Re: Guest Post - (in honor of x trapnel)

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Abolishing software patents which should never have been allowed in the first place (and are not even clearly legal under current law) would be a good place to start.


Posted by: James B. Shearer | Link to this comment | 10-11-12 6:51 AM
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1. Agreed, in theory. But it would make a mess of the industry as currently organised.


Posted by: chris y | Link to this comment | 10-11-12 7:08 AM
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Is that really an important problem? I mean, disruptions happen, and this is a disruption to what seems like an incredibly counterproductive business model.


Posted by: LizardBreath | Link to this comment | 10-11-12 7:13 AM
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No drug company would ever develop anything if they couldn't patent it. It's too expensive to establish that something is safe and/or has some effect against a disease.

Theoretically the system could be replaced with a system where the FDA just gives "prizes" or "awards" instead of a temporary monopoly. In fact this is one of those things that economists are always babbling on about how obvious it is and how maddening it is that it hasn't happened yet.


Posted by: Cryptic ned | Link to this comment | 10-11-12 7:13 AM
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In fact this is one of those things that economists are always babbling on about how obvious it is and how maddening it is that it hasn't happened yet.

How irrational.


Posted by: heebie-geebie | Link to this comment | 10-11-12 7:14 AM
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At the moment, as far as I can see, patents ARE the business model. I'm in favour of junking them anyway, on balance, et ruat caelum.


Posted by: chris y | Link to this comment | 10-11-12 7:16 AM
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6 to 3.


Posted by: chris y | Link to this comment | 10-11-12 7:19 AM
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I agree with 1 and 3.


Posted by: Moby Hick | Link to this comment | 10-11-12 7:22 AM
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And 4, for reasonable values of "new" medication.


Posted by: Moby Hick | Link to this comment | 10-11-12 7:23 AM
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It's too expensive to establish that something is safe and/or has some effect against a disease.

Which is why, of course, some of them don't bother.


Posted by: nattarGcM ttaM | Link to this comment | 10-11-12 7:24 AM
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No drug company would ever develop anything if they couldn't patent it. It's too expensive to establish that something is safe and/or has some effect against a disease.

Simple, then. Bin all drug patents. Drug companies can continue to make money by selling drugs (there are successful generic-pharmaceutical companies out there already). Drugs become cheaper. With the immense savings that this will bring to the NHS, set up massive state-run drug research schemes.


Posted by: ajay | Link to this comment | 10-11-12 7:27 AM
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To what extent do drug companies do significant important research and development? My impression was that it's already the case that important research is predominantly government funded, while drug companies concentrate on finding ways to game the patent system by re-patenting old ideas. But I must admit I'm woefully uninformed about this issue.


Posted by: Unfoggetarian: "Pause endlessly, then go in" (9) | Link to this comment | 10-11-12 7:31 AM
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Agreed, in theory. But it would make a mess of the industry as currently organised.

I don't see this. Note I am not talking about abolishing software copyrights. Abolishing software patents would be bad news for investors in software patent portfolios but other than that I don't see much disruption. And there would be a lot of benefits.


Posted by: James B. Shearer | Link to this comment | 10-11-12 7:34 AM
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12: I honestly don't know, but I have a vague belief that while a lot of basic research, without which drugs couldn't be developed, is done in universities with government funding, the last mile of testing for safety and efficacy on large populations of people, which is very expensive, generally happens in drug companies. But there are probably four or five people here who know better firsthand.


Posted by: LizardBreath | Link to this comment | 10-11-12 7:35 AM
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My impression is that drug companies like, of course, to buy up other people's research. But the process of shepherding a drug through the massive FDA approval multi-stage testing extravaganza is certainly something they do, and it is something that costs an absolute fortune.


Posted by: redfoxtailshrub | Link to this comment | 10-11-12 7:35 AM
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12: In my experience, nothing much big happens without both. But the work I do is not immediately related to drug testing. It's work someone may use to test a drug.


Posted by: Moby Hick | Link to this comment | 10-11-12 7:38 AM
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13: I think the disruption would be that larger, older companies with money for lawyers and big banks of patents are now in a very strong position against small competitors, because they've got a plausible basis for a patent enforcement suit against anything new. Take away that advantage, and suddenly the big companies are instantly worth a whole lot less -- stock prices plummet.

I don't think this is bad enough to be worth avoiding, but it would be a huge shock. (Personally, it'd give Buck all kinds of fun stuff to write about, so for us it'd probably be a plus.)


Posted by: LizardBreath | Link to this comment | 10-11-12 7:38 AM
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In practice, I think "only fix it where it's obviously broken" is a good principle for the patent system - junk patents for business process and software, and reform drug patents, but don't abolish the system altogether.

But intellectually, it's an interesting question, because didn't patents get started in the UK right around the same time the Industrial Revolution did? Which means they could have greatly fostered it, or it could be a post hoc ergo propter hoc fallacy. Maybe industries took off purely because they became profitable, and could have stood up against imitators.


