Do Patents On Medical Diagnostics Violate The First Amendment?
from the certainly-seems-possible dept
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 fine and dandy to patent a diagnostic test. The Supreme Court agreed to hear the appeal on this in the upcoming term, and folks at the Cato Institute have filed a very interesting amicus brief, 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):Prometheus’s patents will also impermissibly restrict public domain activity. These patents’ 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. 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—such as reading the results of medical tests—or inadvertently infringe a patent.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.
For similar reasons, 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. As the Court stated in Eldred v. Ashcroft, 537 U.S. 186 (2003), copyrights could require First Amendment scrutiny if “the traditional contours of copyright protection” were altered. 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. 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.
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:
The patents at issue are not “processes” as the term was understood when section 101 of the Patent Act of 1952 was adopted. The Patent Act’s legislative history explains that the term “process” meant “art,” 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.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.
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 “indication” element of the claims does not describe an action.
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’s are permitted.
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Filed Under: first amendment, patents, processes, traditional contours
Companies: mayo clinic, prometheus
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I'm Rich Bitch
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Re: I'm Rich Bitch
Mwah hah hah hah hah!
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Actually I don't think that's technically true. It's just that courts used to invalidate such patents on a moment's notice and then the CAFC came along and started putting up with this sht.
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Re: Re: I'm Rich Bitch
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"directed to or encompassing a human organism"
Section 33 -
Prohibits issuing a patent on a claim directed to or encompassing a human organism in any application pending or filed on or after the enactment of this Act.
I'm not a doctor, but I'm pretty sure medical diagnostic tests are directed to human organisms. Here's to hope!
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Again, and for emphasis, Prometheus is a case that turned on Section 101 of Title 35, i.e., is the invention eligible for further consideration under Title 35. The CAFC said "yes, it is", but this is but one step in the tortuous process of attempting to secure the grant of a patent.
It bears mentioning that the DOJ has filed a brief supporting the decision by the CAFC, but noting that other provisions of Title 35 may very well render the claims invalid. To date the CAFC has not been asked to pass upon those other provisions.
If this case "tickles your fancy", then Ultramerical, LLC et al. v. Hulu, LLC et al., issued today by the CAFC, will almost certainly have you in maniacal "stitches". It has all the buzz words: business method, patentable subject matter, internet, free content, ads, copyright, Bilski, etc.
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Tests
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Re: Tests
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Perfectly Simple Fix
There is a simple way to fix this sort of outrage. Change the law to eliminate the government-granted monopoly privilege. Monopolies in general are bad for the economy. It looks like they are bad for freedom and human health as well. That is all the more reason to get rid of them.
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Re: Perfectly Simple Fix
It always comes back to the same thing: If there isn't any money in it, would there be as much development of tests and testing equipment going on? Would removing patent protection and the ability to profit from research in these areas make it less likely that tests would be developed into commercial products? Would we instead never see those testing methods brought to the marketplace at all?
In the end, we want those tests, we want them to be available now, and we want them to be available 20 years from now off of patent. We have to start somewhere.
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Re: Re: Perfectly Simple Fix
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Re: Re: Perfectly Simple Fix
Having a complete monopoly on an idea and anything even remotely close to that idea for 20 years doesn't fit any definition of reasonable that I am aware of. Being able to sue your competition out of existence using that government granted monopoly is not reasonable. Suing doctors and researchers trying to save lives is not reasonable.
This is so far beyond reasonable that it makes me sick.
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If they make more money from the treatment rather than from the cure, guess which one you will be receiving.
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Re:
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Re: Re: Re: Perfectly Simple Fix
Think of it this way: you are a pharma company, you work to develop a way to detect certain things, and you find a certain combination of steps that can detect X or Y or whatever. There are a number of steps involved, and you can only do them in a fully equipped lab.
But there is a need to be able to test for X or Y, so you work to build a business case that would allow your company to invest millions into research and development to turn your finding in lab level testing down to a package size and functioning that makes it possible for the tests to be done at a local level, either immediately in the doctors office or with some reasonable processing at the hospital lab level.
Now, there is probably only a market for 50,000 of these tests a year. So before you spend millions, you need to be sure that there is a business case for doing so. A patent is one of those things that allows you to predict your future market. 50k tests in a year isn't maybe enough to justify the work, but 50k tests for 20 years might just do it.
