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« Court Report | Main | Legislation to Enhance Patent Case Expertise Among District Judges Awaits President's Signature »

December 28, 2010

Comments

Kevin, despite what the ACLU would like us to think, Funk Bros. was NOT about patent-eligibility. Funk Bros. was about what we would now call non-obviousness.

Dear Dan:

But the Douglas opinion uses such broad, imprecise language that it is easy for the ACLU and others to make the argument. Rather than pin our hopes on the current Court understanding such a (relatively) subtle patent law distinction, I think Justice Frankfurter's concurrence puts the imprecise language into proper context - the claim was broad enough to cover any combination of bacterial strains that had the desired properties, and so improperly preempted the natural phenomenon. In some ways this tracks written description deficiencies just as well as obviousness as a basis for the Court's opinion ( although I agree that what the Court had in mind is what we now call obviousness).

Thanks for the comment, and happy New Year.

As a "claims first" kind of guy, I struggle with the notion that something in the disclosure can affect the eligibility of the subject matter. However, where the disclosure focuses on one thing (in this case, the algorithm) and treats other information as unimportant, then I understand the court's lack of sympathy for arguments that hinge on the missing information.

Kevin,

Thanks for the analysis - looking back at In re Gram absolutely helps put the Fed Cir decision in Prometheus in context.

Reading the claim, however, is strikes me that the claim lacks novelty (or at the very least is obvious) - it essentially claims how to perform an experiment. Even without modern science, the claim would seem to me to be anticipated by, for example, taking blood from a normal person and a hemophiliac and observing that the hemophiliac's blood does not clot. Then, adding normal blood to the hemophiliac blood and observing that in now clots. Another example may be Karl Landsteiner's work on blood groups and how mixing blood groups causes clumping of RBC for which he was awarded the Nobel Prize in Physiology or Medicine in 1930 - well before Gram. Therefore, while I think the Fed Cir's decision is correct, I am not convinced that it should be decided on non-statutory grounds. The claim is a process and a process is squarely within section 101.

In any event, the Fed Cir analysis is consistent with my recent proposal in Nature Biotech that the court must look at limitations that narrow the scope of the claim. I stated:

"Likewise, in gene and diagnostic patents the court should look at limitations, including the following: the gene covered, the mutations recited, the diseases it claims to diagnose and the tissue source. The Myriad Genetics patents do not seek to exclude all genetic correlations, of all genes, to diagnose all diseases—they claim two genes for diagnosing breast and ovarian cancer. As such, these limitations should be considered in a patentability determination, especially if the justification for the doctrine is to reign in monopolies that unreasonably preempt future progress."

Therefore, in contrast to Gram, the Myriad claims are much narrower and should withstand a non-statutory challenge.

Throughout this whole sorry history of litigation and commentary on the patentability of diagnostic methods, the courts and the patent bar have gotten lost in a forest of tortured legal reasoning and have lost sight of some basic principles. First, does anyone who believes in the patent system really think that diagnostic methods per se should not be patentable subject matter? Hasn't the inventor of a new, useful, and unobvious diagnostic method made a contribution to society that deserves patent protection? Second, such a method is not an abstract idea. Having a real world utility, i.e., benefiting patients, should be enough to obviate any issue about the method being an abstract idea. Third, the issue of whether or not a claim to a diagnostic method preempts a natural principle is ridiculous for all but the most poorly written claims. Every invention under the sun involves the application of natural principles, and an issued claim by law preempts that particular application of the relevant natural principles. Fourth, the machine or transformation test may (or may not) be useful and relevant for evaluating software claims. It makes no sense to apply it to diagnostic method claims.

The following principles should be used to evaluate diagnostic claims. First, the test for patentable subject matter should be whether or not the claim is directed to an abstract idea. Second, a diagnostic test that has a real world utility (i.e., doctors are making medical decisions based on the results, and patients are paying for the results) is not an abstract idea. Third, one or more mental steps in a claim does not render it unpatentable. Fourth, one or more data-gathering steps in a claim does not render it unpatentable. In fact, this real-world activity should be enough to take the claim out of the realm of abstract ideas.

Agreed, Ken - but the problem is that the issue is broached on eligibility grounds, which limits the court's consideration of scope, novelty, etc. The effort, by the ACLU and others, is of course to avoid a case-by-case analysis and make preclusive rules about gene patents (as there were about business methods and algorithms) - but if the Federal Circuit crafts a test (as it seems to be) relying on a "totality of the circumstances" for patent eligibility, we may get to the same place using 101 that we would (perhaps more efficiently) using the other statutory sections.