Posted by: Minivet | Link to this comment | 10-11-12 7:38 AM
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Important research into medications is not predominantly government funded. Almost every potential drug that we non-profit-motivated researchers come up with is established, after costly and boring work by drug companies, to not be useful as a drug, whether because it can't be made in sufficient quantities, because it can't be delivered to the right part of the body without unpleasant invasive injections, because of side effects, because people are the only animal it has no effect on, etc.

The big money goes into taking the drug from "molecule" to "pill with bioavailability", and particularly into trials in humans. Maybe governments would do fifty-million-dollar trials if companies could no longer do so, in theory.


Posted by: Cryptic ned | Link to this comment | 10-11-12 7:39 AM
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14: You know, if I just kept quiet every time I wanted to post something starting out "I honestly have no idea but I have a vague belief", I'd never have anything to say for myself.


Posted by: LizardBreath | Link to this comment | 10-11-12 7:39 AM
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I'm not really a patent lawyer, but my general view is that the connection between patents and innovation varies tremendously between fields. There's a strong case for abolishing software patents entirely and relying on copyright to offer the necessary protection (this makes basic sense to me, as what you're generally trying to protect with software is basically an expression made with a publicly-available language). Everyone I've ever heard from in this says that drug patents are absolutely necessary for R&D absent some kind of state socialism. I think that the whole business method patent experiment has been kind of a disaster. In other areas, there is industrial r+d driven by patentabity. It seems clear to me that the PTO has been handing out patents like candy for a long time, but of course the patent prosecution lawyers disagree.

Historically, I think the creation of the federal circuit was kind of a disaster. From about 1920-1980 we had what was (by most accounts) significantly greater R+D by industries, and that coincided with a period of relatively weak (but nonzero) enforcement of patent rights by the federal district and circuit courts (there used to be jokes: if the judge can understand it, it's obvious and nonpatentable). I think it's pretty clear that the system has now gotten way out of control, particularly in the tech industry, and I don't think it would take too much to unwind it, other than the renunciation of a bunch of bad federal circuit precedents. The problem is figuring out how to get there.


Posted by: Robert Halford | Link to this comment | 10-11-12 7:40 AM
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Bioavailability seems like the most frustrating hurdle for a lot of drugs. You may notice that they are doing great things with treatments for eye diseases, for example, gene therapy. This is because it's easy to apply drugs or siRNA or whatever you want to the eye, and also because the eye is limited in the amount that the immune system can screw up what you're trying to do.


Posted by: Cryptic ned | Link to this comment | 10-11-12 7:42 AM
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18: There are two slightly different benefits to the patent system. First, it gives an incentive to develop new patentable stuff, but it also bribes inventors to make their inventions public -- no more multigenerational secret technologies. I bet the second benefit had an effect at least comparable to that of the first, back when patent protection was instituted.


Posted by: LizardBreath | Link to this comment | 10-11-12 7:42 AM
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20: That's what I mostly do, and I'm usually no fun at all.


Posted by: Awl | Link to this comment | 10-11-12 7:44 AM
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Yeah, that's no good. We need more poorly supported, aggressively defended bombast around here. Halford and I can't do it all.


Posted by: LizardBreath | Link to this comment | 10-11-12 7:46 AM
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"Big company uses its patents to crush smaller upstarts" was actually a surprisingly little-used strategy (in part because of antitrust concerns) until fairly recently. The more traditional patent litigation was "tiny company/inventor you've never heard of with a patent sues big company with profitable business.". It does feel like there's been a shift in the very recent past (like, the last 5 years) to where large companies, particularly tech companies, are using their patents as offensive weapons. The recent FTC/DOJ investigation of Google for patent misuse is interesting and important here.


Posted by: Robert Halford | Link to this comment | 10-11-12 7:49 AM
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massive state-run drug research schemes

IMO this would be a huge step backwards.

Large state-run programs do not often admit failure publicly. The decisions about safety and efficacy of compunds are currently made under fairly clear (though not ideal) protocols of transparency. This transparency would disappear quickly if drug programs and treatment choices were the objects of contention between clever bureaucrat-MDs interested in status and next year's budget.

Drug development and testing is a complicated engineering process, and is going to get more complicated as assays of individual variation become cheaper and more routine. There are tradeoffs between reliability, cost, and speed (i.e, no way to optimize all three for any year's level of technology).

Discussing similar tradeoffs rationally for bridges and roads or public transport is apparently beyond us politically, so the discussion will surely go well now that the topic is life and death.

I've said here before: Most of the cost in the US is phase III, proof of efficacy for at least one condition. If lower costs are the goal, weaken that requirement and allow the possibility that some harmless but useless compounds will be marketed.

This is an unpopular idea, so in some number of years, I expect that useful novel compounds like Gleevec or CCR5 receptor antagonists will belong to Indian or possibly Chinese firms rather than to western ones, since these firms already operate in such a regulatory environment, and are currently limited by serving poor rather than rich patients.


