Supreme Court rules human genes may not be patented
washingtonpost.com
washingtonpost.com
Here is an informed summing up by Dennis Crouch at PatentlyO: "What are the consequences [of the ruling]? My immediate reaction is that for most practical applications, the Court's holding means that even though the broadest possible biotechnology product claims (to the isolated DNA itself) aren't going to be patentable, the key elements in making and using a biotechnology-based invention are still going to be protectable via patents (Part III of the Court's opinion makes this especially clear). This will allow researchers and competitors a little bit of wiggle room to design around biotechnology patents because they can use the basic isolated sequence but there will still be substantial limitations on what they can do with that isolated sequence. For this reason, I'm skeptical that the Court's opinion will have a negative effect on the incentives for creating biotechnology-based applications. To the contrary: by affirming that cDNA can be patented, it may strengthen the incentives for investing in research in this area." (http://www.patentlyo.com/patent/2013/06/myriad-isolated-dna-...)
> "... by affirming that cDNA can be patented, it may strengthen the incentives for investing in research in this area"
If the court had been discussing meaningfully modified DNA, rather than cDNA (which occurs naturally), I'd probably agree with this quotation from Mr. Crouch. As someone who has done molecular biology in an academic research laboratory, it seems as though the Court is using the term "cDNA" to represent some idea slightly different from what scientists mean by cDNA.
Or, at least, their rationale for apotheosizing cDNA is confusing. If intron removal is one of the key steps, and intron removal occurs naturally in the cell before the process of cell harvesting and cDNA creation begins, it is confusing (to me) to say that cDNA creation is a patent-worthy "creation".
The essential transformation (the removal of introns) is done by nature within the cell without any instruction from the lab tech. cDNA creation–the step that SCOTUS seems to view as key–is performed largely because mRNA is not stable in most convenient aqueous solvents. If mRNA were stable, we'd probably have mRNA libraries instead of cDNA ones.
1 = http://blog.carbocation.com/post/52902698213/supreme-courts-...
For example, the test at 23andme was only able to test for a couple BRCA1 mutations because most of them are patented. My wife (whose grandmother died at 29 from breast cancer) had to pay $1,500 to get the test done because of these stupid patents.
Part of me thinks "of course genes can't be patented, no one invented them", and then part of me thinks "using the patent system to protect gene isolation is an interesting legal hack because we don't have a better way to protect the investment involved with gene discovery." And surely it's got to cost something to figure out which genes are interesting to test for, which is the real value in the gene test, right?
But if that's the case, how is anything on the 23andme test cheap? Publicly funded research? Benevolent release of research from private labs? Old research that no one thought to patent? Much more reasonable licensing terms? Oversight by the current patent holder?
How realistic is the specter of "No one will do gene isolation after this decision?"
23andme is actually doing original research. It scares me a little bit that I did it though because 1) I am afraid of genetic discrimination even though some states have made this illegal. 2) I found out genetic disorders that I did not know I had. Fortunately none are horrendously serious but I found out what will probably kill me at some point like it killed some of my grandparents.
For research, they ask as many survey questions as you are willing to answer - anything from "Do you have psoriasis?" to "Do you cry easily?" and many many more. They are then able to correlate answers to these questions with your genetic makeup. The final result should give additional information when aggregated among all their customers.
Beyond that, I assume that many genes aren't patented just like many business processes are not patented. The person that first discovered the gene didn't go through the time and expense to patent it (for whatever reason) and because there was prior art, it's not a good target for other people to patent either.
I have no idea about estimating the actual impact on spending.
For more comprehesive coverage info see http://www.forbes.com/sites/danielfisher/2013/06/13/supreme-...
A crucial point is the cDNA is patentable, which still makes very little sense.
Making cDNA is a standard kit, on order from any number of vendors, and is a standard molecular biology technique.
So basically, the Supreme Court, or at least Justice Clarence Thomas, is completely clueless.
Ease is not the question by which a patent is judged. When you do a PCR reaction, introns or not, you are creating a NEW molecule that didn't exist before. Period. If the judges are claiming that the "information content" is what counts, then that goes against the molecule-patenting precedent - it's really the "molecular identity" which should count.
Now, my preference is to not allow patenting - at all - but to be consistent with the existing patenting landscape, they should have allowed the myriad patents (except for the "method" of comparing a patient sequence with the reference sequence) to pass.
