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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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March 21, 2012

The Supreme Court Makes Me Smile

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Posted by Derek

I wrote here about the Mayo v. Prometheus case, which dealt with patents on the use of thiopurines for autoimmune therapy. But the patents didn't claim any thiopurine drugs themselves. Or their specific use for autoimmune therapy. Or vehicles to administer them in, or methods for their manufacture, or techniques to package them. Nothing as reasonable as any of that.

No, these patents broke new ground. The problem is, the thiopurines are metabolized rather quickly, and to different degrees in different patients. That can make it tricky to know if someone's getting the right dosage - too much is bad, too little is bad. The Prometheus patents comprise these steps:

1. Telling a doctor to administer the drug to a patient.
2. Telling the doctor to measure the metabolite levels in their blood after dosing.
3. Describing the upper and lower acceptable bounds for these metabolites, and telling the doctor that these indicate a need to raise or lower the dosage.

There! That wasn't so good now, was it? I railed against this ridiculous idea at the time, which is tantamount to trying to patent the entire practice of medicine, step by step. (I know! I'll patent the idea of having a hypothesis, testing it by experiments where I manipulate individual variables, and then revising my hypothesis for the next round based on the results! Step three: profit!)

Fortunately for everyone's sanity, the Supreme Court has put the brakes on this stuff. Here comes the voice of reason:

Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. . .

. . .This Court has repeatedly emphasized a concern that patent law not inhibit future discovery by improperly tying up the use of laws of nature and the like. See, e.g., Benson, 409 U. S., at 67, 68. Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are “the basic tools of scientific and technological work,” id., at 67, there is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to “apply the natural law,” or otherwise forecloses more future invention than the underlying discovery could reasonably justify. . .

Yes, yes, yes. This is Justice Breyer's opinion for the unanimous court (he asked the most questions during the oral arguments), and it's absolutely correct and a great pleasure to read. Let's hope we see no more of this nonsense. (Which means, I guess, that we'll just move on to fresh nonsense instead, but patent law is ever fruitful).

Comments (41) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. David Borhani on March 21, 2012 8:02 AM writes...

It's good to see that the Supreme Court can still rule with reason. Perhaps it is not too hopeful to believe that this decision will be the first of many to correct some of the least productive aspects of current patent law.

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2. Alex Besogonov on March 21, 2012 8:15 AM writes...

Well, now you have a taste for what patents are for software.

Because almost ALL software patents are like this (to a practioner skilled in the relevant art).

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3. johnnyboy on March 21, 2012 9:08 AM writes...

Wow, an anonymous decision at the court ? Clarence Thomas must have been having a nap.

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4. NoDrugsNoJobs on March 21, 2012 9:36 AM writes...

Not sure how administering a synthetic drug to a patient and monitoring the metabolites within a certain range and adjusting the dosage based on that drug range finding is an act of nature any more than administering the drug itself like a method of treatment patent but maybe somebody can enlighten me......

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5. PPedroso on March 21, 2012 9:41 AM writes...

@4
I do not know if it is an act of nature but it is pretty obvious and is a rule of pharmacology, the so called therapeutic window. If the drug is outside the therapeutic window is either toxic or ineffective and everyone knows this so I cannot see how one can patent this knowlegde and use for profit!

Its, as you put it, trying to patent the act of administering drugs and expecting an effect.

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6. Anonymous on March 21, 2012 9:45 AM writes...

+1000 to #2 Alex Besogonov...

And what makes it really bad is a lot of times there's only one decent/efficient way to do it.

The problem is that it's *so* obvious no one writes it down, so there's no prior art to cite, or the technique is hidden inside proprietary software, so you can't cite that either.

I hate patents for anything you can't physically touch. I understand IP, but business methods and other silly crap shouldn't be patentable.

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7. NoDrugsNoJobs on March 21, 2012 9:57 AM writes...

