4 ms·

Really going all-in on trying to find an off-label use that'll allow them to repatent this, aren't they?

by NikkiA 4y ago

dariusj18 4y ago
Or someone has a lot in stock and wants to offload it ;)
x86_64Ubuntu 4y ago
Yes, HN has something of a COVID-19 denialism streak.
- dang 4y ago
  HN is divided on topics where society at large is divided. It would be strange if it weren't. It's also a highly international forum and divisive topics play very differently in different places. Readers often mistake a comment for something weird and radical coming from a person nearby, when in fact it's an unremarkable comment coming from a person far away. It's unfortunate that this leads to so many brutal online arguments. In person, people instinctively modulate their communication with respect to such variables; online they don't, because the information isn't available and we can't make it available. https://news.ycombinator.com/item?id=23308098 https://news.ycombinator.com/item?id=23308098
tptacek 4y ago
"Re-patent"?
- akiselev 4y ago
  It's... complicated but I assume the GP meant new drug product exclusivity [1] which is a process by which a pharmaceutical manufacturer can get a short window of exclusivity for a new approved use without rights over the original patent. That exclusivity is largely for generic manufacturers [2] though and it's separate from the patent patent term restoration [3] the FDA grants to patent holders to help with the time it takes to get to market. "Re-patent" would mean something different like Shire patenting Vyvanse by adding an amino acid cap to amphetamines, changing it enough that it becomes a new drug with a new patent. That would require clinical trials and all the expense that goes with them. [1] https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-new-drug-product-exclusivity https://www.fda.gov/drugs/cder-small-business-industry-assis... [2] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity https://www.fda.gov/drugs/development-approval-process-drugs... [3] https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-patent-term-restoration-program https://www.fda.gov/drugs/cder-small-business-industry-assis...
  - tptacek 4y ago
    Modifying HCQ to HCQ' would also do nothing to establish exclusivity over HCQ. It's a weird argument.
    - akiselev 4y ago
      I think the OP just made a fly-by comment using very imprecise language. Most people assume drug exclusivity works through patents without giving generics with expired patents (like HCQ) much thought. They wouldn't need to modify it for exclusivity via Abbreviated New Drug Application - I just don't see the FDA accepting any evidence short of a phase III clinical trial that HCQ helps with Alzheimers to fulfill the new use requirements. At best they'd be able to run a proper clinical trial for some cocktail of generic drugs and use ANDAs to prevent competitors from using those generics in their own cocktail for a few years.
    - DanBC 4y ago
      It would if you sued to prevent the off-label use, which is something that happened with avastin and lucentis for wet AMD.
  - doubleg72 4y ago
    Love when people take the time to know what they are talking about.. Vyvanse is a perfect example, they took a drug and made a prodrug.
DanBC 4y ago
I don't think you re-patent an off-label use, you re-patent a minor modification. See for example ketamine to eskatamine; or citalopram to escitalopram. Once you have the new med you use the courts to prevent the off-label use. See eg lucentis or avastin for Wet AMD.

Really going all-in on trying to find an off-label use that'll allow them to repatent this, aren't they?

by NikkiA 4y ago

Really going all-in on trying to find an off-label use that'll allow them to repatent this, aren't they?

dariusj18 4y ago

Or someone has a lot in stock and wants to offload it ;)

x86_64Ubuntu 4y ago

Yes, HN has something of a COVID-19 denialism streak.

dang 4y ago
HN is divided on topics where society at large is divided. It would be strange if it weren't. It's also a highly international forum and divisive topics play very differently in different places. Readers often mistake a comment for something weird and radical coming from a person nearby, when in fact it's an unremarkable comment coming from a person far away. It's unfortunate that this leads to so many brutal online arguments. In person, people instinctively modulate their communication with respect to such variables; online they don't, because the information isn't available and we can't make it available. https://news.ycombinator.com/item?id=23308098 https://news.ycombinator.com/item?id=23308098

tptacek 4y ago

"Re-patent"?

akiselev 4y ago
It's... complicated but I assume the GP meant new drug product exclusivity [1] which is a process by which a pharmaceutical manufacturer can get a short window of exclusivity for a new approved use without rights over the original patent. That exclusivity is largely for generic manufacturers [2] though and it's separate from the patent patent term restoration [3] the FDA grants to patent holders to help with the time it takes to get to market. "Re-patent" would mean something different like Shire patenting Vyvanse by adding an amino acid cap to amphetamines, changing it enough that it becomes a new drug with a new patent. That would require clinical trials and all the expense that goes with them. [1] https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-new-drug-product-exclusivity https://www.fda.gov/drugs/cder-small-business-industry-assis... [2] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity https://www.fda.gov/drugs/development-approval-process-drugs... [3] https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-patent-term-restoration-program https://www.fda.gov/drugs/cder-small-business-industry-assis...
- tptacek 4y ago
  Modifying HCQ to HCQ' would also do nothing to establish exclusivity over HCQ. It's a weird argument.
  - akiselev 4y ago
    I think the OP just made a fly-by comment using very imprecise language. Most people assume drug exclusivity works through patents without giving generics with expired patents (like HCQ) much thought. They wouldn't need to modify it for exclusivity via Abbreviated New Drug Application - I just don't see the FDA accepting any evidence short of a phase III clinical trial that HCQ helps with Alzheimers to fulfill the new use requirements. At best they'd be able to run a proper clinical trial for some cocktail of generic drugs and use ANDAs to prevent competitors from using those generics in their own cocktail for a few years.
  - DanBC 4y ago
    It would if you sued to prevent the off-label use, which is something that happened with avastin and lucentis for wet AMD.
- doubleg72 4y ago
  Love when people take the time to know what they are talking about.. Vyvanse is a perfect example, they took a drug and made a prodrug.

DanBC 4y ago

I don't think you re-patent an off-label use, you re-patent a minor modification. See for example ketamine to eskatamine; or citalopram to escitalopram. Once you have the new med you use the courts to prevent the off-label use. See eg lucentis or avastin for Wet AMD.