Science
26 February 2010  Vol 327, Issue 5969, Pages 1043-1162
http://www.sciencemag.org/current.dtl

Policy Forum
Intellectual Property: Fixing the Legal Framework for Pharmaceutical Research
Sherry M. Knowles

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 (1–4). 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.

Chief Patent Counsel, GlaxoSmithKline, King of Prussia, PA 19406, USA.