Judge: Gene Patents Are Invalid

from the huge-news dept

Mon, Mar 29th 2010 3:13pm — Mike Masnick

In a huge ruling, U.S. District Judge Robert Sweet has said that gene patents are invalid. As you may recall, last May, the ACLU was the first to finally challenge whether or not genes could be patented. There was a lot of back and forth over the case, with many saying that a ruling against gene patents would throw a wrench into the business plans of many companies, because so many biotech/medical companies have been relying on the idea that gene patents must be valid for so long. But just because many companies relied on a mistaken understanding of patent law, doesn't mean that it should be allowed to continue. The judge made the point clear when it came to gene patents, saying that they:

"are directed to a law of nature and were therefore improperly granted."

The case was brought against Myriad Genetics, who will surely appeal, so this is nowhere close to over. But it involved a test for breast cancer, that Myriad basically had a monopoly over -- and the claim was that this not only made it more difficult for women to get tested, but it also greatly discouraged other research in the field. In part, this was because the patents that Myriad held were incredibly broad.

Patents, of course, are not supposed to be granted on things found in in nature -- and it's hard to argue against the idea that genes are found in nature. Supporters of gene patents often claim that they're not really gene patents, but a patent on identifying the gene, which is a nice semantic game that the judge clearly saw through. This is a huge step forward for encouraging more real research into genetic testing, rather than locking up important information.

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Filed Under: brca1, gene patents, genes, invalid, nature, patents
Companies: aclu, myriad genetics

54 Comments

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Rose M. Welch (profile), 29 Mar 2010 @ 3:17pm

YES!!!!!!!!!!
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Quentin Hartman, 29 Mar 2010 @ 3:20pm

I wonder how this would effect GMO crops currently on the market. Particularly if this might open the door to recourse for the farmers whose crops got contaminated by neighboring use of "roundup ready" crops and were subsequently sued into oblivion by Monsanto.

I hope it goes poorly for Monsanto.
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Esahc (profile), 29 Mar 2010 @ 3:22pm

:-D
Someone give that judge a big hug.
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crade (profile), 29 Mar 2010 @ 3:32pm

As far as I can tell, Myriad Genetics is right, there is nothing different about gene patents that doesn't also apply to other types of patents. It could just as easily be patents on something else that made it more difficult for women to get tested, but it also greatly discouraged other research in the field. Any patent related to medicine or healthcare has that potential.
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Mr. Oizo, 29 Mar 2010 @ 4:00pm

Re:
Of course I disagree. Performing a correlation analysis between gene expression and diseases is fairly common and is quickly becoming so easy that it is just a matter of grabbing the proper biomarkers to predict stuff.

Essentially: this is not an invention it is a discovery. Screening something that makes use of such discovery is just such basic biology that the screening technique cannot even be considered as sufficiently advanced.

What would be more interesting than screening is the healing itself.
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Lonny Paul (profile), 29 Mar 2010 @ 4:06pm

Goodbye to lawsuits against farmers by GMO Corn Mfg!
There have been hundreds of suits against farmers who had a crop cross-pollinate with neighboring GMO crops. They were subsequently sued for Patent violation - and have WON, destroying many farmer's lives.

Hopefully, this will stick and all GMO seeds will no longer be patented and the world will be a better place for bad companies with not enough to do!
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Andrew, 29 Mar 2010 @ 4:15pm

I guess this could go either way. Some industries that depend on gene patents are actually doing a lot to push the research. If they are unable to patent genes then there wouldn't be much motivation.
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Richard (profile), 29 Mar 2010 @ 4:18pm

Re:
As far as I can tell, Myriad Genetics is right, there is nothing different about gene patents that doesn't also apply to other types of patents.
Looks like you can't tell very far...

There is a difference between a discovery and an invention.

Genes are discovered.

Light bulbs, gramophones, lasers and the like have to be invented - they weren't "out there" in nature beforehand like genes. It's a fairly basic distinction, I'm surprised you couldn't see it.
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Spanky, 29 Mar 2010 @ 4:20pm

re
Since this country no longer stands for anything, lets just see how long this lasts, shall we?
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John Duncan Yoyo, 29 Mar 2010 @ 4:21pm

Re:
I wonder if this can be extended to altered genes. The alteration might be the patentable step if it creates something never seen in nature.
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Anonymous Coward, 29 Mar 2010 @ 4:23pm

Re:
I wholeheartedly agree! I would love to see Monsanto the big bully brought to its knees!
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crade (profile), 29 Mar 2010 @ 4:29pm

Re: Re:
I just don't see how the arguments provided don't apply to patents in other areas just as easily.

