US appeals court rules in favor of patenting genes(reuters.com)
reuters.com
US appeals court rules in favor of patenting genes
http://www.reuters.com/article/2012/08/16/us-myriad-patent-idUSBRE87F12K20120816
28 comments
I'm not sure you have understood the argument made by myriad here. Consider a parallel situation: crude oil is a product of nature, but getting it out of the ground and refining it into gasoline or other distillates involves a great deal of technology and ingenuity. If I invented a new way to refine oil into something that had the combustibility of gasoline but behaved differently - ignition at lower or higher temperatures, say, or that burned more cleanly - then my novel formulation would certainly be patentable.
Likewise, Myriad has been granted a patent on the isolated genes - their ability to produce DNA containing the two BRCA genes in quantity. The utility here is that if you're a medical researcher you can just order up this stuff for your research lab in a bottle, so to speak, instead of going through the tortuous business of isolating and purifying it in useful quantities. Now Myriad's competitors would like to do that too, and large research labs would like to do it for themselves. But Myriad has argued, successfully so far, that it invested all the effort and expense in learning how to do this reliably, and is entitled to recoup that investment by selling the product of all its research and development.
They didn't apply for a patent on the genes that lie within people's flesh and blood as part of their own DNA. They applied for a patent on the extracted, purified, and commoditized form of a single gene. If you could come up with a way to extract BRCA and BRCA-2 in a form that's useful to genetic researchers but employing a different process and final form from that of Myriad, then you wouldn't be infringing on their patent. Conversely, if you had spent a lot of money and time on the development of such a technology, wouldn't you be anxious to recoup that investment? It would be nice if they just gave it away, but then how are they going to pay their employees and attract future investors? What exactly are the economic incentives to expend all the effort and expense on developing an industrial process if one is not allowed to commercialize the result?
Likewise, Myriad has been granted a patent on the isolated genes - their ability to produce DNA containing the two BRCA genes in quantity. The utility here is that if you're a medical researcher you can just order up this stuff for your research lab in a bottle, so to speak, instead of going through the tortuous business of isolating and purifying it in useful quantities. Now Myriad's competitors would like to do that too, and large research labs would like to do it for themselves. But Myriad has argued, successfully so far, that it invested all the effort and expense in learning how to do this reliably, and is entitled to recoup that investment by selling the product of all its research and development.
They didn't apply for a patent on the genes that lie within people's flesh and blood as part of their own DNA. They applied for a patent on the extracted, purified, and commoditized form of a single gene. If you could come up with a way to extract BRCA and BRCA-2 in a form that's useful to genetic researchers but employing a different process and final form from that of Myriad, then you wouldn't be infringing on their patent. Conversely, if you had spent a lot of money and time on the development of such a technology, wouldn't you be anxious to recoup that investment? It would be nice if they just gave it away, but then how are they going to pay their employees and attract future investors? What exactly are the economic incentives to expend all the effort and expense on developing an industrial process if one is not allowed to commercialize the result?
The problem with their argument is that pulling out genes in large quantity from an isolated sample is pretty damn easy. Its molecular biology 101; we clone genes all kinds of genes all the time. If you read their technical spec (http://www.myriad.com/lib/technical-specifications/BRACAnaly...) its obvious that while they have the process very streamlined, they're doing nothing fundamentally differently than any other lab would do if Myriad didn't hold these patents. PCR and dye labeling sequencing methods are commonly used tools; the idea that Myriad has come up with anything novel is absurd.
It's easy now; I don't think it was all that easy back in 1994 when they first sequenced BRCA-1 or when they first began work on it back around 1988.
It was easy even then. PCR and Sanger sequencing have been in wide use for a long time. Yes, Myriad did do a lot of streamlining and optimizing, but everything they did was with preexisting technologies. There's nothing novel or innovative at all—they developed a very efficient analysis pipeline, but that's not something anyone should ever be awarded a patent for.
In that case, why haven't their legal antagonists built their case around a straightforward prior art argument, instead of amking normative arguments about the patentability of human DNA?
Not sure, might have something to do with the ACLU/AMP wanting to set a wide reaching precedent that patents of endogenous DNA sequences are not ok? They won't just want to win the single case, they want to change the wider legal landscape concerning patents and biological science.
I did it in an undergrad lab class in 1994. It took some fancy equipment, target data from published reports on particular sequences, appropriate cells, salts, and enzymes. And it took me about 25 lab hours to get it right.