#5 - Is it any more obvious to identify an unknown toxic metabolite and determine its limits of safety than it is to screen a library of compounds and find activity? I don't know many physicians who routinely screen for the toxic metabolite of thiopurine or ever did, was it known as the toxic metabolite before the patent?

I don't believe the court found obviousness here but rather that once a drug was given, nature took over and provided the results bringing me back to my original question - doesn't that apply for the administration of any new drug? Do we think patents for new methods of treatment for old drugs (such as thalidomide) are not valid either? As easy as this decision was for the Supreme court and all of their very intelligent followers on this medchem board, this decision was quite hard for the court of Appeals of the Federal circuit which is staffed by patent experts as judges as well as most of those experienced in the area of personalized medicine and diagnostics. The opinions of what comprises a law of nature are clearly subjective as applied in this case (as are much laws) and they reflect policy choices. if we say we want to encourage personalized medicine, than how do we encourage it? If, for example, discovering a person has a gene that makes treatment with one cancer drug particularly effective, is it a law of nature to assay patients for that gene before treatment? If not, what will this due for companion diagnostics?

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8. PPedroso on March 21, 2012 10:11 AM writes...

I am sorry #7 but we are not in the same page. From what I understood the patent refers to the decision of measuring metabolite levels and then adjust drug dosage. This is pretty obvious and common practice for several therapies that have a narrow therapeutic window (like anticoagulants). If Prometheus had patented the diagnostic method (which they must have done) i would not agree more. But they tried to patent the concept that is obvious and is in the state of the art.
I insist, it's like someone discovering in the past that if you give an oral defined molecule to a patient with hypertension that molecule will lower the tension and patent it closing the field for other companies that develop different molecules for the same indication.
Here the pathology is defined (autoimmune disease), the molecule is defined (thioguanine) and the variable that should be patented is how you measure it in the blood, not the decision to measure it.

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9. Hap on March 21, 2012 10:20 AM writes...

Aren't 1, 2, and the third part of 3 all obvious (not only to a skilled practitioner but to anyone with a functional brain)? At which point, the patent comes down to the boundaries of safety - which isn't an invention because it existed irrelevant of Prometheus's work (they didn't enable it or its discovery - had they described a nonobvious method to determine safety bounds, the method would have been patentable, perhaps). I don't know patent or trade secret law enough to know if you could trade secret the safety bounds, but I would guess not. So, either Dr. Lowe's description is inaccurate or there's no invention. I'm not sure where they grey area is.

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10. Rick Wobbe on March 21, 2012 10:28 AM writes...

OK, some dummy has to ask this and I might as well be that dummy: How is this "discovery" substantially different from the sequence of a gene, say BRCA1? (I'm talking about just the sequence, NOT an assay dependent on the sequence) Yet it seems virtually certain - with all due respect to the efforts of the ACLU, Association for Molecular Pathology, et al - that the Supremes will reverse lower court decisions and enforce the patentability of genes.

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11. NoDrugsNoJobs on March 21, 2012 10:31 AM writes...

When I read this board about medchem matters, I usually get a good education - when I read it about other subjects like this, I usually get a good laugh. The world becomes so simple once it is outside our own expertise. Terms of art like "obviousness" are casually batted around as if the concept itself was setlled once and for all and for all disciplines. I really wish it were all so easy - its kind of like how a medchemist feels when he reads Bill Gate's solution to how to discover drugs more efficiently - it sounds so easy!

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12. Hap on March 21, 2012 10:33 AM writes...

I don't think BRCA1's sequence was the patentable invention, but its isolation and production in purified form was (similar to the use of natural products as drugs - they existed before but their methods of prepn. are patentable).

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13. John W. on March 21, 2012 11:43 AM writes...

Regardless of the merits of the case, for those of you in the pharmaceutical industry the main issue to understand that there is now less subject matter to patent, there will be less research to develop and commercialize testing methods,and there will be fewer jobs in an industry that is contracting at a substantial rate.

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14. Anonymous on March 21, 2012 11:44 AM writes...

