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	<title>Comments on: The Case Against Gene Patents</title>
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	<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/</link>
	<description>Patents, Software Patents, Patent Applications &#38; Patent Law</description>
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		<title>By: Joe</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-7427</link>
		<dc:creator>Joe</dc:creator>
		<pubDate>Mon, 06 Jul 2009 15:02:25 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-7427</guid>
		<description>I don&#039;t understand how a tangible substance (i.e., an isolated nucleic acid) can be a fundamental principle.  Objects and substances, and more often their behavior and properties, can EMBODY fundamental principles.  But it seems a substance by its very nature cannot be a principle.</description>
		<content:encoded><![CDATA[<p>I don&#8217;t understand how a tangible substance (i.e., an isolated nucleic acid) can be a fundamental principle.  Objects and substances, and more often their behavior and properties, can EMBODY fundamental principles.  But it seems a substance by its very nature cannot be a principle.</p>
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		<title>By: adele pace</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-7407</link>
		<dc:creator>adele pace</dc:creator>
		<pubDate>Sun, 05 Jul 2009 00:29:11 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-7407</guid>
		<description>“My objection is that it is stifling research and it is depriving patients of life saving medical treatments.”

&quot;The problem with this state is that it is completely false&quot;&quot;.

.......I can tell you it HAPPENED IN AUSTRALIA. They denied tests to women suspected of carrying the gene for breast cancer because it was too expensive to pay for the privilege of being tested.  A lot of these databases carrying valuable information such as genetic information, a whole host of information, has been FUNDED BY GOVERNMENT, the public purse, and being locked up it &quot;manacles science&quot;.</description>
		<content:encoded><![CDATA[<p>“My objection is that it is stifling research and it is depriving patients of life saving medical treatments.”</p>
<p>&#8220;The problem with this state is that it is completely false&#8221;".</p>
<p>&#8230;&#8230;.I can tell you it HAPPENED IN AUSTRALIA. They denied tests to women suspected of carrying the gene for breast cancer because it was too expensive to pay for the privilege of being tested.  A lot of these databases carrying valuable information such as genetic information, a whole host of information, has been FUNDED BY GOVERNMENT, the public purse, and being locked up it &#8220;manacles science&#8221;.</p>
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		<title>By: mark</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-6969</link>
		<dc:creator>mark</dc:creator>
		<pubDate>Wed, 01 Jul 2009 18:06:20 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-6969</guid>
		<description>Again, disclaimer that I have financial interests in biotechnology related to human genetics. On a somewhat technical point, multiple academic research groups were in close competition for identification of the specific genes for the chromosomal loci then called (anonymously) BRCA1 and 2. The partial revision of the european patent, or at least part of the challenge, was based on such competitive activities. No one can know what &#039;might have been&#039;, but in my experience no single research group has ever really been irreplaceable for finding a human disease gene of major medical significance. In the case of high penetrance recurrent mutations, families harboring such mutations arise by chance all over the world and are ascertained by clinicial geneticists regularly. Conditions that are super rare and of no obvious commercial interest are often studied by only one group, although most genetic discoveries are quickly replicated by other researchers. In the case of low penetrance Hapmap type association studies, there are indeed large well-funded academic consortia studying many of the same diseases that some companies are exploring, and at least in some cases are seeing similar results (for example TCF7L2 for diabetes). I would say that the argument that commercial genetics research finds things that can&#039;t or won&#039;t be found by academia has little empirical evidence to support it. Putting lots of commercial dollars behind research certainly does allow the research to go faster than academia usually does. In the case of diagnostic tests, the key question is whether companies should be allowed to pre-emptively patent gene/disease assocations, or only their particular &#039;kit&#039; or &#039;assay&#039;. In the case of the BRCA genes for example, protein truncation tests are easier and cheaper than whole gene resequencing, but certainly miss more mutations. Exon resequencing can miss heterozygous deletions, etc etc. No one anywhere has a kit that detects all possible mutations, the genome is simply too fluid for that. In the case of patents to protect genes for therapeutic development, the timeline of drug programs is so long that such patents are probably not of very much value in general as they will expire not that long after a drug comes to market. So the patenting company itself gets a few years of protection, enough for a small biotech but probably not for a large pharma company. More than one pharma scientists has suggested to me that they don&#039;t think much of gene patents for therapeutic development as a result. The current debate clearly has more to do with patents for molecular diagnostics, being the most direct to market.

