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[P]
New gene patent guidelines from the USPTO

By cbatt in MLP
Fri Jan 05, 2001 at 05:01:27 PM EST
Tags: Science (all tags)
Science

The U.S. Patent Office has "raised the bar" when it comes to the requirements needed to patent a gene.

The story can be found here.

Update [2001-1-5 15:19:19 by rusty]: As far as I can tell from wading through the beauracratese, the new guidelines are right here. It does include, among other things, an interesting bit about patenting "discoveries".

When Congress enacted the patent statutes, it specifically authorized issuing a patent to a person who ``invents or discovers'' a new and useful composition of matter, among other things. The pertinent statute is 35 U.S.C. 101, which reads: ``Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.'' Thus, an inventor's discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it.


This once again raises the issue of the validity of the entire concept of gene patenting. IMHO, they might as well begin patenting natural resources while they're at it as genes are as ubiquitous as the air we breathe. However I do believe this is a step in the right direction.

But what does this mean for all those companies that have already obtained gene patents? Are they now something of an "old boys club" in that the barrier to entry for competition has been raised?

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New gene patent guidelines from the USPTO | 19 comments (10 topical, 9 editorial, 0 hidden)
No actual info (2.00 / 1) (#1)
by axxeman on Fri Jan 05, 2001 at 12:54:09 PM EST

The page linked to contains about as much info as a typical c-net onepager... -1 here

Being or not being married isn't going to stop bestiality or incest. --- FlightTest

This *is* the web, is it not? (5.00 / 1) (#5)
by jeffg on Fri Jan 05, 2001 at 01:43:41 PM EST

The page linked to contains about as much info as a typical c-net onepager... -1 here

This *is* the web, is it not? Sometimes you have to click a link or two to get the information you desire.



[ Parent ]
And then... (none / 0) (#10)
by titus-g on Fri Jan 05, 2001 at 02:37:21 PM EST

Of course there are these things called search engines...

So you could say go to http://www.google.com/search?q=basmati+rice+patent, Or maybe try looking up some of the many other stoopid patents various corporations have on foods/native cures etc...

geez peeps if you want the world on a plate you should have been born into the Bush family...

Sorry to be contrary, but critics...ergh

--"Essentially madness is like charity, it begins at home" --
[ Parent ]

Surprisingly interesting reading (5.00 / 3) (#13)
by rusty on Fri Jan 05, 2001 at 03:42:52 PM EST

The article in the Federal Register is actually surprisingly (to me anyway) sane and interesting. The gist of responses to comments on gene patentability is that basically, patents do not confer "ownership" of a compound or invention, but they merely confer temporary marketing rights on a method of using something, in exchange for disclosure of how to obtain that thing.

So, in this case, I can't patent a sequence of necleotides. That's just a description. What I can patent is, for example, a method of using that sequence of nucleotides (extracted from their naturally occuring state) to make potatoes glow when they need water.

Now, anyone else can use my description of how to isolate and purify that genetic sequence to make the raw materials. They can further use those chemicals to do anything else they like with them. All the patent covers is their use in making potatoes glow. So, if they want to do that, they have to pay the patent owner a royalty. That's what they mean by the frequently mentioned "utility clause" (yes, Virginia, there is a utility clause).

So we're not in a situation here where genes will be "owned" lock stock and barrel by a company. The PTO's point is that by allowing companies to disclose the methods they use for obtaining and purifying genetic material, the field as a whole will benefit, because everyone else won't have to reinvent that method. They can simply copy my method, and figure out what else to do with the gene. I actually agree that this makes sense.

Further, some objections were that by patenting genes, a company could "own" material that occurs naturally in my body. This also, says the PTO, is silly. It cites an earlier patent on purified and isolated adrenaline as an example-- just because my glands make adrenaline doesn't mean I'm infringing on this patent. The patent covers a way to isolate, purify, and use that chemical to a specific end. Basically, this objection is grounded on a misunderstanding of what a patent is.

Do give the article a read. It's not too dense, once you figure out what "The comment is not adopted." means. :-)

____
Not the real rusty

Wait a minute (4.00 / 1) (#14)
by rusty on Fri Jan 05, 2001 at 03:57:16 PM EST

Ok, after the initial softening up, they eventually get to the punchline. What's up with this bit:
(11) Comment: Several comments stated that DNA patent claim scope should be limited to uses that are disclosed in the patent application and that allowing patent claims that encompass DNA itself would enable the inventor to assert claims to ``speculative'' uses of the DNA that were not foreseen at the time the patent application was filed. Response: The comment is not adopted. A patent on a composition gives exclusive rights to the composition for a limited time, even if the inventor disclosed only a single use for the composition. Thus, a patent granted on an isolated and purified DNA composition confers the right to exclude others from any method of using that DNA composition, for up to 20 years from the filing date. This result flows from the language of the statute itself. When the utility requirement and other requirements are satisfied by the application, a patent granted provides a patentee with the right to exclude others from, inter alia, ``using'' the patented composition of matter. See 35 U.S.C. 154. Where a new use is discovered for a patented DNA composition, that new use may qualify for its own process patent, notwithstanding that the DNA composition itself is patented.
Now that doesn't sound so cool. If I isolate a genetic sequence, I can patent that composition for any use, even if I only describe one use. Thus, any future utility that is found for it could be patented by the discoverer as a process, but the discoverer would still have to pay me royalties just to use the chemicals.

