US and UK May Ban Human Gene Patents

The Dodger writes "The BBC is reporting that the UK and US Goverments are planning an agreement to prevent the 100,000 human genes being patented by private companies. Apparently, various bio-technology and drugs companies, such as Celera, are planning to patent the genes. Luckily, thus far, the UK's Wellcome Trust and the US National Institute of Health have been making each gene public as they are discovered. I think we should start a 'Keep the Human Genome Open Source' campaign." Software patents seem screwy enough, but I've never understood how anyone could have gall enough to patent a gene they merely discovered and didn't create. Or how governments could be dumb enough to issue gene patents, unless they are meant purely as welfare for lawyers, because that is surely what they will become.

Comments

** N E W S W I R E **

[mach_5]

Just announced the US Patent office has just approved a patent for one Issac Newton for his invention/discovery of gravity. All persons who are currently using gravity without paid licencing fees are order to cease use imeadiatly. Major lawsuits are expected as my corporation have alleageady used gravity to their advantages (ie. keeping people seated infront of thier computer too long, .........)

Re:Companies patent genes that they discover

[The Dodger]

Let's take a closer look at this idea of it being fair for companies to patent discoveries they make, so that they can recoup their R&D costs.

Let's say Dodger Genetics Corporation is doing gene research. I'm pumping millions of dollars into research labs, paying scientists, etc. Then, one day, my chief scientist comes into my office and tells me that his guys have discovered the gene that causes cancer.

I pat him on the back and get my lawyers working on a patent application, but when I get to the Patent Office, I discover that Monsanto was there that morning, and _they've_ got the patent on that gene.

So, even though I've forked out what was probably a similar amount as Monsanto, in funding the research, etc., I'm left with nothing, and if I want to make use of my company's discovery, I have to pay Monsanto.

How can that be fair?

The real argument is whether a discovery (as opposed to an invention), should be patentable. Einstein discovered that E=mc^2, but should he have been allowed to patent it?

I'm reminded of the novel 'Friday' by Robert A Heinlein. It's set in the near future, and mentions a power storage technology called Bridgestone, which was named after it's inventor. Daniel Bridgestone figured out a way of storing power - a kind of an improved battery, but in the sense that a thermonuclear bomb can be described as an improved firecracker.

In the novel, Daniel Bridgestone never patented his invention. He simply started churning out "Bridgestones", for use in everything from flashlights to houses. Those who tried to reverse-engineer the devices failed, because they ceased to function when disassembled. There were accusations of monopoly, under-hand tactics, etc., but, when it came down to it, Bridgestone had done nothing wrong. He wasn't even being anti-competitive. There was nothing to stop others from doing exactly what he'd done.

Now that strikes me as fair.

Going back to Dodger Genetics Corporation - would it not be fairer if I were granted a joint patent on the gene, along with Monsanto? And, extending that idea, might it not be better, for scientific discoveries of this nature, for joint ownership to be granted to anyone who can prove that they discovered the whatever, independently?

Now, obviously, this doesn't apply to patents granted for ideas or mathematical formulae, but I feel that there is a strong argument for refusing patents on ideas (such as Priceline.com's "name your price" model) and formulae (E=mc^2), because these type of patents ultimately repress innovation, in my opinion. If someone had patented the idea of electronic mail, or hypertext, where would we all be?

Science shouldn't be patentable. It's noone's Intellectual Property. If Governments are worried about lack of innovation, they should establish and fund research labs, and charge companies for being allowed access to the resulting data.

This commercialism of science is rather worrying. Everything is increasingly geared towards making a profit, and the consumers suffer in the long run.

D.
..is for Dastardly.

Re:great

[hjw]

Like most of the 'issues' facing the biotech people today, this
one cannot be looked at in such a black and white view.

Sure, we should not be allowed to patent genes. Nature has
created them through the long and miraculous process of
evolution. Nature owns the patent on them.

However, with genetic engineering this is somewhat
more complicated. If I splice a gene from one organism into
another, can I patent the new sequence?

Maybe if use the term 'feature' instead of gene, and 'program'
instead of sequence/organism, the problem becomes more familiar to us.

If I 'hack' a 'feature' from one program into another, can I patent the new
program?

It seems rather silly to us advocates of open source.

Maybe we need a Free Gene Foundation......

maybe we can design a newer and better human called GNH
(GNH is Not Human ), pronounce gn-ih....
okay.. maybe not....

Should be simple

[Gleef]

Any genes from a natural organism, a human, dog, fruit fly, whatever, should be considered to have too much prior art to be patentable. The gene was developed by at least the parents of the organism, and in most cases their distant ancestors.

A gene constructed by sequencing in the lab, or by direct genetic manipulation of a creature (as opposed to husbandry) has a good argument for patent protection.