 I&#039;m not arguing one way or the other here, whatever my personal opinions, just offering some hopefully useful technical info.</description>
		<content:encoded><![CDATA[<p>Again, disclaimer that I have financial interests in biotechnology related to human genetics. On a somewhat technical point, multiple academic research groups were in close competition for identification of the specific genes for the chromosomal loci then called (anonymously) BRCA1 and 2. The partial revision of the european patent, or at least part of the challenge, was based on such competitive activities. No one can know what &#8216;might have been&#8217;, but in my experience no single research group has ever really been irreplaceable for finding a human disease gene of major medical significance. In the case of high penetrance recurrent mutations, families harboring such mutations arise by chance all over the world and are ascertained by clinicial geneticists regularly. Conditions that are super rare and of no obvious commercial interest are often studied by only one group, although most genetic discoveries are quickly replicated by other researchers. In the case of low penetrance Hapmap type association studies, there are indeed large well-funded academic consortia studying many of the same diseases that some companies are exploring, and at least in some cases are seeing similar results (for example TCF7L2 for diabetes). I would say that the argument that commercial genetics research finds things that can&#8217;t or won&#8217;t be found by academia has little empirical evidence to support it. Putting lots of commercial dollars behind research certainly does allow the research to go faster than academia usually does. In the case of diagnostic tests, the key question is whether companies should be allowed to pre-emptively patent gene/disease assocations, or only their particular &#8216;kit&#8217; or &#8216;assay&#8217;. In the case of the BRCA genes for example, protein truncation tests are easier and cheaper than whole gene resequencing, but certainly miss more mutations. Exon resequencing can miss heterozygous deletions, etc etc. No one anywhere has a kit that detects all possible mutations, the genome is simply too fluid for that. In the case of patents to protect genes for therapeutic development, the timeline of drug programs is so long that such patents are probably not of very much value in general as they will expire not that long after a drug comes to market. So the patenting company itself gets a few years of protection, enough for a small biotech but probably not for a large pharma company. More than one pharma scientists has suggested to me that they don&#8217;t think much of gene patents for therapeutic development as a result. The current debate clearly has more to do with patents for molecular diagnostics, being the most direct to market.</p>
<p> I&#8217;m not arguing one way or the other here, whatever my personal opinions, just offering some hopefully useful technical info.</p>
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		<title>By: David Koepsell</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5728</link>
		<dc:creator>David Koepsell</dc:creator>
		<pubDate>Fri, 19 Jun 2009 08:01:39 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5728</guid>
		<description>My intent isn&#039;t only to stir the pot, I am trying to defend and promote science.

as for evidence of chilling on science from over-broad patent extension, there&#039;s an excellent article, with empirical evidence, suggesting that this is exactly what is occurring :&lt;a href=&quot;http://www.sciencedirect.com/science?_ob=ArticleURL&amp;_udi=B6V8F-4MV0M6X-9&amp;_user=499885&amp;_rdoc=1&amp;_fmt=&amp;_orig=search&amp;_sort=d&amp;view=c&amp;_acct=C000024500&amp;_version=1&amp;_urlVersion=0&amp;_userid=499885&amp;md5=b7f45063211f2da98648f47f29eb3574&quot; target=&quot;_blank&quot; rel=&quot;nofollow&quot;&gt; http://www.sciencedirect.com/science?_ob=ArticleURL&amp;_udi=B6V8F-4MV0M6X-9&amp;_user=499885&amp;_rdoc=1&amp;_fmt=&amp;_orig=search&amp;_sort=d&amp;view=c&amp;_acct=C000024500&amp;_version=1&amp;_urlVersion=0&amp;_userid=499885&amp;md5=b7f45063211f2da98648f47f29eb3574&lt;/a&gt;

