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<title>Techdirt. Stories about &quot;prometheus&quot;</title>
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<image><title>Techdirt. Stories about &quot;prometheus&quot;</title><url>http://www.techdirt.com/images/td-88x31.gif</url><link>http://www.techdirt.com/</link></image>
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<pubDate>Wed, 21 Mar 2012 06:40:38 PDT</pubDate>
<title>Huge Ruling: Court Rejects Medical Diagnostic Patent</title>
<dc:creator>Mike Masnick</dc:creator>
<link>http://www.techdirt.com/articles/20120320/17195118175/huge-ruling-court-rejects-medical-diagnostic-patent.shtml</link>
<guid>http://www.techdirt.com/articles/20120320/17195118175/huge-ruling-court-rejects-medical-diagnostic-patent.shtml</guid>
<description><![CDATA[ We've been covering the <a href="http://www.techdirt.com/search.php?cx=partner-pub-4050006937094082%3Acx0qff-dnm1&#038;cof=FORID%3A9&#038;ie=ISO-8859-1&#038;q=Prometheus+Laboratories">Prometheus Laboratories v. Mayo Labs</a> case for a few years now, as it was a key case involving whether or not you could patent basic medial <i>diagnostics</i> -- i.e., can you patent basic science and limit doctors from doing such science without paying up.  Tragically, in a series of decisions, the appeals court (CAFC) twice ruled that diagnostics <a href="http://www.techdirt.com/articles/20101220/02310112338/appeals-court-says-again-that-diagnostic-tests-are-patentable.shtml">are patentable</a>, and we were particularly concerned that the oral hearings in the Supreme Court on this case seemed <a href="http://www.techdirt.com/articles/20111207/17201917001/supreme-court-seems-ok-with-patenting-medical-diagnostics.shtml">very narrowly focused</a>.  Of course, as we noted at the time, the oral hearings can be a red herring, as rulings often have little (if anything) to do with what is said during the oral hearings.  This appears to be one such case.
<br /><br />
Instead, it looks like we got a reasonably good (not great, but definitely pretty good) ruling from the Court <a href="http://www.patentlyo.com/patent/2012/03/mayo-v-prometheus-natural-process-known-elements-normally-no-patent.html" target="_blank">effectively rejecting the concept of patenting basic medical diagnostics</a> as laws of nature that are not patentable.  It's always a good sign when Supreme Court IP case rulings are written by Justice Stephen Breyer -- as he remains the one Supreme Court Justice who seems to consistently, and instinctively, understand how excessive intellectual monopolies can cause much more harm than good.  In this case, Breyer wrote the decision which, thankfully, was actually a unanimous decision, rejecting Prometheus' patents, and reiterating that laws of nature are not patentable.
<blockquote><i>
In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.
</i></blockquote>
Breyer's opinion is pretty clear and easy to read and makes some important points:
<blockquote><i>
If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction &#8220;apply the law.&#8221; Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine
whether an object will float.
</i></blockquote>
One nice aside: the ruling also rejects the US government's own brief in the case, which effectively suggested that we get rid of the rule that laws of nature can't be patented, and instead just focus on whether or not the claims are new and non-obvious.   As Breyer wrote, this "risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do."
<br /><br />
Finally, at the end, Breyer highlights the costs and benefits of patents and how the arguments that more patents automatically lead to greater innovation is simply not the case:
<blockquote><i>
Patent protection is, after all, a two-edged sword. On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements. At the same time, patent law&#8217;s general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another.... 
<br /><br />
In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another. And we must recognize the role of Congress in crafting more finely tailored rules where necessary.
