Pharmaceutical firms typically enjoy market exclusivity for new drugs from concurrent protection of the underlying invention (through patents) and the clinical trials data submitted for market approval (through data exclusivity). Patent invalidation during drug development renders data...

From a firm’s perspective two competing forces are driving the decision to invest in innovation. On the one hand, innovative performance is an important driver of profitability and growth. On the other hand, investments in innovation suffer from negative externalities, i.e. spillovers to other...

Two major changes in Brazilian legislation during the 1990s reshaped the local pharmaceutical industry: the ratification of the TRIPS agreement including a provision for pipeline inventions in 1996, and a Generic Drug Act in 1999, which introduced bioequivalence tests and facilitated generic...