@12:

But the BRCA1 patent doesn't cover some artificial use of the gene. That's perfectly patentable, for example with biologics where some company has patented the manufacture and use of a substance derived from the sequence. Myriad's BRCA1 patent covers reading the gene sequence, by any method, and using that information to determine patient treatment. Any method of isolating and sequencing that particular bit of DNA for clinical purposes is infringing Myriad's patent. If I invented a completely new DNA isolation technique, and a completely new sequencing technology, and used it to examine a patient's BRCA1 gene, I would have to pay royalties to Myriad.

So, like commenter #10 above, as far as I can see the BRCA1 patent is just like this overturned "consider thiopurine levels" patent.

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15. Hap on March 21, 2012 11:59 AM writes...

13: Of course, the chemical matter that Prometheus was trying to patent couldn't be used by other companies - ones that might actually 1) employ chemists and 2) do something useful. Just because you can make money doing it doesn't make a gain for the economy or for anyone else - "broken windows", anyone?

11: I'm sure that patent law is much more complicated that it seems sometimes - if it's a field of law, people have been arguing about it for 200 years and so there might be something there to argue. What you haven't explained, though, is why Prometheus's "method" was an invention - which Dr. Lowe's summary makes starkly clear that it wasn't. No invention, no patent - society could have gotten it without you. So either the summary is wrong or Prometheus was wrong. There's not much of a middle ground.

14: I didn't think I liked that decision, and that was why - I thought you couldn't patent knowledge, only implementation (and a particular implementation - your invention, the thing that you made and contributed which didn't exist before you) and that sure sounds like patenting knowledge (though see above for large caveat). Sorry.

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16. johnnyboy on March 21, 2012 12:12 PM writes...

@11: If you read the legal opinion, you'll see that "Laws of nature" in the paragraph cited by Derek is really shorthand for a set of ideas, defined further down in the document as "Laws of nature, natural processes, and abstract ideas are not patentable". In their lawsuit, Prometheus held that measuring a drug metabolite as a way of adjusting the drug dosage was their idea. They did not 'identify' that particular metabolite, their original patent was for a specific measuring kit for those metabolites. If anything, the patent should have covered the method of analysis of their kit. The concept of measuring of any drug metabolite for drug dose adjustement is clearly an 'abstract idea', one that has been in common medical practice for decades for any number of drugs; the court rightly identified as such.

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17. MolecularGeek on March 21, 2012 12:12 PM writes...

@13. So we should allow bad patents to pile up to shore up an industry? Talk about cutting our own throats. The problem isn't a lack of patentable material, the problem is a risk-aversion in management that comes from being driven by quarterly growth and profit statements, and not good science. As long as markets demand "risk-free" returns, we will see repackaged junk-bonds in complex default/derivative schemes (which are "safe" since nobody understands the risks well enough to explain them) drive pharmaceutical and high-tech research enterprise stocks (where the risks are well understood and visible) out of competition.

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18. Patentsnstuff on March 21, 2012 1:10 PM writes...

It might be the right result, but the opinion is a poorly reasoned embarrassment. The court will have to distinguish its reasoning for years to come. The problem is the Justices wouldn't know a natural law if it fell on their head.

Not defending the Prometheus patent, but if you're going to invalidate it do it for the right reasons.

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19. AGman on March 21, 2012 1:36 PM writes...

I'm with #13. I think Derek in fact neglected to
mention that the result effectively ends patent protection for personalized medicine, and could potentially end patent protection for new
therapeutic uses of drugs, for diagnostic screening methods, and for a variety of computer-related software innovations.

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20. alig on March 21, 2012 2:00 PM writes...

This opinion really just kept the status quo. @ #19, this does not effect personalized medicine, from the opinion: "For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, atypical patent on a new drug or a new way of using anexisting drug, the patent claims do not confine their reachto particular applications of those laws."

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21. johnnyboy on March 21, 2012 2:06 PM writes...