</i></blockquote>
All in all this is a good ruling.  It's a <i>little</i> limited in suggesting that you <i>could</i> patent diagnostics that go further rather than just "drafting" on a natural law, but this is definitely a big step in the right direction.  And as Patently-O <a href="http://www.patentlyo.com/patent/2012/03/mayo-v-prometheus-natural-process-known-elements-normally-no-patent.html">notes</a>, it's likely that this ruling will mean that the appeals court will now <i>also</i> be told to go back and re-evaluate its <a href="http://www.techdirt.com/articles/20110729/16573515324/appeals-court-says-genes-are-patentable-because-theyre-separate-your-dna.shtml">awful decision</a> saying genes are patentable in the Myriad Genetics case.  Hopefully, this ruling is a clear statement that not only are diagnostics not patentable, but <i>genes</i> aren't patentable either.  If that's true it will be a <i>huge</i> boost to research in the biotech field, which won't be held back by expensive restrictions and tollbooths.
<br /><br />
Of course, that's not the story you hear from the patent maximalists, who are arguing that this is <a href="http://www.reuters.com/article/2012/03/20/us-mayo-prometheus-patent-idUSBRE82J18I20120320" target="_blank">horrible for the biotech community</a> because it will mean fewer patents.  But that ignores all of the <i>good</i> this does in making it easier to do research, to share results and lead to more real innovations built on basic laws of nature and facts, rather than locking up that knowledge.<br /><br /><a href="http://www.techdirt.com/articles/20120320/17195118175/huge-ruling-court-rejects-medical-diagnostic-patent.shtml">Permalink</a> | <a href="http://www.techdirt.com/articles/20120320/17195118175/huge-ruling-court-rejects-medical-diagnostic-patent.shtml#comments">Comments</a> | <a href="http://www.techdirt.com/articles/20120320/17195118175/huge-ruling-court-rejects-medical-diagnostic-patent.shtml?op=sharethis">Email This Story</a><br />
 ]]></description>
<slash:department>a-step-forward</slash:department>
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<pubDate>Thu, 8 Dec 2011 06:41:48 PST</pubDate>
<title>Supreme Court Seems Ok With Patenting Medical Diagnostics</title>
<dc:creator>Mike Masnick</dc:creator>
<link>http://www.techdirt.com/articles/20111207/17201917001/supreme-court-seems-ok-with-patenting-medical-diagnostics.shtml</link>
<guid>http://www.techdirt.com/articles/20111207/17201917001/supreme-court-seems-ok-with-patenting-medical-diagnostics.shtml</guid>
<description><![CDATA[ We've covered the Mayo v. Promethus Labs case for a while now.  This is the lawsuit over the patentability of medical diagnostic techniques.  If that sounds crazy to you, you're not alone.  Promethius got a patent on a specific way of testing for a disease, and got into a legal fight with the Mayo Clinic, because Mayo dared to diagnose without paying them.  Tragically, an appeals court <a href="http://www.techdirt.com/articles/20090920/2259026254.shtml">said this was fine</a>.  Many doctors were, quite understandably, <a href="http://www.techdirt.com/articles/20090723/0402355634.shtml">horrified</a> at all of this.  The idea that they could violate a patent merely by understanding the science and running a test to detect an ailment?  Horrifying and ridiculous.  When the Supreme Court agreed to <a href="http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml">pick up</a> the case, we had hoped it meant that some common sense might prevail.
<br /><br />
However, that's looking doubtful.  The oral arguments were just heard in the case, and as Tim Lee points out, <a href="http://arstechnica.com/tech-policy/news/2011/12/oblivious-supreme-court-poised-to-legalize-medical-patents.ars" target="_blank">they don't sound good</a>.  You can read the full transcript below, but the oral discussion was extremely narrowly focused on the patentability of this particular diagnostic test, with many comments suggesting that the patentability of a general diagnostic test is not even in question.  In fact, Mayo's own lawyer seemed to concede the point and didn't even bother to argue the issue:
<blockquote><i>
Unfortunately, the justices seemed oblivious to these arguments. And the man who should have been making them, Mayo counsel Stephen Shapiro, completely ignored them. Instead, he seemed to concede the legality of medical patents in general, and focused on nitpicking the details of Prometheus's patent. Specifically, he noted that the patent covers a broad range of metabolite levels and applies for many different autoimmune diseases, and argued that this made the patent invalid.