----

great

[Suydam]

This seems like a good thing. But it's interesting to me that it's viewed as different than patenting the genes of other organisms. I mean come on, we're not THAT different....so either you should be able to patent genes in general, or you shouldn't. In my opinion, that is where the debate should be centered.

...but alas....we're so sure of our own superiority, that we'd never look at it that way.

Re:great

[Jamie Zawinski]

But it's interesting to me that it's viewed as different than patenting the genes of other organisms. I mean come on, we're not THAT different....

I think the relevant difference is that we're the only ones who can buy stuff.

Re:great

[Anonymous Coward]

This is not as recent an issue as people seem to think. Levi Strauss had a patent going in 1864. And I wish you would all learn to spell. It's "JEANS".

Read US Legal Code Title 35 Pt 2 Ch 10 Sec 100 ++

[Greg Merchan]

From my copy:
-CITE-
35 USC Sec. 100 01/26/98

-EXPCITE-
TITLE 35 - PATENTS
PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS
CHAPTER 10 - PATENTABILITY OF INVENTIONS

-HEAD-
Sec. 100. Definitions

-STATUTE-
When used in this title unless the context otherwise indicates -
(a) The term ''invention'' means invention or discovery.
(b) The term ''process'' means process, art or method, and
includes a new use of a known process, machine, manufacture,
composition of matter, or material.
(c) The terms ''United States'' and ''this country'' mean the
United States of America, its territories and possessions.
(d) The word ''patentee'' includes not only the patentee to whom
the patent was issued but also the successors in title to the
patentee.

-SOURCE-
(July 19, 1952, ch. 950, 66 Stat. 797.)

-MISC1-
HISTORICAL AND REVISION NOTES
Paragraph (a) is added only to avoid repetition of the phrase
''invention or discovery'' and its derivatives throughout the
revised title. The present statutes use the phrase ''invention or
discovery'' and derivatives.
Paragraph (b) is noted under section 101.
Paragraphs (c) and (d) are added to avoid the use of long
expressions in various parts of the revised title.


I know no good reason why discoveries should be patentable. This was taken from the US House website. Hmm... maybe I can make a database and sue for patent or copyright infringement if anyone obeys the laws of the US. :)

OT: Does anyone recognize the tags they use? Is there a reader that makes sense of them?

Why human genes are patentable....

[Anonymous Coward]

Speaking as a genetics researcher (but an Open Source one--I've never patented any genes I've discovered, including a couple with *major* financial potential), let me try to explain this.

Ultimately, patents are issued by governments, not to protect "intellectual property" (whatever such a creature might be), but to encourage innovation. In exchange for your hard work, you get exclusive rights to it for a time to exploit your hard work and recoup your expenses in making the invention / discovery / whatever.

So far, so good.

Now, that's where human genes enter in. Those are primarily of financial interest because of their pharmeceutical applications. Allowing patents on them allows pharmeceuticals to recoup their costs in developing treatments based on those genes. And believe me, those costs are in the high millions if not billions these days for some drugs.

So, it's fine if you want to kill genetic patents. They've always struck me as conceptually rather questionable too. But if you do, you're going to have to come up with an alternate way to protect pharmeceuticals' interests. Otherwise, you're going to end all new drug development, which is possibly worse than the evil you're trying to correct.

Re:Why human genes are patentable....

[Eccles]

So, it's fine if you want to kill genetic patents. They've always struck me as conceptually rather questionable too. But if you do, you're going to have to come up with an alternate way to protect pharmeceuticals' interests.

I believe there is trade secret law that covers this. Basically, you aren't required to reveal all you know. Also, you can arrange contracts that require secrecy on the other party's part, with the consequence of substantial monetary damages being awarded if they violate their part of the contract. So if a gene is valuable, make it a trade secret and sell access to the hidden knowledge.

Re:Why human genes are patentable....

[Darth Yoshi]

> Now, that's where human genes enter in. Those are primarily of financial interest because of
> their pharmeceutical applications. Allowing patents on them allows pharmeceuticals to recoup
> their costs in developing treatments based on those genes. And believe me, those costs are in
> the high millions if not billions these days for some drugs.

I can see your point, but I don't see that not allowing human gene sequences to be patented would preclude treatments based on those sequences to be patented.

That is, if company 'A' is allowed to patent a particular human gene, only company 'A' could develop (or license to be developed) treatments for genetic diseases involving this gene.

However, if company 'A' is not allowed to patent that particular gene, that does not prevent them (and companies 'B', 'C', and 'D') from developing (and patenting) treatments for genetic diseases involving this gene.

Granted, there is less financial incentive for company 'A' to do genetic research in the first place (although keeping their research as a trade secret does offer them a headstart in developing treatments).

