I'm not a patent lawyer, but I don't understand how 62-year old drugs still require licenses to be manufactured? Seems like another case of patent law gone mad.
No, I understand that, but I thought once a drug's patent expires then any reputable pharmaceutical company could manufacture it as a generic (with the proper testing of course). Is that not the case here?
Apparently the issue is the testing. You need to purchase a large quantity of pills from the original manufacturer to compare your new batch with and that was hard to obtain.
Ah, I see. It sounds to me like the issue is that there's not enough of a market to attract the interest of another company to get over the initial fixed costs to get the drug approved. Seems like a possible reform would be to streamline the approval process for generics to make this easier.
