ABCnews.com Supreme Court Strikes Down BRCA Gene Patent

[PeterMP]

http://abcnews.go.com/Politics/supreme-court-strikes-brca-gene-patent/story?id=19392299#.Ub8hzZyuiK4

 

There was a thread on this, but I can't find it.

 

But anyway the Supreme Court struck down the concept of patenting human genes at least.  I don't see why this wouldn't extend to genes from other organisms.

 

They did leave the possiblity of some DNA related patents being okay, but certainly not what was being done.

 

Quickly, this should make some tests, like those for the breast cancer gene, much cheaper.

 

The longer term implications in terms of genetic research and biotechs is less clear.

[Larry]

Like the ruling. Looks like they ruled (unanimously) that you can patent something you INVENT, but you can't patent the KNOWLEDGE that "gene X causes Y".

[No Excuses]

It's a fair ruling. The only patents on genes should be the ones artificially synthesized in labs. The work I do in my lab primarily involves creation of transgenes, which should technically be my intellectual property but it's absurd to patent a molecule arising from nature and shared by billions of others.

[twa]

wasn't the stated difference natural genes vs created ones?

[dfitzo53]

wasn't the stated difference natural genes vs created ones?

And it has to be a process that would not be obvious to scientists working in the field.

[Larry]

Now, I will point out that, near as I can tell, the court didn't say that you couldn't patent things related to the gene. 

 

For example, far as I'm aware, if Acme Industries develops a really cheap way of testing for the gene, then they can certainly patent the test. 

 

At least, that's the way I'd want it to be. 

[Bliz]

http://abcnews.go.com/Politics/supreme-court-strikes-brca-gene-patent/story?id=19392299#.Ub8hzZyuiK4

 

There was a thread on this, but I can't find it.

 

But anyway the Supreme Court struck down the concept of patenting human genes at least.  I don't see why this wouldn't extend to genes from other organisms.

 

They did leave the possiblity of some DNA related patents being okay, but certainly not what was being done.

 

Quickly, this should make some tests, like those for the breast cancer gene, much cheaper.

 

The longer term implications in terms of genetic research and biotechs is less clear.

 

Those in the science field would know better than I, but I think the long-term implications should be positive.

 

Until this ruling came down you were prohibited from working with the BRCA1 and 2.  YOu could not work to develop an alternative test that was cheaper, more accurate or, if nothing else, a 2nd opinion.  You can bet the work on that has already begun.  It's encouraging further innovation, and it's also a benefit to the population as a whole.

 

Imagine if the thing you wanted to do was not work with 1 isolated gene, but with a certain sequence of DNA containing 100 genes.  Each owned and patented by 100 different companies.  The hurdles and expense for doing that would have been prohibitive, perhaps impossible to navigate.

 

It opens up fields of research.  And there are still plenty of opportunities, once you have isolated the gene you are interested in, to patent tests or synthetic DNA based on the genes you started with.  It strikes a good and common sense middle ground that still allows for the proper encouragement for research, without unduly restricting medical advances.

[PeterMP]

It opens up fields of research.  And there are still plenty of opportunities, once you have isolated the gene you are interested in, to patent tests or synthetic DNA based on the genes you started with.  It strikes a good and common sense middle ground that still allows for the proper encouragement for research, without unduly restricting medical advances.

 

The biggest issue is that for genetic diseases a very simple and robust test has been created.  This is something that is done in many undergraduate molecular/biochemistry labs (I teach a lab that does this).

 

There is extremely little incentive to understand the genetic basis for disease with the hopes of creating a better test.  Working with DNA today is just that cheap and easy.

 

The other issues is in this case, it probably does encourage research in multiple directions, BUT that's because there was a patent protecting the method and so for many years this company shared their data on the gene sequences (same gene from different people) they obtained so we know a lot about how much variation there is in this gene, where in the gene it is likely to occur, and which variants are more likely to be tied go cancer (they did stop sharing their data because, they claimed people were infringing on the patent, but I think it is also likely they saw this coming).