Posted by: lw | Link to this comment | 10-11-12 7:49 AM
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Dean Baker on Patents


Posted by: X | Link to this comment | 10-11-12 7:51 AM
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Large state-run programs do not often admit failure publicly. The decisions about safety and efficacy of compunds are currently made under fairly clear (though not ideal) protocols of transparency. This transparency would disappear quickly if drug programs and treatment choices were the objects of contention between clever bureaucrat-MDs interested in status and next year's budget.

I don't understand this. You think that researchers paid by the government would have different incentives to claim that the drugs they're testing work when they really don't than they would if they were paid by industry? Break that down for me more?


Posted by: LizardBreath | Link to this comment | 10-11-12 7:51 AM
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X!


Posted by: LizardBreath | Link to this comment | 10-11-12 7:52 AM
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29: The government is watching over private companies as opposed to watching over itself. Thus it has an interest in keeping thing open that it would lack if everything were under one roof. At least I think that is lw's point and I agree with it. I suppose you could get around it with some sort of separation within the government, but there is enough history to indicate that you can't just assume it will work.


Posted by: Moby Hick | Link to this comment | 10-11-12 8:01 AM
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13: I think the disruption would be that larger, older companies with money for lawyers and big banks of patents are now in a very strong position against small competitors, because they've got a plausible basis for a patent enforcement suit against anything new. Take away that advantage, and suddenly the big companies are instantly worth a whole lot less -- stock prices plummet.

I think this is wrong, companies like IBM would not be hurt at all on balance. Big companies worry a lot about having to pay an exorbitant settlement because of some obscure patent that they inadvertently infringed.

Companies like IBM with lots of successful software products are in a strong position because it is so much trouble for their customers to change to a rival product. This holds as long as their competitors can't simply copy their products and copyright protection is enough to prevent that.


Posted by: James B. Shearer | Link to this comment | 10-11-12 8:02 AM
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The decisions about safety and efficacy of compunds are currently made under fairly clear (though not ideal) protocols of transparency.

They really aren't; there are massive problems with drug companies failing to publish all their clinical trial results. Compare, for example, the comparatively good record of something like NICE.


Posted by: ajay | Link to this comment | 10-11-12 8:03 AM
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Say what you will about the drug industry, it is a hotbed of "creative destruction". And it's really true that a lot of the braindead drug prescribing that goes on is the fault of lazy doctors who don't know what things cost or what all the options are.

Drug advertising should be curtailed, of course.


Posted by: Cryptic ned | Link to this comment | 10-11-12 8:03 AM
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Apart from anything else, the results of trials by a government agency would be accessible under the Freedom of Information Act.


Posted by: ajay | Link to this comment | 10-11-12 8:07 AM
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29.
Yes, different incentives. Currently the mechanisms for mandatory sharing of results with the FDA are strong. Less strong but nonzero for subsequent sharing with the public at large, including competitors.

Not a great system, but worst-case outcome is still pretty good.

How well do internal conflicts at your agency usually work out? How about conflicts over public goods, like water, where costs and benefits are clear and we understand basically everything relevant? Basically, I am pessimistic about solving problems this charged and complicated behind closed doors, which is what I strongly believe would happen. (the problems: which compounds to release? How to allocate finite resources to exploring many candidate molecules?)

There is no magic bullet of a solution.

Yes, drug company marketing drives up costs. I do not see this as the central problem in making new treatments available.


Posted by: lw | Link to this comment | 10-11-12 8:07 AM
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26, 32: Yeah, I don't know much about this issue on any serious level, I just know that I've seen the 'startup crushed by patent litigation' story a lot.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:08 AM
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Furthermore, there are entire fields of research that are already government funded. Does CERN have a massive problem with transparency because the LHC beamline experiments are "the objects of contention between clever bureaucrat-DPhils interested in status and next year's budget"? Is this an issue at the Livermore Labs, or the Antarctic Survey, or NOAA?


Posted by: ajay | Link to this comment | 10-11-12 8:09 AM
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33: In the U.S. at least, that is no longer true. The negative trials don't necessarily get published in a journal, but there is a central registry.


Posted by: Moby Hick | Link to this comment | 10-11-12 8:11 AM
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33. The FDA sees much more data than does the public, which public includes the company's competitors. In any case, I see FOIA as extremely adversarial and slow, in practice the equivalent of litigation.

Perhaps there's something I don't know. Can you point to instances of FOIA disclosure resulting in a good, collaborative decision in reasonable time, rather than being a bludgeon to force disclosure of clear abuse?


Posted by: lw | Link to this comment | 10-11-12 8:11 AM
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38: The largest physics experiments conducted by the U.S. government (i.e. the Manhattan Project) included some very untransparent, unethical medial research.


Posted by: Moby Hick | Link to this comment | 10-11-12 8:14 AM
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38.
Yes, IMO closed-door contentiousness and turf battles are huge problems in funding and executing big science.


Posted by: lw | Link to this comment | 10-11-12 8:15 AM
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36: What I'm not seeing is the incentive, at the individual researcher level, for unfortunate behavior. You're talking about 'transparency' -- how would the employees of government agency (with all sorts of explicit regulations about transparency) benefit from secrecy in any particular way, other than the basic "everyone, whoever they work for, wants to keep it secret when they screw up." (And I do work on FOIL litigation a fair amount, and I've seen agencies try to keep secrets. They're in a very bad position to successfully do that compared to private companies.)