I suppose I don't really see the line between unimplemented invention and discovery.. If the idea is not a sufficient advancement, then it is not a sufficient advancement. Then this idea is not worthy of a patent.. How does it extend to "ideas in this field can never be worthy of patents".
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Philip123 (profile), 29 Mar 2010 @ 4:30pm

This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. It is to my mind akin to buying a microscope and then claiming a patent on whatever components of life I find there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious. Can you even place a patent on a computer virus, how much more foolish to claim there is patent protection is the virus might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.

http://healthjournalclub.blogspot.com/
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Bas, 29 Mar 2010 @ 4:31pm

And the entire world depended on this judge, since when something is patented in the US, the whole world has to obey.
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Reagan, 29 Mar 2010 @ 4:34pm

I doubt this ruling will affect the Monsanto lawsuits
Because they can argue much more effectively that their GMOs *are* in fact inventions, in that they do not occur in nature but were created in a lab. I'm sadly unfamiliar with the lawsuits that they've won, but if they have successfully farmers sued because their products cross-pollinated with the farmers, hopefully other legal strategies willbe able to prevent that.

If this ruling stands it'll be an enormous boon for science and health. It's always been ridiculous on its face that companies could patent the application of widely used techniques to identify or characterize genes. I'm glad to see a judge agree
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Anonymous Coward, 29 Mar 2010 @ 4:35pm

Re: Re: Re:
Well, you're kind of in the wrong place to be discussing this, because a lot of this site is dedicated to showing how patents are so general and broad that they never should've been granted in the first place.

In other words, this argument should apply to other areas, but it isn't applied enough.
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Sam Watkins, 29 Mar 2010 @ 4:47pm

all patents are invalid
Nuff said. If I ever need to write a program that uses patented code, I will simply release it anonymously on networks that cannot be censored (to the public domain). Newton and Leibniz came up with the infinitesimal calculus independently and concurrently. Most patented inventions are simpler and more obvious than this calculus. A work of art, that could not ever be reinvented, is one thing. An invention that is a simple, obvious combination of well-known ideas is something else. If something could ever be reinvented by someone else, it should not be allowed to patent it.
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Mr. Oizo, 29 Mar 2010 @ 4:49pm

Unimplemented Invention vs Discovery
Let's say: I have an idea of a tool i would like to make: that is an unimplemented invention

I find something growing in the grass and I eat it: that is a discovery.

The first I might be able to patent; the second is something I found and should never be patentable.

In this case finding BRCA (that is what I think they are talking about) is a discovery, not an unimplemented invention.
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porkster, 29 Mar 2010 @ 5:20pm

Darn it!
I was all set to sue Myriad Genetics if I got breast cancer.
After all it's their patent and no one would be silly enough to copy it so obviously the cancer could be traced back to them.
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Tredder (profile), 29 Mar 2010 @ 5:29pm

Gene Patents
Thank goodness! Patents, in general, were designed to encourage dissemination of new concepts while giving the originator a chance to benefit for a defined period of time.

Unreasonably broad patents on discoveries have done just the opposite. They have stifled further improvements to technology for the benefit of society simply because of the effective stranglehold the beneficiaries of these "patents" have managed to garner.

This has been a long time in coming. Thanks be to an astute judge.
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Anonymous Coward, 29 Mar 2010 @ 5:47pm

It will be interesting to see what happens before the CAFC when this case goes up on appeal after the SCOTUS has remanded In re Bilski for further consideration.
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abc gum, 29 Mar 2010 @ 6:11pm

Re:
"If they are unable to patent genes then there wouldn't be much motivation."

Do you have any verifiable evidence or analysis to back that up that claim?

If so, I'd like to see it.
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Anonymous Coward, 29 Mar 2010 @ 6:16pm

This judgment fits in perfectly with my "judges favor those that keep them employed" theory being that the ACLU is an entity involved in many lawsuits hence keeping judges employed. Nevertheless, it's still a good ruling.
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Brendan (profile), 29 Mar 2010 @ 6:25pm

Excellent News
This should be an interesting appeals process.
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English Nazi, 29 Mar 2010 @ 6:41pm

"it's hard to argue against the idea that genes are not found in nature" - that doesn't look quite right. If you're saying that genes *are* found in nature, shouldn't it be "it's hard to argue against the idea that genes *are* found in nature"?
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Anonymous Coward, 29 Mar 2010 @ 6:46pm

Re:
how about

"it's hard not to argue against the idea that genes are not found in nature"
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raj, 29 Mar 2010 @ 7:40pm

