6 ms·

I doubt sparkie wants the federal government to hoard the patents it pays for. I'm guessing he or she would like to see findings not patented at all.

sliverstorm 13y ago
You've seen how well our patent system works. If the findings were not patented by somebody, Big Corp. would just download the whitepaper, print it, submit it to the patent office and get the patent.
- fnordfnordfnord 13y ago
  An un-patent then, ie anybody can use this thing that taxes paid to develop.
  - 1457389 13y ago
    So let's say I discover a potentially groundbreaking new pathway that can be exploited by a new drug candidate to attack a major disease. Now who is going to go put in $350 million to get that drug candidate through PhI/II/III and beyond, with little guarantee of success, if they have no IP protection to stand on? Why would any rational investor fund such an endeavor when anyone else can step in once all the hard work (averaging $5 billion per successful drug) is done and reap the rewards?
    - benrapscallion 13y ago
      This is indeed the scenario in drug development. Academic research can only take it so far. Someone then has to assume financial risk and bring academic findings to the clinic.
      - 1457389 13y ago
        True, but what is the fundamental problem in allowing academics to patent their drug development research? Without a system like that drugs like Lyrica wouldn't exist.
        dnautics 13y ago
        >Without a system like that drugs like Lyrica wouldn't exist. You don't know that for sure. On the other other hand we do know things, like without the open source ethic Wikipedia wouldn't exist.
        1457389 13y ago
        Come on you can't compare web development to drug development. Ditto with the guy talking about polio. With the current regulatory landscape we need patent protection to incentivize anyone entering this industry. And even then you have CEOs of major biotech firms calling startups a delusional risk given the low probability of success.
        dnautics 13y ago
        Patenting is unneccessary. It also causes a lot of problems like siloization and reduplication of effort, which adds to the cost of drug R&D. The structure of the academic-science-industry complex has become so distorted that I'm not sure CEOs of biotech firms are the most competent people to be developing drugs. Ask any PhD (even those who are in the industry) about what they think of how pharma picks what to put into their pipelines, and you will nearly unanimously get a dispirited answer that is some combination of herd behavior, lack of creativity, legal departments, CYA, and just plain dumb business management. An example: Pfizer closed down their Lansing michigan plant and wanted to force their employees to relocate to San Diego, without doing a real analysis of the decision, and on the eve of the move came to find out that the one person running their fermenter culture system didn't want to move - he wanted to raise his daughters on a farm and San Diego was too expensive for his pay grade. So they lost the ability to basically do every bioassay that they were doing in Lansing. Three years later, I had the opportunity to work next to the massive san diego pfizer campus. The facility was 2/3 empty and pfizer was struggling to find extra tenants and toying with a 'bio-incubator' idea. http://indysci.org/projectmarilyn http://indysci.org/projectmarilyn
    - dnautics 13y ago
      Polio Vaccines. Unpatented.
      - ganeumann 13y ago
        That was a bit of a simpler time, approval-wise. After animal tests Salk first tested the polio vaccine on himself, then on his wife and children. Soon thereafter he tested on a group of children from the Polk State School for the retarded and feeble-minded. Then he lobbied for permission to do mass tests. So, a few things: 1. this testing environment would not fly today, as it should not have then. Testing on children who may not have the ability to give informed consent is unethical. 2. polio was the most dreaded disease in America, for many reasons. More people contributed to the development of a treatment--through the March of Dimes--than for any other disease up to that time. Even though the vaccine was feared and widely known, the mass tests were fiercely opposed by some. When the positive results of the test were announced, the nation treated the news much like the end of a war with exultation, presidential awards, and ticker-tape parades. 3. the polio vaccine was relatively safe and straightforward, as killed vaccines generally are. The killed vaccine was first tested in culture to make sure it was dead. Unlike many other pharmaceuticals, where the effectiveness even after a test can be murky and side-effects abound, a killed vaccine is relatively easy to understand. Testing a drug that may lessen the impact of a particular type of cancer is considerably harder, both in itself and because of today's protective regulations. 4. the polio vaccine was developed by a very small team run by a zealot. The resources required were considerably less than the resources required to develop other drugs. Look at the development of the sulfa drugs for a counter-example: Bayer delayed their widespread release even after they had concluded they were effective and patented them because they wanted to make sure their patent was valid (source: "The Demon Under the Microscope", by Hager.) Bayer had spent a lot of time and money developing the drugs and wanted to make sure they got a return. (Ironically, it was quickly realized that the patented sulfa drugs were in fact a combination of active and inactive parts and the active parts could not be patented; and soon after penicillin was introduced, sidelining the sulfa drugs. It's a fascinating story, well worth the read.) Source for info about Salk: the excellent "Splendid Solution: Jonas Salk and the Conquest of Polio" by Kluger.
