Human Genome and patents

Great Debates
1

In various threads discussing the ramifications of the Genome mapping, and of advances in genetic engineering in general, I keep hearing the refrain “we don’t need to deal with the [moral/political/whetever] issues yet, we’re a long way from [knowing enough/being able to do enough] for that to matter”.

Yeah, we are in the beginning stages of a lot of this, and it may be another generation or two before a lot of current speculation becomes practicable. OK.

But if that’s true, what’s with all the stories of people trying to patent portions of the genome, or various genetic sequences, or what have you?

If we’re allowing patents on this stuff, then I don’t think it’s premature to start sorting out the ethical issues.

But there’s a lot here I don’t understand. Leading me to two questions:

  1. What, exactly, are the proposed patents proposing to patent? How can they be patenting something that “we don’t know enough about yet”?

  2. When exactly is a good time to start sorting out the moral/ethical ramifications? Don’t we need considerable lead time on this sort of thing anyway?

About #2: If you are a geneticist, I’d be very interested to hear how and when you bring ethical considerations to bear on not-yet-fully-developed technologies. I am not looking to get into an argument about what is ethical and what is not (plenty of other threads for that), I’m trying to get a handle on the process by which ethical considerations are to be integrated into our science as we move forward, and I’m trying to get a viewpoint from people working in the field.

2

I am not a genetecist, but I have a problem with the whole concept of patenting something that is already in wide common usage, and has been for thousands or millions of years.

Patents are for inventions. Figuring out something that’s already there is not an invention. Hell if somebody should be able to patent the makeup of my body, when they had no hand in making it.

The only patent I would consider reasonable would be a defensive one, placing the information in the public domain. Fortunately, I have read this was the intention of one of the projects. Was it the one that claims to have finished? Who knows.

3

Patents aren’t only for machines. You can patent a process, such as a new way to smelt iron, for example. IIRC, the gene patents fall under the class of “composition of matter” patents. In this way, they are similar to patents on drugs (which expire after 10 or 15 years; I’m not sure if this is true of the gene patents).

I’m not a patent attorney or a geneticist, so my information may not be 100% accurate, but I believe that you can’t just patent a gene. You must be able to show some utility. If you develop a genetic treatment for, say, diabetes, then you can patent the gene for insulin (I’m sure this is a wild oversimplification). But if you can’t show how you would use the gene, you can’t patent it, even if you are the first person to discover it.

I’m very unsure about this next part, but I believe that if you patent a gene for a certain use, someone else can theoretically patent the same gene for a different use.

With respect to the ethics of the whole thing, I would say that it would be unethical to just patent a gene so that no one else can use it for anything. Fortunately, that’s not possible under the law. But if I want to make money off my genetic treatment for asthma, how is that different from Eli Lilly making money off it’s patent for Prozac?

I realize this doesn’t address question #2. I guess I would say it’s never too early to start thinking about ethics. But I don’t know anything about the institutional process of incorporating ethics into the practical applications of science.

4

While I don’t want to focus the discussion solely on the patenting of actual genes, it was this I was originally thinking of. At one point the NIH and others did submit patent applications for “naturally occurring” genes. The NIH patent application was later withdrawn, but I understand that there are still corporate patent applications seeking to do exactly this and that the issue remains unresolved (and I am having a helluva time trying to track down the facts of the matter on the Web!)

again, if we can try to patent it, I think it’s not too early to discuss the ethical ramifications.

as for part 2:

Maybe I was unclear. I guess when I said “process” I wasn’t thinking of anything one would formally write down. I was thinking this:

If a geneticist says “we can’t do that yet, so it’s premature to argue the morality of it” are we to conclude that until we can do it, we shouldn’t worry about it?
That seemed to me to be a rhetorical question whose answer was clearly no. But then, addressing the same folks I’m paraphrasing, when along the road from idea to reality (what I meant by “process”) do you begin to seriously consider those issues?

C’mon, I know there are people who work in the genetics field on this site. Where are you guys?

5

I’m only going to attempt to address #1 here.

IIRC, current law does allow you to patent human genes that you have discovered. This does not meant that once you “own” a gene, every human has to pay for the right to make that protein. It does mean that you theoretically have the rights to any drug your discovery leads to, or at least some part thereof. This is arguably justifiable, since finding the gene has, at least until now, been a huge part of the process. However, AFAIK, these patents have not been tested in court, and it’s very questionable whether the Supreme Court would uphold their legality. No one really knows.