Re: Re: Re:
if you dont understand the distinction between discovery and invention, I doubt that you will understand that discoveries are not patent-able only inventions are. Discovery of genes are like drawing a map of a newly discovered island. And as you minght know, maps are copyright, not patent-able. Someone else and survey(discover) the island on their own, create a map and sell it. With patents on gene, another person is not even allowed to look at the gene. These companies are NOT patenting the 'process' to isolate the gene or invention to modify or fix a gene. they are patenting the gene itself (akin to patenting the island)
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cc, 29 Mar 2010 @ 8:26pm

stifling!
because no one would get into medicine to help people, oh god no. who'd even think of that?
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Dohn Joe, 29 Mar 2010 @ 10:18pm

Ha! Like that'll last!
So how long before this Judge's name and reputation get dragged through the mud while this decision gets "appealed"? Seriously...do you think giants like Monsanto are going to just let this slide?!?
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Dohn Joe, 29 Mar 2010 @ 10:24pm

Re: stifling!
Yes...but having worked in the deep bureacratic bowels of medicine I can tell you that for each one of those there are 5 very intelligent, narcissistic, manipulative, greedy assholes with an agenda which does not ultimately have "helping people" as it's final goal!
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Richard (profile), 30 Mar 2010 @ 2:45am

Re: Computer Virus Copyright Scam
Can you even place a patent on a computer virus,
No - but it does fall under copyright!

Hey I just thought of a great scam.

Step 1 create computer virus

Step 2 register copyright

Step 3 release virus

Step 4 Sue everyone who has an infected computer for infringement and demand statutory damages.

Somone tell me why this doesn't work under current law (it matches Monsanto's tactics quite closely)
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Richard (profile), 30 Mar 2010 @ 2:47am

Re: I doubt this ruling will affect the Monsanto lawsuits
they do not occur in nature but were created in a lab. actually the DO occur in nature - just in a different plant. All Monsanto does is to transfer them - they don't synthesise the "active" ingredient.
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Vincent Clement, 30 Mar 2010 @ 4:52am

Re:
If they are unable to patent genes then there wouldn't be much motivation.

Says who?
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Anonymous Coward, 30 Mar 2010 @ 6:17am

Re:
Different scenario. GMO crops are not found in nature.
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Anonymous Coward, 30 Mar 2010 @ 6:20am

Re: Re:
I agree with your assessment. The techniques for finding genes are reasonably well known. People are motivated to find genes that might be associated with significant diseases (patent practitioners call this TSM, or teaching, suggestion or motivation). So, you have the technical capability and you have the motivation. It would seem like these things would not be patentable under that scenario, in addition to the fact that the genes are indeed found in nature.
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Anonymous Coward, 30 Mar 2010 @ 6:49am

Re: Unimplemented Invention vs Discovery
The judge stated that the invention must have a specific method of functioning. An "unimplemented invention" would need to have a specific function, and method to that function that describes the invention in entirety. The patent in question had no specific functionality or method, and only mentioned specific discoveries that may be applied in general.
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Anonymous Coward, 30 Mar 2010 @ 6:50am

Re: Re:
Pretty much not. Genetically modified is not found in nature. The genes in question are naturally occurring.
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Anonymous Coward, 30 Mar 2010 @ 6:56am

Re: Re: Computer Virus Copyright Scam
Because under copyright law the infringer has to take affirmative action to copy the work. If the work is forced onto a person's computer, then it would not fall under the statute.
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Steve R. (profile), 30 Mar 2010 @ 7:10am

Re:
"If they are unable to patent genes then there wouldn't be much motivation."

So what. Theoretically we live in a free-market system. What this means is that products come into existence when there is demand for them. If you invent a product and it is uneconomic, too bad.

You ignore the role of university research. It is quite unfortunate that taxpayer dollars can be used by private entities to patent products that should be in the public domain. See the Bayh-Dole Act

Also see How Patents Have Harmed University Research
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crade (profile), 30 Mar 2010 @ 7:56am

Re: Re: Re: Re:
Not to proud to admit a mistake..
What I am trying to understand is how allowing a patent on the test can be harmful and in constast, allowing one on the treatment can be helpful.
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crade (profile), 30 Mar 2010 @ 8:03am

Re: Re: Re: Re: Re:
Thats right, in constast... :)
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anymouse (profile), 30 Mar 2010 @ 8:20am

Re: Re: Re: Computer Virus Copyright Scam
This doesn't apply in the case of Monsanto wiping out farmers who suffered from 'wind drift' of their neighboring farms. Where the farmers did nothing to get infected, but because patented plants were found on their property, they were held liable.

So again, explain why this isn't the same as infecting someone with a computer virus, then suing them for patent infringement.
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Anonymous Coward, 30 Mar 2010 @ 10:55am

Re: Re: Re: Re: Computer Virus Copyright Scam
In the case of infecting someone's computer with a virus, the person doing the infecting took affirmative action to place the virus on a person's computer.

