. The patents prevent other researchers from working on the same gene. This means that a company can hold onto a gene that could be a useful target for gene therapy, and no other company would be allowed to research it, even if the company who filed the patent thought it not worth their while to look into it. This is an indisputably Bad Thing.

If you actually look at a gene patent [usda.gov], you`ll see that what`s patented is the isolated form of the gene, not the gene in the context of the genome - along with methods for purifying and assaying the resulting protein. What is not covered in this patent is the gene in situ. So people with blue eyes, or whatever, needn`t get worried. The gene in your body isn`t patented. What`s worrying is the idea that because a company is patenting so much, it`ll be years before they get round to looking at some of the genes, some of which could be useful either in terms of finding out more about the way humans work, or in terms of finding cures for inherited disorders. The company can sit on the gene, safe in the knowledge that, because it`s patented, no-one else is going to research it until they`re ready.

The thing is, this gene patenting idea is fairly recent. But these days, academics, too, are having to patent their research just in order to prevent their work from being stolen out from under them. This goes completely against the information-sharing ethic that has always been a part of academic science.

So, not quite as scary as the idea of paying royalties to some corporation for your brown hair or strawberry birthmark, but scary nonetheless. Mass patenting of genes is already stifling research. Mass patenting of human genes can only make the problem worse.

Slightly offtopic but related

They're auctioning off the genetic material of "beautiful people". Ron Harris has arranged for an auction of eggs from eight models. You can read more about it from here:
http://abcnews.go. com/sections/us/DailyNews/modelseggs991023.html [go.com]
Or, you can go straight to the website here: http://ronsangels.com [ronsangels.com]

Next up from the site, a sperm auction.

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Sequences, not structures! A complex issue.

Celera is brute forcing DNA sequences, not structures. IIRC from my days as a biochemist, getting a sequence for a gene is the easy step. Determining what the gene does is the hard step, and getting the structure of its protein product is even harder.

What could become A Big Mess (TM) is what a gene patent actually means. It is not difficult to devise a DNA sequence that is different from the wild type that generates the exact same protein, or a slight variant with the same biological function. A bit farther in the future we will have more ways of generating proteins through protein engineering.

But wait, there's more. You can mass-produce the product of a gene without knowing or caring about its sequence or structure. Does the gene patent cover the product of a gene? I realize our patent system in the US is horribly broken but it is my understanding that patents are for specific processes, not for any process that serves a specific goal.

This issue reminds me of the need we have for formalizing defensive patents. A lot of companies issue patents simply to prevent others from doing so, and plan not to profit from them. Celera claims to be doing this, essentially. If there was only a way to guarantee that this were true, and prevent future management from reneging on the promise... then our lives might become a lot easier!

In any case, abusers of this system will eventually be frustrated with the progress of technology, as they are in other areas.

Why the USPTO thinks genes are patentable

This is from a pull-together of summaries by Science Week on gene patenting stories. It is no longer on their site, but is cached on google at

htt p://www.google.com/search?q=cache:9485790&dq=cache :scienceweek.com/arch2.htm [google.com]

The pull-together also includes several other summaries of on-topic stories.

The original article was in Science, 1 May 98 280:689, by John J. Doll (US Government), Director of Biotechnology Examination at the US Patent and Trademark Office

ON THE ADVANTAGES OF DNA PATENTING
In the international community of molecular biologists, a debate has been underway for some time concerning the patenting of DNA. Now John J. Doll (US Government), Director of Biotechnology Examination at the US Patent and Trademark Office presents the following points concerning this issue:

1. Just as the issuing of broad product claims at the early stages of polymer technology did not deter development of other new vulcanizable copolymers, the issuing of relatively broad claims in genomic technology should not deter inventions in genomics.
2. The same patentability analysis is conducted for every patent application, regardless of whether the application is for a computer chip, a mechanical apparatus, a pharmaceutical, or a piece of DNA. In every field of technology -- whether emerging, complex, or competitive -- all the conditions for patentability (such as statutory subject matter utility, enablement, written description, novelty, and non-obviousness) must be met before a claim is allowed.
3. In order for DNA sequences to be distinguished from their naturally occurring counterparts, which cannot be patented, the patent application must state that the invention has been purified or isolated or is part of a recombinant molecule or is now part of a vector.
4. Once a product is patented, that patent extends to any use, even those that have not been disclosed in the patent. A future non-obvious method of using that product may be patentable, but the first patent will be dominant and a license for the use of the product may be required.
5. Without the incentive of patents, there would be less investment in DNA research, and scientists might not disclose their new DNA products to the public. It is only with the patenting of DNA technology that some companies, particularly small ones, can raise sufficient venture capital to bring beneficial products to the marketplace or fund further research.
6. A strong US patent system is critical for the continued development and dissemination to the public of information on DNA sequence elements.

   QY: John J. Doll, Technology Center 1600, USPTO, Washington, DC 20231 US.

   (Science 1 May 98 280:689) (Science-Week 22 May 98)

For a contrary view, this position paper from the American Society of Human Genetics, on the earlier issue of expressed sequence tags is worth reading:

http://www.faseb.org/genetics/ ashg/policy/pol-08.htm [faseb.org]

How do you patent found data?

I don't understand how you can patent decoding something? Sure, the decoded data may be very valuable but it isn't your invention. It may be appropriate to patent the tools and techniques involved in the decoding process, but I don't understand how decoded data can be patented.

Suppose I decode the file format for Microsoft Office 2000? Can I then patent it? I'd love to have Microsoft have to pay me for reverse engineering their work but it doesn't seem realistic.

In the future I can see patenting DNA as a creation: specialized DNA which is the result of some large and expensive research and design process but even then as only a delta to some established DNA. You'd get a patent on the incremental improvement, not on the whole DNA structure.

The patent officers should ask themselves whether it would be appropriate to patent the image of man which would be roughly analogous to patenting its DNA.

Re:capitalism

True, but the line gets a lot blurrier at so-called "intellectual property." Can an idea be patented? Look, for example, at the RSA algorithm. R, S, and A did not create it; they merely discovered it. Not only this, but they published it far and wide before ever even applying for any patents (that's why to this day you can find it in any decent text book on discrete mathematics and number theory).

Now, we get to the human genome. One could argue for "prior art"; after all, I can think of six billion examples currently in existence, and untold billions before that. But the fact is, do we really want someone patenting human genes? Or is this an abuse of the patent system which really doesn't do anything to protect inventors (which is the purpose of the patent system, not protecting business).

Let's put another way. Suppose I were to patent a process consisting of a two major devices (called a "protagonist" and an "antagonist") and a variable number of secondary devices (called "major and minor characters). This process describes an interaction between these devices, including both action and dialogue, and determines an outcome which affects all devices in the process. The process itself is usually documented in books, but can be documented by electronic means or even on motion-picture film.

I just tried, in other words, to patent stories. If I get this patent (which may actually be possible; hell, IBM patented the wheel), I've basically bound every non-technical writer in the country to come to me and pay before releasing any of their work. Is this right? Of course not. The patent does not reflect any work I did at all.

It's the same with human genes. It's nothing but raw data. There is no process described (perhaps pattenting the process by which the data was obtained is one thing, but this is not the case). The data was not even really the creation of the scientists; they merely studied it. Can you patent a piece of paper with some numbers written on it?

The same argument applies to software. Patenting an algorithm does not reflect the work of a company. What reflects the work of a company is its specific implementation of an algorithm (in other words, its code); this cannot be patented but copyrights provide adequate protection of intellectual property of this nature (and, at least when issued to individuals, they can last up to ten times longer than patents, not to mention that they're far less expensive).

I would have no objections is this company were merely patenting the process by which they got this data. That would be highly unscientific, of course (since it kills replication of the experiments, one of the cornerstones of real science), but certainly within their rights. If they copyrighted their data, I wouldn't object; might as well, if only to keep someone from messing with it and re-releasing it for whatever reason. To patent the data they obtained, though, is very different.

Lied to congress?