I really don't understand on any concrete level what specific bad thing you expect agencies to do that drug companies don't.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:15 AM
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In practice, I think "only fix it where it's obviously broken" is a good principle for the patent system - junk patents for business process and software, and reform drug patents, but don't abolish the system altogether.

Worth mentioning one of the more contentious claims from the article:

Any patent system will inevitably grow more and more restrictive over time. In the abstract, it should be possible to balance all these competing concerns. Boldrin and Levine concede that a well-designed patent system would be preferable to abolishing patents altogether. But, they insist, it's impossible to have a well-designed system. That's because as soon as the government starts granting patents, it creates a system that is bound to metastasize and grow more restrictive until it throttles innovation.

Why is that? Established companies with patents have an interest in maintaining their hold on intellectual property, so they start lobbying lawmakers for stronger protections. Since they have more money than start-ups, the pro-patent lobbyists usually win out. Meanwhile, patent offices and patent lawyers have a vested interest in granting ever more patents--even trivial ones--and seeing more litigation.

I don't have a good sense of whether that is true or not. I feel like The Master Switch might be relevant, but I didn't actually read it.


Posted by: NickS | Link to this comment | 10-11-12 8:18 AM
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39: OK, I did not know that. Not the case over here, see:
http://www.guardian.co.uk/business/2012/sep/21/drugs-industry-scandal-ben-goldacre


Posted by: ajay | Link to this comment | 10-11-12 8:19 AM
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44: I mean, if the goal is for research to be publicly released, you put that in the law and regulations governing the agency. Individuals within an agency can work on evading those regulations, but it's unclear to me what you think their incentives are for doing so.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:20 AM
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Yes, IMO closed-door contentiousness and turf battles are huge problems in funding and executing big science.

No doubt. But that wasn't my question. Have these things led to negative results being suppressed?


Posted by: ajay | Link to this comment | 10-11-12 8:22 AM
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38

Furthermore, there are entire fields of research that are already government funded. Does CERN have a massive problem with transparency because the LHC beamline experiments are "the objects of contention between clever bureaucrat-DPhils interested in status and next year's budget"? Is this an issue at the Livermore Labs, or the Antarctic Survey, or NOAA?

I think there are problems, there are strong incentives to hype your results and future prospects so as to preserve your funding stream. So for example you have a lot of money for what appears to me to be an ill-advised tokamak fusion facility.


Posted by: James B. Shearer | Link to this comment | 10-11-12 8:23 AM
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you put that in the law and regulations governing the agency

In my experience, it needs to be in another agency. Clear distinction between watch-dog and investigator is the key from what I've seen.


Posted by: Moby Hick | Link to this comment | 10-11-12 8:24 AM
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The passage quoted in 44 is wrong, historically. As I said, the US had a fairly weak patent regime (in practice) by international standards for almost the entire 20th century, until the late 1970s. The changes since then haven't really been driven by statutory law, but mostly by a court most people have never heard of, the Federal Circuit, and to a lesser extent by the PTO. There's no reason why the patent system couldn't get back to its pre-1975 levels, and indeed AFAICT the pendulum is swinging in the other direction right now.


Posted by: Robert Halford | Link to this comment | 10-11-12 8:25 AM
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what appears to me to be an ill-advised tokamak fusion facility.

essear? Comments?


Posted by: ajay | Link to this comment | 10-11-12 8:26 AM
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43

I really don't understand on any concrete level what specific bad thing you expect agencies to do that drug companies don't.

The profit motive does provide some incentive not to waste money pursuing ideas that are unlikely to pay off (like tokamak fusion).


Posted by: James B. Shearer | Link to this comment | 10-11-12 8:28 AM
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46. If a mistaken opinion leads to fame and power, is it fraud or optimism? Nobody will call you on it if you do it right. Andrew Wakefield and Jan Schon both overreached. Similar behavior on a more moderate scale is much harder to prove to be definitively fraudulent.

An example from the past is Langley, who competed unsuccessfully with the Wright brothers but preserved his budget very nicely. I am not that eager to slam current or recent large projects that went badly.


Posted by: lw | Link to this comment | 10-11-12 8:30 AM
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So does the culture of science.


Posted by: ajay | Link to this comment | 10-11-12 8:31 AM
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47: For myself, I wouldn't worry about negative results being suppressed more than in the current system. I'd worry about the tendency to turn research dollars into program evaluation or quality improvement or something to fill other shorter term goals. From what I've seen, that's what government officials want to do with me. It's not bad or anything, but it won't advance science very fast.


Posted by: Moby Hick | Link to this comment | 10-11-12 8:31 AM
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52: It also provides incentives to pursue drugs that will be profitable but functionally worthless. Not that that's an insurmountable problem, but there are problems in both directions.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:33 AM
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I'd worry about the tendency to turn research dollars into program evaluation or quality improvement or something to fill other shorter term goals. From what I've seen, that's what government officials want to do with me. It's not bad or anything, but it won't advance science very fast.