But it wasn't hard. An undergrad could do it.
Maybe not in 1988, though. I was in junior high then.
But it wasn't hard. An undergrad could do it.
Maybe not in 1988, though. I was in junior high then.
I'm not against techniques, manufacturing methods or process patents. What I'm against is the wholesale patenting of DNA. Now, if someone comes up with a new technique which is more cost effective, faster, safer, etc. they will not be able to sell the thing extracted. The techniques here are what should be theirs, not what exists within us.
I addressed these concerns in the third paragraph, and am not sure what part of my argument it is that you disagree with.
This is the kind of craziness you run into when the absurd oxymoron that is "intellectual property" collides with the real world.
A 2-1 panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., on Thursday upheld the biotechnology company's right to patent "isolated" genes known as BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancers.
...Circuit Judge Alan Lourie, writing for the court majority, said, "Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."
I completely fail to see how [gene] compositions are the "product of man". What am I missing?
...Circuit Judge Alan Lourie, writing for the court majority, said, "Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."
I completely fail to see how [gene] compositions are the "product of man". What am I missing?
If human beings composed said genes, ie. through a splice or more involved process, then said composition is indeed a product of man because it was brought about through deliberate human effort and did not exist before. There are many ethical concerns with patented genes, but whether or not artificial gene composition are products of man seems pretty clear to me.
By way of analogy, rock formations occur naturally, but when a person deliberately carves or arranges the rocks, as in a primitive building or in a statue, it becomes artificial, even if it resembles something that could appear in nature. The same logic would apply here. The problem, as I see it, is that we might end up patenting real people's genes and that could lead to real trouble.
By way of analogy, rock formations occur naturally, but when a person deliberately carves or arranges the rocks, as in a primitive building or in a statue, it becomes artificial, even if it resembles something that could appear in nature. The same logic would apply here. The problem, as I see it, is that we might end up patenting real people's genes and that could lead to real trouble.
After doing some additional reading, I can now see what the basis for the pro-patent argument is. However, I disagree with it as I'm struggling with the concept of "because we touched it, it's now different".
Below is a description, from a patent law blog, of the change that occurs during the gene isolation :
"To be clear, the change in the molecule that the court is discussing is that the isolated DNA molecule is cleaved from the larger chromosomal DNA molecule by enzymatically cutting it off at each end and slightly altering the terminal amino acid groups." [1]
From the same link, one judge ruled this as akin to plucking a leaf from a tree. While the analogy is simplistic - how is it [conceptually] different?
Judge rulings below :
Judge Bryson [minority] :
[E]xtracting a gene is akin to snapping a leaf from a tree. Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention. That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted "markedly different characteristics" to the plucked leaf.
Louie & Moore [majority ruling] :
It is also important to dispute the dissent's analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.
[1]http://www.patentlyo.com/patent/2012/08/gene-patent-debate-c...
Below is a description, from a patent law blog, of the change that occurs during the gene isolation :
"To be clear, the change in the molecule that the court is discussing is that the isolated DNA molecule is cleaved from the larger chromosomal DNA molecule by enzymatically cutting it off at each end and slightly altering the terminal amino acid groups." [1]
From the same link, one judge ruled this as akin to plucking a leaf from a tree. While the analogy is simplistic - how is it [conceptually] different?
Judge rulings below :
Judge Bryson [minority] :
[E]xtracting a gene is akin to snapping a leaf from a tree. Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention. That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted "markedly different characteristics" to the plucked leaf.
Louie & Moore [majority ruling] :
It is also important to dispute the dissent's analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.
[1]http://www.patentlyo.com/patent/2012/08/gene-patent-debate-c...
"It is also important to dispute the dissent's analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort."
They're not creating a new chemical entity. The gene was created by evolution (natural selection, genetic drift, mutation) millions of years ago. The DNA sequence existed and performed its function long before any human began studying it. Furthermore, such information could already be found isolated in the form of mRNA, which contains the same information as the DNA gene (with the thymines replaced by uracils). Ultimately, what really matters for the function of the cell and even the diagnostic method is the information coded in the DNA, RNA, or protein. You are simply using a different alphabet to represent the same thing. And because the information was designed by nature, it shouldn't be patentable.
