Supreme Court rules human genes may not be patented

http://www.washingtonpost.com/politics/courts_law/supreme-court-says-human-genes-cannot-be-patented/2013/06/13/f7681b22-d436-11e2-b3a2-3bf5eb37b9d0_story.html

by chwolfe • 13 years ago

276 56 13 years ago

washingtonpost.com

clarkmoody• 13 years ago

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.

Might be a good sci-fi novel.

kvb• 13 years ago

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.

aroch4• 13 years ago

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!

pdabbadabba2• 13 years ago

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.

pdabbadabba2• 13 years ago

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.

salemh• 13 years ago

Interesting comment and explanation, I was wondering why shares were rising in Myriad and the industry:

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.

jongraehl• 13 years ago

"their crop cross-pollinates with yours, and now they own the seeds of your crop!"

It sounds like you picked up some inaccurate propaganda there. Might want to get that checked out.

andylei• 13 years ago

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!

no court has ever ruled this.

fatman• 13 years ago

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.

tehwalrus• 13 years ago

It's ridiculous that a patent system exists that would allow someone to even try to patent the result of billions of years of evolution.

B-Con• 13 years ago

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.

chm2• 13 years ago

It's hard to draw the line. Cynically:

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.

alexholehouse2• 13 years ago

Yeah this is actually a pretty poor news source (hopefully it will be updated).

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.

_delirium• 13 years ago

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.

alexholehouse2• 13 years ago

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)?

aroch4• 13 years ago

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

epistasis2• 13 years ago

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.

300bps2• 13 years ago

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.

epaulson• 13 years ago

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?"

maxerickson• 13 years ago

"No one" is completely unrealistic. There are all sorts of foundation and government dollars interested in treating diseases.

I have no idea about estimating the actual impact on spending.

300bps2• 13 years ago

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.

fortepianissimo• 13 years ago

What about non-human genes?

And if I make an exact replica of a gene, would it be considered "synthesized?"

RabbitAngstrom• 13 years ago

Not a patent lawyer, but I would think that

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.

daughart2• 13 years ago

Seems like the key element is modification (such as removal of exons). The court specifically referred to patenting modified bacteria.

andyjohnson0• 13 years ago

The judgement: http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf

dpratt3• 13 years ago

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.

exit• 13 years ago

can you explain why?

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?

dpratt3• 13 years ago

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.

silveira• 13 years ago

cDNA is a piece of code (a software) and as such it should be protected by copyright laws, but not patents.

mpyne• 13 years ago

QEDturtles• 13 years ago

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?

daughart2• 13 years ago

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?

Aspirin became newly protected because of a distribution method Bayer invented, so yes, regardless of whether the sequence itself is patented.

grellas• 13 years ago

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-...)

carbocation• 13 years ago

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.

1 = http://blog.carbocation.com/post/52902698213/supreme-courts-...

2 = https://news.ycombinator.com/item?id=5877259

superkamiguru• 13 years ago

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.

rayiner• 13 years ago

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."

pencouch6000• 13 years ago

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.

molbioguy• 13 years ago

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.

aspensmonster• 13 years ago

Not patentable:

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.

unavoidable• 13 years ago

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.

nickthemagicman• 13 years ago

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?

dnautics4• 13 years ago

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.

http://www.indysci.org/mission/onpatenting.html

EDIT: I'm a biologist - not a lawyer, but the child of a lawyer.

X4• 13 years ago

Yes, finally! Finally!!

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..

Supreme Court rules human genes may not be patented

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