Beyond Traditional IP : Addressing Regulatory Barriers

The COVID pandemic has underscored that IP can limit the ability to addressing public health crises because IP owners have the legal right to bar others from making needed supplies. However, what is less well understood yet critical to making medical treatments available are IP-related barriers existing in regulatory laws that complement traditional IP protection. In other words, even if a potential manufacturer of a needed treatment can obviate patent and trade secret hurdles, that manufacturer could be thwarted due to less well understood regulatory barriers. There are two key barriers to treatments for which regulatory authorities are involved in review, such as drugs and vaccines. The most dominant is “data exclusivity” that can prevent approval of follow-on treatments (a generic or biosimilar) by barring reliance on previously submitted clinical data of the comparator original that is used to expedite regulatory approval of these lower-cost treatments. In addition, in some countries “patent linkage” can bar regulatory approval of a safe and effective drug solely due to alleged infringement of patent(s) associated with making that drug. The chapter begins with the genesis of these regulatory protections and their general parameters before discussing their prevalence among countries. The chapter then turns to discussion of proposed and actual modification of TRIPS requirements for COVID and how that intersects with these regulatory barriers. The chapter concludes with recommendations