Background: drug approval, drug patenting, pharmaceutical linkage, and public health policy*


This chapter provides background information required to understand pharmaceutical linkage, including the relevant principles of patent law and food and drug law, with a particular focus on the various pathways and evidentiary requirements for new and follow-won drug approval, pharmaceutical linkage, as well as the manner in which public health policy and economic policy are said to converge in the form of linkage regulations.


patent law

food and drug law

public health policy

economic policy

Pharmaceutical products occupy an established and growing niche in modern healthcare. Estimated global pharmaceutical sales were US$773 ...

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