

U.S. Says Genes Should Not Be Eligible for Patents - HardyLeung
http://www.nytimes.com/2010/10/30/business/30drug.html

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kljensen
Gene patents have not been a "problem" in the same way as software patents.
And, unlike software patents, they are more likely to represent a significant
R&D investment by the applicant.

(I am the author of the paper that showed how much of the human genome is
patented. "Intellectual property landscape of the human genome", Science 2005.
<http://www.sciencemag.org/cgi/content/summary/310/5746/239> )

The brief filed by the government does not alter the law, it's just a letter
to the court that says "this is the current, consensus opinion of the
executive branch." The current law states that DNA (or any other naturally
occurring chemical) cannot be patented unless it is significantly transformed
from it's natural state. However, purification of the DNA is usually enough to
render it patentable. That, of course, is not difficult with current molecular
biology techniques.

But, like any other technology, patent applications covering DNA must meet
many other requirements including non-obviousness and usefulness. Thus, the
claims granted by the USPTO have become increasingly narrow as the field has
matured and there is more prior art. That is, just like any new technology
area the initially granted patents are broad, but they narrow over time.

So, that is a long way of saying, this might be a tempest in a teapot.
Especially because most court watchers expect the Federal Circuit to reverse
the District Court and keep the status quo.

~~~
_delirium
Is non-obviousness actually applied in this sphere? In my corner of computer
science, the non-obviousness bar is so low as to be basically non-existent.
There are tons of patents where A and B each have significant prior art, but
the completely straightforward combination "A+B" somehow gets patented.

~~~
kljensen
It is applied, and it should also be in the CS space. But, as always, there
are bad patents issued because they are examined by busy humans. In these
cases, opponents of the patent have a number of options, most notably asking
for a reexamination of the patent. During reexam, you can bring missed prior
art to the USPTO's attention in an effort to invalidate the patent.

EDIT: I should have also mentioned, another option is to ask the courts to
invalidate the patent (for obviousness, lack of enablement, or any other
statutory requirement) if you are involved in a lawsuit. Even if you are not
sued you can begin such a lawsuit by filing a "declaratory judgement"
complaint against somebody who you reasonably feel might sue you.

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pquerna
Good.

DNA is just a sequence of bits, software is too.

Genetics has turned into a minefield because of patents.

Cross-licensing crap worse than even software.

It will probably take another decade if this ever changes, but I'm hopeful!

~~~
dctoedt
> _DNA is just a sequence of bits, software is too_

That's not the argument being made by DOJ. They're not saying that DNA
sequences per se are unpatentable. On the contrary, they agree that _man-made_
DNA sequences are indeed potentially patentable (assuming they're not
"obvious" in view of other pre-existing DNA sequences, including for example
genes in the wild). The brief argues only that if a DNA sequence occurs in
nature, you shouldn't be able to get a patent on the isolated sequence.

~~~
pjscott
That could be kind of tricky. If we want to make custom proteins, for example,
the most straightforward way to do it is to build up a protein from bits of
naturally-occurring proteins for which we already know the folded structure.

I'll give a more concrete example. Certain zinc finger proteins can bind to
particular DNA sequences. By chaining together a few of these units, we can
engineer proteins that bind to a particular sequence of DNA and promote or
inhibit its transcription into RNA -- obviously a very useful thing to be able
to do.

Do these custom zinc finger proteins count as patentable? On the one hand,
we're mostly plagiarizing from nature. On the other hand, there are a lot of
tough issues to solve in order to get to where we can reliably use these
things. Personally, I think the bioengineering challenges are a bigger barrier
to competition than a patent could be: if someone set up a company that could
sell custom zinc finger arrays at a reasonable price, their expertise would
matter a lot more than any patent.

~~~
dctoedt
That's where obviousness analysis comes in. It's tough to do in hindsight.
That's why courts look to "objective evidence." For example, praise from other
researchers, or extensive citation of the published paper, could be indirect
evidence of nonobviousness.

(One of my partners at my former law firm told a story about representing a
major university in seeking a patent for a biotech invention. It took a number
of years for the PTO to do the initial examination of the patent application.
The patent examiner perfunctorily rejected the application, asserting that the
claimed invention would have been obvious in view of the prior art. My partner
responded that in the years that the inventors had been waiting on the PTO to
examine the patent application, they had been awarded the Nobel Prize for that
very invention. Result: Obviousness rejection withdrawn. Of course, I could
well be misremembering, but it nicely illustrates the principle.)

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carbocation
The government's actual position is more subtle than the NYT title suggests:

"While the government took the plaintiffs’ side on the issue of isolated DNA,
it sided with Myriad on patentability of manipulated DNA."