In the private sector, though, those research dollars would be turned into advertising budgets (bigger than R&D spend for a lot of pharma companies). Swings and roundabouts, Moby.


Posted by: ajay | Link to this comment | 10-11-12 8:33 AM
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Above comments about costs borne in (particularly phase III) trials are true. The dirty little secret about this, though, is that the list price of such trials is really inflated. The system only works because of the possibility of massive margins when you get approval to market.

This is part of the reason that the US overpays for health care by something like 2x to 4x overall. Everyone in the system (barring consumers) is happy because they all have their hands in the same till.

The same level of confidence in efficacy and safety could almost certainly be provided for a small fraction of the current cost, but far fewer people would be getting paid along the way.


Posted by: presidentially | Link to this comment | 10-11-12 8:39 AM
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57: Drug adverts (or was it just the TV ones) used to be outlawed here. It was indeed better, especially for doctors, but not just for them.

I have long and continuing experience with working in research directly for a government agency. It is very a very different environment from a university, where you might be funded by the government but are not directly in the government. The culture is completely different in the government and different in ways that make it harder to do research openly. You have to go out of your way to deal with various minor officials in order to share information of the sort that, when I'm wearing my university hat, gets emailed without a second thought. The hierarchy, especially once you touch a piece of plastic that IT can claim, is much harder to deal with and the amount of time spent dealing with bureaucracy is three or four times higher.


Posted by: Moby Hick | Link to this comment | 10-11-12 8:42 AM
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The profit motive does provide some incentive not to waste money pursuing ideas that are unlikely to pay off (like tokamak fusion).

My understanding that that not having money to pursue ideas that are unlikely to, but might, pay off is a much bigger problem in science, whether publicly or privately funded, than wasting money on those ideas is. Research grants tend to be given to likely winners.


Posted by: Ginger Yellow | Link to this comment | 10-11-12 8:44 AM
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Abolishing software patents which should never have been allowed in the first place (and are not even clearly legal under current law) would be a good place to start.

How about hardware (ME/EE, etc.), too? My company has only avoids being sued by your former employer because we have defensive patents that would force a settlement. Every once in a while we get involved in a lawsuit with another hardware company because they think they can crush a tiny little company like us easily. Because everything in the world in patented (and considered non-obvious, no matter how obvious), they always have grounds for a non-frivolous lawsuit. For the same reason, it's inevitable that they're infringing on some of our patents, too, so there's a settlement, after we spend tens of millions of dollars on lawyers.

I suppose this is actually a good strategy for large companies, because $10M is nothing for a large company, but a significant expense for us, and the end result seems to always be a cross-licensing agreement, which is basically worthless for both parties.


Posted by: sral | Link to this comment | 10-11-12 8:48 AM
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where you might be funded by the government but are not directly in the government.

Not directly in the government is a slippery concept there, particularly if you're talking about a public university (which I haven't heard described as particularly different research environments than private universities).

If we wanted a publicly funded system of drug development, we could do it through funding university research rather than by employing researchers at a federal agency directly, but that would still be government rather than privately funded research.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:49 AM
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negative results being suppressed?

Again, I think Langley is an instructive example. The Wright brothers didn't need much money to fly; what if they needed grants? Publishing against the ideas of powerful people is career-damaging. The negative results are not a file that's burned, it's a quiet explanation that some paper just isn't worth writing. At the margin, this is benign advice, and there's a huge grey area before it becomes vindictive or fraudulent.

58. Possibly, but why hasn't any other country cleaned up by putting such a system into operation?


Posted by: lw | Link to this comment | 10-11-12 8:50 AM
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If we wanted a publicly funded system of drug development, we could do it through funding university research rather than by employing researchers at a federal agency directly, but that would still be government rather than privately funded research.

This.


Posted by: ajay | Link to this comment | 10-11-12 8:51 AM
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The Wright Brothers are indeed an instructive example but not for the reason you think - the US invented the aeroplane but then fell behind because the Wrights turned into, essentially, massive patent trolls.


Posted by: ajay | Link to this comment | 10-11-12 8:53 AM
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60

My understanding that that not having money to pursue ideas that are unlikely to, but might, pay off is a much bigger problem in science, whether publicly or privately funded, than wasting money on those ideas is. Research grants tend to be given to likely winners.

I have my doubts. Obviously you want to direct research money to maximise returns. Possibly funding more low probability high return research would do this but this isn't clear to me. And you have to distinguish between say 1 in a thousand shots and 1 in a million shots.


Posted by: James B. Shearer | Link to this comment | 10-11-12 8:54 AM
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Because if it's a one in a million shot, that means it always pays off. Shorter odds, not so much.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:56 AM
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65: someone ought to have given them some investment capital. Maybe if Bain had been around back then . . .


Posted by: text | Link to this comment | 10-11-12 8:56 AM
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Publishing against the ideas of powerful people is career-damaging.