best,
David</description>
		<content:encoded><![CDATA[<p>My intent isn&#8217;t only to stir the pot, I am trying to defend and promote science.</p>
<p>as for evidence of chilling on science from over-broad patent extension, there&#8217;s an excellent article, with empirical evidence, suggesting that this is exactly what is occurring :<a href="http://www.sciencedirect.com/science?_ob=ArticleURL&#038;_udi=B6V8F-4MV0M6X-9&#038;_user=499885&#038;_rdoc=1&#038;_fmt=&#038;_orig=search&#038;_sort=d&#038;view=c&#038;_acct=C000024500&#038;_version=1&#038;_urlVersion=0&#038;_userid=499885&#038;md5=b7f45063211f2da98648f47f29eb3574" target="_blank" rel="nofollow"> </a><a href="http://www.sciencedirect.com/science?_ob=ArticleURL&#038;_udi=B6V8F-4MV0M6X-9&#038;_user=499885&#038;_rdoc=1&#038;_fmt=&#038;_orig=search&#038;_sort=d&#038;view=c&#038;_acct=C000024500&#038;_version=1&#038;_urlVersion=0&#038;_userid=499885&#038;md5=b7f45063211f2da98648f47f29eb3574" rel="nofollow">http://www.sciencedirect.com/science?_ob=ArticleURL&#038;_udi=B6V8F-4MV0M6X-9&#038;_user=499885&#038;_rdoc=1&#038;_fmt=&#038;_orig=search&#038;_sort=d&#038;view=c&#038;_acct=C000024500&#038;_version=1&#038;_urlVersion=0&#038;_userid=499885&#038;md5=b7f45063211f2da98648f47f29eb3574</a></p>
<p>best,<br />
David</p>
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		<title>By: Gene Quinn</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5670</link>
		<dc:creator>Gene Quinn</dc:creator>
		<pubDate>Thu, 18 Jun 2009 14:05:05 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5670</guid>
		<description>&quot;My objection is that it is stifling research and it is depriving patients of life saving medical treatments.&quot;

The problem with this state is that it is completely false.  This is what is said in media and academic circles, as if it were true, but there is never proof.  The truth is that patents do not stifle research.  The experimental use exception allows for research.  What is stifled is research aimed at commercialization.  For better or worse, Universities really don&#039;t do much pure research any more.  They research to create commercial opportunities that allows them to license and return money to the University.  Why should commercial research be allowed at the expense of the patent owner?  When Universities become businesses they need to play by the same rules as everyone else.  

-Gene</description>
		<content:encoded><![CDATA[<p>&#8220;My objection is that it is stifling research and it is depriving patients of life saving medical treatments.&#8221;</p>
<p>The problem with this state is that it is completely false.  This is what is said in media and academic circles, as if it were true, but there is never proof.  The truth is that patents do not stifle research.  The experimental use exception allows for research.  What is stifled is research aimed at commercialization.  For better or worse, Universities really don&#8217;t do much pure research any more.  They research to create commercial opportunities that allows them to license and return money to the University.  Why should commercial research be allowed at the expense of the patent owner?  When Universities become businesses they need to play by the same rules as everyone else.  </p>
<p>-Gene</p>
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		<title>By: Noise above Law</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5658</link>
		<dc:creator>Noise above Law</dc:creator>
		<pubDate>Thu, 18 Jun 2009 11:33:09 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5658</guid>
		<description>David,

If your only purpose is to stir the pot,...  well then you really aren&#039;t listening to what is being said and no argument will make a difference to you.

This appears to be the case, especially since you take comments directed to your lack of understanding of the legal ramifications of your sloppy logic in the intellectual property world as personal attacks (they are not, nor are they &quot;cheap swipes&quot;).  Wearing &quot;thin skin&quot; as a shield to deflect actually answering the points and rebutting arguments may be a clever lawyer&#039;s tactic, but upon review, it only shows that you have not fully answered the questions put to you.  

Granted, you are dealing with people who have both technical understanding and very specific legal understanding - having feet in Both worlds is what drew me to this particular profession.  The questioning may indeed appear brutal, and this is what I alluded to with the public perception battle, as just as the questions are being put to you, &quot;sound bytes&quot; are also being put ot the audiances at large.  If you want to lesson the sting of the soundbytes, focus on the legal logic.  But then again, your particular legal logic in this arena is weak.

There is more to this exchange than merely &quot;making your points&quot; and running away.  As several have pointed out, your points are found wanting and you have not answered the deficiencies.

