South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

True or False: The Hatch-Waxman Amendment supports innovation by allowing longer patent terms for new drugs.

1. True

2. False

3. Only for certain medications

4. Only if generics are delayed

The correct answer is: True

The Hatch-Waxman Amendment, officially known as the Drug Price Competition and Patent Term Restoration Act of 1984, indeed aims to promote innovation in the pharmaceutical industry, particularly by balancing the need for both new drug development and the subsequent availability of affordable generics. Under the Hatch-Waxman framework, original manufacturers can obtain patent term extensions for new drugs. These extensions aim to compensate for the time taken to develop and bring the drug to market, during which the patent may not have been actively protecting the product from generic competition. By allowing these longer patent terms, the amendment incentivizes pharmaceutical companies to invest in research and development, knowing they have a limited period to recoup their investments without competition from generics. While the Hatch-Waxman Amendment does not provide blanket extensions to every medication, its primary intent is to foster innovation through these mechanisms, thereby supporting the development of new drugs by giving manufacturers an extended period of market exclusivity. Thus, stating that the Hatch-Waxman Amendment supports innovation by allowing longer patent terms for new drugs is accurate.