Could someone define for me what they mean exactly by 'patent protection for personalized medicine' ? That certainly would help in discussing what the impact of the current decision would be.

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22. Sam Weller on March 21, 2012 3:27 PM writes...

Curious to know your opinion about the court decision about generic makers liability:

http://www.nytimes.com/2012/03/21/business/drug-lawsuits-hinge-on-the-detail-of-a-label.html

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23. MikeC on March 21, 2012 3:34 PM writes...

@#14: " Any method of isolating and sequencing that particular bit of DNA for clinical purposes is infringing Myriad's patent. "

What if you aren't sequencing that particular bit of DNA, you are sequencing that person's entire genome? As long as you, the company doing the sequencing, don't go ahead and check for the covered BRCA alleles you aren't infringing the patent. In other news: The cost of getting your genome sequenced and assembled will soon be less than the cost of a licensed BRCA1 test.

Once you have someone's sequenced genome, the algorithm for checking it for the BRCA alleles is trivial - and unpatentable. Even if SCOTUS decided the algorithm was patentable on its own without the physical part of the test, it could still be put in open source software and distributed for free. As long as a doctor didn't charge for the diagnostic ...

if cheap whole genome sequencing services get clinically certified, single purpose DNA diagnostic testing will have to cut prices drastically or it will just disappear.

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24. lazybratsche on March 21, 2012 3:40 PM writes...

I can imagine that there might be standard treatment decision algorithms that physicians use to interpret a patient's genome and a bunch of other omes. Already, in a crude sense, the BRCA1 patent is such an "algorithm", but in my opinion it's entirely trivial and obvious: see if patient has a risk factor. Not much interpretation is needed there. But in more complicated cases (i.e. just about everything) there's no obvious connection between, say, a patient's cancer genome and treatment options. I think that an algorithm that can match a set of drugs to all of the relevant signalling pathway abnormalities would certainly be patentable. The principles might be obvious, but the practice is far from obvious or trivial.

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25. Rick Wobbe on March 21, 2012 3:43 PM writes...

Anonymous, 14,
That's certainly how I have always heard the defense of [insert Company name here]'s patent on a gene described. The "Law of Nature" angle pursued by the Court would therefore apply equally to Prometheus' claims that lack "additional features" (to use the term from Breyer's opinion) and Myriad's claims that lack "additional features", i.e. those that effectively cover the sequence of the gene. It seems to me like both should be ruled the same way, yet I'm willing to bet a cold beer that it won't turn out that way.

As far as predictions that disallowing such claims will kill biomedical innovation are concerned, they seem kind of like saying that the development of new drop forging methods suffers because the earth's gravitational field can't be patented.

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26. zmil on March 21, 2012 5:50 PM writes...

@23

"As long as you, the company doing the sequencing, don't go ahead and check for the covered BRCA alleles you aren't infringing the patent."

I think it would be fine for the company to check for the alleles. The patents are for the isolated DNA sequences, essentially a form of natural product patent. As long as you're doing whole genome sequencing, I think, as you say, you're not infringing the patents because you are not isolating the specific patented molecules. Mapping sequence data onto the genome or searching for specific sequences within your data is certainly not infringing those natural product patents.

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27. Joshua Cranmer on March 21, 2012 9:29 PM writes...

@13: I disagree very strongly with the notion that patent protection is necessary for innovation. In software, for example, it is clear that the best innovations happened only with the complete lack of any patents (the FFT algorithm, without which most of modern technology couldn't exist, happened without patents; furthermore, patenting various features of programming languages would have stifled development to the point that modern software wouldn't exist). Indeed, in some places, patents are pretty much legalized racketeering: "hi, you need to implement this free standard. But to implement it, you need to pay us 2% of your profits."

@23: Just because it's open-source and delivered to customers for no charge doesn't allow you to skirt patent licensing fees. Most patents I'm aware of are actually licensed for a set fee per unit delivered.

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28. MikeC on March 21, 2012 11:29 PM writes...

