4 ms·
Reduce costs of getting FDA approval and reduce patent lengths?
by remontoire 9y ago
Reduce costs of getting FDA approval and reduce patent lengths?
- mcny 9y agoI think I read here about the problem of 1. Patent a drug 2. Make inconsequential changes 3. Patent it again 4. Repeat I don't have any first hand experience in the industry so I don't know if this is a serious problem. I don't even know if it has a name!
- pmyteh 9y agoIt's called 'evergreening', FWIW.
- adrianN 9y agoWhat's stopping a third party from doing 2 and 3?
- celticninja 9y agoThe original patent.
- adrianN 9y agoDoes the original patent apply if the compound is sufficiently different to warrant a new patent? That seems strange to me, but I know nothing about patent law.
- rayiner 9y agoOnce the original patent is expired, you can do whatever you want with it. Evergreening can’t lfsvent you from creating a generic version of the original patented drug. But demand for the generic might be limited if the new version of the drug is better. (People don’t want to be stuck taking an inferior version of a drug.)
- kgwgk 9y agoExclusivity is extended with patents covering new formulations, manufacturing processes, alternative dosings, injection devices, risk evaluation and mitigation strategies... When the molecule itself becomes “free” to copy, there may be still several patents more or less enforceable that prevent competitors from entering the market. Often the validity of patents is decided in court (see Copaxone for a recent high-profile case study).
- deleted 9y ago[deleted]
- marvin 9y agoWhat's stopping doctors from using a replica of the original once the initial patents expire?