Actually, a side benefit of this is the speed at which the Human Genome Project progressed. There were two main groups working on it, the NIH and a private corporation (I forgot the name - it’ll be in any news story about the project recently). As I heard it, they were in competition - the NIH wanted to find as many genes as possible and release them into public domain before the corp found them and patented them. The competition sped up the whole process.

6

The corporation that the NIH and the NIH’s british group allies were racing against was Celera. Celera bluntly stated its intention to patent everything it could, and NIH sped up in response, their stated purpose being in an attempt to put the entire genome into the public domain so it couldn’t be patented.

7

Let’s say I am a genetecist. I work for 3 years to isolate a gene. I finally find it. I don’t know everything that it does, but I have a rough Idea. Let’s say I can’t patent it.

Glaxo-Welcom comes along and uses my data, cures cancer and makes a trillion dollars.

Now, if I get nothing for my discovery because I could not protect it, why should I bother to do any more work on a gene?

8

From the gene itself, or from leveraging information about the properties of the gene? (I don’t think that’s splitting hairs.) Maybe we should focus on protecting the latter. (I’m not even sure that a patent would be the method, but I can see your argument for the need.)

I see your point about wanting to protect one’s livelihood. On the other hand you made it kinda harshly, and I’m thinking: “yeah, why should anyone work to cure cancer if we don’t get paid for it. I mean, what’s the point? In fact, why cure AIDS, or anything else for that matter. Hey, why not re-introduce smallpox, then we can make more money off vaccines!!!”

Anyway, the point of this thread was not whether patenting of genetic material is in and of itself justifiable. The questions were:

  1. can someone clarify exactly what is being patented?

  2. if we can patent it, why is it too early to consider the ethics involved in its use?

9

Sorry, ren, I misunderstood your question. I think that the reason for the confusion about the ethics is that people are talking about several different things. The press conference last week by the Human Genome Project (a government-funded agency) and Celera (a private, but publicly-traded company) announced that they had decoded all of the 3 billion base pairs of human DNA, which looks something like this: ATTCGGATCGAAT… etc.

But this information is worthless, from a medical standpoint, without an understanding of what parts of the sequence represent individual genes. That’s why everyone is saying that the practical application of this research is so far in the future. A huge amount of work needs to be done to figure out where all the functional genes are.

So how can someone patent something we haven’t found yet? The answer is that other researchers have located some genes already, even before they had the raw sequence data (the ATTCGGATCGAAT etc.) They found the locus of the gene first, and figured out the sequence later. This is the reverse of the approach that HGP and Celera were using.

So, in answer to your question, the ability to develop useful treatments from the raw sequence is indeed far in the future, but some scientists have already found individual genes using other methods.

The second point of confusion relates to the different proposed uses of the data: first, to diagnose and cure diseases, and second, to develop DNA maps of individuals for use by their physicians and, possibly, law enforcement. To facilitate the first use, people want to make sure the raw data is freely available to researchers. Both Celera and HGP have said they support this. With DNA mapping, on the other hand, privacy is the main concern.

My sense is that the first problem is more immediate. DNA mapping of individual patients will not happen in the near future. But that doesn’t mean it’s too early to start thinking about the ethical issues.

I did some research last night and I will post more information later, when I get some time.

10

Ren, by your logic, any device that is helpful or saves lives shouldn’t be patented. Teh beauty of capitalism is that you can enrich yourself, and help others. I wonder how many drugs would be created if there weren’t financial rewards.

You said

So I am off topic. Therefore, I am out.

11

Yikes! Mr. Zambezi, get up on the wrong side of the bed today?

You said:

Ummm, I was pointing out that there are other reasons for doing the work than making money. My style was abrasive. I explained why. Guess I pushed some buttons for you, but I don’t see how you could have concluded from that that I don’t think these things should be patented. After all, I explicitly said:

Where exactly in this thread did I say patenting this stuff was bad? It’s a little premature for me to be drawing such a conclusion when I don’t even freakin’ understand what exactly is being patented!!!

Dumb Ox, so are you saying that (for purposes of this discussion) the idea of a ‘gene’ embodies not just the physical structure itself but also an understanding of the purpose of that section of the structure? Therefore what is being patented is not really the structure but the understanding of it?

I have heard the argument that it is not reasonable to patent something that exists in nature (like a tree or an animal or whatever), therefore genes should not be patented. But if the former is true (i.e. previous paragraph) then I can see where this argument may not hold water.

Thanks for the input. If you do find sources for more on this by all means point me to them.