 

Let's say I identify a gene and changes in a gene related to Alzheimer's.  Currently, there is no economic incentive for me to share that data.

 

The information has vaule, but only as long as I'm the person that controls it.  The better I keep it a secret the better off I am.

 

At least with patents, there was the requirement that a reasonable amount of the information was put in the public domain (through the patent application), and there were reseach based exceptions to the patent protection.

 

I think longer term this might simply spur people developing important tests/procedures based on trivial process where what they've really uncovered is new information and rather then at least partially put the information in the public domain (through a patent application) simply hide it as best they can and still make some money.

 

Which will longer term slow biomedical advances and even our ability to assess the value (e.g. how well does it work?) of the tests.

(There are also global considerations here in terms of economics.  If we were the only country that was going to recognize this patent, then that doesn't make a lot of sense in terms of global economics.  I'd be willing to bet some of the money this country is making was going over seas in terms of data storage and management and some things like that.  It doesn't make much sense for us to pay a bunch of money to a company so that they can then use it over seas so that's another consideration.)

 

It's a fair ruling. The only patents on genes should be the ones artificially synthesized in labs. The work I do in my lab primarily involves creation of transgenes, which should technically be my intellectual property but it's absurd to patent a molecule arising from nature and shared by billions of others.

 

I think though, this case (and ones like it) might encourage us to reconsider the objective of the patent process.

 

Is it simply to protect people that create something new?

 

Or is it to create an economic incentive to people that are doing something useful to society?

 

If I go into a lab and fuse part of some random human gene to some part of a random yeast gene and insert into E. coli and make a transgeneic organism, does that have any real value to society?

 

Why should we try to protect it?

 

Maybe it makes more sense to construct a system that creates value to somebody that has done something (even if it is just obain information) that has value too society.

[Bliz]

It opens up fields of research.  And there are still plenty of opportunities, once you have isolated the gene you are interested in, to patent tests or synthetic DNA based on the genes you started with.  It strikes a good and common sense middle ground that still allows for the proper encouragement for research, without unduly restricting medical advances.

 

The biggest issue is that for genetic diseases a very simple and robust test has been created.  This is something that is done in many undergraduate molecular/biochemistry labs (I teach a lab that does this).

 

There is extremely little incentive to understand the genetic basis for disease with the hopes of creating a better test.  Working with DNA today is just that cheap and easy.

 

The other issues is in this case, it probably does encourage research in multiple directions, BUT that's because there was a patent protecting the method and so for many years this company shared their data on the gene sequences (same gene from different people) they obtained so we know a lot about how much variation there is in this gene, where in the gene it is likely to occur, and which variants are more likely to be tied go cancer (they did stop sharing their data because, they claimed people were infringing on the patent, but I think it is also likely they saw this coming).

 

Let's say I identify a gene and changes in a gene related to Alzheimer's.  Currently, there is no economic incentive for me to share that data.

 

If you want to do something with the gene, you'll have to share the data though right?  Explain what your test/process does.  And that's the point of this decision.  You can't just patent the Alzheimer's gene and plant a flag in it.  You have to do something useful with it.  Otherwise how are you going to make money with it?

 

 

 

The information has vaule, but only as long as I'm the person that controls it.  The better I keep it a secret the better off I am.

 

At least with patents, there was the requirement that a reasonable amount of the information was put in the public domain (through the patent application), and there were reseach based exceptions to the patent protection.

 

I think longer term this might simply spur people developing important tests/procedures based on trivial process where what they've really uncovered is new information and rather then at least partially put the information in the public domain (through a patent application) simply hide it as best they can and still make some money.

 

Which will longer term slow biomedical advances and even our ability to assess the value (e.g. how well does it work?) of the tests.

(There are also global considerations here in terms of economics.  If we were the only country that was going to recognize this patent, then that doesn't make a lot of sense in terms of global economics.  I'd be willing to bet some of the money this country is making was going over seas in terms of data storage and management and some things like that.  It doesn't make much sense for us to pay a bunch of money to a company so that they can then use it over seas so that's another consideration.)