Would it be more reasonable for them just not to develop the test because there is no way to pay for the work? You have to be reasonable on both sides of the discussion.
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The work is a scarcity and skilled work is even more scarce. While it may be possible for other labs to duplicate those scarcities, how is it better for healthcare and the public domain for that lab to be the ONLY lab that can perform that test.
That will mean that no one will try to make the test better for fear of infringement and the prices will likely be higher.
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Re: Re: Re: Re: Re: Perfectly Simple Fix
I can't imagine why you wouldn't be able to figure this out yourself. The test, once revealed, is likely going to be able to be copied, and sold at a lower price without the costs of development that the original creators have to bear.
Remember: You cannot have duplication until the original work is done. It's better for healthcare and the public (but not public domain) for the test to be available, rather than for it not to have been developed or having not been brought to market to begin with.
In the short run, you pay a higher price (one that returns income to the developer, who can use the money for their next investment in health care). In the long run, you have a proven test system which, after a period, will be able to be duplicated by anyone willing to try.
As I always say: If you get something 10 years sooner than it would have come out without patents, isn't it worth it to get it now? 10 years sooner is the right answer every time.
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Cost is one--and one which I would argue might not be very successful here. Sure some medical professionals might base it on cost, but once they realize the quality is lower, then well...
Actually, in the long run we pay a higher price. The monopoly price stays artificially high for an extended period and no one can attempt to improve the test or build on it without cost (thus long-term costs as well).
There is no evidence whatsoever that the test came out when it did, due to patents. If there were no patents, there would be companies researching and competing with one another to create tests for profit. Please tell me you aren't really pushing the, "without patents/copyright there would be no [x]" are you? You know that argument fails on its face and has been debunked countless times.
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Patents were always a, "oh, and we should patent this too, if we can" thing.
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Here's me being reasonable:
Prove it. Provide me evidence that patents and the litigation that results from them actually encourage the types of innovation we're referring to here, such as new medical tests and procedures that save lives.
Not anecdotes. Not bullshit. Not pharma funded "studies" with serious methodological problems. Evidence. If you can't do that then your only reasonable, rational course of action is to rethink your worldview. If you do provide that type of evidence, I'll revise my worldview (I'd have to, I'm a rationalist) that patents and the lawyers getting rich at society's expense off them are not a net drain on humanity and a squealing brake on progress.
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It's the system we have now, it's the system that appears to work, because human kind is advancing at a speed never seen before.
So show me that it doesn't work.
Oh, perhaps I can start you off here: Many people around here make all sorts of noise about places like Japan, China, and India as great examples of what happens without copyright or patents. Yet, once Japan caught up to the US in these areas, they almost immediately got serious about enforcing those laws.
The countries that have benefitted the most from poor or non-existant patent law are the one that were the furthest behind, and are playing catch up by skipping many of the steps, using the research and development done in countries with strong patent laws.
So remind me again: Why doesn't it work? Do you think the Chinese or India growth would happen without all the things created in the patent supporting countries?
The squealing break on progress is people who think that taking someone else's work and replicating it without research cost is somehow doing us all a favor. Short term, perhaps. Long term? They are just getting rich on other people's back and are a net drain on humanity.
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I also think that there are very big difference between R&D in computers (and client solutions) compared to medicine and testing. I could imagine that the lead time between the two is very different, as well as the long term implications of each.
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Here's my evidence.