<br /><br />
Asked by Justice Kennedy if a more specific and complex diagnostic technique involving "two or three different drugs" could be eligible for patent protection, Shapiro said yes. "If it leaves room for others to have their own tests with different numbers and different procedures so that it isn't just one test for the whole country, then yes, if it's specific enough," he said. "The specificity is the key."
<br /><br />
Justice Scalia pointed out that making patent-eligibility turn on how complex the diagnostic strategy was, or on how many diseases it claimed to address, was totally unworkable. Shapiro's proposal, he said, was "not a patent rule that we could possibly apply."
<br /><br />
Justices Scalia and Breyer showed some skepticism that patents could cover the use of scientific correlations in medical practice. But the other justices expressed no such skepticism. At one point, Justice Kagan offered some advice to Prometheus's lawyer. "What you haven't done is say at a certain number you should use a certain treatment, at another number you should use another treatment," she said. "I guess the first question is why didn't you file a patent like that? Because that clearly would have been patentable. Everybody agrees with that."
</i></blockquote>
Except, as Lee notes, not everyone agrees with that.  In fact many different groups, including the American Medical Association, argued exactly the opposite in briefs on the case.
<br /><br />
For what's it worth, what's discussed in the oral hearing is not always all that relevant to how the case actually turns out.  The briefs are often more important.  But, either way, it's not looking good.   After a few good years in the mid-2000s, where the Supreme Court really beat back patent excesses, the more recent patent courts have been timid to the point of ridiculous.  In the end, it seems like this case may turn out <a href="http://www.techdirt.com/articles/20100628/0759029989.shtml">like the Bilski case</a>, where the Supreme Court had the opportunity to rule broadly on software and business method patents, but chose to ignore the issue, focusing only on the specific patent in question.
<br /><br />
This seems like a huge waste of the Supreme Court's time and collective intellect.  People look to SC rulings to set precedent and clarify points of law.  Ruling extremely narrowly based on just the specifics of the patent itself doesn't clear up any confusion.  Instead, it just makes things worse.<br /><br /><a href="http://www.techdirt.com/articles/20111207/17201917001/supreme-court-seems-ok-with-patenting-medical-diagnostics.shtml">Permalink</a> | <a href="http://www.techdirt.com/articles/20111207/17201917001/supreme-court-seems-ok-with-patenting-medical-diagnostics.shtml#comments">Comments</a> | <a href="http://www.techdirt.com/articles/20111207/17201917001/supreme-court-seems-ok-with-patenting-medical-diagnostics.shtml?op=sharethis">Email This Story</a><br />
 ]]></description>
<slash:department>bad,-bad-news</slash:department>
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<pubDate>Thu, 15 Sep 2011 14:05:22 PDT</pubDate>
<title>Do Patents On Medical Diagnostics Violate The First Amendment?</title>
<dc:creator>Mike Masnick</dc:creator>
<link>http://www.techdirt.com/articles/20110914/16214915960/do-patents-medical-diagnostics-violate-first-amendment.shtml</link>
<guid>http://www.techdirt.com/articles/20110914/16214915960/do-patents-medical-diagnostics-violate-first-amendment.shtml</guid>
<description><![CDATA[ We've been following the extremely worrisome Prometheus Laboratories v. Mayo Collaborative Services case for a while now.  This is the case in which Prometheus patented some basic medical diagnostics tests, and then sued the Mayo Clinic for daring to do similar diagnostics without paying up.  Tragically, CAFC, the court of appeals for the Federal Circuit, has ruled that it's just <a href="http://www.techdirt.com/articles/20101220/02310112338/appeals-court-says-again-that-diagnostic-tests-are-patentable.shtml">fine and dandy</a> to patent a diagnostic test.  The Supreme Court agreed to <a href="http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml">hear the appeal</a> on this in the upcoming term, and folks at the Cato Institute have <a href="http://www.cato.org/pub_display.php?pub_id=13654" target="_blank">filed a very interesting amicus brief</a>, arguing that such a diagnostic test should not be patentable on two key points.  I don't know that it'll convince the court, but they try out the argument that doing so would actually be a First Amendment violation, and even cite the famous Eldred case to make their argument (emphasis mine in the quote here):