To borrow from &quot;breadcrumbs&quot;, you are dancing with clown feet, and the camel is refusing to drink at the oasis.</description>
		<content:encoded><![CDATA[<p>David,</p>
<p>If your only purpose is to stir the pot,&#8230;  well then you really aren&#8217;t listening to what is being said and no argument will make a difference to you.</p>
<p>This appears to be the case, especially since you take comments directed to your lack of understanding of the legal ramifications of your sloppy logic in the intellectual property world as personal attacks (they are not, nor are they &#8220;cheap swipes&#8221;).  Wearing &#8220;thin skin&#8221; as a shield to deflect actually answering the points and rebutting arguments may be a clever lawyer&#8217;s tactic, but upon review, it only shows that you have not fully answered the questions put to you.  </p>
<p>Granted, you are dealing with people who have both technical understanding and very specific legal understanding &#8211; having feet in Both worlds is what drew me to this particular profession.  The questioning may indeed appear brutal, and this is what I alluded to with the public perception battle, as just as the questions are being put to you, &#8220;sound bytes&#8221; are also being put ot the audiances at large.  If you want to lesson the sting of the soundbytes, focus on the legal logic.  But then again, your particular legal logic in this arena is weak.</p>
<p>There is more to this exchange than merely &#8220;making your points&#8221; and running away.  As several have pointed out, your points are found wanting and you have not answered the deficiencies.</p>
<p>To borrow from &#8220;breadcrumbs&#8221;, you are dancing with clown feet, and the camel is refusing to drink at the oasis.</p>
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		<title>By: adele pace</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5655</link>
		<dc:creator>adele pace</dc:creator>
		<pubDate>Thu, 18 Jun 2009 10:56:51 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5655</guid>
		<description>I think they are entitled to patent the isolation process, a process resulting in the gene being extracted or demonstrating it’s function, but you can’t patent the gene itself. That is just knowledge, it’s the discovery. 

Putting gene sequences into databases accessible only to researchers through licensing fees shows that there are powerful commercial restraints on researchers. The database proposals introduced by Carlos Moorhead have foundered over a period of more than a decade in the US. There is probably a good reason for this.  

I am not calling patent attornies evil….and as for the Diehr ruling ‘anything under the sun being patentable’ my understanding was that the US Supreme Court wanted the Federal Circuit to review the law. 

My objection is that it is stifling research and it is depriving patients of life saving medical treatments. 

There are a lot of practical problems with genes and evidentiary problems. Even if not legally, at least the practical impact is that it is as if the gene itself has been patented rather than the process of isolation. 
Consider the whole Monsanto debacle around gene modification in crops and cross pollination, claims that this was an actionable nuisance with compensation being demanded from neighbouring farmers. I recall reading about a patent granted to make cows grow faster or produce beef more efficiently. Action was brought against cattle owners who owned cattle that they alleged had these genes which were naturally occurring within them.</description>
		<content:encoded><![CDATA[<p>I think they are entitled to patent the isolation process, a process resulting in the gene being extracted or demonstrating it’s function, but you can’t patent the gene itself. That is just knowledge, it’s the discovery. </p>
<p>Putting gene sequences into databases accessible only to researchers through licensing fees shows that there are powerful commercial restraints on researchers. The database proposals introduced by Carlos Moorhead have foundered over a period of more than a decade in the US. There is probably a good reason for this.  </p>
<p>I am not calling patent attornies evil….and as for the Diehr ruling ‘anything under the sun being patentable’ my understanding was that the US Supreme Court wanted the Federal Circuit to review the law. </p>
<p>My objection is that it is stifling research and it is depriving patients of life saving medical treatments. </p>
<p>There are a lot of practical problems with genes and evidentiary problems. Even if not legally, at least the practical impact is that it is as if the gene itself has been patented rather than the process of isolation.<br />
Consider the whole Monsanto debacle around gene modification in crops and cross pollination, claims that this was an actionable nuisance with compensation being demanded from neighbouring farmers. I recall reading about a patent granted to make cows grow faster or produce beef more efficiently. Action was brought against cattle owners who owned cattle that they alleged had these genes which were naturally occurring within them.</p>
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		<title>By: David Koepsell</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5640</link>
		<dc:creator>David Koepsell</dc:creator>
		<pubDate>Thu, 18 Jun 2009 06:08:38 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5640</guid>
		<description>Mike,

If the system weren&#039;t broken, then thousands of researchers would not be trying to fix it.  I am not a lone voice in the wilderness.

If you are convinced it works so well and nothing is problematic, then chime in on behalf of Myriad in the lawsuit, I am sure their attorneys will be thrilled to have you as an expert witness, explaining how their patents never interfered with their research, and how Nobel Laureates like John Sulston, or other prominent scientists like Francis Collins and others are just paranoid, delusional, or mistaken when they argue against the current, though diminishing, practice of gene patenting.  I&#039;m sure they&#039;ll be relieved to hear nothing&#039;s wrong.

I have to bow out now, I&#039;ve made my points many times over and have plenty to do in my day job.  I&#039;ll be back to stir the pot another time.