Despite assurances earlier this year to the US Congress that Celera's discoveries would be freely available, Dr Venter is now seeking to patent more than 6,000 pieces of genetic information.

Ummm.. Isn't that technically purjury under US Law? I recall something like this.. not sure where I read that from, but the gist of it was you can't lie to congress for any reason, or something to that effect..

This only applies if he's a US citizen I suppose..


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Re:How do you patent found data?

Let's suppose I discover some obscure fungus in the Amazonian rain forest, and furthermore my testing shows that it cures cancer. Should I not be able to patent that?

No - you can patent the drug you made from this fungus, but not the fungus itself. The work you expended was turning a fungus into a useful drug, and this is what is rewarded and protected.

Suppose I discover some South American farmer has a tomato cultivar that resists blight. I take a sample back to my lab, figure out which genes are responsible for the resistance, and transfer them to cultivars with more desirable commercial properties. Should I not be able to patent that?

Again, you should be able to patent the product of your work, not the raw materials. The tomato already exists - how can you patent an object (for it is an object, _not_ an idea or a concept) which already exists? That goes against the whole concept of "invention" which is key to patent law.

Let's suppose that I discover that adding baking soda to motor oil (not recommended!) doubles engine efficiency. Should I not be able to patent that?

Yes. You can patent "hey!s Wonder Engine Treatment 2000" which happens to be a scientifically blended combination of engine oil and baking soda. But that is not analogous to this situation. It's more like you discovering this wonder lube, and then trying to patent it's building blocks (i.e. engine oil and baking soda) rather than the product itself. I shall try to explain my understanding of the diffence here: The oil exists. The baking soda exists. The wonder lube is invented by combining the two. This is a new invention and so is patentable. By contrast: The DNA exists. The gene sequence is derived from the DNA by application of a known mechanical process. Nothing new is created or invented. There is nothing new here...how can it be patented? Can I patent your street because I sketch a map on the back of an envelope? Then I could charge you money if you write your address on a form. Hmmm....

For me, the thing I don't like about gene patents is that you can, presumably, get them just by mechanically sequencing base pairs. In my view, it is insufficiently creative to warrant society granting it the status of intellectual property, whatever its legal status. In this sphere, patent protection doesn't incent originality, it merely creates an artificial gold rush. I think you should have to show some novel intellectual insight, sufficient to suggest some non-obvious kinds of applications. Particularly in cases of biological patents, I believe not understanding the biological function of the "discovery" should be sufficient grounds to use the discovery outside the sphere of understanding of the "inventor".

Right on :-) I have no problem with companies patenting drugs, treatments, cosmetic doodads or whatever they create from using this information. But you simply cannot justify a patent on the information itself, IMHO.

It's just not that simple....

First off, HUGO, the Human Genome Project, will in any event publish this particular information in due course.

A discovery can reasobaly considered IP in some situations, and so can a description. For instance, the Ordinance Survey have the rights to their particular description of the topology of Britain. All they've done is draw something that everyone has access to, but they've drawn it in a particular way. The OS can sue me if I use their maps in a book without permission. They can't sue me if I use their maps to work out how tall a mountain is, and then put that information in my book. Nor can they sue me if I draw my own maps from my own observations.

What is Celera proposing? That no-one may every make use of the human genome data without their permission? Or are they simply saying that if they go to the trouble of describing the genome in a useful way, and packaging it up, that people will have to pay to get that package. If the latter, I see no problem.

If they are trying to patent the Genome itself, then its farcical. If they are trying to patent their tools for working it out, or their method of displaying it, or their tools for making it searchable, that's fine.

A particular description of something is patentable, the thing described isn't necessarily.

Now there are grey areas. Could the first person (it may have been the OS) to come of with the idea of contour lines have declared them IP? Well, that's a grey area, and that's the controversial area, but it's unclear to what extent Celera are trying to do something like that.

Patents vs. Trade secrets.

Trade secrets are moraly preferable, since, unlike patents, they don't limit the freedom for other people to use information they have found for themselves.

In this case they are also practically preferable, since the human genome project will make the information available to everybody.