US appeals court rules in favor of patenting genes
reuters.com
reuters.com
Or wait, if you posses "their" genes, can you make them take them back?
Ugh. The sheer stupidity of the legal system sometimes.
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?
But it wasn't hard. An undergrad could do it.
Maybe not in 1988, though. I was in junior high then.
...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?
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.
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?
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.
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...
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.
"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...
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.)
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.
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.
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.
(This is a totally disgusting ruling by the way... another win for putting money over the life of fellow human beings)
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?
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.
"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.
http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...
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.
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.
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.
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).
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 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.
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.
Are isolated DNA sequences per se un-patentable?
... 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...
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.
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.
(via Wikipedia)
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.
Patents at issue: 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.
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 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.
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).