Nearly all experiments require you to modify what you're observing in order to measure it. That's why I feel the argument asserting that because you "modify" something makes it susceptible to patent protection is weak. If I combine water with some powder and sell it, I can patent the final product or maybe even the process to make it, but not the water. Water was present before I had the idea. BRCA1 was there before we had the idea of linking it to cancer, it's a substance just like water.
The troubling thing in this case is there's not even a modification involved. Cutting a DNA segment from the chromosome doesn't alter its sequence. In fact, separating DNA pieces happens routinely during recombination.
The problem is that they're not only protecting the diagnostic tool like the majority ruling says, they're claiming ownership of a chemical substance present in all humans that was invented by nature. I would support patenting the DNA sequencing method they used, but never the gene itself.
They're not creating a new chemical entity. The gene was created by evolution (natural selection, genetic drift, mutation) millions of years ago. The DNA sequence existed and performed its function long before any human began studying it. Furthermore, such information could already be found isolated in the form of mRNA, which contains the same information as the DNA gene (with the thymines replaced by uracils). Ultimately, what really matters for the function of the cell and even the diagnostic method is the information coded in the DNA, RNA, or protein. You are simply using a different alphabet to represent the same thing. And because the information was designed by nature, it shouldn't be patentable.
Nearly all experiments require you to modify what you're observing in order to measure it. That's why I feel the argument asserting that because you "modify" something makes it susceptible to patent protection is weak. If I combine water with some powder and sell it, I can patent the final product or maybe even the process to make it, but not the water. Water was present before I had the idea. BRCA1 was there before we had the idea of linking it to cancer, it's a substance just like water.
The troubling thing in this case is there's not even a modification involved. Cutting a DNA segment from the chromosome doesn't alter its sequence. In fact, separating DNA pieces happens routinely during recombination.
The problem is that they're not only protecting the diagnostic tool like the majority ruling says, they're claiming ownership of a chemical substance present in all humans that was invented by nature. I would support patenting the DNA sequencing method they used, but never the gene itself.
Wouldn't the chemical isolation of elements, as done in the 18th and 19th centuries, be a better analogy? Doing so required a human transformation, requiring skill, knowledge, and effort, yet would anyone patent an element? We are still creating new heavy elements in particle accelerators; are those patentable?
If the argument is that the gene is modified in its isolation by changing the terminating amino acids, we could extend the analogy to include changes to the electron shell of an element brought about by chemical processes.
If the argument is that the gene is modified in its isolation by changing the terminating amino acids, we could extend the analogy to include changes to the electron shell of an element brought about by chemical processes.
See, this is not a field I'm really involved in, so I can't comment on the particulars. Case in point: what you describe is the isolation of a preexisting gene, rather than the creation of a new one, which is different from what I was thinking of.
But if the copyright is on the isolated gene, then I think the logic would follow that the copyright wouldn't apply to instances of the gene that haven't been isolated. Ie, plucking a leaf wouldn't allow you copyright leaves, but would allow you to copyright plucked leaves. (Which is stupid, but for different reasons.)
But if the copyright is on the isolated gene, then I think the logic would follow that the copyright wouldn't apply to instances of the gene that haven't been isolated. Ie, plucking a leaf wouldn't allow you copyright leaves, but would allow you to copyright plucked leaves. (Which is stupid, but for different reasons.)
If I understand correctly, it's a pre-existing gene that is modified by its removal / isolation. It appears to be an incredibly subtle change that in no way alters the fundamental characteristics of the gene itself.
So yes, by extension they would hold no copyright over the genes in a given person's body, but it might extend to cover any tests or work that is done with those genes in the body - such as cancer screening tests.
So yes, by extension they would hold no copyright over the genes in a given person's body, but it might extend to cover any tests or work that is done with those genes in the body - such as cancer screening tests.
We're talking about patents not copyrights...
the isolated DNA molecule is cleaved from the larger chromosomal DNA molecule by enzymatically cutting it off at each end and slightly altering the terminal amino acid groups
If that's what they patented, then I think we're all in the clear... DNA doesn't have amino acids. Whew! And here I thought a court might have made a terrible mistake in a ruling about something that they didn't fully understand.
If that's what they patented, then I think we're all in the clear... DNA doesn't have amino acids. Whew! And here I thought a court might have made a terrible mistake in a ruling about something that they didn't fully understand.
The "amino acids" language is from the blogger, not the opinion. Also, without trying to defend the decision--the judge who wrote the opinion (Alan Lourie) has a PhD in chemistry and worked as a chemist and scientist for Monsanto and Wyeth.
