3 ms·
This isn't (AIUI) relevant to that exact problem. As Wikipedia explains: "[T]he Orange Book lists patents that are purported to protect each drug. Patent list
by flipbrad 2y ago
This isn't (AIUI) relevant to that exact problem. As Wikipedia explains:
"[T]he Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent. "
It sounds like it's easy for manufacturers to.keep adding patents, and the onus is on the generics to make the case that they're not violating. Perhaps most are just scared away, until every listed patent expires (and no new ones are added in the interim)