@27: "Just because it's open-source and delivered to customers for no charge doesn't allow you to skirt patent licensing fees. Most patents I'm aware of are actually licensed for a set fee per unit delivered."

Who would you charge the fee to?
The person who adds a trivial algorithm to a free software program? A medical association that certified the program? A person who downloaded it and used it to check their genome?
Even if a doctor was the one to run the program, they still haven't broken the patent: none of them did the whole process, they just used the algorithm, which in isolation is unpatentable.


@27:"I disagree very strongly with the notion that patent protection is necessary for innovation."

Depends on the type of innovation and the development route it has to take to get to market. If it's the type that requires up to a few FTEs in labor and a few million dollars in facilities equipment, supplies, etc., maybe so. If it's the type that requires a few thousand FTEs and eight or nine figures on top of those labor costs, then some sort of protection is necessary.

What does each tick or tock on Intel's development cycle cost?

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29. MikeC on March 21, 2012 11:47 PM writes...

@26: I think a sequencing company would get in trouble if they reported results/interpretations for BRCA alleles. For one thing, the first part of all sequencing processes is fragmenting chromosomes into lots of smaller pieces. That would probably qualify as "isolating" the BRCA gene as far as Myriad's lawyers are concerned, even if that was not the specific intent.

On the other hand, it turns out the software I posited has existed since 2010!

http://cbcb.umd.edu/software/BRCA-diagnostic/

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30. zmil on March 22, 2012 12:37 AM writes...

@29

If that were so, then whole genome sequencing of humans for diagnostic purposes would always run afoul of gene patents (Except for Oxford Nanopore, I guess) which strikes me as unlikely.

Anyway, I don't see how deep sequencing counts as isolation- the sequences are not, well...isolated. They're all sequenced simultaneously. At least w/ Illumina, which is the platform I'm most familiar with.

Fragmenting chromosomes is not sufficient, people were doing that before PCR, even. You have to specifically isolate and purify one of their patented BRCA sequences. At least that's how I read the patent. But I'm a biologist, not a lawyer.

I've always wondered if some sort of DNA hybridization assay could get around that patent anyway...

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31. zmil on March 22, 2012 12:43 AM writes...

As is generally the case, I've discovered someone else thought my thoughts before me, and better:

http://www.genomicslawreport.com/index.php/2009/08/11/whole-genome-sequencing-and-gene-patents-coexist-for-now/

Someday I'll have an original thought. Someday...

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32. Chris on March 22, 2012 6:41 AM writes...

As a patent agent, I have to wonder about the logic used by the court here. I more or less track with the USPTO's official amicus brief on this, in which they argue that the patent should be invalid for reasons of novelty, not utility. There is, in my opinion, an unacceptable level of vagueness imposed by saying a metabolite's levels in serum is in some sense a "law of nature". Far better to make an argument that doctors already knew that certain upper and lower limits were necessary and had a "good enough" idea of what those limits were. But a 9-0 decision means I and the USPTO are wrong, apparently.

What will really be interesting is how this will impact on Myriad. If the isolated BRCA1, being a molecule not found in nature, has not existed in nature before and was heretofore not known to have any particular economic value, then it ought to be as patentable as any new chemical entity. The Supreme Court (fortunately) goes out of its way to say that new drugs and new uses of old drugs are not "laws of nature", so small molecule pharma looks safe. But will the CAFC and lower courts look at this gene the same way, now that they have this new precedent to work from? Or similarly, on biologics?

It's all well and good for us as chemists to complain about software and gene patents as a scourge on innovation. But if the pharmaceutical industry has no patents, there is no industry. This decision may be right in verdict but the analysis will create trouble for decades to come.

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33. johnnyboy on March 22, 2012 8:27 AM writes...

@32: Maybe i'm not reading your argument right, but your statement "BRCA1 being a molecule not found in nature (...) ought to be patentable as a NCE" is obviously wrong, as BRCA1 is part of the genome.