This is an interesting point, and this very background may have found its way into the ruling. Specifically, that the judge has a background in chemistry and directly speaks to the difference in perspective between biologists and chemists :
"We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than by their functions" [1]
The blogger goes on to state in more plain terms :
"In other words, this ruling affirms that molecular biology is, in fact, chemistry, if you want to look at it that way."
[1]http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
"We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than by their functions" [1]
The blogger goes on to state in more plain terms :
"In other words, this ruling affirms that molecular biology is, in fact, chemistry, if you want to look at it that way."
[1]http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
This makes perfect sense... I could easily see how a chemist could come to one conclusion, whereas a biologist would come to a completely different conclusion. In this case, I think the judge's chemistry training actually worked against him.
I think one of the weaknesses is in replication - the process of replicating genes is most certainly not a product of man.
So if a rock carved into a primitive statue is mine, and if rock could naturally replicate, split into two, would the second rock which I had no hand in creating, still be my product? And the third?
So if a rock carved into a primitive statue is mine, and if rock could naturally replicate, split into two, would the second rock which I had no hand in creating, still be my product? And the third?
I think it would. If the original statue was your product and the new statues would only have come into existence because of your original, then the criteria for copyright would still apply. The reason is that copyright is meant to give creators some legal control over stuff which is liable to be copied without his control.
Of course, there are a lot more difficulties in copyrighted genes than in other copyrighted works, but I think that is due to the failure of the copyright system to take into account the unique nature of genes rather than the ineligibility of genes for copyright as the law stands.
I suspect that what will happen is that the genes will remain copyrightable and the law will be modified to account for the unique dangers copyrighted genes present, likely through limiting the power copyright holders possess over them.
Of course, there are a lot more difficulties in copyrighted genes than in other copyrighted works, but I think that is due to the failure of the copyright system to take into account the unique nature of genes rather than the ineligibility of genes for copyright as the law stands.
I suspect that what will happen is that the genes will remain copyrightable and the law will be modified to account for the unique dangers copyrighted genes present, likely through limiting the power copyright holders possess over them.
Except that the company that tries to patent BRCA gene has nothing to do with its "carving". Your analogy doesn't work.
I feel that this is similar to patenting genetically modified seeds, which has already been happening for awhile.
So does this mean if someone is found to have BRCA1 or BRCA2 genes then they have to pay Myriad Genetics Inc a license fee? Maybe we all need to take out licenses just in case, otherwise we'll get those patent trolls writing us nasty letters...
(This is a totally disgusting ruling by the way... another win for putting money over the life of fellow human beings)
(This is a totally disgusting ruling by the way... another win for putting money over the life of fellow human beings)
I can understand being able to patent how they find out what is in those genes, but I can't, for the life of me, understand how they can patent the genes themselves, such that nobody else can do anything that includes those genes.
The second question I have is what is wrong with the appeals court and patents? They have been overturned many times by SCOTUS. Who is populating that court and why are they so in favor of patents?
The second question I have is what is wrong with the appeals court and patents? They have been overturned many times by SCOTUS. Who is populating that court and why are they so in favor of patents?
Ironically, it's because a number of the Federal Circuit judges have technical backgrounds and worked in industry. The two judges in the majority in this opinion, Lourie and Moore, have a PhD in chemistry from U Penn and a BS/MS in Electrical Engineering from MIT, respectively. My engineering degree is in a non-CS field, and I have found that outside the software realm, scientists and engineers generally view the patent system positively.
I think the Supreme Court, who isn't caught up in whether some specific process is technically like another process that's already patentable, is looking more at the broader ethical implications of certain types of patents.
I think the Supreme Court, who isn't caught up in whether some specific process is technically like another process that's already patentable, is looking more at the broader ethical implications of certain types of patents.
There is so much hyperbole from both sides. The important thing to understand is that they are absolutely not patenting "genes" as such, despite what any sensationalist headline might read. From the article:
"Myriad's argument is that when it isolates the genes by removing them from the body, this process changes their chemical structure, and the company's test looks for this distinct chemical form"
So they are saying they are patenting not the gene, but a different compound that is produced by transforming the gene. They do not test the gene for BRCA mutations but the secondary compound.
