Huge Ruling: Court Rejects Medical Diagnostic Patent

from the a-step-forward dept

Wed, Mar 21st 2012 6:40am — Mike Masnick

We've been covering the Prometheus Laboratories v. Mayo Labs case for a few years now, as it was a key case involving whether or not you could patent basic medial diagnostics -- 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 are patentable, and we were particularly concerned that the oral hearings in the Supreme Court on this case seemed very narrowly focused. 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.

Instead, it looks like we got a reasonably good (not great, but definitely pretty good) ruling from the Court effectively rejecting the concept of patenting basic medical diagnostics 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.

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.

Breyer's opinion is pretty clear and easy to read and makes some important points:

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 “apply the law.” 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.

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."

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:

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’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....

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.

All in all this is a good ruling. It's a little limited in suggesting that you could 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 notes, it's likely that this ruling will mean that the appeals court will now also be told to go back and re-evaluate its awful decision saying genes are patentable in the Myriad Genetics case. Hopefully, this ruling is a clear statement that not only are diagnostics not patentable, but genes aren't patentable either. If that's true it will be a huge boost to research in the biotech field, which won't be held back by expensive restrictions and tollbooths.

Of course, that's not the story you hear from the patent maximalists, who are arguing that this is horrible for the biotech community because it will mean fewer patents. But that ignores all of the good 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.

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Filed Under: biotech, diagnostics, gene patents, laws of nature, medical, patents
Companies: mayo clinic, myriad genetics, prometheus

42 Comments

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ltlw0lf (profile), 21 Mar 2012 @ 6:58am

Patent Maximalists
PM1: "I got here two weeks ago. You owe me $25."
PM2: "I got here two months ago. You owe me $100."
PM3: "I got here two years ago. You owe me $10,000."
GOD: "I got here before any of you, knock it off!"

And they accuse us of being entitled! I am glad the government (through the Supreme Court) brought some rationalization to this. I wish copyrights would become more normalized with patents in length and in not bat-shit crazy "I can copyright a single paragraph and sue the world for the rest of my life and my great grand-children's lives."
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Ninja (profile), 21 Mar 2012 @ 6:59am

I suddenly got the urge to patent "a biological system the provides wide are for molecular exchange between atmospheric air and a liquid multi-component solution containing sufficient quantities of hemoglobine".

I hereby propose a contest, TD sponsored, of absurd patents that the US Patent system would grant. Let the lulz mayhem begin ;))
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fogbugzd (profile), 21 Mar 2012 @ 7:06am

An interesting twist in this case may have been an attempt to get Breyer disqualified from hearing the case. Breyer's wife held Nestle stock, and just before oral arguments were heard Nestle bought the company that is involved in the lawsuit. This would have meant that Breyer, a usually sane person on copyright issues, would have had to disqualify himself. Instead his wife sold the Nestle stock on the morning of oral arguments.
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fogbugzd (profile), 21 Mar 2012 @ 7:08am

Re:
I should note that there may have been other reasons Nestle bought the company, but it certainly looked suspicious. Whatever the circumstances, Breyer and his family deserve some kudos for doing the right thing.
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Torg (profile), 21 Mar 2012 @ 7:15am

Re:
Normally I'm against simple patents like that, but I think I'd support that one being upheld. It'd give the medical community a wonderful incentive to reinvent the lung.
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John Doe, 21 Mar 2012 @ 7:22am

I have a patent, copyright and trademark on DNA
I hold the patent, copyright and trademark on DNA. Now I demand you pay me a $1,000,000 license or stop using DNA. If you do neither of the above, I will have the DHS, ICE, MPAA, RIAA and the DOJ kick down your door and confiscate your DNA!
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Anonymous Coward, 21 Mar 2012 @ 7:32am

"...to share results..."

