Beyond Patents: Protecting Drugs through Regulatory Law
This chapter explains regulatory laws that provide complementary protection to patent laws by limiting competition from generic manufacturers. In particular, it focuses on explaining “data exclusivity” and “patent linkage”—protection provided in the regulatory laws of some countries that may create additional hurdles to the entry of generic drugs.
Keywords: compulsory protection, patent law, generic drug manufacturers, competition, data exclusivity, patent linkage
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