Patent Reform
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Cory Geesaman
Mar 21, 2012, 2:07:00 PM3/21/12
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Most of you that are interested in this have likely already heard about it, but for anyone who hasn't - the supreme court took a pretty big step in terms of patent reform (and did it unanimously):
Cathal Garvey
Mar 21, 2012, 3:53:52 PM3/21/12
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Let's all wait and hope this applies to gene patents too in due course..any legal experts out there wanna make a prediction or assessment?
Cory Geesaman <co...@geesaman.com> wrote:
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Nathan McCorkle
Mar 21, 2012, 4:08:26 PM3/21/12
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Can anyone here interpret that document? I got bored after a while and
didn't finish it.
didn't finish it.
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Nathan McCorkle
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College of Science, Biotechnology/Bioinformatics
leaking pen
Mar 21, 2012, 4:55:17 PM3/21/12
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Yeah. Basically the patent in question was a "process" patent. Inject patient. Measure blood levels. Stop injecting patient if blood levels are too high, inject them again if they are too low.
The supreme court judgement was that that was an unpatentable process, under what is referred to as the DUH rule (which is to say, its an OBVIOUS application of a natural law. The official phrase is "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." ) The natural law in question was that levels of drug in the blood correspond to toxicity.
The supreme court judgement was that that was an unpatentable process, under what is referred to as the DUH rule (which is to say, its an OBVIOUS application of a natural law. The official phrase is "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." ) The natural law in question was that levels of drug in the blood correspond to toxicity.
John Griessen
Mar 21, 2012, 7:10:41 PM3/21/12
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On 03/21/2012 03:08 PM, Nathan McCorkle wrote:
> Can anyone here interpret that document? I got bored after a while and didn't finish it.
> Can anyone here interpret that document? I got bored after a while and didn't finish it.
This part in the opinion, after the syllabus, seems essential to me:
"To put the matter more succinctly, the claims inform a relevant audience
about certain laws of nature; any additional steps
consist of well understood, routine, conventional activity already
engaged in by the scientific community; and those steps,
when viewed as a whole, add nothing significant beyond the sum of
their parts taken separately. For these reasons we believe that
the steps are not sufficient to transform unpatentable natural
correlations into patentable applications of those regularities."
drllau
Mar 21, 2012, 8:40:03 PM3/21/12
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Since I specialise in IT/IP law, I'll explain the gist
1) Court did not disallow on basis of novelty or inventiveness
2) Instead they ruled that it was outside statutory subject matter
3) in essence it is a metabolic equation with set points discovered (therefore natural law)
Supreme Court’s recent decision in In re Bilski, process claims that are directed to “abstract ideas” are unpatentable subject matter. In contrast, applications of abstract ideas can be patented. Whilst on one hand Mayo v Prometheus may have rolled back the borders of subject matter (metabolic regulatory pathways), on the other hand it did so because the process of informing doctor was "obvious". We discussed this on IPprofessionals LinkedIn group and the general conclusion was that this decision adds more confusion and less predictability to diagnostic methods. Conjecture is that if you change the external decision loop (say to lookup a database depending on ethnic subgroup) then it may be a new application of the discovery.
In summary, a moral victory but can still be potentially legally worked around.
Lawrence
http://www.linkedin.com/in/drllau
1) Court did not disallow on basis of novelty or inventiveness
2) Instead they ruled that it was outside statutory subject matter
3) in essence it is a metabolic equation with set points discovered (therefore natural law)
Supreme Court’s recent decision in In re Bilski, process claims that are directed to “abstract ideas” are unpatentable subject matter. In contrast, applications of abstract ideas can be patented. Whilst on one hand Mayo v Prometheus may have rolled back the borders of subject matter (metabolic regulatory pathways), on the other hand it did so because the process of informing doctor was "obvious". We discussed this on IPprofessionals LinkedIn group and the general conclusion was that this decision adds more confusion and less predictability to diagnostic methods. Conjecture is that if you change the external decision loop (say to lookup a database depending on ethnic subgroup) then it may be a new application of the discovery.