Having said this, I find this patent frightening because by definition, if their secondary compound is sufficiently different to the gene itself then it should be quite simple to work around this patent. However it is not; if it was, people would not be forced into paying $3000 for every breast cancer test. I do not believe that the entire medical community is too stupid to come up with a workaround. It has to be that this "secondary" compound is a trivial transformation of the DNA that occurs as a natural consequence of just about any attempt to extract it. If it wasn't, people would just be extracting it a different way and there wouldn't even be a court case.
So I see the principle of this being generally OK but the specific case being wildly wrong.
"Myriad's argument is that when it isolates the genes by removing them from the body, this process changes their chemical structure, and the company's test looks for this distinct chemical form"
So they are saying they are patenting not the gene, but a different compound that is produced by transforming the gene. They do not test the gene for BRCA mutations but the secondary compound.
Having said this, I find this patent frightening because by definition, if their secondary compound is sufficiently different to the gene itself then it should be quite simple to work around this patent. However it is not; if it was, people would not be forced into paying $3000 for every breast cancer test. I do not believe that the entire medical community is too stupid to come up with a workaround. It has to be that this "secondary" compound is a trivial transformation of the DNA that occurs as a natural consequence of just about any attempt to extract it. If it wasn't, people would just be extracting it a different way and there wouldn't even be a court case.
So I see the principle of this being generally OK but the specific case being wildly wrong.
For a nice analysis of the issues at stake (and the nuances are not trivial)...
http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
This is a great analysis, thank you for sharing.
While the ruling does go out of its way to point out that this is about "...patent eligibility and not patentability" and intended to be of limited scope, I believe there is still some cause for concern.
After all, this ruling itself was based heavily on the precedent set in Chakrabarty. It's hardly a stretch to imagine this ruling in turn setting precedent for other rulings on gene patent eligibility [and, perhaps patentability] down the road.
While the ruling does go out of its way to point out that this is about "...patent eligibility and not patentability" and intended to be of limited scope, I believe there is still some cause for concern.
After all, this ruling itself was based heavily on the precedent set in Chakrabarty. It's hardly a stretch to imagine this ruling in turn setting precedent for other rulings on gene patent eligibility [and, perhaps patentability] down the road.
If Myriad's process does in fact change the chemical structure of the gene and it is the altered structure which is able to be tested then I see some merit in their argument.
That is, if it is the altered form which is protected, rather than the gene in its basic form.
I would have to read the full judgment to get a better handle on the case though.
That is, if it is the altered form which is protected, rather than the gene in its basic form.
I would have to read the full judgment to get a better handle on the case though.
Exactly -- Is the gene mutated, is the question.
I wonder what this means for whole-genome sequencing. If we sequence the entire genome of a patient, and we discover this mutation, would we have to pay Myriad? Or, are we not allowed to look in that gene-region? Or just not allowed to tell the patient? What about the next gene?
I know that this is really just a patent on a specific genetic test, but what about the next gene, and the next one...
This will only get messier before it (hopefully) gets better.
I know that this is really just a patent on a specific genetic test, but what about the next gene, and the next one...
This will only get messier before it (hopefully) gets better.
The decision is narrower than it is made out to be in this thread. There are many prongs that must be met for something to be patentable. This decision is about patentable subject matter: whether an isolated DNA sequences are the kind of thing that can be patented (irregardless of whether any particular DNA sequence is deserving of a patent). This decision says that an invention is not automatically non-patentable just because it is an isolated DNA sequence.
Therefore, some of the points being raised in this thread fall outside the scope of the decision. For example, you can't patent certain chemical compounds which are naturally occurring. Those patents fail not on the subject matter bar (because chemical compounds are patentable subject matter) but on the novelty bar (because naturally occurring compounds are not novel). It's quite possible that the lower court will find that Myriad's patents fail on that ground.
It's worth reading the decision itself, here: http://www.cafc.uscourts.gov/images/stories/opinions-orders/....
It's pretty well-written and should be digestible for lay-people. The background starts on page 6. The claims start on Page 9. A basic background on genetics starts on page 10. The discussion on declaratory judgment jurisdiction can be skipped, and the analysis of whether isolated genes are patentable subject matter starts on page 36. An important discussion of what is NOT the subject of the appeal starts on page 37. In particular:
"Before reviewing the applicability of the Supreme Court’s Mayo holding to the claims of the Myriad patents, however, it is important to state what this appeal is not about... The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives... Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo. The issue is patent eligibility, not patentability." (p. 37).