        13y ago
    - betterunix 13y ago
      "Now who is going to go put in $350 million to get that drug candidate through PhI/II/III and beyond, with little guarantee of success, if they have no IP protection to stand on?" You, as the final stage of your research, using government money.
      - throwawaykf03 13y ago
        What most people are missing here is that government money only gets you as far as the discovery, and that's if you're lucky enough to, you know, discover something. More likely, you run out of money with nothing to show. I have no cites handy, but the success rate of drug R&D is pretty darn low. Say you do get something. Now you want the government to also be involved in the commercialization of the discovery? I think people would argue they are already involved enough, what with the FDA and all. Further: the person making the discovery spent half a decade of their lives after college to get a PhD, and very likely many years of post-doc, to be extremely specialized in an extremely narrow area of some field. Now you want them to be product managers and manufacturers and businessmen as well? This is one problem patents solve: Division of labor. Let those who are good at science and technology do their thing, and let people who are good at commercializing do their thing, and let IP ensure one both sides have means to reap appropriate rewards.
HarryHirsch 13y ago
You can argue that anything done at a university was done with university facilities (and certainly by the individual researchers). You can also look at it from the angle of efficiency (which way of commercializing a university's research is the best way of doing more research there). Congress did both, and they came up with Bayh-Dole. I'm not saying that this is the best environment, but it is the environment that we have, and these arguments are not outrageous. Besides, this is the environment that biotech startup are coming from, and top universities are making big dollars from royalties. That's why I said that it's really complicated.
- cowsandmilk 13y ago
  Universities charge the government for use of their facilities. It is an overhead rate often of 60+% on top of the costs of paying researchers, buying lab supplies, etc. Frequently there is triple dipping, where a university gets a grant for a piece of equipment, charges the grants directly for use of that equipment, then also claims they need to be paid in the overhead for making the equipment available. Anyone familiar with the finances sees it as ridiculous.
  - Loughla 13y ago
    From my (albeit limited) experience in two large state universities, one of which with a direct focus on research, and two much smaller local colleges, your statement is a bit inflammatory, and isn't 100% accurate. All grants are allowed to charge indirect costs to the grant fund. These indirect costs are used to cover the cost of facilities, maintenance and all the little bits that no one ever thinks about. No one buys a piece of equipment expecting there to be no maintenance whatsoever. These indirect costs are always governed by an agreed-upon rate set between the host institution and the funding entity. The federal government in particular has very clearly spelled out rules regarding this. For example - the grant that funds my work right now has a very clearly legislated indirect cost rate of 8%. If our indirect costs exceed that 8% monthly, we can lose our funding. Now where we get into the part where you're not 100% accurate, and I believe being a bit inflammatory is the triple dipping. Institutions can get a grant to purchase equipment, and then charge the same grant for the use of the equipment. The institution can charge for the personnel hours that run the equipment on related projects, they can charge that indirect cost that we discussed earlier, but that's about it. It's not as if they can just make up a number and charge the government that much to use the equipment for related projects. There are circulars from the Office of Management and Budget that dictate what you can and can't do with your money - for example, colleges and universities have to adhere to the cost principles outlined in OMB A-21, available here: http://www.whitehouse.gov/omb/circulars_a021_2004 http://www.whitehouse.gov/omb/circulars_a021_2004 if you want some light reading. On top of the basic OMB circulars, all federal grants have additional legislation that add further stipulations to how money can be spent, but come from any number of 1000 sources, so I'm not going to cite them. Anyway, the institution cannot just charge the government for use of the equipment. Secondly - they are not paid 'overhead' for making the equipment available. They are paid an indirect cost rate to maintain, store and generally keep the facility running for grants. This rate is very clearly spelled out in any grant documents. I've not seen 60+% in any grant I've ever worked with. In smaller institutions they tend to be around 10-20%. On the larger campuses, the average indirect rate was 32%. Anyone familiar with the finances know that there are legislation and regulation in place to dictate all of this, and while it may be convoluted, it's really not as predatory as you make it out to be.