You are correct, of course, about Myriad, but I notice in my reading that the idea of preemption is thrown about quite casually, so that a test on specific mutations in a specific gene for a specific disease (Myriad) somehow "preempts" the natural phenomenon of mutations leading to a propensity to develop breast cancer.

Thanks for the comment, and all the best in the New Year.

Geoff:

Yes, there are people who "believe in the patent system" (whatever that means) who think that a correlation between the presence/absence/amount of a biomolecule and a trait/disease/condition, while perhaps scientifically important, is not deserving of patent protection under current law. For the one-hundredth time, we are not talking about a mode of determining the presence/absence/amount of a biomolecule. That is, has been, and always will be deserving of patent protection, provided it is new and nonobvious (and provided that there is some useful purpose for determining the presence/absence/amount of the biomolecule). No, we are talking about the actual correlation. The patent system is designed to provide an incentive to invent and disclose. But the discovery of a biomarker correlation is just "basic science" stuff (causes, functions, correlations). Basic science is done at universities, government agencies, and non-profit research institutes, and researchers at those places don't need a patent system in order to discover and disclose. They are motivated by things like continued employment and tenure, and they don't get tenure based upon the number of patents in which they are a listed inventor. Everyone raves about the Bayh-Dole Act, but I think the evidence is inconclusive as to whether Bayh-Dole has really resulted in more innovation (notwithstanding what you read by AUTM and other fanboys).

Kevin,

Thanks for bringing up the importance of evaluating the claimed subject matter in Prometheus versus that in Grams. Your comment about the Grams claims being overbroad relative to the scope disclosed also brings me to my next point: "preemption" should be evaluated under 35 USC 112, paragraph 1, not 35 USC 101, for whether the claimed scope is supported by the disclosure. That's what O'Reilly v. Morse stands for (contrary to the common misperception that this case was about patent-eligibility).

Dear Gary:

The other side of the coin is that unprotected disclosure converts the U.S. university and government research enterprise into an unpaid R&D arm of every large corporation on earth (and not just US corporations). There is ample anecdotal evidence of representatives of companies foreign and domestic reviewing scientific journals as they were published 30 years ago for promising leads for new inventions. I agree that research will always be done for the reasons you mention (and others including pure curiosity), but you don't have to be a "fanboy" to think protecting that effort to prevent free-riding is a good idea. (Jon Soderstrom at Yale has a lot more data on this point.)

The problem with the calculus you posit is that it promotes non-disclosure. Just because the past 30 years have been driven by university discovery doesn't mean the next 30-50 will be the same - and destroying the incentive of corporations to support university research will reduce the likelihood that this paradigm will persist. This is especially true since the next 50 years are likely to be dominated by research that can be done effectively (and secretly) by corporations.

I am curious about where the Myriad claims fit in your scheme. While the "mode" of detecting a mutation was known, Myriad arguably provided identification of specific mutations at specific positions in a specific gene to identify the propensity of a woman to get a specific disease. Assume none of this is in the prior art - is the Myriad diagnostic claim patentable?

Thanks for the comment, and Happy New Year.


"but if the Federal Circuit crafts a test (as it seems to be) relying on a "totality of the circumstances" for patent eligibility, we may get to the same place using 101 that we would (perhaps more efficiently) using the other statutory sections.

"

lol wut?

Kev. You say the craziest things.

"You are correct, of course, about Myriad, but I notice in my reading that the idea of preemption is thrown about quite casually, so that a test on specific mutations in a specific gene for a specific disease (Myriad) somehow "preempts" the natural phenomenon of mutations leading to a propensity to develop breast cancer."

Because that is the only use for that particular abstract idea is it not Kev?


Similarly, had the court bothered to take into consideration abstract ideas rather than simply natural phen. as argued then they would have had this issue on their hands in Mayo as well.

Though, tbh, the disctrict court ruled on other grounds iirc in ACLU.

"There is ample anecdotal evidence of representatives of companies foreign and domestic reviewing scientific journals as they were published 30 years ago for promising leads for new inventions."

How is that the "other side of the coin"? That happens, so wut? People also read our patents and make products etc in their country where no patent exists from time to time. When they're not too busy playing in the dirt that the world bank has left them that is.

