3 ms·

> just for the purpose of extending their patent I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs

by new299 7y ago

> just for the purpose of extending their patent I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them? > The idea is you bring the top pharmaceutical researchers into the NIH... Projects I’ve seen suggests that technology development carried out in an academic context often requires significant refinement (or complete reworking tbh) when being brought to market. So, it’s not clear to me how well the model you suggest would work. Perhaps it would be best to have a public organization that manufactures genetic drugs first and build from that. But... I think that may also have issues.

skohan 7y ago
> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them? So it's because of a loophole created in the Hatch-Waxman act, which basically stipulates that if a drug company creates a "new chemical version" of a name-brand drug, then it's possible to extend the patent for 5 years and block the FDA approval of any generics. [0] [0]: https://www.upcounsel.com/how-long-does-a-drug-patent-last https://www.upcounsel.com/how-long-does-a-drug-patent-last > Projects I’ve seen suggests that technology development carried out in an academic context often requires significant refinement (or complete reworking tbh) when being brought to market. So, it’s not clear to me how well the model you suggest would work. So the problem, as I see it, is that the people who profit from the production and sale of drugs also have an essential monopoly over the talent pool which is capable of developing new drugs. As a result, the incentive is for them to direct their R&D resources in ways which maximize profitability rather than maximize health outcomes. In such a system as I have described, there would still be room for drug companies to do the work of producing drugs, but the incentives for the R&D process could be aligned with the general population rather than drug company shareholders. The current system represents something of a conflict of interest.
- refurb 7y ago
  I think you mean new chemical entity (NCE). That’s not a small tweak, that’s an entirely new drug. And the older drug can still be sold by genetics companies.
  - skohan 7y ago
    The point is not the level of effort that it takes to create the drug, the problem is they are allocating resources to research drugs to treat already-served ailments due to the profit motive rather than trying to find solutions for conditions which are not yet adequately treated.
    - refurb 7y ago
      What does adequately treated mean? It may come as a surprise, but most pharmaceutical advances come as incremental changes. I can't find it, but there was an interesting chart showing life expectancy of colon cancer over time. Each of the new advances only added 2-3 months of life. However, after a decade, life expectancy had grown by almost 5 years. So my comment for you is that they wouldn't be putting R&D money into something unless there was enough demand for it.
      - skohan 7y ago
        So for instance, take a look at this study on the cost/benefit evaluation of patent extensions in the pharma industry: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3672218/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3672218/ What they found is that the strategies used by drug companies to "evergreen" their patented drugs resulted in massive unnecessary expenditures with negligible differences in outcomes.
        refurb 7y ago
        Yeah, but that article suggests the problem lies with the hospital, not the drug company. The hospital is choosing to use these marginally better drugs over the cheaper generics. And I take issue with their claim that pregabalin is an evergreen strategy for gabapentin. Those are two very different drugs.
DanBC 7y ago
> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them? Have a look at Avastin (Bevacizumab) and Lucentis (ranibizumab). https://www.nih.gov/news-events/news-releases/avastin-lucentis-are-equivalent-treating-age-related-macular-degeneration https://www.nih.gov/news-events/news-releases/avastin-lucent... AMD is a leading cause of blindness. Avastin is a cancer medication that was found to be effective to treat Age-related macular degeneration (AMD), although it wasn't licenced for that usage. The makers reformulated and came out with Lucentis which they licenced for use with AMD. Lucentis is considerably more expensive than avastin. https://www.bbc.co.uk/news/health-30138097 https://www.bbc.co.uk/news/health-30138097 > Lucentis typically costs about £700 for an injection, but the price for Avastin is about £70. In the UK the drug companies not only forbade off-label use of avastin, but they went to court to prevent this use. They lost. https://www.hsj.co.uk/finance-and-efficiency/breaking-nhs-wins-landmark-legal-battle-against-drug-companies/7023422.article#.W6TH58DoL6U.twitter https://www.hsj.co.uk/finance-and-efficiency/breaking-nhs-wi...
- Consultant32452 7y ago
  It sounds to me like the cost to get a drug certified for use is the problem here. In the US it's literally a billion dollars. If it were cheaper, it would be worth paying for certification of a new use for an existing out of patent drug by a generic manufacturer.
  - mandevil 7y ago
    So called "Off-Label" usage is totally legal in the US right now, for free. Drug companies get in trouble for advertising off-label use (that is totally verboten, the FDA regulates drug company advertising and so it can only be done for something the FDA has approved), but your doctor can prescribe something for off-label use totally legally at any time. Estimates are that about 20% of all prescriptions are for off-label use. Also, the billion dollar number is for developing a new medicine, and includes the costs of all the attempts that failed along the way, not for running tests to get an already approved drug certified for a new usage.
refurb 7y ago
You are correct. The original drug will be a generic - cheap and ubiquitous. The only way “making small tweaks” works to extend a patent is if you can convince doctors and insurers it’s worth it.