<blockquote><i>
Prometheus&rsquo;s patents will also impermissibly restrict public domain activity. These patents&rsquo; final step is entirely mental. Patents whose final step is mental have the effect of transforming non-infringing, public domain activity into infringing activity for those who are aware of the thought that triggers infringement. <b>This effect discourages the dissemination of knowledge, because access to patented knowledge places individuals in situations where they must elect to cease doing what was previously a public domain activity&mdash;such as reading the results of medical tests&mdash;or inadvertently infringe a patent.</b>
<br /><br />
For similar reasons, <b>the patents at issue unconstitutionally restrict freedom of thought, by putting parties at risk of incurring damages for patent infringement when they recognize the correlations described in the patents at issue. The First Amendment protects freedom of thought and places limits on patent protections, just as it does on copyright protections.</b> As the Court stated in Eldred v. Ashcroft, 537 U.S. 186 (2003), copyrights could require First Amendment scrutiny if &ldquo;the traditional contours of copyright protection&rdquo; were altered. <b>The patents at issue here represent an unprecedented departure from the traditional contours of patent protection; only recently have parties sought patent protection for claims which final element encompasses pure thought</b>. Even if the patents at issue are otherwise patentable subject matter, these patents unconstitutionally restrict freedom of thought in violation of the First Amendment and should be invalidated.
</i></blockquote>
This is a creative argument and compelling to me... but I would guess that the court won't buy it.  While it's true that the court has said that First Amendment scrutiny for copyright only comes into play when the traditional contours of copyright law are altered, to date, the Supreme Court doesn't seem to recognize any alteration as violating the traditional contours.  Within copyright law, for example, it's hard to reasonably argue that the shift from an opt-in copyright system with formalities, to an "everything is automatically copyrighted pretty much forever," was not a change to the traditional contours of copyright law... but the Supreme Court didn't think it met that standard.  So I'm not sure they'll be convinced by this argument, unfortunately.  Still, if it somehow is effective -- and, for whatever reason, the court seems more sympathetic to arguments of harm done by bad patent law than it does with copyright law -- it actually could turn around and be useful precedent for copyright as well.  Here's hoping the court actually surprises and finds this argument compelling.
<br /><br />
The briefs other main argument may have less overall impact on things like copyright, but could be more compelling, and if accepted, could have a nice impact on patent law.  In this case, the argument is that such things do not actually qualify as a "process" as was traditionally understood under patent law, and this case represents an opportunity to re-establish the "traditional contours" of what constitutes a process for patentability purposes:
<blockquote><i>
The patents at issue are not &ldquo;processes&rdquo; as the term was understood when section 101 of the Patent Act of 1952 was adopted. The Patent Act&rsquo;s legislative history explains that the term &ldquo;process&rdquo; meant &ldquo;art,&rdquo; as it had been used in earlier patent statutes. Patentable arts were limited to processes which aimed to produce an effect on matter, and these patents do not.
<br /><br />
Moreover, the patents at issue here do not describe a process by either a historic or general definition of the term. A process is a series of actions, and the &ldquo;indication&rdquo; element of the claims does not describe an action.
<br /><br />
Enforcing the patents here will have a deleterious economic effect on the healthcare and medical research industries and will retard innovation. Empirical evidence shows that other abstract process patents, such as software and business-method patents, have resulted in aggregate financial losses for American firms and have discouraged rather than encouraged innovation. The effect of abstract process patents on software and financial firms will spread to the healthcare and medical research industries if patents such as Prometheus&rsquo;s are permitted.
