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Wednesday, 21 March 2012

Zeus denies fire to Prometheus

“Madness,” “..lost their minds...,” “disaster for personalized medicine,” were a few of the thoughts that ran through this Kat’s head as he sat down to write this post. But since this is a sober and respectable blog, I will start with something more objective.

Having fundamentally misunderstood the nature of invention, the United States Supreme Court has dealt a potentially disastrous blow to personalized medicine in its decision in Mayo v Prometheus, which invalidated Prometheus’s claim to a diagnostic correlation.

The fate of personalized medicine?
The claim concerned the use of thiopurine drugs to treat patients with autoimmune diseases. It was known that different people metabolize thiopurines differently, so the safe and effective amount of drug to be administered will vary from person to person. Methods of measuring metabolites were also known, so that in principle a doctor could personalize the dosage by measuring the metabolite levels, and then adjusting the dosage upwards or downwards depending on whether the metabolite levels were low or high. The problem in the prior art was that the proper metabolite range was not known. A doctor could measure the metabolite level, but the result would not help her decide whether to increase or decrease the dosage. The technical contribution in the patent was to determine the optimal range for the metabolite. (This contribution is assumed to be inventive; the case went to the Supreme Court on a summary judgment decision on the issue of patentable subject matter, so there was no finding on obviousness.) The claim at issue, which was held to be invalid, stated the optimal metabolite range, and instructed the physician to adjust the drug dosage accordingly.

Justice Breyer summarized the core of the Court’s reasoning as follows:

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

In effect, an invention is unpatentable if the sole inventive contribution is the discovery of a law of nature. This misunderstands the nature of invention. As Jacob LJ has pointed out in Aerotel, [2006] EWCA Civ 1371 [32], “[p]atents are essentially about information as to what to make or do.” The term “intellectual” property signals this basic fact. In Fujitsu Ltd's Application, [1996] RPC 511, 523 Laddie J noted similarly that “most inventions are based on what would be viewed by many people as discoveries.” The same point was made by Lord Justice Clerk Hope in Househill v Neilson, (1843) 1 WPC 673, 683, one of the earliest subject matter cases, concerning Neilson's invention of the hot-blast furnace, when he noted that the “main merit” of the invention may consist in “the discovery of the principle in science, or of the law of nature, stated in the patent.” More poetically, in Hickton’s Patent (1909), 26 RPC 339, 348 (CA) Buckley LJ remarked, “I think you are losing grasp of the substance and seizing on the shadow when you say that the invention is the manufacture as distinguished from the idea. It is much more true to say that the Patent is for the idea as distinguished from the thing manufactured.” Consequently the traditional English position, and indeed the traditional US position, is that the inventive concept may lie in an idea or the discovery of principle of nature, but that principle must be claimed as a practical application, and not purely as an abstract idea. In the US Supreme Court Frankfurter J made the same point in Funk Bros 333 US 127, 135 (1948): “Everything that happens may be deemed ‘the work of nature,’ and any patentable composite exemplifies in its properties ‘the laws of nature.’ Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost every patent.” 

Unfortunately, Frankfurter J was dissenting in Funk Bros, which was the key decision where US Supreme Court jurisprudence departed from the traditional understanding of the prohibition on patenting of abstract ideas, and the US Supreme Court has struggled with this basic concept ever since. So, in Prometheus the US Supreme Court re-affirmed its peculiar view that a scientific principle cannot provide the inventive concept: “‘[P]ost-solution activity’ that is purely ‘conventional or obvious,’ the Court wrote [in Flook], ‘can[not] transform an unpatentable principle into a patentable process.’” This misses the point that purely conventional post-solution activity can turn an abstract idea into a practical application.

A rule that a principle of nature cannot provide the inventive concept to support a patent would completely undermine the patent system, and even the post-Funk Bros US Supreme Court has grasped this principle, albeit dimly. In explaining some of the prior cases in which a scientific principle did underpin the invention, the Court invoked a kind of physicality requirement. So, in relying on Neilson v Harford, (1841), 1 WPC 295, another English case concerning Neilson’s blast furnace, the Court explained that in Neilson “the claimed process included not only a law of nature but also several unconventional steps (such as inserting the receptacle, applying heat to the receptacle externally, and blowing the air into the furnace) that confined the claims to a particular, useful application of the principle.” This is not persuasive; indeed, it is a complete misunderstanding of Neilson. Neilson’s patent was very broadly claimed, and it was only the fact that the post-invention activity needed to implement it was purely conventional or obvious to a skilled person that saved the invention from an insufficiency attack. Similarly, there is no reason to believe that there was any unconventional post- invention activity in the invention held to be patentable in Diamond v Diehr, 450 US 175 (1981).