"I agree that research will always be done for the reasons you mention (and others including pure curiosity), but you don't have to be a "fanboy" to think protecting that effort to prevent free-riding is a good idea. "

Heaven forbid someone "free-ride" (i.e. "use") on some research provided many (most?) times by the gov. Wouldn't want that now would we!?!?!?!!? We get to pay for it while its in dev. and then pay for it again through the patent tax levied on the companies actually putting those things into practice. Heaven knows I'd enjoy paying Myriad 1k$ for a 35$ test because, gasp, they took their federally funded research to the "I want money office" before their fellows could ensure that I only paid 35$.

"The problem with the calculus you posit is that it promotes non-disclosure. "

Oh yes, those darned researchers are notorious for that. Happens like, every single time a major breakthrough is acheived!

Although to be clear, I kind of agree with you Kev, disclosure is nice. But I've been thinking about it, and see if you think about this like I am. We live in an era of a flood of information or "disclosure", what we really value now is the ability to find the disclosures we need. The patent system does not even attempt to provide that. Now, imagine if you will, a patent system that actually promotes what we need, as proposed above, and how different it is from our current system.

Just so everyone can understand where Kevin is coming from, you need to read the previous thread where he refuses to simply state his answer to the question whether a claim that merely adds a mental step to a an old method is patentable under 102 or 103, as a matter of law. Here's his (non) answer:

**So there are pros and cons to each position. Ultimately, I think non-disclosure is worse than over-patenting, but that's my choice - my bias, if you will.**

So there you have it. Because the risk of "non-disclosure" of a fact is the worse thing ever, people should be precluded from thinking about a fact, or in certain instances, speaking about it.

Make no mistake: if all the steps in your claim are identical to the prior art except for a "novel" mental step of appreciating a result (i.e., a non-patentable fact) flowing from those steps (and Prometheus admits this expressly in its specification) then you are effectively patenting a mental step. You can add a step to the claim of communicating one's thoughts about this non-patentable fact, and now you are patenting communicating a fact to somebody.

The Gram issue is a red herring. If we want to accept the Federal Circuit's simple minded 101 test ("any claim that comprises a step that transforms any tissue of an organism is 101 eligible"), then we must move on to 102 and 103. Is there case law supporting the patenting (under 102 or 103) of methods that are identical to prior art methods except for an addititional mental step? I'm not aware of any. But I seem to recall some case law saying that is appropriate to ignore mental steps when evaluating a claim under 102 or 103. What were the policy considerations in those cases?

Because some people like or need analogies:

Prior art teaches a method of mixing A and sugar to make C, then measuring sweetness of C, because sometimes you may want to make C sweeter (e.g., if it's not sweet at all).

Patent claim: A method of mixing A and sugar to make to make C, then measuring sweetness of C, **wherein if sweetness of C is below 212.23 sweetness units, a need to add more sugar is indicated.**

The last part of the claim is a mental step (note: sweetness scale is objective, industry recognized and runs from 1 to 1000 units, where 212.23 sweetness units is recognized as low sweetness by most people).

Anyone think this is patentable over the prior art (102 or 103)? If I was making C according to the old method before the patent was filed, how is the claim not equivalent to patenting a new way of thinking about an old result? And what difference should it make if I speak my thoughts about that fact to someone ("this needs more sugar")?

These facts are directly analogous to those in Prometheus, by the way. If anyone is confused or disagrees, let me know and I'll set you straight.

6, you sound like the fish that can't imagine not being wet. You are correct that things are disclosed now, since disclosure is protected by patents for technologies that need protection to develop. (I grant you that there is some empirical evidence that some technologies, like IT, may "suffer" from patenting, but that doesn't apply to biotech).

And when I say "free-ride," I don't mean that they sell the products of American invention in their country - I mean they sell it here. I assume you would agree that it would be worse for a foreign company to sell a product made using American invention (for reference, see the period from 1975 to about 1990).

Finally, "a test on specific mutations in a specific gene for a specific disease (Myriad)" is not an abstract idea.

Thanks for the comment.

Now, Shot, you know context is everything. And the context of the other thread is what the CAFC was asked to do - decide a 101 question, which you think is better decided as a 102 question. I'm sure they'll get to it eventually, and then we can have the debate you seek (or maybe not - they may agree with you).

You are correct that I won't answer your hypothetical, because that's all it is - and in the context of the question before the court, an irrelevant one.

No one is keeping anyone from thinking about anything. The patent claim is keeping an infringer from practicing a patented method and charging for it. For the limited period of the patent term. If the claim is "just" as you posit, then 102/103 will be sufficient to invalidate it. Which in my view is better than using 101, which is too blunt a tool to be wielded with the required precision.