</i></blockquote>
Again, I'm hopeful, but not expecting this to convince the court.  So far, with cases like Bilski, the court has been hesitant (and I'd argue even that's a generous word choice) to recognize the evidence of the patent system holding back innovation or harming US business.  So while the brief is really well written and argued, and I find it compelling, my guess is that the Court will continue to have a big blind spot on this.<br /><br /><a href="http://www.techdirt.com/articles/20110914/16214915960/do-patents-medical-diagnostics-violate-first-amendment.shtml">Permalink</a> | <a href="http://www.techdirt.com/articles/20110914/16214915960/do-patents-medical-diagnostics-violate-first-amendment.shtml#comments">Comments</a> | <a href="http://www.techdirt.com/articles/20110914/16214915960/do-patents-medical-diagnostics-violate-first-amendment.shtml?op=sharethis">Email This Story</a><br />
 ]]></description>
<slash:department>certainly-seems-possible</slash:department>
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<pubDate>Tue, 21 Jun 2011 19:10:22 PDT</pubDate>
<title>Supreme Court Will Review The Patentability Of Medical Diagnostic Tests</title>
<dc:creator>Mike Masnick</dc:creator>
<link>http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml</link>
<guid>http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml</guid>
<description><![CDATA[ For a few years now, we've been following the case of Prometheus Laboratories v. Mayo Collaborative Services, which looked into the question of whether or not <a href="http://www.techdirt.com/articles/20090723/0402355634.shtml">certain medical diagnostic <i>tests</i> could be patented</a>.  Doctors are vehemently against such patents, believing, completely correctly, that it's ridiculous to patent a <i>test</i> to determine if someone has a particular ailment.  The Mayo Clinic has pointed out the ridiculousness of all of this, and has been fighting this for the precedential value:
<blockquote><i>
"The patents are based on observations of the laws of nature," says David Herbert, chief administrative officer for Mayo Medical Laboratories. "We chose to make a stand." Such "observational" patents increase costs, slow innovation, and worsen patient care, he says. "It doesn't allow the test to be performed close to the bedside, and there's no ability to have second opinions." 
</i></blockquote>
Unfortunately, as we noted last December, the appeals court for the Federal Circuit (CAFC, whose motto sometimes feels like "patent everything!") decided that <a href="http://www.techdirt.com/articles/20101220/02310112338/appeals-court-says-again-that-diagnostic-tests-are-patentable.shtml">it's perfectly fine and dandy to patent such diagnostic tests</a>.  At the time, we noted that this issue would likely end up at the Supreme Court... though I partly wondered if the Supremes would wait for the slightly related Myriad Genetics case on patenting genes.
<br /><br />
Instead, the Supreme Court is forging ahead directly on the medical diagnostics issue, and <a href="http://www.patentlyo.com/patent/2011/06/supreme-court-to-revisit-patentable-subject-matter-eligibility.html" target="_blank">has agreed to hear the case</a>.  Of course, it's quite difficult to predict which way it will go.  For a period of about five or six years, it seemed like the Supreme Court (which had mostly ignored patent issues for a while) had taken a bunch of patent cases in order to smack down CAFC for its expansionist and overly broad rulings.  However, with a new court in place, the last few years have shown the pendulum swing back towards supporting CAFC's thinking on many of these issues.  Hopefully this case ends up going the other way, and the Supreme Court makes it clear that patenting a medical test is not what the law was intended for, and should not be allowed.<br /><br /><a href="http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml">Permalink</a> | <a href="http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml#comments">Comments</a> | <a href="http://www.techdirt.com/articles/20110621/02045514781/supreme-court-will-review-patentability-medical-diagnostic-tests.shtml?op=sharethis">Email This Story</a><br />
 ]]></description>
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