
US appeals court rules in favor of patenting genes - doktrin
http://www.reuters.com/article/2012/08/16/us-myriad-patent-idUSBRE87F12K20120816
======
wheaties
So, um, if they "own" the genes, do we get to sue them for a lethally
defective product which is infecting millions of people worldwide?

Or wait, if you posses "their" genes, can you make them take them back?

Ugh. The sheer stupidity of the legal system sometimes.

~~~
anigbrowl
I'm not sure you have understood the argument made by myriad here. Consider a
parallel situation: crude oil is a product of nature, but getting it out of
the ground and refining it into gasoline or other distillates involves a great
deal of technology and ingenuity. If I invented a new way to refine oil into
something that had the combustibility of gasoline but behaved differently -
ignition at lower or higher temperatures, say, or that burned more cleanly -
then my novel formulation would certainly be patentable.

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?

~~~
thronemonkey
The problem with their argument is that pulling out genes in large quantity
from an isolated sample is pretty damn easy. Its molecular biology 101; we
clone genes all kinds of genes all the time. If you read their technical spec
([http://www.myriad.com/lib/technical-
specifications/BRACAnaly...](http://www.myriad.com/lib/technical-
specifications/BRACAnalysis-Technical-Specifications.pdf)) its obvious that
while they have the process very streamlined, they're doing nothing
fundamentally differently than any other lab would do if Myriad didn't hold
these patents. PCR and dye labeling sequencing methods are commonly used
tools; the idea that Myriad has come up with anything novel is absurd.

~~~
anigbrowl
It's easy _now_ ; I don't think it was all that easy back in 1994 when they
first sequenced BRCA-1 or when they first began work on it back around 1988.

~~~
thronemonkey
It was easy even then. PCR and Sanger sequencing have been in wide use for a
long time. Yes, Myriad did do a lot of streamlining and optimizing, but
everything they did was with preexisting technologies. There's nothing novel
or innovative at all—they developed a very efficient analysis pipeline, but
that's not something anyone should ever be awarded a patent for.

~~~
anigbrowl
In that case, why haven't their legal antagonists built their case around a
straightforward prior art argument, instead of amking normative arguments
about the patentability of human DNA?

~~~
thronemonkey
Not sure, might have something to do with the ACLU/AMP wanting to set a wide
reaching precedent that patents of endogenous DNA sequences are not ok? They
won't just want to win the single case, they want to change the wider legal
landscape concerning patents and biological science.

------
doktrin
_A 2-1 panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C.,
on Thursday upheld the biotechnology company's right to patent "isolated"
genes known as BRCA1 and BRCA2, which account for most inherited forms of
breast and ovarian cancers.

...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?

~~~
astine
If human beings composed said genes, ie. through a splice or more involved
process, then said composition is indeed a product of man because it was
brought about through deliberate human effort and did not exist before. There
are many ethical concerns with patented genes, but whether or not artificial
gene composition are products of man seems pretty clear to me.

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.

~~~
doktrin
After doing some additional reading, I can now see what the basis for the pro-
patent argument is. However, I disagree with it as I'm struggling with the
concept of "because we touched it, it's now different".

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...](http://www.patentlyo.com/patent/2012/08/gene-patent-debate-
continues-federal-circuit-finds-isolated-human-genes-patentable.html)

~~~
astine
See, this is not a field I'm really involved in, so I can't comment on the
particulars. Case in point: what you describe is the isolation of a
preexisting gene, rather than the creation of a new one, which is different
from what I was thinking of.

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.)

~~~
doktrin
If I understand correctly, it's a pre-existing gene that is modified by its
removal / isolation. It appears to be an _incredibly_ subtle change that in no
way alters the fundamental characteristics of the gene itself.

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.

------
kamjam
So does this mean if someone is found to have BRCA1 or BRCA2 genes then they
have to pay Myriad Genetics Inc a license fee? Maybe we all need to take out
licenses just in case, otherwise we'll get those patent trolls writing us
nasty letters...

(This is a totally disgusting ruling by the way... another win for putting
money over the life of fellow human beings)

~~~
rayiner
To be fair, they explicitly punted the ethical angle. They point out that it's
Congress's job to do the balancing of money versus life and exclude such
patents if they deem it to be good policy.

~~~
kamjam
And we all know how much ethics politicians have...

------
SoftwareMaven
I can understand being able to patent _how_ they find out what is in those
genes, but I can't, for the life of me, understand how they can patent the
genes themselves, such that nobody else can do anything that includes those
genes.

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?

~~~
rayiner
Ironically, it's because a number of the Federal Circuit judges have technical
backgrounds and worked in industry. The two judges in the majority in this
opinion, Lourie and Moore, have a PhD in chemistry from U Penn and a BS/MS in
Electrical Engineering from MIT, respectively. My engineering degree is in a
non-CS field, and I have found that outside the software realm, scientists and
engineers generally view the patent system positively.

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.

------
refurb
For a nice analysis of the issues at stake (and the nuances are not
trivial)...

[http://pipeline.corante.com/archives/2012/08/17/the_myriad_g...](http://pipeline.corante.com/archives/2012/08/17/the_myriad_gene_patent_case_trickier_than_you_might_think.php)

~~~
doktrin
This is a great analysis, thank you for sharing.

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.

------
grabeh
If Myriad's process does in fact change the chemical structure of the gene and
it is the altered structure which is able to be tested then I see some merit
in their argument.