Finally, promoting non-disclosure is the fastest way to have knowledge privatized - because if I have no incentive to disclose, I will keep my knowledge as arcane as possible, profiting for as long as I can on that non-disclosure. Which is hard to do if I am selling an iPod, but no so hard to do if I discover a way to predict a propensity for cancer.

So much for comment 1. We'll get to the setting straight time shortly.

Well, some of the differences between your hypo and reality (Prometheus) is that 1) the effective drug level was not known and 2) unlike sweetness, it was not "relative" - too little and you don't have effectiveness, too much and you have toxicity.

And, on the facts I'm not sure anyone ever did the test for drug levels or metabolites in the prior art - the test could have been done, but (since the court was not presented with a 102/103 issue) we have no evidence that such a test was in the prior art ("could have been" isn't recited in 102).

So, while I'm sure you think your hypo and Prometheus are spot-on, I don't agree. Your hypo does suggest, however, that there should be a corollary to that old saw - "bad hypotheticals make bad law."

Are we straight yet?

Kevin, yeah I know about Soderstrom's data. I just don't think "free riding" is a problem.

Go take a look at the research dollars at the 50 largest universities, and you will find that corporate-sponsored research represents a very small percentage. It's just not enough to get worked up about.

The biotechnology/life sciences boom was the result of Chakrabarty, not Bayh-Dole. But try telling that to someone that works in tech transfer (or a patent attorney that does a lot of prep/pros for universities). You'll be looked at as if you are an alien.

Yes, the Univ. of Utah patents that Myriad controls relating to methods for screening BRCA1 for the presence of mutations (and claims directed to the detection of specific mutations) are no good. Doesn't matter that you may have not been motivated to screen a person's BRCA1 sequence prior to the discovery of its involvement in breast cancer -- what matters is that sequencing human DNA was not new in 1994 (or whenever it was that the applications were filed). All you're left with is the correlation, but that's just a mathematical formula (if X, then Y).

All this discussion of 101 v. 102/103 in the context of these claims is positively weird.

For the record, I am not opposed to patents for biomarker correlations. I just don't think current law permits them. We have different kinds of patents (utility, design, plant), so what's wrong with Congress coming up with a diagnostic patent?

Dear Gary:

Agreed on the weirdness, but this topic brings it out.

I'm not sure that the claims are invalid because the method for detecting the mutation was known, if the specific mutation in the specific gene giving rise to a propensity to develop a specific cancer was not. All that was the result of the inventive effort, so without it you don't have a correlation in the first place.

With regard to corporate research, it isn't corporate support so much as university scientists and universities being compensated for their inventions - I'd rather have this system than the one where university technology is expropriated.

Finally, I agree about Chakrabarty with regard to gene patents, but there is a lot more coming from universities under Bayh-Dole than gene patents - for example (I've been meaning to post on this), Princeton University just built a state-of-the-art chemistry facility with the monies they received from royalties on a drug developed using university technology. So there are a lot of benefits (as well as some downsides).

I like the idea of a diagnostic patent - care to flesh it out (we accept guest posts).

Thanks for the comment. Happy New Year.

Kevin "You are correct that I won't answer your hypothetical, because that's all it is"

So you don't even see a potential 102/103 issue in the circumstance I indicated? Really? It's rather glaring to me and, like I said earlier, to all the Ph.D./attorneys I've spoken to. We've discussed it a lot. I figured everyone would be interested in discussing it, especially in light of the fact that Prometheus' claims are still alive under 101.

"some of the differences between your hypo and reality (Prometheus) is that 1) the effective drug level was not known"

Kevin, Prometheus does not claim administering an "effective" level of a drug. Even Judge Lourie recognized that. The structure of the claim with respect to the mental step (the wherein clause) is identical.

"2) unlike sweetness, it was not "relative" - too little and you don't have effectiveness, too much and you have toxicity."

The mental step is novel and non-obvious in both instances, Kevin. That's all that matters here, other than being useful and related to the preceding steps. The novelty of the mental step is certainly irrelevant for determining 101 eligibility, as we now know (unless the Supremes reverse). 101 eligibilty in Prometheus derived solely from the preceding transformation steps. Lourie also recognized that the mental step itself could not be patented. But apparently you believe that if the non-mental steps were in the prior art, then one who practices the prior art could still be prevented from thinking or even communicating certain unpatentable facts about results that inherently flow from the practice of the prior art. That's the inevitable conclusion that follows if claims such as the ones I've described are patentable under 102/103 based on subsequent "novel" mental steps. Perhaps you don't have a problem with that because it would encourages more patent filing which, arguably, trumps everything.