This Kat’s impression is that the US Supreme Court subject matter jurisprudence since Funk Bros has been driven by an intuitive understanding of inventions as being things, and traditional mechanical things at that. When the true nature of invention as information is inescapable, as in the computer cases (Flook 437 US 584 (1978) and Benson 409 US 63 (1972)), in Bilski 561 US ___ (2010), and Prometheus itself, the Court is likely to hold the invention unpatentable. When the invention can be framed in a manner which makes it seem to be more of a thing, as in Diehr, the Court is likely to hold it patentable. (Ironically, there is no trace of an inventive step anywhere in Diehr, as the principle of nature in that case, the Arrhenius equation, was in fact not new at all.)

An expert in administrative law
The most sensible part of Justice Breyer’s decision, in this Kat’s view, is the final two pages, where he admits that the Court has no idea of what it is doing in terms of promoting innovation, and says that it should therefore stick with established precedent. The only problem with this argument is that in the US established precedent at the Supreme Court level has been off the rails for half a century.

What are the implications? On its face, this is potentially disastrous for personalized medicine. It must be acknowledged that it is very difficult to assess the impact of patents on innovation in any field, even those which are well-established and well-studied. We do know that patents are important in pharmaceutical and chemicals, and more generally it seems that patents are more important in so-called discrete-product industries, like pharmaceuticals and chemicals, and less important, and potentially counter-productive, in complex-product industries, such as software. Ultimately the effect of Prometheus on innovation in personalized medicine is a difficult empirical question, but this Kat’s sense is that personalized medicine is closer to the pharmaceutical / discrete-product end of the spectrum. Consequently, while the principle in Prometheus is the same as in Flook, the implications are potentially much more serious. I am not yet at the stage of my life where personalized medicine is important to me, but I do hope to get to that age eventually, and at a purely personal level I am not at all happy about what Prometheus means for my health in the coming decades.

At another level, there has been a very clear disagreement between the Federal Circuit and the US Supreme Court in all areas of patentable subject from the computer cases, through to Prometheus. This Kat’s view is that the Federal Circuit has consistently had the better of the debate, and in no instance more clearly than this one. Is Prometheus a taste of what is to come in Europe once the CJEU has the last word in patent cases?

Here is more of this Kat’s take on the rule of against abstract claims, and on US subject matter jurisprudence.

10 comments:

MaxDrei said...

Norman writes:

"The claim at issue, which was held to be invalid, stated the optimal metabolite range, and instructed the physician to adjust the drug dosage accordingly."

but I had gathered that the claim merely requires the doctor to think about whether to change the dose. You still infringe, whether or not you adjust the dose.

Conversely, the granted EPO claim is directed to an in vitro test procedure.

Would Nestle have fared better at SCOTUS if they had been less ambitious with their claim form. 20 years of monopoly on an invention which adds a new thought to an old process (prescribing a dose of a drug) is a big ask of a panel of 9 individuals, all of whom have families, and all of whom want personalised medicine from a doctor who has read and assimilated all the newest scientific papers on optimising dosages of the drugs they are on.

Anonymous said...

From the report, I take it that Norman considers the Supreme Court decision to be flawed. I am not of the same opinion. The identifcation of an optimum range of metabolite (here between 230 and 400 pmol per 800 million red blood cells although 450 would still apparently infringe) is a simple discovery. Telling the world that if the concentration is too low it needs to be increased and likewise if too high needs to be decreased does not deserve patent protection however it is dressed up.

MaxDrei said...

Anon, is not the point that, prior to the invention, nobody knew that the measure of the optimal dose was to get the concentration of this particular designated metabolite into this particular numerical range.

I am supposing this to be a research finding that is invaluable to patients. I am supposing that patents are there to encourage investment in research to arrive at such invaluable findings. I am supposing there was something novel, enabled and not obvious here, so that the key to it was presenting a claim that would not have SCOTUS recoiling in disgust at the sheer greed of the Applicant. The crux issue was the breadth of the claim, was it not? Is breadth to be filtered out with 35 USC 101, or with some other statutory provision, like 112?

Or are you also against the claims issued by the EPO, in the parallel patent?

Norman said...

MaxDrei, I agree that it would be possible to frame a claim based on this discovery that would be valid; my sense is that the more closely it is tied to a specific embodiment, and preferably a tangible physical embodiment, the more likely it is to be valid. With that said, I'm not sure the granted EPO claim goes far enough. The in vitro test is routine, and I suspect it would be considered merely conventional post-solution activity.