sliverstorm 13y ago

You've seen how well our patent system works. If the findings were not patented by somebody, Big Corp. would just download the whitepaper, print it, submit it to the patent office and get the patent.

fnordfnordfnord 13y ago
An un-patent then, ie anybody can use this thing that taxes paid to develop.
- 1457389 13y ago
  So let's say I discover a potentially groundbreaking new pathway that can be exploited by a new drug candidate to attack a major disease. Now who is going to go put in $350 million to get that drug candidate through PhI/II/III and beyond, with little guarantee of success, if they have no IP protection to stand on? Why would any rational investor fund such an endeavor when anyone else can step in once all the hard work (averaging $5 billion per successful drug) is done and reap the rewards?
  - benrapscallion 13y ago
    This is indeed the scenario in drug development. Academic research can only take it so far. Someone then has to assume financial risk and bring academic findings to the clinic.
    - 1457389 13y ago
      True, but what is the fundamental problem in allowing academics to patent their drug development research? Without a system like that drugs like Lyrica wouldn't exist.
      - dnautics 13y ago
        >Without a system like that drugs like Lyrica wouldn't exist. You don't know that for sure. On the other other hand we do know things, like without the open source ethic Wikipedia wouldn't exist.
        1457389 13y ago
        Come on you can't compare web development to drug development. Ditto with the guy talking about polio. With the current regulatory landscape we need patent protection to incentivize anyone entering this industry. And even then you have CEOs of major biotech firms calling startups a delusional risk given the low probability of success.
        dnautics 13y ago
        Patenting is unneccessary. It also causes a lot of problems like siloization and reduplication of effort, which adds to the cost of drug R&D. The structure of the academic-science-industry complex has become so distorted that I'm not sure CEOs of biotech firms are the most competent people to be developing drugs. Ask any PhD (even those who are in the industry) about what they think of how pharma picks what to put into their pipelines, and you will nearly unanimously get a dispirited answer that is some combination of herd behavior, lack of creativity, legal departments, CYA, and just plain dumb business management. An example: Pfizer closed down their Lansing michigan plant and wanted to force their employees to relocate to San Diego, without doing a real analysis of the decision, and on the eve of the move came to find out that the one person running their fermenter culture system didn't want to move - he wanted to raise his daughters on a farm and San Diego was too expensive for his pay grade. So they lost the ability to basically do every bioassay that they were doing in Lansing. Three years later, I had the opportunity to work next to the massive san diego pfizer campus. The facility was 2/3 empty and pfizer was struggling to find extra tenants and toying with a 'bio-incubator' idea. http://indysci.org/projectmarilyn http://indysci.org/projectmarilyn
  - dnautics 13y ago
    Polio Vaccines. Unpatented.
    - ganeumann 13y ago
      That was a bit of a simpler time, approval-wise. After animal tests Salk first tested the polio vaccine on himself, then on his wife and children. Soon thereafter he tested on a group of children from the Polk State School for the retarded and feeble-minded. Then he lobbied for permission to do mass tests. So, a few things: 1. this testing environment would not fly today, as it should not have then. Testing on children who may not have the ability to give informed consent is unethical. 2. polio was the most dreaded disease in America, for many reasons. More people contributed to the development of a treatment--through the March of Dimes--than for any other disease up to that time. Even though the vaccine was feared and widely known, the mass tests were fiercely opposed by some. When the positive results of the test were announced, the nation treated the news much like the end of a war with exultation, presidential awards, and ticker-tape parades. 3. the polio vaccine was relatively safe and straightforward, as killed vaccines generally are. The killed vaccine was first tested in culture to make sure it was dead. Unlike many other pharmaceuticals, where the effectiveness even after a test can be murky and side-effects abound, a killed vaccine is relatively easy to understand. Testing a drug that may lessen the impact of a particular type of cancer is considerably harder, both in itself and because of today's protective regulations. 4. the polio vaccine was developed by a very small team run by a zealot. The resources required were considerably less than the resources required to develop other drugs. Look at the development of the sulfa drugs for a counter-example: Bayer delayed their widespread release even after they had concluded they were effective and patented them because they wanted to make sure their patent was valid (source: "The Demon Under the Microscope", by Hager.) Bayer had spent a lot of time and money developing the drugs and wanted to make sure they got a return. (Ironically, it was quickly realized that the patented sulfa drugs were in fact a combination of active and inactive parts and the active parts could not be patented; and soon after penicillin was introduced, sidelining the sulfa drugs. It's a fascinating story, well worth the read.) Source for info about Salk: the excellent "Splendid Solution: Jonas Salk and the Conquest of Polio" by Kluger.
      - 13y ago
  - betterunix 13y ago
    "Now who is going to go put in $350 million to get that drug candidate through PhI/II/III and beyond, with little guarantee of success, if they have no IP protection to stand on?" You, as the final stage of your research, using government money.
    - throwawaykf03 13y ago
      What most people are missing here is that government money only gets you as far as the discovery, and that's if you're lucky enough to, you know, discover something. More likely, you run out of money with nothing to show. I have no cites handy, but the success rate of drug R&D is pretty darn low. Say you do get something. Now you want the government to also be involved in the commercialization of the discovery? I think people would argue they are already involved enough, what with the FDA and all. Further: the person making the discovery spent half a decade of their lives after college to get a PhD, and very likely many years of post-doc, to be extremely specialized in an extremely narrow area of some field. Now you want them to be product managers and manufacturers and businessmen as well? This is one problem patents solve: Division of labor. Let those who are good at science and technology do their thing, and let people who are good at commercializing do their thing, and let IP ensure one both sides have means to reap appropriate rewards.

