
Supreme Court rules human genes may not be patented - chwolfe
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
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grellas
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-...](http://www.patentlyo.com/patent/2013/06/myriad-isolated-dna-out-cdna-
in.html))

~~~
carbocation
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-...](http://blog.carbocation.com/post/52902698213/supreme-courts-
myriad-decision-is-deeply-confused-over)

2 =
[https://news.ycombinator.com/item?id=5877259](https://news.ycombinator.com/item?id=5877259)

------
300bps
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
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?"

~~~
300bps
>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.

~~~
sachinag
Genetic discrimination is illegal nationwide thanks to 2008 GINA:
[http://www.genome.gov/10002077](http://www.genome.gov/10002077)

~~~
rflrob
Mostly true. If you note the exceptions, life insurance is exempt.

------
alexholehouse
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-...](http://www.forbes.com/sites/danielfisher/2013/06/13/supreme-
court-rejects-human-gene-patents-sort-of/)

A crucial point is the cDNA _is_ patentable, which still makes very little
sense.

~~~
_delirium
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.

~~~
alexholehouse
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)?

~~~
chm
I'm not sure if this answers your question:

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.)

------
clarkmoody
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.

~~~
aroch
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!

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

[http://www.washingtonpost.com/business/myriad-genetics-
share...](http://www.washingtonpost.com/business/myriad-genetics-shares-surge-
after-mixed-ruling-from-supreme-court-on-gene-
patentability/2013/06/13/c680ff46-d441-11e2-b3a2-3bf5eb37b9d0_story.html)

 _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._

~~~
aroch
I suppose I could be happy about it since I'm a share holder in Amgen and
Qiagen.

------
QEDturtles
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?

~~~
daughart
> 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.

------
aspensmonster
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
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
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?

------
tehwalrus
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
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.

------
molbioguy
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.

------
fatman
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.

------
fortepianissimo
What about non-human genes?

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

~~~
RabbitAngstrom
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.

------
superkamiguru
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
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."

------
andyjohnson0
The judgement:
[http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf](http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf)

------
X4
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..

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

~~~
mpyne
Copyright lasts an eternity longer than patents do. Are you sure that's what
you want?

------
dpratt
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
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?

~~~
dpratt
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.

~~~
a_bonobo
...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.

~~~
dpratt
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.

------
pencouch6000
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.