You are completely right that the biological molecules could be considered identical to small chemical molecules, and that trivial chemical manufacturing steps could be patented; I do not do synthesis but all the synthetic organic chemists I know are pursuing incredibly complex and difficult procedures that are not on the same playing field as any PCR reaction, and I did not know that simple and straightforward techniques could be patented (which would seem to be counter to the "person skilled in the art" bar that's commonly used for patents, but I am not a synthetic chemist).
However, and I may be completely out of line, I think that the most important thing with patent law is to go for maximum utility as opposed to maximum consistency. Patent law is legal invention intended to maximize innovation and advancement, there is no underlying need for consistency in different realms. The biological and chemical realms have completely different monetization strategies, and it would make sense for the IP realms to be different, just as there are completely different standards for patents of composition, methods and systems. If somebody is using cDNA of a particular gene as a therapy and selling that compound, I could see that being patentable. However, I can't see patents of cDNA for diagnostic purposes being patentable; there the cDNA patent blocks any innovation on the interesting part, the analysis of information.
Furthermore, what constitutes a "trivial chemical manufacturing step" is not really appropriate for a legal decision. Even if step 12 in the synthesis is obvious, is it trivial to decide to use a 500 L batch fed reactor with piping radius X, with a copper pipe, and chiller unit Z for step 12? But in the molecule patents, the steps to synthesis are not necessarily relevant. All that is claimed is the structure of the molecule.
"all the synthetic organic chemists I know are pursuing incredibly complex and difficult procedures"
Keep in mind that the pursuit of complex and difficult procedures (or, really, the molecules that lead to them) is the essential purpose of synthetic organic chemistry in academia, and industrial chemistry is a very, very different beast. Those easy reactions that you learned in your intro ochem class textbook (SNs, Es, Aryl substitutions, halogenations, nitrations, carbonyl chemistry...) it's really those reactions that dominate industrial chemistry - for several reasons - they don't require exotic conditions (extreme cold, extreme hot) - they aren't super exothermic - that's a huge problem when you scale to 500 L you don't want your reaction chamber to turn into a bomb - they have been around for decades so optimization techniques are well characterized - they have been around for decades so regulatory approval is simpler.
But all of this is moot, because the patenting of a molecule doesn't generally hing on the process.
Consider - if you had a Drexler-like nanomachine that could 3d-print a molecular structure on demand, such that chemistry would essentially become "kit-ified" in the same way that molecular biology is, should then chemical patents then be invalidated?
"Patent law is legal invention intended to maximize innovation and advancement, there is no underlying need for consistency in different realms. The biological and chemical realms have completely different monetization strategies, and it would make sense for the IP realms to be different, just as there are completely different standards for patents of composition, methods and systems."
That is generally supposed to be for congress to decide, not the courts.
The same does not hold true in the US, thanks to Bridgman Art Library vs. Corel
"Bridgeman Art Library v. Corel Corp., 36 F. Supp. 2d 191 (S.D.N.Y. 1999), was a decision by the United States District Court for the Southern District of New York, which ruled that exact photographic copies of public domain images could not be protected by copyright in the United States because the copies lack originality. Even if accurate reproductions require a great deal of skill, experience and effort, the key element for copyrightability under U.S. law is that copyrighted material must show sufficient originality."
http://en.wikipedia.org/wiki/Bridgeman_Art_Library_v._Corel_....
Of course, this is one ruling by one court. It could be challenged. In the meantime, it looks like the SCOTUS has taken the view that copies can be yours, even if the original isn't.
The practical difference is that the originals are in the genetic makeup of billions and circulating freely, whereas notable paintings tend to be unique and tightly controlled.
If an algae produces molecule A, one can determine its structure and (in theory) synthesize it in a lab. Both will be structurally identical. Of course, if the chemist wants to add X or Y moieties to the original algal molecule, he can. One could also determine the source of a certain molecule (bio vs. lab) by looking at the different isotopes in each molecule.
(In theory because some syntheses are practically extremely difficult.)
It's a good thing that the SC struck this down, since it could lead to really weird claims over humans. Imagine if someone receiving patented genes in a treatment absorbed some of that information into their own genetic makeup. Then when they had children, the company could claim that the child contains their intellectual property.