On the bright side, in less than one human generation (about 30 years), the human genome will be mapped, any patents will have expired, and genetic treatments should be commonplace.

Re:Why human genes are patentable....

[Anonymous Coward]

I don't really understand why they shouldn't be able to patent drugs they produce, or if they
can then why they need to patent the genes too. Could you explain better why they would
need to patent genes to recover their costs of recovering drugs?

Because a patent on a drug is meaningless. If I'm your competitor and I know that your cool new drug is a chemical of class X targetting receptor Y, I can just use a slightly different chemical of class X (say, X + epsilon) which also targets receptor Y. I can then undercut your pricing dramatically, since I don't have to recoup the billions of dollars you spent developing the original; I only spent $20,000 developing the similar.

Incidentally, I don't believe for a moment that ending gene patents would end all drug
development, do you think maybe you're guilty of hyperbole there? Maybe there'd be less,
but you're saying there'd be none?

You have absolutely no familiarity with drug companies if you think they would continue without a guaranteed way to make money. That's simply how they work. So no, I don't think I was being in the least bit hyperbolic. Do you have any idea of how much they've already invested because of the promise of being able to patent what they discover? Do you have any idea of how many human genes they have already patented?

Human genes are not interesting

[arivanov]

Human genes at the current phase of research are not that interesting. The interest in the sequences of microorganisms that cause diseases is much greater.

The reason for this is that as long as you patent all relevant sequences specific for the diagnostics of a disease (for example the interesting G-rich parts from a viral genome) you possess monopoly on the diagnostics of that disease.

Contrarily to the human genome where most of the stuff is still theory, this is actual practice. And it being is widely used/abused.

Copyright Notice.

[Anonymous Coward]

1. You may copy and distribute verbatim copies of the person's genome as you receive it, in any medium, provided that you conspicuously and appropriately publish on each clone an appropriate copyright notice and disclaimer of warranty; keep intact all the bodily functions that refer to this License and to the absence of any warranty; and give any other recipients of the person a copy of this License along with the clone.

2. You may modify your clone or clones of the person or any portion of it, thus forming a work based on the person, and clone and distribute such modifications or work under the terms of Section 1 above, provided that you also meet all of these conditions:

a) You must cause the modified genes to carry prominent notices stating that you changed the genes and the date of any change.
b) You must cause any offspring that you grow, that in whole or in part contains or is derived from the person or any part thereof, to be licensed as a whole at no charge to all third parties under the terms of this License.
c) If the modified clone normally follows orders interactively when at work, you must cause it, when started working for such interactive use in the most ordinary way, to wear or chant an announcement including an appropriate copyright notice and a notice that there is no warranty (or else, saying that you provide a warranty) and that users may redistribute the clone under these conditions, and telling the user how to view a copy of this License. (Exception: if the person itself is interactive but does not normally speak or write, your work based on the person is not required to chant an announcement.)

I Have Prior Art!

[Twinkle]

In fact, we all do, I've personally had the genes in question for just over twenty-six years. My mother has (with 50% probability) got the same genes and has had them since before the genome project started.

Question is, do I get the patent crushed or take a back-hander from The Man?

T.

P.S If I discover a mountain, can I patent that too?

Reference

[rde]

Check out the Sanger Center's arguments against patenting. Worth a read.

It is not the gene, it is the application

[Lars Arvestad]

Roblimo wrote I've never understood how anyone could have gall enough to patent a gene they merely discovered and didn't create.

The thing is that they patent the application of what a gene express. So for example, it is believed that leptin is involved in the metabolic system and therefore could be used in defeating obesity. The gene is not patented but the idea of using it as a medicin is.

This is a practice that has been going on for quite a while if I have understood things. In medicine, you can not patent a surgical method, but if that method needs a special tool, you can patent it.

In my mind, there is some justification for "patenting a gene" if a company has had to shell out significant amounts of money and time to develop a cure based on a well known substance, but what has started now is no more than an industrial patenting. Apparently, many "gene patent" applications from Celera are based on predicted expression and function of a gene. Once you have the data, it is not that hard (although it is a major research field) to come up with a prediction that could obstruct others from using the gene.

Celera has sworn to make all data they produce public after while (letting their customers get first dibs in the data), so that is not what the Human Genom project is most worried about. The reason they try to make their data public within 24 hours is that they too make predictions on function in order to prevent more patents based on predictions.

Lars

This is just silly.

[cemerson]

Mother nature has prior art for human genes, which will of course be very similar or identical to that of many animals. I don't quite understand how the questions comes up at all.

Now if someone came up with a brand new gene which did something useful, then that should fall under the same roof as software patents, IMO. That argument's been done to death.

Still worries me...