Here's a book, plenty of sources, studies and analysis:
http://levine.sscnet.ucla.edu/general/intellectual/againstfinal.htm
Here's a research paper:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1868979
And another:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1856610
And more:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1502864
http://papers.ssrn.com/sol3/paper s.cfm?abstract_id=969447
We had a whole series at Techdirt a few years ago, with linked sources and studies, here's two parts of it that are relevant:
http://www.techdirt.com/articles/20080313/031128532.shtml
http://www.techdirt.com/articl es/20080318/004156568.shtml
General stories just in the last 6 weeks:
http://www.techdirt.com/articles/20110811/10245715476/what-if-tim-berners-lee-had-patented-w eb.shtml
http://www.techdirt.com/articles/20110805/16234115415/company-claims-patents-generating-ma p-database-getting-real-estate-industry-to-pay-up.shtml
http://www.washingtonpost.com/todays_paper/ Business/2011-08-21/G/1/26.1.946072474_epaper.html
http://www.economist.com/node/21526370?fsrc=scn/ tw/te/ar/patentmedicine
http://online.wsj.com/article/SB10001424053111903639404576518493092643006.h tml
http://www.reuters.com/article/2011/09/09/rambus-patents-idUSN1E7860P320110909
http://www.tech dirt.com/articles/20110906/19274615832/if-your-business-strategy-relies-suing-others-youre-not-busin ess-youre-leech-system.shtml
Follow the links. Read the evidence yourself. Again, I'm asking for your evidence, your sources, your studies. Put up, or shut up.
It's the system we have now, it's the system that appears to work,
Doesn't appear to work to me.
because human kind is advancing at a speed never seen before.
The speed of technological advance started increasing before patents came around. There were no patents during the Renaissance. Today we have exponential growth, sure, but the evidence looks to me that is in spite of patents, not because of them. The fastest growth areas are where patents are ignored - at least until the lawyers catch up and then sue the early innovators.
Oh, perhaps I can start you off here: Many people around here make all sorts of noise about places like Japan, China, and India as great examples of what happens without copyright or patents. Yet, once Japan caught up to the US in these areas, they almost immediately got serious about enforcing those laws.
So your argument is that they don't need patents until there's legacy industries that decide they can stomp out competition with them? Not helping your cause here...
taking someone else's work and replicating it without research cost
Let me spell it out to you.
THIS IS A WONDERFUL THING.
I can think of no greater compliment to an inventor or discoverer than to spread the knowledge they worked so hard at so that everyone can benefit from it. The fact that knowledge and ideas can be spread infinitely without cost is wondrous (if I was religious, I'd say it is a miracle, and as an atheist the feeling I get in experiencing knowledge and understanding is "spiritual"). That you think that knowledge should be hoarded and controlled is to me, selfish, and unethical.
All progress, every last bit of it, is built on what came before. Without mastering fire, we couldn't make bronze tools. Do you want to force everyone to start from square one, naked in the woods, fending for themselves? I'm sure you don't, so I imagine you support education. But something weird happens when we get very close to "now" in teaching children or others how to do things. Patents suddenly mean that anything discovered or invented less than 20 years ago is "off limits" to anyone without a toll being paid. That is a horrible thing, and evidence shows it is not necessary.
So where is your evidence?
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Patenting stuff in the public domain
Oh! It's already happening. Just one more manifestation of the greed that seems to be sweeping the world. "I want it all, and you can't have any of it," seems to be the prevailing attitude.
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Your second assumption is erroneous as well, in my experience. In fact, at IBM and another company we often collaborated with pharma to share research management techniques.
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Sick of Patents
Sadly, there is no hope for change. It seems almost all western governments are now controlled entirely by money. For a politician to do anything for the good of the people they represent, or society at large, is unheard of. Further, if a politician did do such, they'd be ousted because the media spins things in such a way as to convince people to vote against their own self interests. It is truly appalling.
I don't know what has to happen. But I don't see any possibility to incrementally fix anything. I gave up that dream when I saw Obama's failure to get much done. The few things he did get done are still attacked to this day, and threatened for repeal - and those actions were very reasonable (e.g. Obamacare, which was a great compromise, making it a less than stellar bill, but a step in the right direction... still, it is vilified).
I give up.
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Patents don't lock you into 20 years ago. They lock a narrow, fine, and tight area up for 20 years to come. But they do not knock anyone back 20 years.
Further, given (a) that patents are public, and (b) we can all see the end results, and (c) most people skilled in the art can rip the patent together to understand after the fact how it happened, they are not locked up but instead informed.
Understanding how something is done in general leads to other advancements. Example, knowing that a certain type of cancer cell reacts with a certain chemical compound to produce a test might give other researchers a push towards a treatment or other as a result of how that interaction happens.