In order to be patentable, an invention must meet various requirements. One of those requirements is having patentable subject matter. It is a necessary, but not sufficient, criterion of patentability.
There were three questions before the court: whether two types of isolated gene sequences were not patentable subject matter, and whether Myriad's method of comparing genes against "known bad" genes was patentable subject matter. The court decided that the isolated gene sequences were patentable subject matter but that the comparison method was not. It punted on the policy question of whether gene patents were desirable:
"But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us. As will be seen, on the limited questions before us, we conclude that the composition claims and the screening claim involving growing a transformed host cell meet the standards for patent eligibility, while the claimed methods for “analyzing” or “comparing” do not." (p. 38).
The heart of the decision is on page 38-39. It basically argues that the "isolated gene sequences" as distinguished from the genes themselves, are patentable, just as any man-made chemical compound is patentable:
"The principal claims of the patents before us on remand relate to isolated DNA molecules... They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in § 101. As to those claims, the issue of patent-eligibility remains, as it was on the first appeal to this court, whether they claim patent-ineligible products of nature. We hold that they do not. The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules." (p. 38-39).
Therefore, some of the points being raised in this thread fall outside the scope of the decision. For example, you can't patent certain chemical compounds which are naturally occurring. Those patents fail not on the subject matter bar (because chemical compounds are patentable subject matter) but on the novelty bar (because naturally occurring compounds are not novel). It's quite possible that the lower court will find that Myriad's patents fail on that ground.
It's worth reading the decision itself, here: http://www.cafc.uscourts.gov/images/stories/opinions-orders/....
It's pretty well-written and should be digestible for lay-people. The background starts on page 6. The claims start on Page 9. A basic background on genetics starts on page 10. The discussion on declaratory judgment jurisdiction can be skipped, and the analysis of whether isolated genes are patentable subject matter starts on page 36. An important discussion of what is NOT the subject of the appeal starts on page 37. In particular:
"Before reviewing the applicability of the Supreme Court’s Mayo holding to the claims of the Myriad patents, however, it is important to state what this appeal is not about... The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives... Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo. The issue is patent eligibility, not patentability." (p. 37).
In order to be patentable, an invention must meet various requirements. One of those requirements is having patentable subject matter. It is a necessary, but not sufficient, criterion of patentability.
There were three questions before the court: whether two types of isolated gene sequences were not patentable subject matter, and whether Myriad's method of comparing genes against "known bad" genes was patentable subject matter. The court decided that the isolated gene sequences were patentable subject matter but that the comparison method was not. It punted on the policy question of whether gene patents were desirable:
"But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us. As will be seen, on the limited questions before us, we conclude that the composition claims and the screening claim involving growing a transformed host cell meet the standards for patent eligibility, while the claimed methods for “analyzing” or “comparing” do not." (p. 38).
The heart of the decision is on page 38-39. It basically argues that the "isolated gene sequences" as distinguished from the genes themselves, are patentable, just as any man-made chemical compound is patentable:
"The principal claims of the patents before us on remand relate to isolated DNA molecules... They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in § 101. As to those claims, the issue of patent-eligibility remains, as it was on the first appeal to this court, whether they claim patent-ineligible products of nature. We hold that they do not. The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules." (p. 38-39).
I largely agree, but to me it raises the question of where the inventive step is when your "isolated DNA sequence" is simply mechanically or trivially derived from something existing in nature through a systematic process. Can a venture fund now submit a patent for all 20,000 human genes and own the whole human genome? If not, why not?
What I find hard to understand is that if Myriad has patented but one transformation of the DNA (and this being part of the justification for why it is patentable), then surely there must be many other transformations that enable the same test to be carried out, and people should be freely and easily working around this. But they don't seem to be; it seems through patenting one specific transformation Myriad have secured a monopoly on any kind of testing of the gene. I don't understand how they are having their cake and eating it too here.
What I find hard to understand is that if Myriad has patented but one transformation of the DNA (and this being part of the justification for why it is patentable), then surely there must be many other transformations that enable the same test to be carried out, and people should be freely and easily working around this. But they don't seem to be; it seems through patenting one specific transformation Myriad have secured a monopoly on any kind of testing of the gene. I don't understand how they are having their cake and eating it too here.
