The value of patent term extensions to the pharmaceutical industry in the USA

摘要

In the last 20 or so years various kinds of exclusivity have been introduced in the US, which go beyond the basic patent protection. The most important of these is patent term restoration, but other new incentives introduced include the paediatric extension, exclusivity for drugs with limited patient populations (orphan drugs) and data exclusivity. Since 1988 over 500 products have benefited from patent term restoration and over 130 from the paediatric extension. Of the 40 best selling products in the US in 2006, 26 benefited from patent term restoration and 19 from the paediatric extension, with 29 products benefiting from one or both. The overall impact on these 29 was to increase average effective patent life from 9.2 to 12.8 years, an increase of over three and a half years. About 39 per cent of the top 40 sales of over US