In the case of GMO's going onto a farmer's land, the owner or creator of the GMO did not deliberately place the GMO on a neighboring farmer's land.

Just because the scenarios are different and because I explained them does not mean I support suing farmers on neighboring land. In fact, it seems like that the GMO should take affirmative action from preventing their GMO from drifting onto a neighboring farmer's property. What if you do not want the GMO? I saw a recent article that said two things:

(1) GMO crops have lower yields than non-GMO crops.

(2) Weeds are developing resistance to Roundup, which means the effectiveness of Roundup is decreasing.

Plus, there are questions that are being raised regarding the safety of Roundup, which I think has been banned in some European countries.

In a few more years this entire conversation will be moot. The Roundup soy bean patents expire in 2014, I think, and the corn patents expire a couple of years later. Unfortunately, by then Roundup may be of far less use than it once was.
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Mr. Oizo, 30 Mar 2010 @ 12:34pm

Re: Re: stifling!
Agreed entirely ! Especially in Switzerland I found such crappy attitude. Most group leaders I saw are like you describe and their interest is not in udnestanding things or advancing society or so; it is just claiming work done by others as if they did it.
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Anonymous Coward, 30 Mar 2010 @ 4:55pm

Re: Re: Re: Re: Re: Computer Virus Copyright Scam
It doesn't matter anyhow. I hate Monsanto as much as the next guy, but I figure we should use real data to back it up. The scenarios everybody uses aren't really happening. How many farmers have been sued due to cross-pollination from neighboring fields? The answer is "not many". Most are violations of contracts after purchasing RoundUp Ready seed, and while Monsanto's agreements may be draconian, and their tactics Spanish-Inquisition-esque, this has nothing to do with cross-pollination. Percy Schmeiser is an example that is used a lot, but he knowingly sprayed his fields with RoundUp to select for the resistant seed and specifically planted that the next year. It makes the case far less cut and dry since he knew he was planting 80-90% RoundUp Ready seed the following year. So, once again, please hate on Monsanto. Hate on their draconian rules, their probably illegal practices, and genetic patents as a whole, but lets not end up using bad data (and as a corollary, feel free to correct anything that I've written).
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Anonymous Coward, 30 Mar 2010 @ 5:06pm

Re: Re: Re: Re: Re: Re: Computer Virus Copyright Scam
Have to agree with you here. I keep hearing people claiming that thousands or tens of thousands of farmers have been sued by Monsanto because their farms were contaminated by GM seed. Yet, when you try to research actual numbers you come up with anecdotes, but very little data. Hyperbole seems to be a frequent substitute for facts.
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Mark, 1 Apr 2010 @ 12:02pm

Read Daniel Suarez's "Freedom TM" to see the logical conclusion of gene patents on non-industrial farmers. Fictional story, but all-too-truthful analysis.
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inventor, 2 Apr 2010 @ 10:33am

...not an invention it is a discovery
35 U.S.C. 101 Inventions patentable. 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
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selenius, 2 Apr 2010 @ 9:16pm

The article is not entire clear what "gene patents are invalid" means. I am sure that Myriad Genetics will be able to overturn this ruling if it involves a gene that has been manipulated or created i.e. a new development, or a new combination that does not occurs in nature. However, i hope that the ruling stands because genetic engineering is in its infancy and the current GE that is going on is a danger to this world. A little bit if knowledge is a dangerous thing, not to mention the grossly unfair practises of Monsanto against farmers.
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m, 3 Apr 2010 @ 1:39pm

Genes and the Judge
Finally, common sense
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Nathan Taylor, 14 Apr 2010 @ 8:18am

Re:
I had the same thoughts... I wonder...
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Nathan Taylor, 14 Apr 2010 @ 8:18am

Re:
I had the same thoughts... I wonder...
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Bill Hoag, 3 Nov 2010 @ 6:57pm

I created the animal
and it is registered with the US Patent and Trademarks Office in Washington DC as a living animal, namely a sheep. Interesting as I have spent in excess of $2 million dollars of my own personal money to create this animal over 20 years. Now I can't produce enough of these animals to meet the demand, they possess novel polymorphisms never been found anywhere in the world in any animal; and if I continue they have the cure to many neurological diseases in humans; and some JUdge is going to tell me I don't own the animal and everything inside the animal? PS Wasn't Penicillan developed from plants?
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me, 1 Dec 2010 @ 1:11pm

Idiots that dont understand how much money people invested and how much research was done now dont want the people that came up with remarkable technology to get paid for it.
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