It is not at all clear that this possible benefial effect of the decision will be realized. It is quite possible that commercially significant research will be held even more closely to the chest. True, independent discovery and commercial exploitation would be free of any patent law constraints, but this only arises when a third party engages in the rearch necessary to replicate what is then being held elsewhere as a trade secret.
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Anonymous Coward, 21 Mar 2012 @ 7:37am

But without patents .... [insert lie here]
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Anonymous Coward, 21 Mar 2012 @ 7:44am

Re:
I hereby patent a medical diagnostic system that involves directing a light reception apparatus at a patient to detect if there are any unusual anomalies.

I also patent a method of using a sound generation apparatus to generate and deliver a combination of sounds to a patient in order to get a combination of sounds back, and then using a sound reception apparatus to detect those sounds in an effort to determine any symptoms that the patient experiences.
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Anonymous Coward, 21 Mar 2012 @ 7:48am

It may be a sound ruling in and of itself, but it may create more problems long term than it fixes. Essentially, any research that uses "natural properties" may in fact have no real pay off in the end.

I wouldn't be shocked to see companies moving away from research into testing systems of this type, as they have little chance to make their investments back.
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Andrew D. Todd, 21 Mar 2012 @ 7:52am

A Special Case of Titration, Which is Itself a Special Case of Control Theory
Prometheus Laboratories v. Mayo Labs could equally well have been handled as "immediate obviousness." The process described in the Prometheus patent, that of administering a dose, measuring metabolites, and adjusting the dose, has long been known as titration, by analogy with the corresponding process in chemistry. I do not know exactly how old the technique is-- I would guess a hundred years or more-- but I do have a reference in a Merck Manual, dating from 1982 (14th edition, Ch. 271, "Plasma Concentration Monitoring," p. 2261-2271). The description is not quite as explicit as one might wish-- unlike patent examiners, internists are not morons, and people writing for that audience do not indulge in baby-talk. The article provides a short list of drugs for which the method of titration was in common use in 1982, together with desired blood concentration targets. I also have a 1983 Physician's Desk Reference, in which the term "titration" is used, without any special explanation. (I should explain that I am an engineer, not a physician, and I picked up a set of old medical books in a thrift store for about five dollars a volume about twenty years ago, along with certain other reference works which I could not justify paying anything like full price for, notably Brown on Copyrights. These medical books happen to be useful at the moment, because they can be used to prove antiquity, which the internet cannot)

http://en.wikipedia.org/wiki/Titration_(disambiguation)
http://en.wikipedia.org/wiki/Tit ration
http://medical-dictionary.thefreedictionary.com/titration

I suppose titration can be described as an abstract process, and it is certainly immediately obvious to use it for any drug whose blood concentration can be measured. Furthermore, Titration is a special case of feedback. There is a whole branch of applied mathematics, Control Theory, which deals with the efficacy of systems of feedback control, whether they tend to exhibit positive (destabilizing) or negative (stabilizing) feedback. Again, this is not a very new field-- I took an undergraduate course in the subject back in 1982. I dug out my old textbook [what a wonderful thing it is to be a pack rat] and the copyright date of that is 1970.

At any rate, titration of an additional drug falls under the "obvious to try" fork of KSR v. Teleflex. There is an a-priori fifty-percent chance that when something is injected into a lab rat, it will behave in a manner compatible with titration.

Many patent examiners actually are stupid. A significant number of patent lawyers merely play at being stupid when it suits their convenience.
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:Lobo Santo (profile), 21 Mar 2012 @ 7:53am

Recursion
I hereby patent a series of steps vis'a'vis program/algorithm which results in getting a patent.

I will not be licensing this to anybody, and suing anybody who violates my patent by attempting to patent something.

Now that that's done, let's close up the patent office and get some actual work done.
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Ninja (profile), 21 Mar 2012 @ 7:54am

Re: Re:
Well, my patent was a grammar fail but I don't think they review anything in the patents department of the US Govt...
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BentFranklin (profile), 21 Mar 2012 @ 7:55am

Hooray! As a result of this ruling the Union of Concerned IP Scientists has set the clock back 5 minutes on the countdown to IP apocalypse.
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Anonymous Coward, 21 Mar 2012 @ 8:03am

Re: Recursion
If I had the money, this is exactly what I would do. Would it work? Well, it would probably get pushed through but the courts would slap it down. However, it would show how retarded the patent process is.

