Tuesday, February 12, 2008

BIO Report Finds Little Empirical Evidence to Supports Calls for Patent Reform

The Biotechnology Industry Organization (BIO) recently released a report entitiled "Proposed Patent Reform Legislation: Limitations of Empirical Data Used to Inform the Public Policy Debate." 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).

I recently conducted a study seeking to uncover empirical evidence of the impact of "human gene patents" on biomedical research and access to biomedical technologies. Human gene patents have been the subject of much controversy in recent years and are a primary target of H.R. 997, the bill introduced in Congress last year to bar the patenting of DNA and DNA-related inventions. I particular, I performed a comprehensive database search seeking a to identify all instances where a "human gene patent" has been asserted in a U.S. court. An article describing the results of my study will publish shortly in the University of Missouri - Kansas City Law Review, and is currently available on SSRN.

To summarize some findings of relevance to the debate over the need for patent reform, I found relatively little litigation has been brought alleging infringement of human gene patents in the context of research or genetic diagnostic testing, and the lawsuits that have been filed have tended to settle early. Noncommercial research has never been the subject of a lawsuit. I found no evidence of a patent thicket, little if any patent troll activity, and few if any instances where the assertion of a human gene patent has denied the public access to genetic diagnostic testing or other medical technology. Furthermore, the number of active human gene patent litigations has dropped off dramatically in recent years - to my knowledge, the only active litigations involve Amgen and its erythropoietin patents, which claim priority to applications filed in the early 1980s and which are set to expire over the next several years.

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