Thursday, February 14, 2008

BIO report: no empirical evidence to support patent reform

Yet again we see the absence of empirical evidence to support policymaking in the intellectual property arena. This time a report from the Biotechnology Industry Organization (BIO) points out quite reasonably that there is little empirical evidence to support the notion that the patent system needs radical reform to protect us from patent trolls, overbroad patents, poor quality patents etc. It might be intuitively "obvious" that such things would damage innovation, access and commercialisation, just as it might feel intuitively "obvious" that millions of people swapping songs freely on the Net causes damage to CD sales. But there is no demonstrable causal link and little or no empirical evidence in either case enabling us to see the real effect of a multitude of complex interracting parameters. Law Professor, Chris Holman says:
The report critiques three recent studies by the FTC, NAS and NRC that have been widely cited by those claiming the current patent system is broken and in need of major reforms. In particular, the report points out a dearth of empirical evidence to support allegations that poor quality patents, patent thickets, patent trolls, etc., are impeding innovation and product commercialization. The report also notes a recent trend in the courts tightening up the requirements of patentability (e.g., Fisher and KSR) and limiting the availability of permanent injunctions (eBay v. MercExchange) could effectively address many of the concerns expressed by critics of the patent system, obviating the need for a legislative fix.

Particularly with respect to biotechnology and so-called "gene patents," scholars have noted that most of the attacks on the current patent regime are often based on assumptions and anecdote. See, e.g., See Timothy Caulfield et al., Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies, 24 Nature Biotechnology 1091, (2006). Empiricial studies that have been conducted indicate that third party patents have had little impact on biomedical research, particularly in the noncommercial academic sector. See, e.g., John P. Walsh et al., View from the Bench: Patents and Material Transfers, 309 Science 2002, 2002-03 (2005).
Holman has looked into the impact of human gene patents on research, specifically trying to find all instances where such patents had been the subject of litigation in the US courts. He found a limited number of cases and seems to have concluded that these patents are not therefore a big problem. Of course revorded litigation tells us nothing of the chilling effect of such patents or the collective of cease and desist letters in cases which never reach the litigation stage. In addition to the culture of secrecy in the academic and commercial life sciences that John Wilbanks talks so eloquently about, the lack of apparent litigation in this area, at least as turned up by Professor Holman, would constitute insufficient evidence for me to drop my concerns about human gene patents yet.

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