Engraving label: segmented drug label;
The first quarter of 2005.
Description: American patent link system.
Hatch-Waxman Act determines the patent linking system, some of which are briefly described as follows (for more information, you can search for the keyword "Hatch-Waxman, American patent linking system" by yourself):
1. The original drug research enterprise needs to submit the corresponding patent information when applying for drug marketing, and the FDA will register it in the Yellow Book. (orange book system)
2. Generic drug companies need to file a patent declaration for each patent listed in the Yellow Book when applying. (patent declaration system)
2. 1 American patent claims can be divided into two categories, the first category is four certifications, and the other category is two statements.
2.2 Among them, certification: I declare that the orange book does not list relevant patents; Two. Declare that the patents listed in the Yellow Book have expired; III statement, promising not to market generic drugs before the patent expires; IV. Declare that the patents listed in the Yellow Book are invalid, unenforceable or generic drugs are not infringing.
2.3 Statement: The first statement (also called mini-statement viii) states that when the original drug has multiple indications, the generic drug only needs to be approved for those indications for which the original drug does not have patent protection. The second statement is that there is no patent (compared with certificate I, it means there is no patent, and certificate I means there is patent, which is not listed in the orange book).
Originally, generic drugs should have the same drug label, but for the first statement, it is called engraving label because it excludes the indication that the original drug has patent protection.