 

It's a fair ruling. The only patents on genes should be the ones artificially synthesized in labs. The work I do in my lab primarily involves creation of transgenes, which should technically be my intellectual property but it's absurd to patent a molecule arising from nature and shared by billions of others.

 

I think though, this case (and ones like it) might encourage us to reconsider the objective of the patent process.

 

Is it simply to protect people that create something new?

 

Or is it to create an economic incentive to people that are doing something useful to society?

 

If I go into a lab and fuse part of some random human gene to some part of a random yeast gene and insert into E. coli and make a transgeneic organism, does that have any real value to society?

 

Why should we try to protect it?

 

Maybe it makes more sense to construct a system that creates value to somebody that has done something (even if it is just obain information) that has value too society.

 

Patent rules apply to many fields.  The Supreme Court isn't making policy here.  They're applying the law - the same law - to all sorts of institutions.  And the decision here is a natural extension of the rule that says you can't patent a flower or an animal.  You can't pull a limb off a tree and patent it.  But if through innovation you create a process to turn a tree into something useful like paper, you can patent that process. 

 

Same rules apply to all fields, and it's not the Supreme Court's job to look at the policy of are we encouraging or discouraging scientific innovation.  If there is sufficient discouragement--and I'm convinced there is not, here--then Congress can act to provide additional protections (provided those companies donate enough money to their reelection campaigns).

 

I'm also very much opposed to any idea of a value test.  Who administers the test and how?  You want some bureaucrat in the patent office tasked with understanding if your transgenic organism is useful or not?  What would they base it on?  Who would present the contra opinion to your application declaring its usefulness?  What if they deny the patent and years down the road it becomes super valuable?  Can you sue?

 

No thank you.  If you want to pay the fee to patent and hold something that's completely useless and stupid, that's your problem.

[Larry]

Let's say I identify a gene and changes in a gene related to Alzheimer's.  Currently, there is no economic incentive for me to share that data.

A valid point, imo. But science has managed to advence knowledge for a long time, without people patenting abstract knowledge.

Newton's law of gravitation really advanced society. We didn;t have to make it illegal for anybody to do any device, or any research, that used gravity, to incentivize him to publish his work.

Some types of knowledge have managed to progress, simply for the intangible results of that knowledge.

[Larry]

I'm also very much opposed to any idea of a value test.  Who administers the test and how?  You want some bureaucrat in the patent office tasked with understanding if your transgenic organism is useful or not?  What would they base it on?  Who would present the contra opinion to your application declaring its usefulness?  What if they deny the patent and years down the road it becomes super valuable?  Can you sue?

 

No thank you.  If you want to pay the fee to patent and hold something that's completely useless and stupid, that's your problem.

I've seen counter arguments to that, though.

That a big problem with our patent system right now, is that the patent office will basically put a rubber stamp on anything, and if the invention is trivial or obvious or is an invalid patent for some other reason, then, well, somebody can go to court and let the court rule on whether to throw it out.

Which is how we get to things like Microsoft claiming to have not only patented the concept of the double click, but in fact, the concept of any binary control executing multiple commands, based on different patterns of triggering the control. (Despite the fact that there were numerous devices already doing that, before they decided to patent it.)

That's how we get to "yeah, I know my patent is completely bogus. But it will take you three million dollars, and 8 years, to get it thrown out. (And, during that time, I'll have an injunction forbiding your company from making any products whatsoever.) Or you can just pay me one dollar for every product your company sells."

[PeterMP]

If you want to do something with the gene, you'll have to share the data though right?  Explain what your test/process does.  And that's the point of this decision.  You can't just patent the Alzheimer's gene and plant a flag in it.  You have to do something useful with it.  Otherwise how are you going to make money with it?