Or career making, depending on who turns out to be right.


Posted by: LizardBreath | Link to this comment | 10-11-12 8:56 AM
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I'm really encouraged that this discussion is asking the right question: how do you arrange the funding, and should it be state-directed or through a property right, and what are the costs and benefits of the different kind of funding. It's encouraging that people don't think drug research can be usefully provided forever by kickstarter fundraisers and amateur hobbyists.


Posted by: Robert Halford | Link to this comment | 10-11-12 8:57 AM
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I'm really encouraged that this discussion is asking the right question: how do you arrange the funding, and should it be state-directed or through a property right, and what are the costs and benefits of the different kind of funding. It's encouraging that people don't think drug research can be usefully provided forever by kickstarter fundraisers and amateur hobbyists.


Posted by: Robert Halford | Link to this comment | 10-11-12 8:57 AM
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I'm really encouraged that this discussion is asking the right question: how do you arrange the funding, and should it be state-directed or through a property right, and what are the costs and benefits of the different kind of funding. It's encouraging that people don't think drug research can be usefully provided forever by kickstarter fundraisers and amateur hobbyists.


Posted by: Robert Halford | Link to this comment | 10-11-12 8:57 AM
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God damn it.


Posted by: Robert Halford | Link to this comment | 10-11-12 8:59 AM
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God damn it.


Posted by: Robert Halford | Link to this comment | 10-11-12 8:59 AM
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75

Is there a drug for triple vision?


Posted by: Von Wafer | Link to this comment | 10-11-12 8:59 AM
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But I repeat myself.


Posted by: JP Stormcrow | Link to this comment | 10-11-12 8:59 AM
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77

Followed by double vision? Somebody heal me!


Posted by: Von Wafer | Link to this comment | 10-11-12 8:59 AM
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78

Possibly, but why hasn't any other country cleaned up by putting such a system into operation?

Actually, several countries do a better job of this.
None perfect, but in general we could learn a lot from France, some of what the UK does, Germany. Canada has some good ideas too, but not very efficient either.

However a problem comes up in analysing this sort of thing. The US market is so big, and so inefficient, that it basically distorts the development and regulatory efforts of most companies, most places in the world. It is lucrative enough that it is very difficult to decide not to make it a/the primary target.

(caveat: I'm much more familiar with the device side than pharma, particularly outside of US)


Posted by: presidentially | Link to this comment | 10-11-12 8:59 AM
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79

Obviously you want to direct research money to maximise returns.

If you mean financial returns, absolutely not.


Posted by: Ginger Yellow | Link to this comment | 10-11-12 8:59 AM
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61

How about hardware (ME/EE, etc.), too? ...

I find software patents particularly egregious because the courts could (and should in my opinion) have thrown them out from the start (as unpatentable). As I understand it they have never been ratified by the Supreme Court but of course the court will be reluctant to toss them all out at this point.


Posted by: James B. Shearer | Link to this comment | 10-11-12 9:02 AM
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81

Just the place for a Snark! I have said it thrice: What I tell you three times is true.''


Posted by: The Bellman | Link to this comment | 10-11-12 9:02 AM
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77: Followed by double vision? Somebody heal me!

PUT IN YOUR EARPLUGS, PUT ON YOUR EYESHADES, YOU KNOW WHERE TO PUT THE CORK.


Posted by: OPINIONATED TOMMY | Link to this comment | 10-11-12 9:02 AM
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70 had me convinced, but 71 and 72 made me reconsider.


Posted by: Walt Someguy | Link to this comment | 10-11-12 9:03 AM
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62: That's not far from what we have, except for the final trials.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:03 AM
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funding University research

In the US, research grants belong to the University, which takes a cut of at least 50% for overhead, more at very good universities, not to the professor. This is often a problem for people changing jobs or wanting to collaborate with companies that like their research, because they need approval from the University's attorneys.

Public funding works well for some problems, might for a modification of this one. But dropping the existing problem onto the existing structures would be disastrous as far as I can see.


Posted by: lw | Link to this comment | 10-11-12 9:04 AM
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65: They're from Dayton. What do you expect?


Posted by: Moby Hick | Link to this comment | 10-11-12 9:04 AM
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79

If you mean financial returns, absolutely not.

No I mean returns to society as a whole.


Posted by: James B. Shearer | Link to this comment | 10-11-12 9:05 AM
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69

Or career making, depending on who turns out to be right.

Being right often isn't enough.


Posted by: James B. Shearer | Link to this comment | 10-11-12 9:07 AM
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No I mean returns to society as a whole.

In that case, the pharma industry is largely working on the wrong problems, as is the med. dev. industry.


Posted by: presidentially | Link to this comment | 10-11-12 9:07 AM
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90

Can we all agree that passing the substance of the following, an innovation in Indian patent law bitterly contested by pharma on a near-constant basis, would do a lot of good?

The following are not inventions within the meaning of this Act:-

...

the mere discovery of a new form of a known substance which does not result in increased efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

39: See the BMJ - despite the law, only 20% of phase 2, 3, and 4 trials for which reporting was mandatory had results reported to the registry within a year of completion.


