Policy ForumIntellectual Property

Fixing the Legal Framework for Pharmaceutical Research

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Science  26 Feb 2010:
Vol. 327, Issue 5969, pp. 1083-1084
DOI: 10.1126/science.1184188

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Summary

The cost of drug research and development (R&D) has increased from ∼$230 million per drug in the early 1980s to $1.2 billion today, with R&D currently requiring about 10 to 15 years per drug (14). This investment of time and money cannot be sustained without a legal system that provides sufficient time to recoup the investment and to secure a reasonable return, as well as the ability to make important business decisions that remain correct over a long period of time. Pharmaceutical companies have historically relied on two kinds of market protection: (i) the exclusive ownership of their own clinical research and (ii) patents. However, the U.S. Hatch-Waxman Act (5), which is designed to strike a balance between innovative pharmaceutical research and access to generic drugs, is flawed. Further, U.S. courts sometimes retroactively change standards for patent protection long after large R&D efforts have been initiated, which increases the risk to defend and rely on patent protection.