Also, patent suing people who infringe on patents.
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Anonymous Coward, 21 Mar 2012 @ 8:06am

Re:
Monopolies need justification, their lack doesn't.

"It is quite possible" provides no empirical evidence nor justification

"commercially significant research will be held even more closely to the chest."

The claim that this will occur is purely a faith based statement. I want an evidence based patent system, not a faith based one. Government established monopolies are known to cause economic harm and there is plenty of evidence that patents harm innovation. All I see in favor of the argument that they help innovation is faith based statements. These aren't good enough, if the government is to sacrifice my rights we should not allow it to do so based purely on faith based claims. I want evidence.

That your justification is based solely on unfalsifiable speculation, with no evidence whatsoever, suggests you have no justification. That which is unfalsifiable is probably false.

and if a company thought it can maintain a monopoly through trade secrets then it has little reason to get a patent. In fact, where are the patents that tell me how to build my TI calculator or my computer or my cell phone? All of that information is trade secret you say? But these companies have plenty of patents.

and R&D has happened and will continue to happen without patents. Countries that have traditionally been very patent aversive and that are patent aversive relative to the U.S. have been very innovative and, in fact, the U.S. used to be more innovative than it is now because the founding fathers were very skeptical of patents, Thomas Jefferson was initially against IP, and they sought to strictly limit their impact.
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Anonymous Coward, 21 Mar 2012 @ 8:09am

Re:
They could have set it back 10 minutes by actually working on stuff instead of wringing their hands. But hey, someone has to scream "the sky is falling" just to make this more fun, and Mike can't be on duty 24 hours per day.
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TtfnJohn (profile), 21 Mar 2012 @ 8:10am

Re:
What you say may, indeed, turn out to be the case. But I'm not sure that, where diagnostic tools are concerned, there would be much of a lag between the initial discovery by Firm A and independent discovery by Firm B. If Firm A charges more than the market wants to support then that provides the incentive for Firm B to do whatever research may be necessary. Or for Firm B to simply build on what Firm A is holding as a trade secret.

Then again what occurs in nature has long been held to be not patentable and all that the US Supreme Court has done is reaffirm that. Essentially nothing has changed except that the court has corrected a ruling by a lower court. If some biotech companies are dependent on patents on natural processes and known diagnostic routines then it's time they broke their addiction to patents or, for that matter, trade secrets.

If they service what they know at reasonable cost then the incentive for Firm B to reinvent their wheel will be far less than if they are perceived as charging too much.
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gorehound (profile), 21 Mar 2012 @ 8:22am

Re: I have a patent, copyright and trademark on DNA
+1
And you wonder why Medical Stuff is sky high in pricing.
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ken (profile), 21 Mar 2012 @ 8:34am

Re: Patent Maximalists
This reminds me of this joke:

A scientist said to God "we don't need you anymore, we can create life ourselves".

God said "OK create life out of sand.

The scientist stooped down to pick up sand and God stopped him and said "No, that is my sand. Create your own".
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Watchit (profile), 21 Mar 2012 @ 8:53am

Re:
I hereby patent a system of drafting patents from natural laws into patentable ideas.
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jilocasin (profile), 21 Mar 2012 @ 8:56am

Re:
That of course supposed that companies are actually _doing_ any research in this area.

Most of the time, actual research is done by Universities. Commercial companies then either write patent application off of someone else's research, or 'licenses' the right to commercially exploit it from a gullible researcher.

The end result is that researchers and other scientists are encouraged to hoard their data/results/etc. This leads to _less_ research being done greatly _slowing_ the pace of scientific progress. Just to add insult to injury, by erecting toll booths to basic medical knowledge, fewer people can afford to be helped.

Plenty of research has been and will be done without a mythical patent paycheck dangling at the end.

It's the perennial lie that gatekeepers (and patent/copyright attorney's) keep reiterating.

Claim:
Without patents - research won't get done. Innovation will slow or stop completely.