More generally, the more closely the claim is tied to a particular embodiment, the easier it is to take the substance while avoiding infringement. Prometheus' problem is that once the optimal range becomes commonly known by doctors, a competitor that simply provides the metabolite test without indicating whether the results are within the optimal range, would enable doctors to use the information without either party infringing a claim such as the EPO claim. So even if the EPO claim were valid in US law, I'm not sure it would provide adequate protection.

I acknowledge that there is a problem with directing infringement actions at doctors for interpreting test results, but I don't think that a prohibition on patents based on discoveries is the appropriate response. If that problem is a serious one, it would be better to approach it directly, perhaps with something along the lines of the US exception for medical practioners 35 USC 287(c)(2)(A).

MaxDrei said...

Thanks for that, Norman. I'm not a chemist. What confuses me is that you say the test for this particular metabolite was old routine. Why were people paying for it, I wonder, if not to help them correlate with the dosage regime.

In that case, I'm not sure that running the stats to come up with 230 rather than 200, or 250, as the lower end of the range or 400 as the upper end rather than 375 or 425, is a big enough deal to justify a patent.

Hans Sachs said...

Dear Norman Kat:

If, as it seems, this decision makes you upset to the point of physical and/or mental distress, then I suggest that you have a treatable condition that should respond if you take two aspirin with two ounces of 80 proof single malt Scotch whisky every hour on the hour for four hours. It this is ineffective or induces negative side effects, increase the dosage by 1 aspirin and one ounce of Scotch whisky each hour until the discomfort of any negative side effects dissipates or until your illness is cured.

To save the IPKat from any liability, I should add that this is neither medical not legal advice. But if it were medical advice, it would surely be "patent pending" - at least according to your logic. If it were legal advice, the provider would either be the toast of the town or subject to disciplinary hearings.

Diego Teixeira said...

Although not the same thing as the dose-optimising patent at issue, it should be noted that there is empirical evidence medical diagnostics packs do quite well even without patents. The economic nature of the market for diagnostics tests means that competition based on quality, rather than price, helps keep good, reliable, firms afloat.

I am sure, therefore, that personalized medicine will do very well without the need for patents like the one at issue in this case. The damage from monopoly of a drug-optimising method is grossly disproportionate than fears of removing disincentives in this area - which research shows are ill founded, to repeat my main point.

MaxDrei said...

The distress amongst patent lawyers in the USA is mostly on the esoteric point that SCOTUS tainted its analysis of eligibility with considerations of novelty and obviousness. One supposes that briefings from patent lawyers immersed in English law were plentiful, but nobody told the Justices how the EPO sees eligibility.

Personally, I think the best medicine for patent law is the EPO line, in which novelty and obviousness is kept out of eligibility (35 USC 101 and Art 52, EPC). In other words, do novelty and obviousness relative to the state of the art but do eligibility first, on an absolute basis, without reference to the day-to-day situation with the state of the art.

Randall Rader, chief at the CAFC, is often in Munich and therefore, I guess, has absorbed the EPO line. But SCOTUS likes to disagree with the CAFC. Is this sort of squabbling what we might expect, if the CJEU gets to sit on top of DG3? If so, what a disaster for patent law in Europe.

Tim Roberts said...

For my money, Norman's is the best analysis of Prometheus to date. Nobody thinks you should be able to patent a 'law of nature'. The question is, whether you need a special provision in the law to do this, or whether normal rules of novelty already prevent it. I disagree with him only on the relatively trivial matter of whether the patent should have been granted or not. As far as I can see, the claim SCOTUS considered was to two physical steps known in combination, and an 'indicates' clause ['wherein a (particular result)'indicates a need' to (change or maintain the dosage rate)]. SCOTUS treated this clause as a third 'step'. But who takes it? The fact is that this claim does not distinguish from the prior art - the results obtained in the prior art 'indicate' in exactly the same way, the only difference is that we didn't know this before. Should you be able to stop someone doing something that's been done before on the basis that you've told them something new about it?

I agree entirely with MaxDrei about this decision as a portent. There is no reason to think the CJEU would do any better than the US Supreme Court.

Anonymous said...

Since Prometheus, we're all in a flap
The Supreme Court's decision is unsound?
Still, a new end in view
Doesn't make something 'new'
(Adhesive Dry Mounting v. Trapp)

(1910) 27 RPC 341

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