Extending the Monopoly – How ‘Secondary Patents’ Can Be Used to Delay or Prevent Generic Competition upon Expiry of the Basic Product Patent

Abstract

Over the past few decades, increasingly sophisticated patent strategies have been employed by many companies in the research-based pharmaceutical industry to protect drug products beyond expiry of the basic patents to the active ingredients per se using so-called ‘secondary patents’. A company wishing to enter the market with a generic product should now be prepared to navigate its way through a maze of additional patents surrounding the drug product before it can get to the market. Even then, the generics company may find itself at a competitive disadvantage in that it may be blocked from using the compound produced by the most economical route or using the most stable or efficacious forms of the drug. This paper discusses and illustrates the ways in which patents can be obtained for developments at various stages in the life cycle of a drug, thereby helping to extend the effective patent life for the drug beyond the expiry date of the basic patents.