5 ms·

I am not sure why this is written as if drug repurposing is an under-explored concept. Repurposing generics has becoming increasingly popular, because the clin

I am not sure why this is written as if drug repurposing is an under-explored concept. Repurposing generics has becoming increasingly popular, because the clinical trial risk is much better in phase 2/3 (where most of the money is lost) than for novel compounds. Combine that with FDA fastrack designation for orphan diseases, and it's become quite the popular space for innovation. Even some of the papers "cited" by this article contradict it. > This means that if one company pays for the expensive clinical trials showing that a specific treatment protocol for an off-patent drug works in a new indication, they cannot prevent others from “free riding” on this valuable information, which is a “non-rivalrous non-excludable” public good once it is published online This isn't true. Composition of matter patents are not the only patents. If so, we wouldn't see generic repurposing at all, and obviously that isn't correct.

1vuio0pswjnm7 5y ago
How do we charge royalties on method of use patents. Do we use prescription data from pharmacies. For the purposes of calculating royalties how do we prove whether and how anyone in posession of a drug actually uses it.
- savvak 5y ago
  That's the point, under the current system you can't enforce a royalty. You could theoretically use e-medical records to detect infringement, but you can't build a business case on suing individual patients and doctors taking an old drug for a new indication. You could outlaw prescribing drugs off-label but that isn't politically feasible. Pharmacies and doctors are encouraged to automatically prescribe low cost generics where available vs a branded drug, by reference to the INN.
pkaye 5y ago
Colchicine is a very old drug used to treat gout and other diseases which went into orphan disease patent because some company figured out proper dosage. Now the drug became expensive in the US but everywhere else benefited by knowing the proper dosage and no increase in price. I'd rather American consumers not end up solely paying for all these costs.
savvak 5y ago
As noted above, according to research, the chance of a drug getting a new indication falls to almost zero soon after generic entry - see https://pubmed.ncbi.nlm.nih.gov/33397471/ https://pubmed.ncbi.nlm.nih.gov/33397471/. This is because you cannot enforce a monopoly price if there is generic competition: even if you use a method of use patent over the composition of matter, you can't stop patients and doctors prescribing the "old" drug off-label - suing patients and doctors is not commercially realistic. Therefore, there is a well-recognised market failure (see https://www.healthaffairs.org/do/10.1377/hblog20140306.037370/full/ https://www.healthaffairs.org/do/10.1377/hblog20140306.03737...) that needs to be addressed with new market incentives or financial models e.g. pay for success contracts.
- chris_va 5y ago
  I read that paper the opposite way. 32% being repurposed seems like a pretty high number. I cannot reconcile these articles with the high investment in repurposing I see in pharmaceutical startups.
  - savvak 5y ago
    The analysis in the paper shows that once a drug goes off-patent its chance of being repurposed approaches 0%. There is repurposing of on-patent drugs while a monopoly profit can be enforced. That's not the point. The point is that information about which off-patent drugs work in new indications is the definition of a non-excludable and non-rivalrous public good. There is no way to enforce a monopoly profit if people can take the generic drug off-label or have it compounded in a pharmacy. Therefore, there is a tragedy of the commons preventing private investment to unlock this generic drug repurposing innovation (unless someone can come up with a new patented formulation that will not be subject to off-label competition, which is not always possible). A pay for success contract is a solution to this problem. You can also enforce differential pricing for repurposed generic drugs while preventing off-label competition using e-medical records, but this is also another kind of pay for success mechanism (like an advance market commitment or the agreement to pay a minimum order of the Covid vaccines under Operation Warp Speed). However, it might not be politically and commercially feasible to prevent off-label use, especially for generics which are widely prescribed for other off-patent indications.

1vuio0pswjnm7 5y ago

How do we charge royalties on method of use patents. Do we use prescription data from pharmacies. For the purposes of calculating royalties how do we prove whether and how anyone in posession of a drug actually uses it.

savvak 5y ago
That's the point, under the current system you can't enforce a royalty. You could theoretically use e-medical records to detect infringement, but you can't build a business case on suing individual patients and doctors taking an old drug for a new indication. You could outlaw prescribing drugs off-label but that isn't politically feasible. Pharmacies and doctors are encouraged to automatically prescribe low cost generics where available vs a branded drug, by reference to the INN.

pkaye 5y ago

Colchicine is a very old drug used to treat gout and other diseases which went into orphan disease patent because some company figured out proper dosage. Now the drug became expensive in the US but everywhere else benefited by knowing the proper dosage and no increase in price. I'd rather American consumers not end up solely paying for all these costs.

savvak 5y ago

As noted above, according to research, the chance of a drug getting a new indication falls to almost zero soon after generic entry - see https://pubmed.ncbi.nlm.nih.gov/33397471/ https://pubmed.ncbi.nlm.nih.gov/33397471/. This is because you cannot enforce a monopoly price if there is generic competition: even if you use a method of use patent over the composition of matter, you can't stop patients and doctors prescribing the "old" drug off-label - suing patients and doctors is not commercially realistic. Therefore, there is a well-recognised market failure (see https://www.healthaffairs.org/do/10.1377/hblog20140306.037370/full/ https://www.healthaffairs.org/do/10.1377/hblog20140306.03737...) that needs to be addressed with new market incentives or financial models e.g. pay for success contracts.

chris_va 5y ago
I read that paper the opposite way. 32% being repurposed seems like a pretty high number. I cannot reconcile these articles with the high investment in repurposing I see in pharmaceutical startups.
- savvak 5y ago
  The analysis in the paper shows that once a drug goes off-patent its chance of being repurposed approaches 0%. There is repurposing of on-patent drugs while a monopoly profit can be enforced. That's not the point. The point is that information about which off-patent drugs work in new indications is the definition of a non-excludable and non-rivalrous public good. There is no way to enforce a monopoly profit if people can take the generic drug off-label or have it compounded in a pharmacy. Therefore, there is a tragedy of the commons preventing private investment to unlock this generic drug repurposing innovation (unless someone can come up with a new patented formulation that will not be subject to off-label competition, which is not always possible). A pay for success contract is a solution to this problem. You can also enforce differential pricing for repurposed generic drugs while preventing off-label competition using e-medical records, but this is also another kind of pay for success mechanism (like an advance market commitment or the agreement to pay a minimum order of the Covid vaccines under Operation Warp Speed). However, it might not be politically and commercially feasible to prevent off-label use, especially for generics which are widely prescribed for other off-patent indications.