My opinion is that the decision is correct: isolated genes are patentable subject matter. I think the Myriad patent should fail on novelty: they isolated a bunch of variations on the BRCA genes that were indicative of cancer. These variations are naturally occurring and indeed common. Just as you can't patent the chemical composition of sulfuric acid, because it's common in nature and thus not novel, you shouldn't be able to patent these variations.
If I understand it right, the basis for the "novelty" is not the mutations, rather it is that they are testing cDNA (effectively, a gene with exons spliced out, but as DNA not RNA - so this never exists in nature as such, because splicing occurs on the RNA transcript).
My problem with it is that the so called "novel" molecule is a result of a process that is not inventive - it is a systematic process that is routinely done all the time, and which is entirely based on and constrained by the natural enzymes that perform it. So I don't see why a molecule that is merely a mechanical result of a non-novel process is novel.
My problem with it is that the so called "novel" molecule is a result of a process that is not inventive - it is a systematic process that is routinely done all the time, and which is entirely based on and constrained by the natural enzymes that perform it. So I don't see why a molecule that is merely a mechanical result of a non-novel process is novel.
Let us rephrase the issue for clarity.
Should naturally occurring chemical compounds or slight alterations thereof be patentable?
For me the answer is a vehement no. But there is an entire industry with many supporters which already disagrees. I suppose there is some merit to such a viewpoint - I arrived at that phrasing while struggling to find some way this judgement could not be considered an exemplary display of stupidity.
There is the problem though that arguments from costs, difficulty of process and analysis will probably only be valid for a short time. At current improvement rates, toddlers will soon be isolating, sequencing and printing novel sequences with their companion pads. Maybe a bit of a silly phrasing but meant to emphasize how while this ruling may currently possibly be considered not utterly insane, it will become rapidly more utterly insane.
I apologize for being unable to completely separate my biases from this post. I really tried.
Should naturally occurring chemical compounds or slight alterations thereof be patentable?
For me the answer is a vehement no. But there is an entire industry with many supporters which already disagrees. I suppose there is some merit to such a viewpoint - I arrived at that phrasing while struggling to find some way this judgement could not be considered an exemplary display of stupidity.
There is the problem though that arguments from costs, difficulty of process and analysis will probably only be valid for a short time. At current improvement rates, toddlers will soon be isolating, sequencing and printing novel sequences with their companion pads. Maybe a bit of a silly phrasing but meant to emphasize how while this ruling may currently possibly be considered not utterly insane, it will become rapidly more utterly insane.
I apologize for being unable to completely separate my biases from this post. I really tried.
The "district court erred in focusing on the informational content of the molecules, and not the actual composition of matter itself"
... dunno why this makes me nervous...?
"In other words, this ruling affirms that molecular biology is, in fact, chemistry, if you want to look at it that way. The court goes on to say that if we as a society want to put DNA in a separate category for terms of patent law (because of its unique informational content, etc.), then Congress should get to work on revising the US Code. It's not a matter for the courts to write that in by themselves. " http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
... dunno why this makes me nervous...?
"In other words, this ruling affirms that molecular biology is, in fact, chemistry, if you want to look at it that way. The court goes on to say that if we as a society want to put DNA in a separate category for terms of patent law (because of its unique informational content, etc.), then Congress should get to work on revising the US Code. It's not a matter for the courts to write that in by themselves. " http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
The decision clearly tries to support the way biotech companies make money. I know lobbying is allowed in U.S.politics, but I thought it was a felony to 'lobby' in a court?
This is not a lobbying effort (at least not in the same way one could lobby a senator). This was a court case. In lawsuits there are almost always financial incentives in play for either party, but this doesn't automatically make it lobbying. (A common example of lobbying is company A 'wining and dining' legislatures in order to seek favorable votes or provide input on new legislation.)
I disagree that the intent of the decision was to support the way biotech companies make money. The intent is to interpret the law and decide based on this interpretation. The interpretation given is that "...the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."
I don't know nearly enough about genetics or molecular biology to form an opinion on whether this interpretation has merit. However, this interpretation is where arguments for or against the ruling should be founded on.
I disagree that the intent of the decision was to support the way biotech companies make money. The intent is to interpret the law and decide based on this interpretation. The interpretation given is that "...the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."
I don't know nearly enough about genetics or molecular biology to form an opinion on whether this interpretation has merit. However, this interpretation is where arguments for or against the ruling should be founded on.
No, lawyers are not all felons.
