4 ms·
It depends - if someone uses the same compound but provably for a different indication (like maybe anti-periodontic diseases or something) or for a different in
by fakedang 5mo ago
It depends - if someone uses the same compound but provably for a different indication (like maybe anti-periodontic diseases or something) or for a different intake mechanism, they could get another patent and proceed with trials.
Granted, it's not going to be easy because the original patent has expired so it's going to be very easy for an upstart Indian company to conduct basic clinical trials, use part of the data of the second patent's holder to prove equivalency (they did this test so we don't need to do this test), and then get approved through an accelerated pathway in the FDA. Which is why even well-capitalized players will shy away from what could be a cash cow.
- cubefox 5mo agoAnti-periodontic diseases are highly irrelevant compared to cavities. Not even the original cavity application did manage to get enough funding at the time. So there will be no Indian upstart, there is and likely will be nobody who invests the money into ultra expensive trials. The ship has sailed.
- fakedang 5mo agoI wasn't trying to quote a directly applicable example, just wanted to illustrate a potential pathway for post-expiry commercialization.