[snopes]

I think it's great that they're going to put the brakes on Celeron. Vintner is an ass. There's still a problem here, though. (Disclaimer: I'm not a geneticist. I just provided net support at a govt. sequencing lab for a year)

Sequencing just provides the mapping of the genes. It doesn't tell you a damn thing about what they do. That's call phenotyping.

He did not believe the move would inhibit new medical discoveries, as a map of a gene does not reveal its function - that would remain to be discovered. What it would do, Dr Morgan said, was to "ensure that no one company can stop others working on a gene."

I think the above quote seems to suggest that pharma will still be allowed to get patents around phenotypes. Though there isn't a great deal of competition in modern drugs, my suspicion is that we'll see even less with gene therapies. If there's only one way to fix the screwed up genes that cause a particular disease, then that one method will be owned. This isn't perl programming. Genetics is a pretty set thing.

This policy is certainly a step in the right direction and I'm sure the NIH, et al will continue to race the private concerns on phenotyping as they've done with sequencing, but I'm sill concerned that gene based cures will be out of reach for most people long after they're developed. Maybe that's not much different from how things work today, but it's still a problem.

In the beginning, there was no prior art . . .

[jsm2]

Well, the question then arises of who can patent the human genome. . .

I notice that Pope John Paul has recently made a statement saying that evolution is "More than a theory", and is now accepted as fact by the Catholic Church.

Their position would be that God created the seeds of life, and developed the process which allowed the human genome to evolve, guiding the process at all stages. . . . kinda hard to patent something you don't believe exists, but if the Pope is now admitting evolution, that removes the last obstacle for the Catholic Church claiming to represent the Original Inventor of the source material.

I think I need to get me one of those Jesuit IP lawyers ....

jsm

Genetic Public Licence

[PhilHibbs]

That's what I think it should be called.

I think this should be extended to all naturally occurring genes, and patents should be restricted to the use of a gene in a specific circumstance for a demonstrated benefit.

There does need to be some commercial benefit to gene research, though, so it needs to be carefully balanced.

Shouldn't be necessary... but sadly is

[Lerc]

The agreement mentioned in this article is a kludge. What is needed is a fix.

As we tend towards this information society that all pretentious journalists talk about, we are bound to come up with new bunches of information that would be worth something to someone. What is needed is a sensible approach to patenting, not sticking patches over the bits that look really bad and let the rest go.

The annoying thing is that most patent laws around the world seem to be relativly reasonable. The problem is that the people allocating patents seem to have only a passing interest in what the law says.

Some people say that software patents shouldn't be allowed and proceed to cite their favorite stupid soffware patents. But almost all of the absurd software patents shouldn't have been granted under the current laws.

I'm not sure if the EFF(or some other group) could sue the patent office for negligence. Something has to be done. Their ignorance regarding software patents is hurting the programming people. If a government misses patching an issue (like dna patenting) It could potentially hurt all people.

Something needs to be done. Is anybody in a position to do it?

Re:Should Pharmecutical companies have right to ki

[pompomtom]

The relevant principle is known as Compulsory Licencing (spel?). National governments are empowered, under crisis circumstances, to produce generic versions of expensive drugs. Of course, when South Africa attempted to do this recently with AIDS drugs, US pharmaceutical companies leaned on Al Gore, who in turn threatened the South African government with a withdrawal of aid, who in turn backed down.

The point I'm making is that it's not the fault of the law in such cases... rather of US hegemony and the power of lobbying groups.



Buckets,

pompomtom

Patenting of *any* genes might be harmful

[mini]

Human genes are not the only one that are dangerous to allow patenting. Financial times has an interesting article on how companies holding patents for gene-manipulated food can get a stranglehold on all of us. Read it up at here.

IMHO, this issue is as least as scary as M$, especially given the history of companies like DuPont (anyone remembers Jack Herer's book ("the emperor wears no clothes"?). Clearly, companies should in general be protected to reap the rewards of their research and work. However, this protection needs to be balanced with the protection of society and (yeah, corny), humankind.

I don't see a lot of serious effort to address this issue politically. IMHO, this is the time to act.

The patent system is may disappear in a while...

[Basje]

A while a lot of patents are being applied for, regulations vary wildy among countries. With globalistation, it will be near impossible to enforce.

Considering all the silly patents that are given out, and the lack of means to enforce them worldwide, imo the system will disappear in the near future.

Sweat Of The Brow vs. The Commons

[Seth Finkelstein]

One problem is that the aspect "human" is distracting people. At it's core, this is just another go-around regarding how much of some knowledge should be able to become property. The familiar arguments are there:

1) If you don't give the corporations enough, they won't develop the products
vs.
2) Developing a product shouldn't result in a complete monopoly in all cases

I think a basic point in the human genome case is that there was a great deal of public development that needs no post-facto monopolization.