 

Patent rules apply to many fields.  The Supreme Court isn't making policy here.  They're applying the law - the same law - to all sorts of institutions.  And the decision here is a natural extension of the rule that says you can't patent a flower or an animal.  You can't pull a limb off a tree and patent it.  But if through innovation you create a process to turn a tree into something useful like paper, you can patent that process. 

 

Same rules apply to all fields, and it's not the Supreme Court's job to look at the policy of are we encouraging or discouraging scientific innovation.  If there is sufficient discouragement--and I'm convinced there is not, here--then Congress can act to provide additional protections (provided those companies donate enough money to their reelection campaigns).

 

I'm also very much opposed to any idea of a value test.  Who administers the test and how?  You want some bureaucrat in the patent office tasked with understanding if your transgenic organism is useful or not?  What would they base it on?  Who would present the contra opinion to your application declaring its usefulness?  What if they deny the patent and years down the road it becomes super valuable?  Can you sue?

 

No thank you.  If you want to pay the fee to patent and hold something that's completely useless and stupid, that's your problem.

 

1.  The test to determine the sequence of a gene is very trivial, not patented protected (the patent is expired if there ever was one (it might not have been patented), and based on the gene.  The company couldn't patent a new test so they patented a gene.

 

In each position of your DNA, you can have four different possibilites (A, G, C, T).  If I know that you have a T at position 154,000 you are very likely to get cancer, I can no longer patent that (where position 154,000 would be in gene X so by patenting that gene I was essentially trying to patent the right to use that information).

 

What this company had done is said, we own the patent for this gene, and you can't do anything (including determine the sequence) with the gene in a person, unless you met a research exception.  The Supreme Court has said that's not legal and anybody can determine the sequence of anybody's BRCA gene and based on what is known predict the probability of that person getting breast cancer.

 

I have a test for Alzheimers were I know that if in that gene you have a T at positoin of 345 (of the gene), you have a 80% chance of getting Alzheimers at an early age.  The Supreme Court has essentially said there is nothing patentable there that would prevent anybody from determining if that position is a T or not.

 

2.  Why do I need to share?  Send me a swab from your cheek and a check for $100, and I'll send you the results, which won't be the sequence, but based on what we know the probability that you will get Alzheimers before age 60 (that's how these things work now even.  You don't get the sequence back.  They send you some sort of analysis results.)

 

3.  I understand what the job of the Supreme Court is, and I think based on the law the decision is probably right.  I wastrying to create a larger conversation about the issues and what might make sense to do.

 

4.  But isn't that what has essentially happened now?  Hasn't Congress (and aren't they really essentially bueracrats) arbitrarily said this can be patented and this can't be?  Congress is essentially saying that creation of something has value (it can be protected and hence has value), but simply obtaining knowledge doesn't.

 

How does that make any sense?

 

In terms of the specifics, I think many of those issues could be worked out in a manner better than now and certainly there could be some look at the economics of the thing after the "patent" has been applied for.

A valid point, imo. But science has managed to advence knowledge for a long time, without people patenting abstract knowledge.

Newton's law of gravitation really advanced society. We didn;t have to make it illegal for anybody to do any device, or any research, that used gravity, to incentivize him to publish his work.

Some types of knowledge have managed to progress, simply for the intangible results of that knowledge.

 

I think though with respect to recent history, you have to take into account the increased in patenting acceptence and even pressure in academia and then the "value" that patents are given as academic institutions now look for non-traditional revenue streams.

 

http://www.technologyreview.com/article/402321/academic-patent-binge/

 

Historically, patents have counted for very little or nothing during tenure and promotional decisions, but that's changing as universities are more pressured to be more economically independent and there is more money in patents.

 

And papers in the peer reviewed literature have been heavily counted and even required in many cases.

 

I don't doubt that we will see "confidential" non-patent based licensing agreements to companies where publishing the research would greatly diminish the value of the information and from the university that type of thing having a lot of value (because of the money it brings in).

 

Not to mention the economic value to the individual too in many cases.

 

**EDIT**

Note, I'm not saying that science is going to come to stand still, but I can see this having a negative impact on the growth of science in the related fields as compared to letting the patent stand.