In summary, a moral victory but can still be potentially legally worked around.
Lawrence
http://www.linkedin.com/in/drllau
Cory Geesaman
Mar 26, 2012, 9:59:24 PM3/26/12
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Good news!
On Wednesday, March 21, 2012 3:53:52 PM UTC-4, Cathal wrote:
On Wednesday, March 21, 2012 3:53:52 PM UTC-4, Cathal wrote:
Let's all wait and hope this applies to gene patents too in due course..any legal experts out there wanna make a prediction or assessment?Cory Geesaman <co...@geesaman.com> wrote:
>Most of you that are interested in this have likely already heard about
>it,
>but for anyone who hasn't - the supreme court took a pretty big step in
>
>terms of patent reform (and did it unanimously):
>http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf
>
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drllau
Mar 27, 2012, 1:06:12 AM3/27/12
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And the Australia case is likely to follow
http://www.councilforresponsiblegenetics.org/blog/post/Myriad-Geneticse28099-cancer-gene-patents-go-to-trial-in-Australia.aspx
http://www.councilforresponsiblegenetics.org/blog/post/Myriad-Geneticse28099-cancer-gene-patents-go-to-trial-in-Australia.aspx
Mega
Apr 15, 2013, 2:27:06 AM4/15/13
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Some news, guys...
Will the Supreme Court end human gene patents after three decades?
Court considers invalidating breast cancer gene patents—and thousands of others.
Ashley Heath
Apr 16, 2013, 3:48:14 PM4/16/13
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Personally I think that whether you agree with patenting human genes or not, it is not up to the US Supreme Court to make that decision. Their responsibility should be only to decide what is correct based on current law. It is the responsiblity of our elected representatives to create the laws that the Supremes rule on, based (one would like to hope) on the public viewpoint. So what is the current law? Unfortunately I suspect that presently patenting human genes is in fact perfectly legal.
leaking pen
Apr 16, 2013, 4:33:23 PM4/16/13
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That IS the Supremes job, and their judgement is, its not legal based on current law. (That is the role of any judge, interpretation of the law)
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Avery louie
Apr 16, 2013, 4:38:34 PM4/16/13
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That being said, iirc their review is based on it being constitutional- not based on public opinion.
--AAshley Heath
Apr 16, 2013, 5:13:45 PM4/16/13
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True, but nothing I read in the oral arguments suggested to me that they had a clear fix on that, certainly they all appear to be "morally" opposed to it, but the actual legal points...?? Which ones will positively rule out the patents? And it is not always the case that the Supremes simply stick to legal interpretation in making their decisions as I am sure you and Antonin Scalia well know! The late, great Robert Bork certainly did.
leaking pen
Apr 16, 2013, 5:31:05 PM4/16/13
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Reading the oral arguments, it's clear the Justices didn't quite "get it" as they spent a lot of time talking about the process of extracting dna and finding the genes. But it seems they got exactly why the genes themselves dont represent a transformation or new process.
To view this discussion on the web visit https://groups.google.com/d/msg/diybio/-/H9_Sq5lRgbQJ.
Cathal Garvey
Apr 17, 2013, 4:41:11 AM4/17/13
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-----BEGIN PGP SIGNED MESSAGE-----
Hash: SHA256
I wouldn't be so sure! Patenting genes is based on the shaky premise
that extracting the DNA coding for a gene is analogous to extracting
the elemental form of a reactive metal like aluminium. As the latter
was successfully patented (which already seems dodgy to me), they
reasoned that they could patent the "purified" form of a gene.
As you need a purified form of DNA to do anything further, like
sequencing or manipulation, that effectively grants them a monopoly on
the DNA itself. And as they were allowed to patent "shit within 90%
identity of this DNA", their patent coverage is broad enough to cover
whole genuses of life they've never actually sequenced or isolated
themselves.