~~~
nodata
How long is a piece of manipulated DNA? Would claiming prior art be
mathematically feasible on all manipulated DNA?

~~~
carbocation
The first question is similar to asking, "How long is a string?" Arbitrarily
long.

I think that "prior art" and "obviousness" claims for certain classes of
manipulations should (in a world run by biologists) be useful. For example, if
you discover New Gene X and manipulate its DNA to tag its protein product with
a fluorescent protein, that's pretty damn obvious because that's what we do
with every other protein.

~~~
sprout
It's all obvious in the natural world (and living things reuse code without
regard for law.)

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DaniFong
I am, frankly, amazed that gene patents are now ineligible where
software/business method patents remain so. This _might_ be consistent with
whatever theology the courts have sanctified, but it is the exact opposite of
what makes sense for business and innovation.

Firms are forced to pay for their research toward FDA approval, and that
approval is extended only to a very specific drug or treatment. The narrowness
of this channel yields one of the only business situations where patent law,
from an innovation perspective, makes sense.

Contrast this with business method patents and software patents: you can use a
zillion different idea, each independently patentable, for any business or
product, there is a much smaller barrier to entry, and there are many ways to
accomplish the same thing. Patents go from being quite valuable for the
innovator to being, at best, a distraction, and at worst, a minefield.

Oy.

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lutorm
That's the first sane official statement about patents I've heard in a long
time. There must be something I'm missing in this debate, because to me the
fact that naturally occurring genes are not inventions is as obvious as that
mathematical theorems are. (It's actually even _more_ obvious, the genes can
be plainly seen around us, when you know they're there.) It's as if software
algorithms were written on the leaves of trees around us, but we needed to dye
them to see the source.

Whether a _synthetic_ gene is an invention is a different story to me. That's
much more closely related to whether software is patentable. But no one would
seriously argue that they could patent RSA if they turned a rock over and
found the algorithm written down, no matter how many stones they had to turn
to find it.

~~~
dctoedt
> _It's as if software algorithms were written on the leaves of trees around
> us, but we needed to dye them to see the source._

Love the vivid analogy. But couldn't the same thing be said about any "method"
invention?

~~~
lutorm
Yes. It's not a black and white area. In principle, every method that works is
just discovered, just like a theorem is.

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ghshephard
To play devil's advocate - one could argue that allowing gene's to be patented
would result in a vast amount of resources being invested, immediately, to
decode and determine precisely what each of them do - with the rewards from
such decoding being secured for 18 years (patent lifetime) - at which point
anyone would be free to use the information.

In the absence of a patent incentive, the alternative, then, will hopefully be
large government and other large public investments making up the difference.

~~~
carbocation
I won't do the full analysis justice in a brief comment, but this is an
empirical question that has some evidence.

The draft human reference genome was published 10 years ago. Prior to this,
dozens of genes were discovered and patented by Celera. Celera gave free
access to these genes to academics, but required payment for any for-profit
activity. By one analysis, genes that were ever controlled by Celera, despite
these relatively loose restrictions, as of 2009 had 30% less research done on
them than those genes that were never controlled by Celera.

<http://www.nber.org/~heidiw/papers/5_12_10a_hlw.pdf>

~~~
JunkDNA
I worked for a very well known company who licensed some of the early genes
that were patented by companies like Celera. It was such a painful experience
and the arrangement caused tons of legal knots years later. When the license
period ended I distinctly remember an email asking that in addition to
surrendering all documents related to the genes, we had to "forget" anything
we might have learned personally about them. By that time they were all
publicly known, so it was a bit hard to tease out what was learned as a result
of the patented genes vs. what you learned from a search at NCBI.

~~~
carbocation
If you blog, I'd love to see that comment fleshed out in longer form. Your
story sounds very interesting!

~~~
JunkDNA
I don't have a blog because I have yet to convince myself other people would
be interested in what I have to say. I might have to start one.

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Mithrandir
I'm sure Ozzy Osbourne is relieved:
[http://www.scientificamerican.com/article.cfm?id=ozzy-
osbour...](http://www.scientificamerican.com/article.cfm?id=ozzy-osbourne-
genome)

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makeramen
Ugh, anyone seen Food Inc.? It still doesn't solve the problem of Monsanto and
their genetically modified crop, bullying small farmers.