"on the facts I'm not sure anyone ever did the test for drug levels or metabolites in the prior art - the test could have been done, but (since the court was not presented with a 102/103 issue) we have no evidence that such a test was in the prior art ("could have been" isn't recited in 102)."

I believe I pointed this out to already, Kevin, but the specification of Prometheus' patent notes: "Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP"

Of course, you can try to make some "technical" argument, Kevin, that nobody could have predicted that if the levels of 6-MP metabolite are really really low in a subject who is not responding to the therapy that maybe, just maybe, you might *think* about upping the dose.

Of course, if your patient isn't responding now and you do what the prior art suggests, then there's a good chance you'll infringe this "method of optimizing treatment" patent even if you never touch the patient again. Exactly like my method of making C.

"No one is keeping anyone from thinking about anything. The patent claim is keeping an infringer from practicing a patented method and charging for it."

I didn't see a step of "charging" anyone for anything recited in the patent. Is that from the prosecution history or something?

Dear Shot:

Do you know of anyone offering these tests for free?

Let's say you work as in-house lawyer in a tissue testing lab, Kevin. Your lab was testing 6-MP levels in various subjects, including gastrointestinal patients, long before the patent was filed. In fact, you even have your own patent on a method for testing 6-MP levels in such subjects that you use anytime such a test is requested.

So one day you this patent and the Federal Circuit case saying that the last step is only a mental step and you don't infringe claim 46 if that's all you do. You have to also do the determination. You tell everyone in the lab about the case.

The next day the lab gets a request, like the one you've seen many times before, and it says "6-MP level needed for 6-MP treated patient 2X32 with gastrointestinal illness."

The lab tech comes to you and says "Kevin, I don't feel comfortable doing this test because if the level of 6-MP is really low, then I'm infringing the patent, just like that case says."

Do you tell the tech to go ahead and infringe or do you tell the tech to shut his/her eyes?

The next day the CEO comes to you and asks why the heck you told anyone in the company about the case. What do you tell the CEO?

Kevin: "Do you know of anyone offering these tests for free?"

Kevin, since when does a price being charged for a patented service affect the patentability under 102/103 of claims that do not recite a step of charging a customer? Or affect whether such claims are infringed by the providing of the service?

It almost seems if you are trying to help Prometheus find some more people to sue. Or maybe just trying to change the subject?

You can rest assured that I agree with you that certain information is valuable, Kevin. Who could disagree with that? Nor could anyone dispute the fact that if one has valuable information, one should be able to profit from it. But patent it?

As I noted above, if your patent allows you to theoretically (albeit not always practically) control what people who are practicing the prior art are thinking or saying about the prior art, then you are effectively patenting information itself.

Is that the correct result, Kevin? I just can't recall any court anywhere ever approving the use of patents for this purpose.

I posted a nice hypothetical that put the issues into focus but it somehow has not made it up here.

Shot:

All your arguments are predicated on the 102/103 issue. We can go 'round and 'round about this all day. I promise that when the CAFC considers the Prometheus claims under 102/103, we will post on it.

In any event, it certainly sounds like your in-house lawyer would have a good non-willful infringement position to give her CEO. Until we get a decision on invalidity under 102/103, we'll just have to wait to see how this goes.

Thanks for the comment.

Kevin: "All your arguments are predicated on the 102/103 issue."

Uh .... yes. As I said, I am assuming the 101 issue is decided but now we are left with a case (Prometheus) that says that a mental step alone isn't patentable under 101 and an asserted claim that is (as admitted by the patentee) nothing more than a mental step added to a prior art method.

"We can go 'round and 'round about this all day."

We? You haven't said a darn thing about the 102/103 issue, Kevin. You made some irrelevant comments about my hypothetical but you haven't even acknowledged the existence of a serious 102/103 issue with the claims. Your position is that adding a "non-obvious" mental step (not really non-obvious in Prometheus case, as I've pointed out and you have not addressed) as the last step of an old method makes the claim patentable under 102/103? Really?

"it certainly sounds like your in-house lawyer would have a good non-willful infringement position to give her CEO."

How wonderful. No treble damages! I'm sure the CEO will be ecstatic. So what is the "good non-willfull infringement position" Kevin? I'm all ears.

I give you credit for persistence, Shot. But I'm not playing - let's have an actual case to discuss before we waste more electrons.

Kevin,

Nice comment about not wanting to "waste more electrons." But didn't Nuitjen say electrons (e.g., signals) aren't patent-eligible? Just a little New Year's Eve humor before we enter 2011! Have a very nice New Year.

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