Referring to the number of nucleotides in BRCA1/2 as n, what happens if I develop a test that checks (1) if nucleotides 1->3n/4 of BRCA1/2 are present (2) if nucleotides n/4->n of BRCA1/2 are present (3) if the substrings in (1) and (2) are "properly overlapping". Given this information, I can perform their test without ever "creating" (i.e. isolating) their patented "gene".
"Myriad's argument is that when it isolates the genes by removing them from the body, this process changes their chemical structure, and the company's test looks for this distinct chemical form"
Edit: INAL but appears "just" be a method patent, with claims directed to comparing or analyz-ing gene sequences.
We need an anlaysis of full opinion / more info; not sure the reporting is all that great.
Edit: INAL but appears "just" be a method patent, with claims directed to comparing or analyz-ing gene sequences.
We need an anlaysis of full opinion / more info; not sure the reporting is all that great.
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Can someone explain what these patents safeguard? The author has not made it clear what the actual result of this ruling is.
What does it mean to have a patent for a gene?
"The conditions of Myriad’s BRCA patent require that the only laboratories legally allowed to test and sequence the genes are the ones affiliated with Myriad."
(via Wikipedia)
(via Wikipedia)
It really isn't a patent for a "gene". You don't have to pay them a licensing fee if you have that gene mutation. But, if you want to find out if you have the gene, then you have to pay for their test.
"Myriad's patenting effort has drawn opposition from groups such as the American Medical Association"
It amazes me that when experts weigh in on a topic it doesn't get more consideration for their view. Just like software. When that majority of engineers tell you software patents are stupid you should believe them.
It amazes me that when experts weigh in on a topic it doesn't get more consideration for their view. Just like software. When that majority of engineers tell you software patents are stupid you should believe them.
If you can patent seeds, then why not genes. Monsanto has been notorious for throwing around their weight when it came to protecting their patented seeds, if this ruling stands I am actually scared to see what comes of it.
Monsanto actually engineers those seeds. They added some special sauce to come up with those seeds. In this case, the "inventors" discovered a naturally occurring mutation. They didn't have to "do" anything to produce the gene... that is why it is troubling.
Funny how you can never patent/copyright a recipe but you patent the recipe of a seed. BTW din't Monsanto actually come up their secret sauce by stealing indigenous plants from places like India, and then trying to develop genetically modified versions of them?
The court decision: http://www.aclu.org/files/assets/10-1406_0.pdf
Patents at issue: 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.
Patents at issue: 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.
Ouch. Now its back to the Supreme court to 'do the right thing' which is unfortunate. Does anyone have a link to the published decision? I would be interested in reading their reasoning that got them to this.
I can understand patenting a technology for identifying these genes, but the genes themselves? This is ridiculous. Isn't there a way for someone to identify prior art and have the patent voided?
Amazing and completely topsy-turvey ruling!
As far as I know, no where else in the world would you be able to patent a natural thing or arrangement yet be unable to patent a test you designed yourself for it...
As far as I know, no where else in the world would you be able to patent a natural thing or arrangement yet be unable to patent a test you designed yourself for it...
If I'm correct, this is about patenting isolated genes, right?
If so, holy crap. I don't know, but this triggers so many ill feelings in me. This is such a blatantly obvious violation of basic human morals.
If so, holy crap. I don't know, but this triggers so many ill feelings in me. This is such a blatantly obvious violation of basic human morals.
> If I'm correct, this is about patenting isolated genes, right?
No. Myriad claims they transformed the gene into something else in the process of isolating it. The court accepted this claim. So the precedent set here is not that isolated genes can be patented, but rather about what the threshold is for transformation such that something can be considered patentable.
(I'm totally against the decision btw, but I think it's important this distinction is understood).
No. Myriad claims they transformed the gene into something else in the process of isolating it. The court accepted this claim. So the precedent set here is not that isolated genes can be patented, but rather about what the threshold is for transformation such that something can be considered patentable.
(I'm totally against the decision btw, but I think it's important this distinction is understood).
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Patenting a method to isolate the genes would be okay; but patenting the genes themselves; holy shit!
DNA is code, so you work around the same way... Implement the idea and effect, but as your own.
Eventually, companies will own the rights to our genes and we will merely license them.
Countdown until bioshock style gene dispensers?
Or wait, if you posses "their" genes, can you make them take them back?
Ugh. The sheer stupidity of the legal system sometimes.