Patenting genes or cell receptors has always seemed like the height of sophistry to me - and whether doing so helps 'support an industry' should not be relevant. Genes sequences and protein structures are descriptive scientific information, not inventions, and as such should remain in the public access realm. Patents should cover novel ways to use these sequences, not the sequences themselves.

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34. Anonymous Academic on March 22, 2012 8:46 AM writes...

@27: Even if a doctor was the one to run the program, they still haven't broken the patent: none of them did the whole process, they just used the algorithm, which in isolation is unpatentable.

I'm not sure if I totally understand what you're saying here, but algorithms certainly are patentable (although I agree with @27 that they shouldn't be). Moreover, I'm pretty sure that if you use a patented technology without a license, regardless of whether or not you actually implemented any of the patent claims, you are legally liable. Individual doctors probably wouldn't be targets, but what about companies like 23andme?

@30: If that were so, then whole genome sequencing of humans for diagnostic purposes would always run afoul of gene patents (Except for Oxford Nanopore, I guess) which strikes me as unlikely.

A literal reading of the patent claims shows that it's not at all unlikely; there just hasn't been a good opportunity or target to sue yet. There has never been a shortage of improbable lawsuits brought by overzealous patent holders, and some of them are quite successful. The case of Eolas Technologies and their patent on the "interactive web" is an excellent example: even though a judge recently ruled against them in one lawsuit, a number of companies had already settled rather than go to court. Ariad and their NF-kappa B patent were almost as ridiculous, effectively making entire fields of research out of bounds for pharmaceutical companies.

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35. Karl on March 22, 2012 9:07 AM writes...

#13 says "Regardless of the merits of the case, for those of you in the pharmaceutical industry the main issue to understand that there is now less subject matter to patent, ..."

Well, that depends on whether you're talking about matter that ought to be patentable or not. But let's move on to your main points:

" ...there will be less research to develop and commercialize testing methods,..."

Stuff and nonsense. You have it exactly backwards.

If a Prometheus-like patent were valid, THAT would suppress research into testing methods by anyone other than Prometheus, because there would be no point -- Prometheus would be able to restrain or drain your work, so why bother.

" ...and there will be fewer jobs in an industry that is contracting at a substantial rate."

Since your second point is incorrect, this one clearly is too, at least insofar as the two are related. (Which is not a given, mind you.)

Unless you're talking about the legalized protection racket industry? We can only hope that there will be fewer jobs in that one, since it's intrinsically parasitical and non-productive.

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36. zmil on March 22, 2012 10:38 AM writes...

@33
"Maybe i'm not reading your argument right, but your statement "BRCA1 being a molecule not found in nature (...) ought to be patentable as a NCE" is obviously wrong, as BRCA1 is part of the genome.

Patenting genes or cell receptors has always seemed like the height of sophistry to me - and whether doing so helps 'support an industry' should not be relevant. Genes sequences and protein structures are descriptive scientific information, not inventions, and as such should remain in the public access realm. Patents should cover novel ways to use these sequences, not the sequences themselves."

You're missing the key word in the quote: "isolated BRCA1 being a molecule not found in nature"

They're not patenting the sequence, but the isolated molecule. Patents don't have to be inventions. Natural product patents have a long history. Like with insulin. You can't patent the insulin made by your body, but you can patent the isolated protein.

@34
"A literal reading of the patent claims shows that it's not at all unlikely; there just hasn't been a good opportunity or target to sue yet. There has never been a shortage of improbable lawsuits brought by overzealous patent holders..."

Oh, I wouldn't be too surprised if they tried to sue, but I would be very surprised if the courts accepted their argument. Whole genome sequencing does not isolate specific DNA molecules in any normal sense. It replaces isolation with microscopy, essentially.

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37. Chris on March 22, 2012 11:23 AM writes...

@33 zmil I think has pointed out the key feature: "isolated".

And in particular, the fact that any polypeptide separated from its surroundings is a different molecule from the DNA sequence that originally contained it.