[DCSaints_fan]

Let's say I identify a gene and changes in a gene related to Alzheimer's.  Currently, there is no economic incentive for me to share that data.

 

If you're working for a private company, no, but if you in academia that would be a pretty high impact paper. 

[PeterMP]

Let's say I identify a gene and changes in a gene related to Alzheimer's.  Currently, there is no economic incentive for me to share that data.

 

If you're working for a private company, no, but if you in academia that would be a pretty high impact paper. 

But that only matters if my institution emphasis publications over liscensing agreements that bring in money, and the difference in many places is decreasing.

[Bliz]

 

 I’ll take your word for it that the test is that simple.  I really don’t know anything about that.  But even if it is, there can still be room for improvement right? Someone starts with what Myriad has been doing, and then figures out
that you can predict with much more accuracy if you look at the combination of three different positions.  But I didn’t think the Supreme Court had said that the test itself is not patentable.  There was something else Myriad was doing that they left open for protection, having to do with cDNA.  It went over my head and I just skimmed that
portion of the opinion because the detail of the science wasn’t what interested in me (nor do I necessarily trust the Supreme Court to have the explanation of the precise science correct).

 

Regarding #2, not to attack the hypothetical, but I’m pretty sure you’d still have to share in that scenario.  How do you develop the test without research and peer-reviewed publications?  Plus federal regulation comes into play
here.  If you start selling that test, you better believe you’ll get a knock on the door.  You’re going to have to demonstrate the science behind it, unless you want to get fined to hell and shut down by the govt for false advertising.  Heck, they regulate what General Mills can say on a box of cheerios.  They're not just going to sit idly by and take your word for it that you can actually predict Alzheimer's with some measure of certainty.

 

As in many things, it’s a question of degree.  What is the true effect on research into some of the most severe diseases of our time if, at the end of the day, you can make good money but not insane money if you figure out
the test?  How much of the money for that sort of research presently comes from R&D departments of companies hoping to make insane money, vs government grants, charity or special interest groups? 

 

[PeterMP]

 

 I’ll take your word for it that the test is that simple.  I really don’t know anything about that.  But even if it is, there can still be room for improvement right? Someone starts with what Myriad has been doing, and then figures out

that you can predict with much more accuracy if you look at the combination of three different positions.  But I didn’t think the Supreme Court had said that the test itself is not patentable.  There was something else Myriad was doing that they left open for protection, having to do with cDNA.  It went over my head and I just skimmed that

portion of the opinion because the detail of the science wasn’t what interested in me (nor do I necessarily trust the Supreme Court to have the explanation of the precise science correct).

 

Regarding #2, not to attack the hypothetical, but I’m pretty sure you’d still have to share in that scenario.  How do you develop the test without research and peer-reviewed publications?  Plus federal regulation comes into play

here.  If you start selling that test, you better believe you’ll get a knock on the door.  You’re going to have to demonstrate the science behind it, unless you want to get fined to hell and shut down by the govt for false advertising.  Heck, they regulate what General Mills can say on a box of cheerios.  They're not just going to sit idly by and take your word for it that you can actually predict Alzheimer's with some measure of certainty.

 

As in many things, it’s a question of degree.  What is the true effect on research into some of the most severe diseases of our time if, at the end of the day, you can make good money but not insane money if you figure out

the test?  How much of the money for that sort of research presently comes from R&D departments of companies hoping to make insane money, vs government grants, charity or special interest groups? 

 

 

1.  The test is that simple.

 

2.  Knowing about multilple positions still doesn't give you anything patentable.  It only requires that you know the sequence of the person of interest, which positions are important and at what level, and then some basic statistics.  The cDNA issues comes from using DNA molecules to make something new (the idea of transgenes and transgenic organisms (which relates to the Monsanto case this Court also heard where the supported Monsanto's right to have patented organisms and vigorously defend those patents by taking people to court).  That's the type of thing they said was legal.).  There is a reason why people are saying this is a good thing in terms of patients, it is now because many different people will be able to perform the test that Myraid was performing under their patent.