12

Dumb Ox wrote:

Close, but no cigar. According to a recent article in Scientific American you merely have to suggest some possible utility that might be realized at some future date… You don’t have to demonstrate that utility. That’s where I have a bit a problem with the current gene patenting process - the individuals/groups applying for the patent don’t really have to understand the structure and application of what it is they are patenting. This is completely dissimilar to patents in all other fields of science.

Imagine that I build an electronic gizmo and apply for a patent, only the normal patent committee is unavailable so I’m referred to the gene patent committee. Here’s my hypothetical dialog with them:

Me:
“I’d like to patent this electronic doo-hickey.”

Patent Committee:
“What’s it do?”

Me:
“Well, it might be an amplifier of some sort or maybe an electronic filter. I’m pretty sure it’s worth gobs of money, though, so I need to protect it.”

Patent Committee:
“So how’s it supposed to work?”

Me:
“I’m not really sure. That’s why I need to protect it, so I can go get funding to figure out just what it is.”

Patent Committee:
“Well, have you got a name for it? You can’t use doo-hickey; that name’s already taken.”

Me:
“Sure. I’ve got a great name for it. I call it the Amazing Electronic Gizmo Thingy.”

Patent Committee:
“My, that IS a nice name. Alrighty then, patent granted…”

Me:
“Thanks can I buy you a beer?”

Patent Committee:
“No thanks, we’re still drinking on the Margaritas from our last patent we granted… NEXT!”

13

“Well, have you got a name for it? You can’t use doo-hickey; that name’s already taken.”

Now THAT’S freakin’ hilarious!

14

ren, yes, I am having a bad day. I had to write up two employees who committed blatant acts of insubordination and one started screaming and quit.

And I am hot on this because I just got a major testing lab to create one of my inventions and anything that sounds like a person may be saying “if the invention is for the betterment of society, you should do it for free” sets me off.

you said

Which made me think that you were saying that folks like me should be just doing this for the warm fuzzy feeling we get.

mea culpa. Now I am going to have a dip, drink a beer and relax before my head explodes.

15

S’arright. I was kinda hopin’ you’d come back.

Q for you, given your experience bringing ideas to market: Since that the patent system is such a mess w/r/t genetics, are there any alternatives to that system to secure some kind of financial support for the effort? Royalties maybe? (you get your support w/o restricting usage, which I think is the main bone of contention)

16

ren

Well, that argument isn’t entirely accurate. It’s true that you can’t patent a tree, but the National Cancer Institute (I think) owns the patent on taxol, which is a natural product of the Pacific Yew tree. Although taxol exists in nature, it needed to be isolated and researched in order to be useful. Just like a gene.

My understanding is that you need both. The reason the NIH withdrew its patent application, as you mentioned earlier, is that the Patent Office rejected it, on the grounds that NIH had failed to show utility. Check it out.

So your question “What exactly are we patenting?” is exactly the crux of the issue, since DNA, all by itself, is not an invention. As JoeyBlades pointed out, the Patent Office has been accused of being too lax in its requirement that applicants show utility. However, keep in mind that drug companies get patents on new compounds all the time based on speculative claims. That is, they get the patent before they demonstrate that a compound is safe and effective, which is established later, during FDA trials. The difference is that most drugs are synthetic, and therefore novel, compounds.

This brings us to two other requirements that patents must meet. They must be novel and they must be “non-obvious.” I’ll let you read about this firsthand, since I don’t completely understand it myself. Try here.

And since you asked, this site had the best list of articles related to this controversy that I could find.

17

Micro Furry

The second half of this is partly right. When Celera started work, the Human Genome Project (NIH) moved their projected completion date from 2010 to 2005, and later to 2001. What HGP was worried about was that Celera would copyright the raw data.

But Celera originally said it only wanted to patent 100-300 genes of the estimated 120,000 in the genome. It has maintained that position until the present. True, they’ve filed 6500 provisional patent applications, but this isn’t unusual in this field (Incyte Pharmaceuticals has filed 7500), and is only done as interim protection for their discoveries, until they can figure out which ones are the most lucrative. Human Genome Sciences and Incyte Pharmaceuticals have been far more aggressive in getting actual patents for individual genes.

Celera’s position is interesting. They plan to make money primarily from subscriptions to their database of the genome. They intend to annotate the entire genome with medical information in the same way that Lexis-Nexis annotates legal cases, and then sell this data on a nonexclusive basis. In this way, they say, the data will be “freely available,” as Bill Clinton and Tony Blair have asked. Gene patents will only be a secondary source of income. They’ve said that if the Supreme Court disallows gene patents, it wouldn’t change their business model at all.