3 ms·
If I understand things correctly (not assured by any means, as I've only skimmed some of the sources), the abuse vector looks something like this: 1) A company
by 0xcde4c3db 3y ago
If I understand things correctly (not assured by any means, as I've only skimmed some of the sources), the abuse vector looks something like this:
1) A company files that trivial "improvement" patent, or simply picks a recent patent out of its portfolio whose applicability to the drug is unclear. Hilariously, in the linked example from the article, the "improvement" was merely to claim that a metabolite was the active molecule rather than the drug per se, and thus change the instructions for when to take the pill relative to mealtimes.
2) The company files for an Orange Book listing asserting that the new patent applies to the old drug.
3) A generic manufacturer seeking approval disputes this assertion in its ANDA (abbreviated new drug application) filing.
4) The FDA provisionally approves the generic.
5) The generic manufacturer starts tooling up for manufacturing and taking orders for the product.
6) The brand-name manufacturer sues the generic manufacturer, which automatically triggers a 30-month stay on the approval.