Posted by: Minivet | Link to this comment | 10-11-12 9:07 AM
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we could do it through funding university research

If Unfogged is going to devise a glorious new research funding model, allow me to advocate for one that doesn't turn researchers into full time grant writers.


Posted by: AcademicLurker | Link to this comment | 10-11-12 9:10 AM
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86: 65: They're from Dayton. What do you expect?

My mother is from Dayton, you blackguard!


Posted by: JP Stormcrow | Link to this comment | 10-11-12 9:12 AM
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90.last: They also said that an undetermined number of those didn't have to be reported until two years. But, yes, the negative results will get there slower. They don't get cited and don't get into good journals (usually), so the incentive is to put the write-up at a lower priority.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:13 AM
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92: As long as she doesn't hold any patents, it will be fine.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:14 AM
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91 seems impressively wrongheaded. "Hi, we're from the government. We'd like to back up this dump truck full of cash and unload it into your biochemistry department so you can research interesting problems that will improve the lot of humanity."
"Great! ...waitaminute, does this mean we have to do paperwork?"


Posted by: ajay | Link to this comment | 10-11-12 9:14 AM
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95 seems to miss the "full time" part, i.e. the key point.


Posted by: | Link to this comment | 10-11-12 9:16 AM
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Do y'all think the Wright Brothers would have found that investment capital if Bain had an office in Kitty Hawk?


Posted by: text | Link to this comment | 10-11-12 9:16 AM
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But maybe Bain has an office in Kitty Hawk now.


Posted by: text | Link to this comment | 10-11-12 9:16 AM
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I would agree that 90 sounds like a great idea, under the assumption that it makes sense from a chemistry point of view (that is, that you can draw a reasonably sensible line between things that are 'the same substance' and things that aren't, even if it's imperfect).


Posted by: LizardBreath | Link to this comment | 10-11-12 9:27 AM
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I've never understood why, other than the reluctance of judges to get involved in matters technical, the nonobviousness prong has been construed so as to make it basically irrelevant. I get it that a lot of things look "obvious" in retrospect that didn't seem obvious at the time, but it's that prong that's supposed to distinguish between genuinely "new" ideas that are worthy of protection and disclosure and attempts to use the patent system to aggressively protect minor tinkering.


Posted by: Robert Halford | Link to this comment | 10-11-12 9:28 AM
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other than the reluctance of judges to get involved in matters technical

I think that's it -- that the advance of technology has made it much easier to snow non-technical people about what's obvious to anyone that understands the field at all, and judges, while clever people generally, are usually very non-technical.


Posted by: LizardBreath | Link to this comment | 10-11-12 9:32 AM
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95 seems to miss the "full time" part, i.e. the key point.

I'm not sure why an expansion of government funding would lead to more application writing per researcher rather than an expansion of the number of researchers with the same amount of application writing being done by each one. But IANAA, so please feel free to correct me.


Posted by: ajay | Link to this comment | 10-11-12 9:33 AM
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100

I've never understood why, other than the reluctance of judges to get involved in matters technical, the nonobviousness prong has been construed so as to make it basically irrelevant. ...

I think this is evidence for the proposition that patent regimes tend to get more inclusive over time driven in this case by the collective interest of the patent bar.


Posted by: James B. Shearer | Link to this comment | 10-11-12 9:34 AM
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And does this mean that we could make academic researchers' lives much easier by giving them less funding?


Posted by: ajay | Link to this comment | 10-11-12 9:34 AM
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with the same amount of application writing being done by each one

We are already in a situation where in some areas at least, grant writing quickly becomes your primary effort, in significant cases essentially the only effort (plus the associated lobbying) of the then inaccurately named "PI".

I read 91 as saying "let's fix that".


Posted by: presidentially | Link to this comment | 10-11-12 9:37 AM
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Don't forget the possibility that current funding levels are perfectly tuned for optimal outcomes!


Posted by: redfoxtailshrub | Link to this comment | 10-11-12 9:37 AM
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I read 91 as saying "let's fix that".

Yes, despite what you might think from 106, me too.


Posted by: redfoxtailshrub | Link to this comment | 10-11-12 9:38 AM
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105: but would more money actually change that for the worse?


Posted by: ajay | Link to this comment | 10-11-12 9:41 AM
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I'm not sure why an expansion of government funding would lead to more application writing per researcher rather than an expansion of the number of researchers with the same amount of application writing being done by each one. But IANAA, so please feel free to correct me.

The non-hypothetical 1990s expansion of government funding in the US led to an expansion of the number of researchers, combined with an increase in the amount of application writing done by each one.


Posted by: Cryptic ned | Link to this comment | 10-11-12 9:43 AM
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Government money replacing private money would certainly make the paperwork worse. I view that as somebody else's problem a reasonable trade for more money.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:44 AM
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I'm just going by the recent history of NIH funded research, but the pattern seems to be:

1. NIH expands it's extramural research budget by X%

2. Universities immediately expand the research operations by more than X%, including expensive new buildings, many new hires & etc.