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.

~~~
bootz
Exactly -- Is the gene mutated, is the question.

------
mbreese
I wonder what this means for whole-genome sequencing. If we sequence the
entire genome of a patient, and we discover this mutation, would we have to
pay Myriad? Or, are we not allowed to look in that gene-region? Or just not
allowed to tell the patient? What about the next gene?

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.

------
rayiner
The decision is narrower than it is made out to be in this thread. There are
many prongs that must be met for something to be patentable. This decision is
about patentable subject matter: whether an isolated DNA sequences are the
kind of thing that can be patented (irregardless of whether any particular DNA
sequence is deserving of a patent). This decision says that an invention is
not automatically non-patentable just because it is an isolated DNA sequence.

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/...](http://www.cafc.uscourts.gov/images/stories/opinions-
orders/10-1406.pdf).

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).

~~~
zmmmmm
I largely agree, but to me it raises the question of where the inventive step
is when your "isolated DNA sequence" is simply mechanically or trivially
derived from something existing in nature through a systematic process. Can a
venture fund now submit a patent for all 20,000 human genes and own the whole
human genome? If not, why not?

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.

~~~
rayiner
My opinion is that the decision is correct: isolated genes are patentable
subject matter. I think the Myriad patent should fail on novelty: they
isolated a bunch of variations on the BRCA genes that were indicative of
cancer. These variations are naturally occurring and indeed common. Just as
you can't patent the chemical composition of sulfuric acid, because it's
common in nature and thus not novel, you shouldn't be able to patent these
variations.

~~~
zmmmmm
If I understand it right, the basis for the "novelty" is not the mutations,
rather it is that they are testing cDNA (effectively, a gene with exons
spliced out, but as DNA not RNA - so this never exists in nature as such,
because splicing occurs on the RNA transcript).

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.

------
Dn_Ab
Let us rephrase the issue for clarity.

 _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.

~~~
doktrin
I tend to agree. This has the potential to make the current software patent
debacle look like a walk in the park.

------
001sky
The "district court erred in focusing on the informational content of the
molecules, and not the actual composition of matter itself"

... 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...](http://pipeline.corante.com/archives/2012/08/17/the_myriad_gene_patent_case_trickier_than_you_might_think.php)

------
el_cuadrado
The decision clearly tries to support the way biotech companies make money. I
know lobbying is allowed in U.S.politics, but I thought it was a felony to
'lobby' in a court?

~~~
dkokelley
This is not a lobbying effort (at least not in the same way one could lobby a
senator). This was a court case. In lawsuits there are almost always financial
incentives in play for either party, but this doesn't automatically make it
lobbying. (A common example of lobbying is company A 'wining and dining'
legislatures in order to seek favorable votes or provide input on new
legislation.)

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.

------
psb217
Referring to the number of nucleotides in BRCA1/2 as n, what happens if I
develop a test that checks (1) if nucleotides 1->3n/4 of BRCA1/2 are present
(2) if nucleotides n/4->n of BRCA1/2 are present (3) if the substrings in (1)
and (2) are "properly overlapping". Given this information, I can perform
their test without ever "creating" (i.e. isolating) their patented "gene".

------
001sky
"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"

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.

------
angrydev
Can someone explain what these patents safeguard? The author has not made it
clear what the actual result of this ruling is.

------
pepve
What does it mean to have a patent for a gene?

~~~
cheald
"The conditions of Myriad’s BRCA patent require that the only laboratories
legally allowed to test and sequence the genes are the ones affiliated with
Myriad."

(via Wikipedia)

------
logn
"Myriad's patenting effort has drawn opposition from groups such as the
American Medical Association"

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.

------
dkroy
If you can patent seeds, then why not genes. Monsanto has been notorious for
throwing around their weight when it came to protecting their patented seeds,
if this ruling stands I am actually scared to see what comes of it.

~~~
mbreese
Monsanto actually engineers those seeds. They added some special sauce to come
up with those seeds. In this case, the "inventors" discovered a naturally
occurring mutation. They didn't have to "do" anything to produce the gene...
that is why it is troubling.

~~~
nivla
Funny how you can never patent/copyright a recipe but you patent the recipe of
a seed. BTW din't Monsanto actually come up their secret sauce by _stealing_
indigenous plants from places like India, and then trying to develop
genetically modified versions of them?

------
bstpierre
The court decision: <http://www.aclu.org/files/assets/10-1406_0.pdf>

Patents at issue: 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001;
5,753,441; 6,033,857.

------
ChuckMcM
Ouch. Now its back to the Supreme court to 'do the right thing' which is
unfortunate. Does anyone have a link to the published decision? I would be
interested in reading their reasoning that got them to this.

------
jdechko
I can understand patenting a technology for identifying these genes, but the
genes themselves? This is ridiculous. Isn't there a way for someone to
identify prior art and have the patent voided?

------
drucken
Amazing and completely topsy-turvey ruling!

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...

------
kitsune_
If I'm correct, this is about patenting isolated genes, right?

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.

~~~
zmmmmm
> If I'm correct, this is about patenting isolated genes, right?

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).

------
anuraj
Patenting a method to isolate the genes would be okay; but patenting the genes
themselves; holy shit!

------
jaekwon
DNA is code, so you work around the same way... Implement the idea and effect,
but as your own.

------
mratzloff
Eventually, companies will own the rights to our genes and we will merely
license them.

------
theklub
Countdown until bioshock style gene dispensers?

