Like Bilski, this represents a short-term victory for those favoring patent protection but also shows that the Supreme Court is at least trying to impose limits on the Federal Circuit's idea that basically everything under the sun should be eligible for patent protection.
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-...)
My take on this ruling is found here[1], discussed on HN here[2].
> "... 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.
Anyone that has used a genetic testing service has seen that they test you for hundreds of genetic disorders and traits. If not for patents on genes they could test for thousands.
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.
So this is the crux of it for me - why is testing for some of these genes not covered by any patents, and yet others are covered by 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?"
>But if that's the case, how is anything on the 23andme test cheap?
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.
If I understand the situation correctly, it seems fairly similar to the status quo with drugs, for better or worse. You can't patent chemicals naturally occurring in plants that have medicinal uses, but you can patent synthetic versions of the same drug.
I think you do understand it correctly, but I find it very disturbing. The difference between these two situations is night and day: the complete synthesis of naturally occurring small molecules is unique each time, and can require dozens of PhD-level chemists and a decade or more to complete, if it's even possible. It requires a huge amount of invention, and a huge amount of discovery.
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.
So, I have a background in chemistry and molecular biology and I take the exact opposite opinion - there's no categorical difference between the total synthesis and PCR. There are total syntheses that are straightforward - and the synthesis of most commercial drugs are usually very straightforward (for obvious economical reasons). And (rarely) you can have dastardly PCR reactions that refuse to work except under highly fine-tuned conditions that for long periods of time unexplainably work in the hands of only one researcher.
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.
>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.
a method patent generally should not be "simple and straighforward" (but there are always things like "patent on a method to swing on a swing"). But molecule patents are not method patents.
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.
Well, I wouldn't say that...cDNA patents are like saying "You can't copyright that public domain book in .doc format but if you make it a PDF you can". cDNA is no different than post-transcriptional mRNAs that have already been processed to remove introns (Which is part of the "unnatural" claim) in terms of the data stored; cDNA and mRNA are just two different storage mediums. Albeit they have some different biological consequences but thats nothing special as far as patents should be concerned
In Europe you can secure a copyright on a photograph of a work in the public domain (e.g. a Rembrandt). Provided that you've kept the source away from cameras, you can enforce your copyright on the grounds that any instance of "your" image were either copied illegally, or created illegally.
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."
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.
So I'm not super familiar with drug patent laws - can those synthetic version and naturally occurring version be identical (as in chemically) or does the natural one need to be subtly different (e.g. extra methyl group, or whatever)?
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.)
depends on the patent. Usually a drug patent will claim "molecule scaffold with substitutents X can be {list of substituents}, Y can be {list of substitutents}". Then they will claim a very broad list substituents. It may not always be enforceable, if you can claim that your derivative substituent is "non-obvious" but most people won't bother because the litgation will be a PITA.
Interesting contrast to the patenting of crop genes by Monsanto: their crop cross-pollinates with yours, and now they own the seeds of your crop!
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.
I'm not entirely convinced this ruling is a win...making cDNA patentable is, from my view in academic research, not a good thing. I also don't understand why the Court is under the impression that cDNA is something magical that is synthesized originally by some complex thing (OK, it's complex but not groundbreaking and has been used for a long time now).
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!
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.
Well, the patent was not on the process of creating cDNA, it was on the product -- they patented the cDNA itself, not the process for creating it. It is a composition of matter patent. Therefore, the question to ask is whether the cDNA itself exists in nature, not whether the process for making it does.
But there's no reason the product cDNA should be patentable. It's that a cDNA is, quite literally, just a different storage medium from mRNA. It'd be like saying you can't patent X because it's in .doc format but if you make it a PDF we'd be happy to let you patent it.
Not arguing but, fyi: the patent was not on the process of creating cDNA, it was on the product -- they patented the cDNA itself, not the process for creating it. It is a composition of matter patent.
But the information in the cDNA already exists in the mRNA. The justices seemed to argue that removing the introns was the step that makes cDNA patentable, but the introns are already removed from an mRNA molecule that is about to be translated into a protein.
No, that's not remotely plausible even if Myriad had won. They had patented isolated DNA. Biological processes such as human reproduction were always free and clear. Furthermore, your characterization of Monsanto's patents doesn't seem accurate.
Hypothetically, if Myriad were able to synthesize and market genes, could they patent a synthetic analog to a naturally occurring gene?
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?
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 part about introns and exons is very important. Normal ("naturally occurring") DNA has a bunch of extra stuff that is not coded for proteins (introns) and that may not serve much useful function for therapeutic research but are useful as unique identifiers/markers.
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.
There's 3 billion base pairs in human DNA, not to mention the other millions of species out there. It seems like your chance of finding a naturally occurring complement to what you want, without introns, is pretty good.
Then what?
you're correct, it seems like me to be an intellectually misinformed decision. In all cases, a PCR reaction is essentially the creation of a molecule that never existed before in nature. Whether or not they played the trick with the introns.
I think it's really the whole philosophical "create vs discover" thing. Only things that are created (with other restrictions) can be patented, things that are discovered cannot be.
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.
I don't get the cDNA part of the ruling. If the spliced message exists naturally, and it must in order to be expressed, how does a DNA copy of that spliced message represent something novel whereas the full unspliced gene does not. After all most cDNA is initially generated from a naturally occurring template in the cell, since you're looking for what's naturally expressed.
I don't know whether to smile at this decision, or frown because it took the Supreme Court to strike this down. I think I'll smile at the continuation of recent trend of the Supreme Court benchslapping the Federal Circuit, and slowing the unintended consequences of a specialized appeals court.
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.
Does anyone else feel like there should be a different procedure when the court isn't an expert on the fields in question that our brought up to them? I'm not even sure how to standardize that. Just that I feel like there is an issue how scientific rulings are made.
Courts by necessity rule on lots of different things that they aren't experts in. If we have specialized courts for scientific issues, should we have specialized courts for accounting issues, securities issues, etc? Have you ever seen the accounting systems in a modern corporation? It can get highly technical and complicated.
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!
This is just me being pedantic, but I want one exception to this - every person, upon birth, should receive an automatic instantaneous patent on their own genome (and only their own genome) that is valid for the lifetime of the owner. I should be free to be able to sell this patent, but upon first sale, the patent expiration rules change to the default.
This raises a good point - perhaps I'm not looking for a patent, but rather a copyright. My goal is to ensure that the only legal owner of my particular genome is myself, and thus I can authorize who can possess a copy of it and issue 'licenses'. In fact, the more I think about it, the concept of patenting a particular genetic code is akin to patenting the contents of a book; it just doesn't apply.
...except that a book is an original work - your genome is derivative of your parents, and very similar to your relatives, and still somewhat similar to people of your ancestry.
I get the argument that it is a derivative work, but a personal genome also has the unique property of literally being the absolute essence of my own person. I morally and ethically possess a right to the usage of that essence, and I think it would be a very good idea for society to set up a legal framework that protects that right.
cDNA is not used for most of the genetic tests (it was back in the day, not anymore). A lot of companies like Ambrygen and GeneDX use gDNA(genomic...i.e naturally occurring) to report the mutations. Hence, its a huge victory.
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-...)