3. University planners assume that the NIH budget will continue to rise at an ever increasing pace indefinitely and plan accordingly, so that university research faculty numbers increase by a great deal more than X%

4. The rate at which grants are successfully funded drops precipitously, since the number of would be fundees grew much more rapidly than the funding

5. Researchers respond by writing ever more grants in hopes that if they throw enough proposals at the agency at least one might get through.


Posted by: AcademicLurker | Link to this comment | 10-11-12 9:45 AM
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It seems like you could maintain the private drug industry if you switched from patents to lump sum invention prizes for commercializing cool new drugs. Private companies would certainly pursue those, and you would have whatever advantage you wanted of decentralized private actors doing the commercialization stage. You might or might not want to link the prize to drug sales -- it seems like the link between profits and the number of sales is way more problematic in pharma than in other areas of private business.


Posted by: PGD | Link to this comment | 10-11-12 9:47 AM
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111: in short, universities are terrible managers. OK, thanks...


Posted by: ajay | Link to this comment | 10-11-12 9:48 AM
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Is there actually planning at the university level? I don't know anybody in the higher levels, but it sure doesn't look planned to those sitting on the bottom.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:49 AM
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4 to 112.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:50 AM
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113,114: it's more complicated than that even, when you start talking "centers of excellence" and the N-? level funding agencies.


Posted by: presidentially | Link to this comment | 10-11-12 9:53 AM
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I think maybe I'm in a center of excellence. I know I'm part of a center and we keep getting money so I assume we're excellent.


Posted by: Moby Hick | Link to this comment | 10-11-12 9:55 AM
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Today's SMBC is on point.


Posted by: LizardBreath | Link to this comment | 10-11-12 9:57 AM
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114

Is there actually planning at the university level? I don't know anybody in the higher levels, but it sure doesn't look planned to those sitting on the bottom.

There is a pretense of planning as when Summers cost Harvard a billion dollars "hedging" their interest rate exposure.


Posted by: James B. Shearer | Link to this comment | 10-11-12 9:59 AM
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118. Yeah, also Newton was the kind of guy IRL who would totally have done that if he could.


Posted by: chris y | Link to this comment | 10-11-12 10:08 AM
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The plan is to make a list of billionaire alumni and send out legions of young attractive beggars after them.


Posted by: peep | Link to this comment | 10-11-12 10:11 AM
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||
Colton car update: We raised $2,865! I'm going ahead with car research so I'll be prepared to buy something as soon as he gets his head a little more together.

My priorities for the money will be car, prepaid insurance for a year, replace windshield wipers, etc., as needed, gas card, LED license place holder. It won't be a panel van, so no airbrushing, I think.

I have a couple of knowledgeable people here to consult, but if anyone has any specific advice, I'd be happy to receive it via e-mail. ("Specific" meaning models that will be tough to find used parts for, a bad year for a particular model that otherwise might be a good choice, a website you've found to have reliable assessments of the kind of beater we're talking about, etc.)
|>


Posted by: Sir Kraab | Link to this comment | 10-11-12 10:28 AM
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Truck Nutz?


Posted by: LizardBreath | Link to this comment | 10-11-12 10:33 AM
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I'm hopeful we can fanute the coupe to that ghost, dog.


Posted by: M/tch M/lls | Link to this comment | 10-11-12 10:50 AM
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119 isn't so much "planning" at the university level, it's just a (bad) decision related to endowment/portfolio management.


Posted by: Nathan Williams | Link to this comment | 10-11-12 11:02 AM
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125

119 isn't so much "planning" at the university level, it's just a (bad) decision related to endowment/portfolio management.

The swaps were connected with ambitious construction plans so not just bad portfolio management. See here .


Posted by: James B. Shearer | Link to this comment | 10-11-12 11:13 AM
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A question for the legal folks around here: is this statement as strong as it sounds, and is it generally applicable?

"To establish a sufficiently strong causal nexus, Apple must show that consumers buy the Galaxy Nexus because it is equipped with the apparatus claimed in the '604 patent--not because it can search in general, and not even because it has unified search"

That certainly doesn't seem to be the standard that's been used in any of the suits my company has been involved in.

Here's the entire (PDF) ruling


Posted by: sral | Link to this comment | 10-11-12 12:29 PM
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That's a ruling about whether Apple can get a preliminary injunction on sales of Samsung products, not on whether there's infringement in the first place. I don't know what suits your company has been involved in (or when) but the rules about when you can get an injunction in patent matters has tightened a lot recently -- until about 5 years ago you could get an injunction almost automatically upon a showing of likelihood of infringement (or infringement); that's no longer the case.


Posted by: Robert Halford | Link to this comment | 10-11-12 12:44 PM
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Also topical: patented beans.


Posted by: Moby Hick | Link to this comment | 10-11-12 1:11 PM
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128: Thanks, that makes sense.


Posted by: sral | Link to this comment | 10-11-12 1:12 PM
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