Might be a good sci-fi novel.
cDNA is synthesized by reverse transcription of mRNA, which already contains the exons yet for some reason the court finds that "exon only" DNA is patentable. There are millions of cDNA fragments with a good proportion of known relevance. There's nothing inherently "unnatural" about creating cDNA using reverse transcription; it's how retroviruses like HIV work!
http://www.washingtonpost.com/business/myriad-genetics-share...
The high court ruled that genes naturally found in the body cannot be patented, but that synthetically created genetic material, called cDNA, can be patented. That leaves an opening for Myriad to continue making money, Justice Clarence Thomas wrote in the court’s majority decision.
The Supreme Court's move triggered a rally in genetic companies, while none as powerful as Myriad's gains. Industry giant Amgen rose 75 cents, or 0.8%, to $97.12. Smaller genetic companies such as Vermillion, Enzo Biochem and Qiagen rose 1%, 0.9% and 0.7% respectively.
It sounds like you picked up some inaccurate propaganda there. Might want to get that checked out.
no court has ever ruled this.
e.g. If they isolate a gene that makes a person immune to a specific desease then found a way to package and distribute that gene, could they patent it? It occurred in nature, but something new would be created in packaging it for distribution.
Also, nature can create new genes. If Myriad has a patent on a gene that nature produces later (1 in a bazillion chance), what happens to Myriads patent?
Aspirin became newly protected because of a distribution method Bayer invented, so yes, regardless of whether the sequence itself is patented.
1111000010101010
Patentable:
0000111101010101
But don't worry, it's OK because you're only patenting the XOR of the original information string with a string of one's, not the original string itself. That's _clearly_ different. Someone please come in here and tell me why I've got this all backwards and this isn't actually a disaster built on an intellectually dishonest distinction without a difference. I'm not a biologist nor lawyer nor judge by any means, but this is what the ruling looks like to me.
The cDNA mentioned in the judgment is not a simple XOR of the original information. It is an XOR of the information after the section of DNA has been isolated, and with all the introns stripped out. Using cDNA, one cannot recreate the original full DNA strand because it is like lossy compression.
http://www.indysci.org/mission/onpatenting.html
EDIT: I'm a biologist - not a lawyer, but the child of a lawyer.
The problem arises, when do you draw the line? When you spend thousands of man hours in a scientific lab and millions of dollars to piece together a bit of understanding, was it discovered or created?
The answer is often somewhat obvious. But I imagine that, behind closed (or semi-closed) doors, there are a lot of very persuasive people arguing for a very permissive definition of "create".
While it's probably hard to properly classify everything accurately the first time you see it, hopefully time lets us get a better perspective and quickly re-classify.
What part of yourself (or anything else, really) is not the product of billions of year of evolution? To what extent can your actions be considered "original"? Can you prove that all of your actions, inactions, beliefs and ideas are an original and non-obvious product of your "self"? Can you prove the discontinuity between "you" and billions of years of evolution? All it takes is a reasonable doubt.
I don't like the Supreme Court decision, but one has to break the circle somewhere.
And if I make an exact replica of a gene, would it be considered "synthesized?"
1)the ruling focuses in on retrieval of how DNA is naturally stored, which is more or less the same in all organisms
2)you can replicate just about any gene, either chemically or via PCR. The form is definitely "snythesis," and I would assume the latter is as well but I do not know the law offhand.
Courts have experts to explain to them the legally significant aspects of different issues, and it works reasonably well.
In my experience, courts, at least federal appellate courts and the Supreme Court, don't usually get decisions wrong because they don't understand the problem domain. Instead, courts don't share the value systems of people within those fields. And that irritates practitioners on philosophical grounds.
Consider internet technology. People who work on internet technology tend to have a value system that emphasizes certain characteristics ("the internet perceives censorship as damage and routes around it."). But you don't have to believe in free and universal access to information, etc, to understand how TCP uses sequence numbers to create a reliable protocol out of unreliable IP.
I feel the same is true with things like gene patents. The objections do not seem to me to be based on pointing out how the Supreme Court doesn't understand this or that bit of science. The objections are philosophical: "you can't patent nature."
Genes shouldn't be allowed to be patented at all!!
Hail to all those Genetic-Engineers, I'm proud whenever I discover that you've leaped forward in deciphering nature, but stop patenting the shit out of it!
Whoa..
patents incentivize innovation (supposedly). no one invents their own genes.
if someone wins the genetic lottery and has a gene that confers immunity to X, they get to monopolize the distribution of that immunity?
why?