Fact:
With patents - research is encumbered. It's more difficult and goes against the scientific method. Innovation is slowed by unneeded lawsuits, complicated license deals, rent seeking by non-practitioners.

Claim:
Without copyrights - nothing creative will be produced. If people can't be guaranteed a return on every use of a copyrighted work for nearly a century no one will bother to create anything.

Fact:
With copyrights - less original material can _legally_ be produced. Creativity existed long before copyrights were introduced. Creativity is greater in those areas with lax or non-existent copyright laws. Creativity doesn't happen in a vacuum. It is the interplay of the creative mind, the popular culture and everything that's come before. Most current creative works are illegal in jurisdictions with the strongest copyright laws. Creativity occurs in spite of copyrights not because of it.
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Watchit (profile), 21 Mar 2012 @ 9:00am

Trolls
Ever notice how trolls never bother to comment on posts were they can't boil down their side of the argument to "but... but... Piracy is illegal and you are all entitled freeloading pirates!"
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varagix, 21 Mar 2012 @ 9:30am

Re: Trolls
I think its funny that most internet trolls tend to align themselves with the patent trolls, copyright trolls, and trademark trolls.

Must be a part of their culture or something.
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Mr. Oizo, 21 Mar 2012 @ 9:36am

Re: Re:
Interesting ! Allthough it can be looked upon from different viewpoints.

A- she sold her stock because of the lawsuit
a1- because she knew the stock would go down
a2- because she knew it could cause problems to her husband
B- she sold her stock because she didn't like the new managament, irrespective of the lawsuit.
C- non of the above
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Anonymous Coward, 21 Mar 2012 @ 10:25am

so Prometheus is an ironic name?
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Mike Masnick (profile), 21 Mar 2012 @ 1:11pm

Re:
It is not at all clear that this possible benefial effect of the decision will be realized. It is quite possible that commercially significant research will be held even more closely to the chest.

You say this as if rules of nature of possible to hide via trade secret.

Most of us know that's crazy.
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Anonymous Coward, 21 Mar 2012 @ 1:15pm

Re: Re:
Mike, you understand that many of these test do rely on what you call the rules of nature, but only when done in certain order, certain combinations, or in certain ways. It explains why we have known the properties of most of the items involved for a very long time, but the tests are new - because nobody considered the combinations or actions required to make it happen.

I just feel bad for people who would benefit from certain testing, but may not be able to get it in the future because nobody wants to develop something for charitable uses.
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Anonymous Coward, 21 Mar 2012 @ 1:16pm

Re: Re:
Excellent rant, maybe 6/10

Sadly, your "facts" are assertions, not solid facts. Care to try again?
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Anonymous Coward, 21 Mar 2012 @ 1:17pm

Re: Trolls
I find it equally amusing that those who seek to tear down all the systems that we work with generally don't add much to the discussion except insults.

In that regard, you are truly a champion!
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Watchit (profile), 21 Mar 2012 @ 2:08pm

Re: Re: Re:
necessity is the mother of invention, as long as it is needed their will be those who provided resources to make it happen, at least in most cases.
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Watchit (profile), 21 Mar 2012 @ 2:15pm

Re: Re: Re: Re:
Either way their will be

1. less research done because of hindrance from patents

or

2. less research done because of a smaller chance to recoup

That is why a happy medium must be found in order to maximize innovation.
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Watchit (profile), 21 Mar 2012 @ 2:19pm

Re: Re: Trolls
I don't want to tear down the patent system, I want a patent system that works, and works efficiently. One that genuinely rewards those who innovate rather than those who seek to build fortresses and cannons out of said patents.
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Watchit (profile), 21 Mar 2012 @ 2:27pm

Re: A Special Case of Titration, Which is Itself a Special Case of Control Theory
Interesting :D
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Anonymous Coward, 21 Mar 2012 @ 3:11pm

Re: Re:
I disagree. The correlations identified by Prometheus' licensor (a hospital in Canada) were found only after extensive clinical research. It apparently took Mayo several years before it came up with its own set of correlations.