Of course, the two (metal and DNA) are *not* comparable, and a
sufficiently informed judge could infer that. Even *if* you accept
that a metal can be patented because its metallic form is not apparent
in nature, DNA *is* readily apparent in the same form as its
"purified" form. Not only that, aluminium is not in "use" prior to
extraction, making the definition of "prior art" a bit ambiguous, but
I definitely "use" my DNA all the time. Indeed, I have more uses and
contexts for that DNA every day than Myriad have ever had during the
term of their patents.
So, given the extensive prior art and the fact that "purification" of
DNA is not even remotely similar to the level of transformation needed
to isolate significant quantities of elemental aluminium, it's not
clear at all that there's a legal basis for gene patenting.
What encouraged people at the time to overlook these well-recognised
differences was the (false) belief that patenting would encourage
rapid sequencing of the human genome. Of course, it did, but in the
opposite sense: it was the terror that the whole human genome would be
owned by one jerk that triggered a consortium of public-interest
groups to sequence the human genome and put it in the public domain.
It's questionable if said monopolist could even have successfully
sequenced (and therefore patented) the genome without nicking their
work in any case.
And, there is ample research in the intervening time to show that
patented genes receive less research time/funding and result in fewer
innovative outcomes, so even the fragile belief that patents would
encourage innovation has ended up being broken.
That leaves neither a legal groundwork for gene patents to rest on,
nor a shared mis-belief to encourage tolerance. With any luck, the
lobby-money will prove insufficient this time, and we'll see US patent
law improve for the first time in I-don't-even, with the abolition of
human gene patents. I can't imagine that "natural gene patents" will
outlive "human gene patents" for much longer.
> Court considers invalidating breast cancer gene patents�and
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I wouldn't be so sure! Patenting genes is based on the shaky premise
that extracting the DNA coding for a gene is analogous to extracting
the elemental form of a reactive metal like aluminium. As the latter
was successfully patented (which already seems dodgy to me), they
reasoned that they could patent the "purified" form of a gene.
As you need a purified form of DNA to do anything further, like
sequencing or manipulation, that effectively grants them a monopoly on
the DNA itself. And as they were allowed to patent "shit within 90%
identity of this DNA", their patent coverage is broad enough to cover
whole genuses of life they've never actually sequenced or isolated
themselves.
Of course, the two (metal and DNA) are *not* comparable, and a
sufficiently informed judge could infer that. Even *if* you accept
that a metal can be patented because its metallic form is not apparent
in nature, DNA *is* readily apparent in the same form as its
"purified" form. Not only that, aluminium is not in "use" prior to
extraction, making the definition of "prior art" a bit ambiguous, but
I definitely "use" my DNA all the time. Indeed, I have more uses and
contexts for that DNA every day than Myriad have ever had during the
term of their patents.
So, given the extensive prior art and the fact that "purification" of
DNA is not even remotely similar to the level of transformation needed
to isolate significant quantities of elemental aluminium, it's not
clear at all that there's a legal basis for gene patenting.
What encouraged people at the time to overlook these well-recognised
differences was the (false) belief that patenting would encourage
rapid sequencing of the human genome. Of course, it did, but in the
opposite sense: it was the terror that the whole human genome would be
owned by one jerk that triggered a consortium of public-interest
groups to sequence the human genome and put it in the public domain.
It's questionable if said monopolist could even have successfully
sequenced (and therefore patented) the genome without nicking their
work in any case.
And, there is ample research in the intervening time to show that
patented genes receive less research time/funding and result in fewer
innovative outcomes, so even the fragile belief that patents would
encourage innovation has ended up being broken.
That leaves neither a legal groundwork for gene patents to rest on,
nor a shared mis-belief to encourage tolerance. With any luck, the
lobby-money will prove insufficient this time, and we'll see US patent
law improve for the first time in I-don't-even, with the abolition of
human gene patents. I can't imagine that "natural gene patents" will
outlive "human gene patents" for much longer.
> thousands of others.
>
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Ashley Heath
Apr 17, 2013, 4:10:04 PM4/17/13
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Yes, I guess we will just have to wait and see.
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