by new299 7y ago

skohan 7y ago

> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them? So it's because of a loophole created in the Hatch-Waxman act, which basically stipulates that if a drug company creates a "new chemical version" of a name-brand drug, then it's possible to extend the patent for 5 years and block the FDA approval of any generics. [0] [0]: https://www.upcounsel.com/how-long-does-a-drug-patent-last https://www.upcounsel.com/how-long-does-a-drug-patent-last > Projects I’ve seen suggests that technology development carried out in an academic context often requires significant refinement (or complete reworking tbh) when being brought to market. So, it’s not clear to me how well the model you suggest would work. So the problem, as I see it, is that the people who profit from the production and sale of drugs also have an essential monopoly over the talent pool which is capable of developing new drugs. As a result, the incentive is for them to direct their R&D resources in ways which maximize profitability rather than maximize health outcomes. In such a system as I have described, there would still be room for drug companies to do the work of producing drugs, but the incentives for the R&D process could be aligned with the general population rather than drug company shareholders. The current system represents something of a conflict of interest.

refurb 7y ago
I think you mean new chemical entity (NCE). That’s not a small tweak, that’s an entirely new drug. And the older drug can still be sold by genetics companies.
- skohan 7y ago
  The point is not the level of effort that it takes to create the drug, the problem is they are allocating resources to research drugs to treat already-served ailments due to the profit motive rather than trying to find solutions for conditions which are not yet adequately treated.
  - refurb 7y ago
    What does adequately treated mean? It may come as a surprise, but most pharmaceutical advances come as incremental changes. I can't find it, but there was an interesting chart showing life expectancy of colon cancer over time. Each of the new advances only added 2-3 months of life. However, after a decade, life expectancy had grown by almost 5 years. So my comment for you is that they wouldn't be putting R&D money into something unless there was enough demand for it.
    - skohan 7y ago
      So for instance, take a look at this study on the cost/benefit evaluation of patent extensions in the pharma industry: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3672218/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3672218/ What they found is that the strategies used by drug companies to "evergreen" their patented drugs resulted in massive unnecessary expenditures with negligible differences in outcomes.
      - refurb 7y ago
        Yeah, but that article suggests the problem lies with the hospital, not the drug company. The hospital is choosing to use these marginally better drugs over the cheaper generics. And I take issue with their claim that pregabalin is an evergreen strategy for gabapentin. Those are two very different drugs.

DanBC 7y ago

> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them? Have a look at Avastin (Bevacizumab) and Lucentis (ranibizumab). https://www.nih.gov/news-events/news-releases/avastin-lucentis-are-equivalent-treating-age-related-macular-degeneration https://www.nih.gov/news-events/news-releases/avastin-lucent... AMD is a leading cause of blindness. Avastin is a cancer medication that was found to be effective to treat Age-related macular degeneration (AMD), although it wasn't licenced for that usage. The makers reformulated and came out with Lucentis which they licenced for use with AMD. Lucentis is considerably more expensive than avastin. https://www.bbc.co.uk/news/health-30138097 https://www.bbc.co.uk/news/health-30138097 > Lucentis typically costs about £700 for an injection, but the price for Avastin is about £70. In the UK the drug companies not only forbade off-label use of avastin, but they went to court to prevent this use. They lost. https://www.hsj.co.uk/finance-and-efficiency/breaking-nhs-wins-landmark-legal-battle-against-drug-companies/7023422.article#.W6TH58DoL6U.twitter https://www.hsj.co.uk/finance-and-efficiency/breaking-nhs-wi...

Consultant32452 7y ago
It sounds to me like the cost to get a drug certified for use is the problem here. In the US it's literally a billion dollars. If it were cheaper, it would be worth paying for certification of a new use for an existing out of patent drug by a generic manufacturer.
- mandevil 7y ago
  So called "Off-Label" usage is totally legal in the US right now, for free. Drug companies get in trouble for advertising off-label use (that is totally verboten, the FDA regulates drug company advertising and so it can only be done for something the FDA has approved), but your doctor can prescribe something for off-label use totally legally at any time. Estimates are that about 20% of all prescriptions are for off-label use. Also, the billion dollar number is for developing a new medicine, and includes the costs of all the attempts that failed along the way, not for running tests to get an already approved drug certified for a new usage.

refurb 7y ago

You are correct. The original drug will be a generic - cheap and ubiquitous. The only way “making small tweaks” works to extend a patent is if you can convince doctors and insurers it’s worth it.