A major thrust of the book is that once off-patent, others can copy a drug -- but the actual process for creating it is not in the patent. The ingredients are,

A major thrust of the book is that once off-patent, others can copy a drug -- but the actual process for creating it is not in the patent. The ingredients are, and it's up to the generic manufacturers to create a set of manufacturing steps that result in the same biological impact. An analogy would be getting the ingredients list for a cake, but not the assembly steps. The manufacturers also need to prove that the impact is the same, but used fabricated evidence to do so. They also operate plants that are not subject to random inspection -- FDA inspections in foreign countries are pre-announced for political and visa reasons, and are under-staffed, leading to additional fraud.