How does patent law affect the generic drug industry?
A. The so-called “Waxman-Hatch Act of 1984” (also known as the “Drug Price Competition and Patent Term Restoration Act of 1984”) provided a compromise between pioneering drug companies and generic drug manufacturers (and their customers). The act provides a series of checks and balances for both the first marketer of a new drug and manufacturers that wish to produce a generic version of a drug. This is a complicated issue, but for a summary of the act, see http://library.lp.findlaw.com/articles/file/00553/007032/title/subject/topic/administrative%20law_federal%20agencies/filename/administrativelaw_2_13.
