Legitimate Patent Extension Or Patent System abuse?

Abstract

This article examines strategies used by innovators in the pharmaceutical industry in order to extend the legal monopolies available to them in order to prevent generic sales of their products for as long as possible. We examine patent procurement strategies in which secondary patents are filed for developments relating to a specific active ingredient. Another strategy adopted by innovators has involved the registration and de-registration of particular drug formulations in order to influence the relevant dates for calculating both patent term extensions and also the term of regulatory data exclusivity. We conclude that, in all cases, while the letter of the law has been complied with, in certain cases, readers may conclude that the spirit of the law has not been complied with. We expect that over the next 5-10 years, patent granting authorities and national courts will increasingly scrutinize these types of activities in order to ensure ethical behavior on the part of all stakeholders.