Composition of matter claims, dealing entirely with actual production/manufacture of the molecule so protected, should never be infringed by non-destructively reading the genome. But there is a reading of this new ruling that would suggest BRCA1's utility is pure discovery, there being no special or novel technical expertise required to create isolated BRCA1. Essentially, given the start of the art of molecular biology, if any gene identified as a marker for something is a "law of nature" and the synthetic technique for the isolated BRCA1 is not novel, then one could argue from Prometheus that there's "nothing left to patent" once you remove the law of nature.

That may be the right call for policy reasons, I don't know. But it certainly calls into question whether a molecule, otherwise new, could be invalidated for utility reasons simply because interaction with its target, its presence in blood, etc. is a law of nature. That possibility is not very high given SCOTUS has used new drugs as a counterexample. But if chemistry ever becomes as reliable as molecular biology, we may well have a very hard time sustaining that argument.

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38. Rick Wobbe on March 22, 2012 11:33 AM writes...

It seems to me that the argument that the Mayo v. Prometheus result or a finding against Myriad in the BRCA1 case will kill industry innovation rests on three key assumptions: 1, monetary return is sine qua non for innovators; 2, without revenue from IP, there will be no money to support future innovation; 3, maximizing financial return to the first innovator is most beneficial to overall innovative productivity and, therefore, society.

History is replete with examples that belie the first two assumptions, so I don't think they're generally valid. Assumption 3 raises the question of whether you get more profitable innovation from: a, allowing Prometheus and Myriad to enforce their patents to the maximum extent or b, freeing other innovators from the constraints of those patents. For marketed drugs, option "a" seems superior. In the Prometheus and Myriad cases, it seems to me that more innovation results from findings like the one in the Prometheus case (option "b").

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39. MikeC on March 22, 2012 11:39 AM writes...

@34: "I'm not sure if I totally understand what you're saying here, but algorithms certainly are patentable (although I agree with @27 that they shouldn't be). "

Algorithms can be patented - as long as they are part of some tangible process. In this case, the tangible process was getting the relevant sequence information from the patient, scoring it, and then using the diagnostic to direct treatment. Courts have already ruled that this particular algorithm (comparing BRCA sequences) on its own was just an abstract idea, and those claims in Myriad's patent were disallowed.

@34: " Individual doctors probably wouldn't be targets, but what about companies like 23andme?"

I think if a company does both the sequencing and the scoring for alleles patented as diagnostics they run the risk of being sued - they are using both sections of the patent, even if the sequencing-genome-vs-isolating-gene part is iffy. They would probably also run the risk of getting sued for indirect infringement if they provided the raw data and then said "go download CBCB's diagnostic software on your own to find out your BRCA results". But if all they do is provide raw data and leave the patented sequences unremarked, they're judgement proof.


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40. Anonymous BMS Researcher on March 23, 2012 7:27 AM writes...

Aside from the vital and complex issue of what constitutes patentable subject matter, and how that applies to gene patents (which for me is not an abstract question since I'm a named inventor on such a patent), something else struck me about the Supreme Court's ruling. The opinion cites a preprint of a forthcoming article, giving the URL to the PDF file on a patent law blog (adding that a copy was in the Case File maintained by the Clerk of the Court). I don't regularly read US Supreme Court rulings, so I don't know whether this represents the first time they cited a blog. I'll bet the maintainers of that blog were thrilled to have been cited by SCOTUS; it is difficult to imagine a higher honor for such a blog.

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41. Rick Wobbe on March 27, 2012 7:16 AM writes...

Lo and behold! The Supremes weigh in on Myriad... or not.
(http://www.nytimes.com/2012/03/27/business/high-court-orders-new-look-at-gene-patents.html?ref=business)

This is going to go on for a while, kids. Settle in for a long bumpy ride. The question becomes: will innovation perish quickly if the courts find against these patents or slowly from boredom waiting for the outcome? My guess is that scientists will keep on discovering stuff.

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