These are not things that one can quickly determine by reference to a medical text. They are difficult and time consuming to discover, which quite easily can cut in the direction of using trade secrets in lieu of patents.
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Mike Masnick (profile), 21 Mar 2012 @ 3:47pm

Re: Re: Re:
I disagree. The correlations identified by Prometheus' licensor (a hospital in Canada) were found only after extensive clinical research. It apparently took Mayo several years before it came up with its own set of correlations.

You are either being willfully obtuse, or don't understand some rather basic points. The correlations did take time to create, but you can't hide them via trade secret.

These are not things that one can quickly determine by reference to a medical text. They are difficult and time consuming to discover, which quite easily can cut in the direction of using trade secrets in lieu of patents.

You can't hide those things via trade secret.

That's the point. Which you still missed.

You're good at that.
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Anonymous Coward, 21 Mar 2012 @ 4:01pm

Re: Re: Re: Re:
There are many things already in the "public eye" that are well preserved via the utilization of trade secrets.

I am not saying that communications will shut down, but only that I would not at all be surprised if some move in a direction placing greater emphasis on trade secrets.
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Anonymous Coward, 21 Mar 2012 @ 5:51pm

Re: Re: Re: Re:
Maybe this will help in better understanding what I am trying to say. Section 3426.1(d) of the California Civil Code defines a trade secret as follows:

(d) "Trade secret" means information, including a formula,
pattern, compilation, program, device, method, technique, or process, that:

(1) Derives independent economic value, actual or potential, from not being generally known to the public or to other persons who can obtain economic value from its disclosure or use; and

(2) Is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

If correlations meet the criteria specified above, then certainly their maintenance as a trade secret is one possible avenue to consider if a patent would prove to be problematic for the reasons outlined in the Prometheus case.
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Anonymous Coward, 21 Mar 2012 @ 10:03pm

Re: Re: Re: Re: Re:
They can keep their 'secret' to themselves for all I care, but they have no right to tell me that I can't do x without good justification. That they will no longer tell me what it is I can't do (which is what a patent is), I don't care, because there is no benefit to me from that.

Patents are useless. Necessity will drive people and businesses to naturally advance diagnostic and other tools to

A: Compete

B: Solve Necessary Problems

If a business doesn't advance its technology then other businesses will and that business will be put out of business. It will naturally innovate, it has to.

The argument that innovation will be stifled without patents is unfounded in evidence.

and companies are already protected by trade secret monopolies, so why do they need patents for anything important? Anything important they already have as trade secret and can sue for that.

If you mean entities will sue others who develop similar solutions for trade secret infringement, then the effect of these trade secrets is the same as a patent, that is, a government established monopoly. But the point here is that we are arguing against government established monopolies, not simply the renaming of them from 'patent' to 'trade secret'.

If a company wants to keep a secret, let it, I don't care. But if others independently come up with similar ideas (and they will certainly, they must, to compete), it's none of the governments business to stop it unless there is a very good socially beneficial reason to.
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Anonymous Coward, 21 Mar 2012 @ 10:04pm

Re: Re: Re: Re: Re: Re:
and by 'good' I mean evidence based, not the faith based nonsense I get from IP extremists.
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Anonymous Coward, 22 Mar 2012 @ 5:14am

Re: Re:
What, you mean like this guy?
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staff, 3 Apr 2012 @ 5:50am

another biased article
The Constitution says �To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries�. Therefore, if an invention is useful and promotes science, it should be patentable. It�s that simple.

Masnick and his monkeys have an unreported conflict of interest-
https://www.insightcommunity.com/cases.php?n=10&pg=1

They sell blog filler and "insights" to major corporations including MS, HP, IBM etc. who just happen to be some of the world�s most frequent patent suit defendants. Obviously, he has failed to report his conflicts as any reputable reporter would. But then Masnick and his monkeys are not reporters. They are patent system saboteurs receiving funding from huge corporate infringers. They cannot be trusted and have no credibility. All they know about patents is they don�t have any.
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