Effective Patent Life of Antiretroviral Drugs in the U.S 1987-2006

Society is faced with balancing the reward from innovation for finding new drugs with adequate access to affordable drugs, especially for drugs targeting life-threatening diseases. This study examines the effective patent life of antiretroviral (ARV) new molecular entities (NMEs) approved for marketing in the United States between 1987 and 2006.

Data derived from the FDA and the U.S. Patent Office. A comparison between the effective patent life (i.e.time from FDA drug approval to patent expiration) of ARVs and other NMEs was performed. Group differences were assessed using group comparison t-tests.

All ARVs NMES (n=21) and 363 NMEs from other classes were included in the analysis. An average of 4.1±3.5 patents for ARVs and 2.8 ±2.2 patents for other NMEs were listed in the Orange Book (OB). ARVs had an average of 13.8±3.3 years of effective patent life for the first patent vs. 10.9±4.2 year for other NMEs (p<0.01). Also, ARVs had an average of 17.61±3.57 years of effective patent life for the last patent vs. 14.8±4.7 year for other NMEs. The effective patent life listed in the OB for the last patent of 7 ARVs (33.3%) exceeded 20 years. ARV FDA review time was 0.5±0.2 years for ARVs vs. 1.9±.1.4 years for other NMEs.

ARVs have an average of 3 more years of patent protection than other therapeutic classes in the U.S.. Longer protection may encourage R&D but also limits competition and consumers end up paying higher prices for patented ARVs than they would have paid otherwise for generic substitutes.