I'm torn. At first blush, it would seem that this is an unmitigated Bad Thing. This basically means that one company can in fact own an isolated genetic sequence. But, think about it for a bit. Company A spends $150 million fundng a lab that eventually manages to isolate and purify a particular gene. Company A files a patent on that gene and one use of it. Company B comes along and says "hey, we can use that for this other use!" Company B doesn't have to figure out how to obtain the genetic material, because Company A has already done that, and made it available in a patent disclosure. So, would it be fair to not let Co. A recoup all that money they spent figuring out how to get the stuff?

The key is that isolating genetic sequences entails a real-world cost. Where's the incentive for Celera to spend outlandish amounts of money isolating genes if any other company can then come along and use them for free? Now, I love free software, and I'd love to see that kind of sharing rule the day in other fields. But I'm not going to tell anyone that they aren't allowed to make money on something if that's how they choose to go. And in a capitalist economy, the promise of making money is what drives research. So, this would seem to be the best fit for how to encourage further genetic research.

Note that I'm basically writing this as I read the article, so feel free to ream me on any inaccurate or wrongheaded claims I may be making. :-)

____
Not the real rusty
[ Parent ]

depends... (none / 0) (#15)
by cbatt on Fri Jan 05, 2001 at 04:32:59 PM EST

on the definition of "composition" I believe.

They mention "an isolated and purified DNA composition". If that means a general applicaton of DNA, then it's a fairly scary proposition. However, I'm lead to believe that by language alone, they are aiming at something a lot more specific than that, say a very tiny portion of DNA designed for extremely specific usage such as the modification of already existing DNA. Unfortunately I do not have to time right now to analyse their published information and I am deffinately Not A Lawyer or someone in the know regarding patent laws.


As an aside I would also like to thank you for adding that extra information into the story, and for the spelling corrections. I would have if the capability had been there, and I didn't resubmit because it was already garnering quite a few positive votes and I thought a re-submission would've clogged the que.

(I also remember a story a while back on glowing potatoes that shouldn't have been posted in the manner that it was. I wonder which idiot did done that?)

-----------
Before you can understand recursion
you must understand recursion.

[ Parent ]

Ah but... (none / 0) (#16)
by loner on Fri Jan 05, 2001 at 05:07:19 PM EST

Regarding your comments about company A having the exclusive right to the gene. That'll be cool as long as company A is willing to charge other parties a reasonable amount for non-exclusive use of the same gene. Then company B can still implement their own use of the gene while helping company A recoupe some of its expnses.

But company A could also decide to outright deny everybody else the use of that gene (which would be their right), and stick to marketing their own sole use of the gene for the next 20 years. Then company A will be in effect shutting the world from many good alternative uses of the same gene, all in the name of capitalism.

I suppose this is not so bad in the world of genetics, since any company with the means to discover a new use for a gene will also be able to offer company A a reasonable price for the right to use it. But the possibility is still there.

[ Parent ]

Good Point (none / 0) (#17)
by Captain Derivative on Fri Jan 05, 2001 at 10:46:32 PM EST

It ultimately gets down to what patents (on anything, really) are supposed to do versus how patents are sometimes actually used. For example, building on what you've said:

What's supposed to happen: Company A, having patented the uses of a DNA composition, licenses use of it to other companies, who use the DNA composition for other uses. The licensees benefit, since the cost of licensing from Company A will be much cheaper than the costs of the research & development of developing the methodology themselves. Company A benefits, because it's recouping the costs they spent extracting and finding uses for the DNA. And society benefits, because all the companies can offer services derived from the DNA composition at a cheaper cost. All around a Good Thing.

What could happen instead: Company A uses the patent on the DNA composition to give itself a monopoly over the use of the gene. Other companies are prohibited from using the gene, and Company A can charge ridiculous fees for consumer services derived from it. Furthermore, Company A might not find all the possible uses of the gene that other companies may have been ready and able to discover and use, since Company A might not have the resources to develop additional uses, or may see more profit by sitting on it. Society loses out on these alternate uses, and pays more for those that are left. All around a Bad Thing.

