‘Gene Patents’ Stifle Research?

Patently BIOtech

The Federal Trade Commission has noted that “concern previously centered on the belief that biotechnology patent protection was too strong” and “would actually obstruct commercialization on new products, thereby hindering follow-on innovation.  This problem has yet to materialize.  The reasons for this are numerous and are often straightforward matters of basic economics. In addition to licensing being widely available, researchers make use of a variety [of] strategies to develop working solutions to the problem of access, including inventing around, going offshore, challenging questionable patents and using technology without a license.” Indeed, the FTC recently concluded that concern that patenting upstream technology, or “research tools,” would actually obstruct commercialization of new products and hinder follow-on innovation in biotechnology “has yet to materialize.”

In 2007, David Adelman from the University of Arizona and Kathryn DeAngelis from Piper Rudnick published a detailed study of more than 52,000 biotechnology patents granted in the United States between January 1990 and December 2004.  In the words of the two authors, their study described “the general trends in biotechnology patenting including patent counts, patent-ownership patterns, and the distribution of biotechnology patents across distinct areas of research and development.” They concluded that “this analysis finds few tangible signs of patent thickets that define the anticommons.”

The National Research Council of the National Academies of Science found that “the number of projects abandoned or delayed as a result of technology access difficulties is reported to be small, as is the number of occasions in which investigators revise their protocols to avoid intellectual property complications or pay high costs to obtain access to intellectual property.  Thus, for the time being, it appears that access to patents or information inputs into biomedical research rarely imposes a significant burden for academic biomedical researchers.” 

A 2005 survey of scientists involved in biomedical research found that “patenting does not seem to limit research activity significantly, particularly among those doing basic research.”   Only one percent of a random sample of 381 academic scientists reported a project delay of more than a month due to patents on materials necessary for their research, and none reported abandoning a research project due to the existence of patents. (Id. at 17; see also Walsh et al., View from the Bench, 309 Science 2002 (2005).

An earlier study found that patents “rarely precluded the pursuit of worthwhile projects.”  It noted that “for a given project, usually fewer than a dozen outside patents require serious consideration, and the number of licenses required is much fewer, often none.” (Id.) When requested, licenses were often available at minimal or no cost. (Walsh, Patents & Access, at 17.) “Thus, not only are barriers or delays rare, but costs of access for research purposes are negligible.” (Id.)

Myriad appears to have never asserted its patents based on genetic testing research, but only against substantial direct commercial competitors.”

Indeed, the evidence in the Myriad case showed that a vast amount of BRCA-related clinical and experimental research has been conducted since Myriad’s patents issued.  Another study confirmed this and concluded that “the present analysis and accompanying observations do not point to the existence of a wide patent thicket in genetic diagnostic testing.

Arguments about stifling research also ignore the protection provided to researchers under 35 U.S.C. §271(e)(1)  and the common law research exception.

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