Best
David</description>
		<content:encoded><![CDATA[<p>Mike,</p>
<p>If the system weren&#8217;t broken, then thousands of researchers would not be trying to fix it.  I am not a lone voice in the wilderness.</p>
<p>If you are convinced it works so well and nothing is problematic, then chime in on behalf of Myriad in the lawsuit, I am sure their attorneys will be thrilled to have you as an expert witness, explaining how their patents never interfered with their research, and how Nobel Laureates like John Sulston, or other prominent scientists like Francis Collins and others are just paranoid, delusional, or mistaken when they argue against the current, though diminishing, practice of gene patenting.  I&#8217;m sure they&#8217;ll be relieved to hear nothing&#8217;s wrong.</p>
<p>I have to bow out now, I&#8217;ve made my points many times over and have plenty to do in my day job.  I&#8217;ll be back to stir the pot another time.</p>
<p>Best<br />
David</p>
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		<title>By: Mike</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5598</link>
		<dc:creator>Mike</dc:creator>
		<pubDate>Wed, 17 Jun 2009 17:43:23 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5598</guid>
		<description>Your arguments are defeated by the fact that your problem does not exist.  

Please explain how In re Kubin does not address all of your arguments.
&quot;Kubin and Goodwin’s disclosure represents some minor advance in the art. But “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress.” KSR, 550 U.S. at 419.”

Simply put: &quot;No one can patent your genome.&quot;  
A mother has never given birth to an isolated gene sequence.
Simple human genome sequences are no longer patentable (in re Kubin).
As innovation evolves, patent scope evolves.  As in all technologies, as biotechnology matures patent scope becomes narrower.  

There is no reason to place special limits on just biotechnology innovations that will cause undue burdens and unforeseen consequences in the field.  Government funding is fickle and fluctuates over time without regard for market, public demand or need.  Scientific funding covers everything from oceanography to human metabolism and cannot be mandated from above in any logical way.  The market is demand driven and will provide solutions for the greatest number of people where required.  Eventually todays innovations will become tomorrows public domain and that is the purpose of patents.

The system is not broken, please don&#039;t try to fix it.  Those of us who work in the field will tinker with it to ensure it is on track and claims are appropriate.

Thanks for your time,

Mike</description>
		<content:encoded><![CDATA[<p>Your arguments are defeated by the fact that your problem does not exist.  </p>
<p>Please explain how In re Kubin does not address all of your arguments.<br />
&#8220;Kubin and Goodwin’s disclosure represents some minor advance in the art. But “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress.” KSR, 550 U.S. at 419.”</p>
<p>Simply put: &#8220;No one can patent your genome.&#8221;<br />
A mother has never given birth to an isolated gene sequence.<br />
Simple human genome sequences are no longer patentable (in re Kubin).<br />
As innovation evolves, patent scope evolves.  As in all technologies, as biotechnology matures patent scope becomes narrower.  </p>
<p>There is no reason to place special limits on just biotechnology innovations that will cause undue burdens and unforeseen consequences in the field.  Government funding is fickle and fluctuates over time without regard for market, public demand or need.  Scientific funding covers everything from oceanography to human metabolism and cannot be mandated from above in any logical way.  The market is demand driven and will provide solutions for the greatest number of people where required.  Eventually todays innovations will become tomorrows public domain and that is the purpose of patents.</p>
<p>The system is not broken, please don&#8217;t try to fix it.  Those of us who work in the field will tinker with it to ensure it is on track and claims are appropriate.</p>
<p>Thanks for your time,</p>
<p>Mike</p>
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		<title>By: Mike</title>
		<link>http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/#comment-5592</link>
		<dc:creator>Mike</dc:creator>
		<pubDate>Wed, 17 Jun 2009 16:28:04 +0000</pubDate>
		<guid isPermaLink="false">http://www.ipwatchdog.com/?p=4102#comment-5592</guid>
		<description>My apologies David.  

I had typed the first text and it was lost when your response posted.

My second post assumed the first post was lost. 

There is some redundancy in the two arguments, although I am glad the vaccine example returned.

Have a great day!

Mike</description>
		<content:encoded><![CDATA[<p>My apologies David.  </p>
<p>I had typed the first text and it was lost when your response posted.</p>
<p>My second post assumed the first post was lost. </p>
<p>There is some redundancy in the two arguments, although I am glad the vaccine example returned.</p>
<p>Have a great day!</p>
<p>Mike</p>
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