7 ms·

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

by 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
        1457389 13y ago
        I'm sure we could agree on how the system is fucked, but where is the alternative? Fact is, people in this thread who are railing against academics holding patents don't seem to get how the system is built in the first place. If they do, they should be proposing alternatives, not just scoring cheap political points against Big Pharma and Big Academia.
        dnautics 13y ago
        you don't need to 'propose alternatives'. You just do it. Make a drug. Don't patent it. Get it approved. Sell it. I mean, this is what I'm working on (see the damn link). Is that good enough?
        1457389 13y ago
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.

by 1457389 13y ago

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
      - 1457389 13y ago
        I'm sure we could agree on how the system is fucked, but where is the alternative? Fact is, people in this thread who are railing against academics holding patents don't seem to get how the system is built in the first place. If they do, they should be proposing alternatives, not just scoring cheap political points against Big Pharma and Big Academia.
        dnautics 13y ago
        you don't need to 'propose alternatives'. You just do it. Make a drug. Don't patent it. Get it approved. Sell it. I mean, this is what I'm working on (see the damn link). Is that good enough?
        1457389 13y ago

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.