The pharmaceutical business is dominated largely by two types of entities: large, research-intensive corporations, and the smaller "generic" drug "knock-off" artists. because the former organizations have to put so much of their budget into research and development (R&D), a form of investment which is often akin to pouring money into a hole, the 17-year exclusive monopoly of a patient is often the only way such a company can remain profitable. However, because of a concern for public safety, all substances prepared for human consumption must be put through extensive testing by the FDA. This testing could take a long period of time, and it was feared that any substantial FDA tests would eat up the monopoly period, putting the development-oriented drug companies out of business. Companies might have a minuscule period of time in which to recoup their often phenomenal research investment before the generic drug manufacturers would come in and undercut the market with cheaper versions of the same drugs. Responding to lobbying efforts of large pharmaceutical companies, Congress enacted a series of statutes to address what legislators saw as "two unintended distortions of the 17-year patent term."
Jonathan L. Mezrich, The Patentability and Patent Term Extension of Lifesaving Drugs: A Deadly Mistake, 6 J.L. & Health 111 (1991-1992)