James Boyle in the FT:
"Imagine a process of reviewing prescription drugs which goes like this: representatives from the drug company come to the regulators and argue that their drug works well and should be approved. They have no evidence of this beyond a few anecdotes about people who want to take it and perhaps some very simple models of how the drug might affect the human body. The drug is approved. No trials, no empirical evidence of any kind, no follow-up. Or imagine a process of making environmental regulations in which there were no data, and no attempts to gather data, about the effects of the particular pollutants being studied. Even the harshest critics of drug regulation or environmental regulation would admit we generally do better than this. But this is often the way we make intellectual property policy."
Read the article to get his wider perspective of the issue and his specific concerns relating to the 1996 EU Database directive and lobbyist attempts to push similar legislation in the US without any supporting empirical evidence about the potential benefits or disadvantages. I particularly like James' rules of thumb for regulators:
1. "when someone with a profit margin over 20% asks you for additional monopoly protection, pause before agreeing."
2. "Do no harm! Do not create rights without strong evidence that the incentive effect is worth the anti-competitive cost."