I wouldn't be so wary of gene patents if I had good assurance that the "owners" of the gene would fairly license it to other companies, since after all that is the theory behind patents in the first place. Unfortunately there have been too many cases especially in computing where patents have been used to try to gain monopoly power for twenty years (e.g. Amazon's one-click shopping). But if we prohibit patenting genetic information altogether, the companies with the resources to discover these genes and their uses won't be able to find and develop products from them. Sure, there will be non-corporate researchers doing the work, but they will almost certainly have far less funding and therefore won't be able to utilize the DNA compositions as well as the big companies.


--
Hey! Why aren't you all dead yet?! Oh, that's right, it's only Tuesday. -- Zorak


[ Parent ]
These are *bad*. (4.00 / 1) (#18)
by Alik on Sat Jan 06, 2001 at 12:17:42 AM EST

With due respect to Rusty's comment below, I think he's missed a few things. First off, although the patent is defined to apply to the actual molecule and not the sequence itself, there's no way to use the gene without ending up making the molecule. Hence, if you use the gene in some way, you infringe. (Thankfully, they've made a specific ruling that using it in your own body doesn't count, because having it integrated into a chromosome is somehow magically different than the pure form. However, if I took a patented gene, stuck it into an artificial chromosome, and then used that, I guarantee you they'd get me for infringement.)

Second, their utility clause is bogus. If you read down the article, you'll come to a section discussing "homology" and whether or not it counts for utility. Homology is a gene's resemblance to other known genes (and, presumably, its protein product's resemblance to enzymes of known function). Given the number of genes we now know, chances are that most isolated genes are homologous to *something* for which we have a clue about function. Doing a homology match is literally as simple as entering your gene sequence into a web form and waiting the few hours it takes for the machine to get to your job in the queue. Combine this with automatic sequencing, and you can have yourself a nice little thing where you put in your sample and it sequences the gene, identifies homology, and prints out a patent application for you to sign. The only thing this utility requirement does is state that you can't say "Well, if we don't figure out what it does, we can just express the protein and use it as food-grade protein."

The document does seem to carry a large chunk of "Hey, our hands are tied. The law says these are the only reasons we can deny patents and the law says everything is patentable if a human discovers it. If you don't like it, change the law and quit bothering us." I'm not able to tell if they really mean that they'd be willing to adopt some of those comments if it were legal, or if they're just trying to stonewall in favor of having more applications to process and thus more income.

Also bogus is their claim that patents stimulate inventors to "invent around" the patent. If you need to make use of a specific gene, you can't "invent around" it; any other gene which made the same (or a very similar) protein product could easily be judged infringement in court because it's a pitifully obvious and trivial change to the originally patented object.

All told, though, even this wouldn't be so bad if they didn't last twenty fucking years. IMHO, that's *way* too long for one company to hold that kind of power over a key medical discovery.


Right, and not (none / 0) (#19)
by rusty on Sat Jan 06, 2001 at 03:16:26 PM EST

...although the patent is defined to apply to the actual molecule and not the sequence itself, there's no way to use the gene without ending up making the molecule. Hence, if you use the gene in some way, you infringe.

Looks that way. Or, at least, if you want to use the gene, you have to pay royalties, assuming the patent-holder will allow you to at all. What I missed initially was that the utility clause doesn't mean that that utility is all you have rights to, but instead it grants you patent ownership over the molecule itself.

The document does seem to carry a large chunk of "Hey, our hands are tied. The law says these are the only reasons we can deny patents and the law says everything is patentable if a human discovers it. If you don't like it, change the law and quit bothering us."

I know a few patent examiners, and I honestly think that is how the office feels. They don't think of themselves as something that has to make a lot of money, but as a government office. They really are just following the laws. In this case, perhaps, the laws suck, but there isn't anything the patent office can do about that. They have granted bad patents in the past, but basically, that's because patent examiners are kids fresh out of college who have little or no expertise in the fields they're examining for. Hence something that is trivially obvious (like one-click shopping) gets a patent because it sounds non-obvious to a non-expert.

Also bogus is their claim that patents stimulate inventors to "invent around" the patent. If you need to make use of a specific gene, you can't "invent around" it; any other gene which made the same (or a very similar) protein product could easily be judged infringement in court because it's a pitifully obvious and trivial change to the originally patented object.

I thought what they meant by "invent around" was that you'd use the existing patent description to obtain the gene, and then find new uses for it and patent those, referencing the old patent. You still have to pay royalties, but you save the cost of isolating the gene yourself. I think "around" here means like a shell, not like an evasion.

I also agree that 20 years is too long. That was laid down in a time when things just took longer to do. You'd patent an invention, and it might be 10 years before you got around to marketing it. It just doesn't take that long anymore to develop a new technology to the point where it starts to pay for itself (well, *most* new technologies), and the time should be shortened accordingly.

____
Not the real rusty
[ Parent ]

New gene patent guidelines from the USPTO | 19 comments (10 topical, 9 editorial, 0 hidden)
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