Patent-related barriers to market entry for generic medicines in the European Union: A review of weaknesses in the current European patent system and their impact on market access of generic medicines

摘要

Patents are effective tools for promoting innovation in the pharmaceutical sector. Originator companies should be able to recoup their R&D investments during the term of the basic patent/SPC on an active pharmaceutical substance. Generic competition should be available immediately after expiry of that term. The chances of market entry for generic medicines companies in all markets the day following expiry of the main basic patent in all European Union markets is, however, not possible or, at best, is extremely difficult. Due to a diminishing number of newly registered products and contracting product pipelines, originator companies may be tempted to unjustly prolong the patent monopoly of existing products. The result is known as the 'evergreening' of a basic patent with the help of follow-on patents to keep generic competitors off the market. These follow-on patents are often weak or trivial and, upon careful examination, it is clear that they should never have been granted. Patent quality is therefore of the utmost importance.