ANATOMY OF A FAILURE TO LAUNCH: A REVIEW OF BARRIERS TO GENERIC AND BIOSIMILAR MARKET ENTRY AND THE USE OF COMPETITION LAW AS A REMEDY
The purpose of this whitepaper is to examine the evolution of specific barriers to generic and biosimilar market entry in the European Union (“EU”) over the last decade with consideration of the application of competition law as a potential remedy
It provides an updated overview of some of the strategies used to delay generic and biosimilar entry such as:
- the use of patent thickets, secondary patents and so called ‘evergreening’ strategies;
- The exploitation of the divisional patent system;
- The concept of patent linkage, including:
(a) what patent linkage is and how the issue of patent linkage is compounded due to the number of secondary patents granted to companies; and
(b) the misuse or misdirection of the medicines regulatory framework to,for example, link marketing authorisation grant to patent expiry or activities taken directly against competent authorities seeking to restrain their activities.
- the use of ‘product hopping’ strategies;
- the use of predatory pricing strategies; and
- the use of misleading statements designed to inhibit competition.