In more general terms, consider the idea of cellular phones. We don't have a single standard and a single phone, rather we have multiple carriers, multiple transmission types, multiple formats, and many different ways of "skinning the cat". Each of those has come to market even as each has been patent in various parts. Companies didn't look at the first cell system and say "oh well, Motorola gets that for 20 years", they looked at the patents, they looked at the methods, and they looked at the results, and went back to their labs to find a different and better way to accomplish the same thing.
They were not locked up for 20 years.
Further, let's say you want to work in the very narrow area that already has a patent holder. Well, while you cannot bring a product to market in that window, you can research, develop, and such. Since most medical breakthroughs take years, not minutes, it is unlikely that there is much in the way of overlap anyway. Plus if you come up with something really good, almost every patent holder is willing to license their technology, because it brings them more money, especially if you are not competitive to them in the market place for their products.
See, that is another miracle of the patent world: companies can both use their patents themselves AND license the technology to others. There is nothing stopping them. Some choose not to, but many do choose to license as a way to drive more revenues and to finance future developments.
If you think that everything is locked up for 20 years and have a nice day, you obviously haven't spent much time in the real world.
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Quite frankly, over the course of several decades working with this body of law I have yet to see any patent that prevents anyone from working within the area to which the patent pertains in order to come up with their own solutions.
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Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Perfectly Simple Fix
Narrow, fine, tight area? Oh, like the patent thicket surrounding smartphones? Medical research thickets? Nanotech? Green tech? Bullshit. And you have to know this. You're being willfully ignorant.
they are not locked up but instead informed.
Myth. If you'd bother even glancing at the links I'd posted, that would've been made clear. I'm sure it's a waste, but I'll link again.
http://www.techdirt.com/articles/20070321/021508.shtml
http://papers.ssrn.com/sol3/papers.c fm?abstract_id=969447
http://www.techdirt.com/articles/20061205/110247.shtml
Besides, we all know that having knowledge of a patent only triples the damages that lawyers ask for.
Example, knowing that a certain type of cancer cell reacts with a certain chemical compound to produce a test might give other researchers a push towards a treatment or other as a result of how that interaction happens.
But if a researcher wants to do so, they have to pay up, or get sued.
Further, let's say you want to work in the very narrow area that already has a patent holder. Well, while you cannot bring a product to market in that window, you can research, develop, and such.
Really? So no medical researchers have ever been sued unless they brought a product to market?
http://www.nature.com/news/2011/110405/full/472020a.html
How about medical researchers who can't even perform their research because someone else has a patent?
http://www.medindia.net/news/US-Stem-Cell-Research-is-Being-Hindered-by-Rush-for-Patents- 79959-1.htm
http://www.techdirt.com/articles/20110127/17434012864/cures-paralysis-diabetes-blindnes s-hindered-patents.shtml
See, that is another miracle of the patent world: companies can both use their patents themselves AND license the technology to others.
Licensing is a protection racket, its extortion, its blackmail. "Give us money or we'll send our thugs^H^H^H^H^H lawyers, after you. We have this piece of paper granted us by the government that says we own an idea and you can't use it." Selfish. Unethical.
Again, I ask. Where is your evidence? Prove it. Put up, or shut up.
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But because most patents are purposefully very vague, the supposed "limited" right is now miles wide.
Quite frankly, over the course of several decades working with this body of law I have yet to see any patent that prevents anyone from working within the area to which the patent pertains in order to come up with their own solutions.
From my comment above:
http://www.medindia.net/news/US-Stem-Cell-Research-is-Being-Hindered-by-Rush-for-Patents-799 59-1.htm
So now you have.
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Ok, enough of the generic argument
Am I making an accurate reading here? Because if that is really the case, I am a bit stunned.
Essentially they seem to be saying 'apply a test dose, take a reading. If the reading is low, apply more, but if it is high, apply less.'
I don't see how you can patent an observation and a natural leap of intuition that many could make on their own, without even being aware of a patent. To me that is like saying, fire makes things hot, hot things can make more fire. But if I use a hot thing to make fire, I need to pay someone because they DOCUMENTED a natural reaction?
Someone, please make this make sense to me.
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Re: "directed to or encompassing a human organism"
A 'claim' in a patent application is a descriptive reference to something you want a patent on, often aided by illustrations and diagrams.
You're essentially morphing 'a claim directed to or encompassing a human organism' into 'a claim directed to a process directed to or encompassing a human organism'.
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