HarryHirsch 13y ago

You can argue that anything done at a university was done with university facilities (and certainly by the individual researchers). You can also look at it from the angle of efficiency (which way of commercializing a university's research is the best way of doing more research there). Congress did both, and they came up with Bayh-Dole. I'm not saying that this is the best environment, but it is the environment that we have, and these arguments are not outrageous. Besides, this is the environment that biotech startup are coming from, and top universities are making big dollars from royalties. That's why I said that it's really complicated.

cowsandmilk 13y ago
Universities charge the government for use of their facilities. It is an overhead rate often of 60+% on top of the costs of paying researchers, buying lab supplies, etc. Frequently there is triple dipping, where a university gets a grant for a piece of equipment, charges the grants directly for use of that equipment, then also claims they need to be paid in the overhead for making the equipment available. Anyone familiar with the finances sees it as ridiculous.
- Loughla 13y ago
  From my (albeit limited) experience in two large state universities, one of which with a direct focus on research, and two much smaller local colleges, your statement is a bit inflammatory, and isn't 100% accurate. All grants are allowed to charge indirect costs to the grant fund. These indirect costs are used to cover the cost of facilities, maintenance and all the little bits that no one ever thinks about. No one buys a piece of equipment expecting there to be no maintenance whatsoever. These indirect costs are always governed by an agreed-upon rate set between the host institution and the funding entity. The federal government in particular has very clearly spelled out rules regarding this. For example - the grant that funds my work right now has a very clearly legislated indirect cost rate of 8%. If our indirect costs exceed that 8% monthly, we can lose our funding. Now where we get into the part where you're not 100% accurate, and I believe being a bit inflammatory is the triple dipping. Institutions can get a grant to purchase equipment, and then charge the same grant for the use of the equipment. The institution can charge for the personnel hours that run the equipment on related projects, they can charge that indirect cost that we discussed earlier, but that's about it. It's not as if they can just make up a number and charge the government that much to use the equipment for related projects. There are circulars from the Office of Management and Budget that dictate what you can and can't do with your money - for example, colleges and universities have to adhere to the cost principles outlined in OMB A-21, available here: http://www.whitehouse.gov/omb/circulars_a021_2004 http://www.whitehouse.gov/omb/circulars_a021_2004 if you want some light reading. On top of the basic OMB circulars, all federal grants have additional legislation that add further stipulations to how money can be spent, but come from any number of 1000 sources, so I'm not going to cite them. Anyway, the institution cannot just charge the government for use of the equipment. Secondly - they are not paid 'overhead' for making the equipment available. They are paid an indirect cost rate to maintain, store and generally keep the facility running for grants. This rate is very clearly spelled out in any grant documents. I've not seen 60+% in any grant I've ever worked with. In smaller institutions they tend to be around 10-20%. On the larger campuses, the average indirect rate was 32%. Anyone familiar with the finances know that there are legislation and regulation in place to dictate all of this, and while it may be convoluted, it's really not as predatory as you make it out to be.