Beyond Patents: Protecting Drugs Through Regulatory Laws

Abstract:     
Although patents are the prototypical type of protection that most people consider applicable to protecting drugs, patents are just the most-established and well-known method available to protect drugs from competition. However, there are other types of mechanisms in regulatory laws that provide patent-like protection or further strengthen existing patent protection.

This chapter provides an in-depth explanation of two types of regulatory laws that provide important protection to drug companies: data exclusivity and patent linkage. As noted in earlier chapters (separately posted on SSRN), not all countries currently provide such protection, but these mechanisms are highly desired by drug companies and thus are frequently included in FTAs that impose TRIPS-Plus requirements. Because these protections may be additional hurdles to generic competition, a thorough understanding of these requirements (as well as how they intersect with patent protection) is important to anyone interested in promoting access to medicine.

Number of Pages in PDF File: 33

Keywords: data exclusivity, patent linkage, generic drugs, Hatch-Waxman, PhARMA

JEL Classification: K11, K19, K20, K29, L52, L65, O32, O34, O39

Accepted Paper Series