 

And there are multiple positions involved in the BRCA and breast cancer.  That's why it is useful for in terms of public information for Myraid to have some sort of protection if they are putting the data out there in the public domain (which they did for a while).  But they still don't have anything patentable with respect to BRCA that is preventing other people to do breast cancer tests now.

 

3.  I could do the research, but there is nothing that requires me to publish things in peer reviewed journals.  Even if I have a grant from the federal government there is no requirement for me to publish my results.  It helps in getting future grants, but if my choice is to publish and put myself in a better position to get future grants or to not publish and make millions of dollars for me and my institution, I think the choice is pretty straight forward.  Publishing in peer reviewed journals might help convice people that my test is worthwhile, but it is not a requirment.

 

4.  There is no FDA regulation of genetic tests (or most tests where a device isn't be sold directly to the individual).  It is buyer beware.  I could absolutely do what I said.  I guess, especially if I was wrong, you could sue me over false advertising, and I'm not sure of the legal requirements in such a case in of sharing properitery information.  And anyway the FDA approval process is different and much of the information is not in the public domain the way that it is the case for patents.

 

Look at Jenny McCarthy and other similar people and what they write about vaccines and autism.  The FDA isn't knocking on their door demainding their information.

[Bliz]

4.  There is no FDA regulation of genetic tests (or most tests where a device isn't be sold directly to the individual).  It is buyer beware.  I could absolutely do what I said.  I guess, especially if I was wrong, you could sue me over false advertising, and I'm not sure of the legal requirements in such a case in of sharing properitery information.  And anyway the FDA approval process is different and much of the information is not in the public domain the way that it is the case for patents.

 

Look at Jenny McCarthy and other similar people and what they write about vaccines and autism.  The FDA isn't knocking on their door demainding their information.

 

I was thinking more about the FTC than the FDA

 

Jenny is selling books and horribly bad information, but it's just speech.  That's not quite the same as saying "pay me $100 and I'll conduct a medical test that will tell you the likelihood your kid gets autism."  Not my area of expertise, but I would expect it to be more akin to touting the heatlh benefits of  an herbal supplement you're selling.  Which the FTC can and does regulate.  So I think if you want to advertise your test, you have to be able to satisfy the FTC that you have objective evidence to support the claim that your test is accurate.

[PeterMP]

4.  There is no FDA regulation of genetic tests (or most tests where a device isn't be sold directly to the individual).  It is buyer beware.  I could absolutely do what I said.  I guess, especially if I was wrong, you could sue me over false advertising, and I'm not sure of the legal requirements in such a case in of sharing properitery information.  And anyway the FDA approval process is different and much of the information is not in the public domain the way that it is the case for patents.

 

Look at Jenny McCarthy and other similar people and what they write about vaccines and autism.  The FDA isn't knocking on their door demainding their information.

 

I was thinking more about the FTC than the FDA

 

Jenny is selling books and horribly bad information, but it's just speech.  That's not quite the same as saying "pay me $100 and I'll conduct a medical test that will tell you the likelihood your kid gets autism."  Not my area of expertise, but I would expect it to be more akin to touting the heatlh benefits of  an herbal supplement you're selling.  Which the FTC can and does regulate.  So I think if you want to advertise your test, you have to be able to satisfy the FTC that you have objective evidence to support the claim that your test is accurate.

I don't know much about the FTC, but at some level Myraid is already doing this.

 

We all know what gene they are looking at (BRCA), but we don't know all of the changes they are looking at and how much risk they assign to different changes becuase they quit reporting that information.

 

They are predicting whether you will get cancer based on datat that is not completely in the public domain.  I'm just adding another level to it where what gene I'm looking at won't even be in the public domain.

 

I'd be some what shocked if there wasn't an FTC process that allowed for confidentiality like what we see with the FDA.

 

(Quick google search shows there is something called a Uniform Trades Secret Act and members of the FTC are subject to it.)