Intellectual property is arguably the lifeblood of discovery. But as academic scientists increasingly accept industry funding and engage in commercial activities such as patenting, the concern is that biomedical research will suffer as rights holders refuse to share their materials and information. Patents, however, may not be the issue, according to two recent surveys and a new report by the National Academy of Sciences.1
"The problem is not patents per se," says John P. Walsh, associate professor of sociology at the University of Illinois-Chicago. "It's a combination of scientific competition, wanting to publish first, and commercial interests more broadly." Additionally, he points out, many academic scientists tend to largely ignore patents anyway.
In a survey of biomedical researchers conducted in late 2004, Walsh and colleagues found that only 5% of academic bench scientists regularly check for patents on work related to their research. More often, difficulties arise when scientists ask for tangible research inputs, such as materials and data, and are rebuffed. In the survey, 19% of biomedical researchers reported their most recent request for material was denied. This is resulting in a greater number of people having to abandon projects, says Walsh.
While this situation is undoubtedly affecting academic researchers, it is having an even greater impact on bioscientists working in industry, according to an American Association for the Advancement of Science (AAAS) Scientific Community Members survey.2 In the survey, 76% of polled industry bioscience researchers reported that their research had been negatively affected compared to 35% of university-based bioscience researchers. Of those experiencing problems, 58% said their work was delayed; 50% said they had to change their research; and 28% abandoned their projects altogether. The most common cause cited was overly complex licensing negotiations.
"Academia seems less affected by patenting than industry when it comes to gaining access to knowledge, perhaps because it continues to maintain the more traditional and informal channels of how it has historically shared intellectual property," says Stephen A. Hansen, project manager of the AAAS Science and Intellectual Property in the Public Interest (SIPPI) program. The AAAS survey found that material transfer agreements were the most common means of sharing patented technologies, not formal licensing agreements, and two-thirds of respondents cited publishing as their primary means of sharing intellectual property.
But things could be changing to make the unencumbered exchange of information more difficult, according to a report by the National Research Council of the National Academy of Sciences (NAS) in Washington, DC.3 The Madey v Duke University4 decision in 2002 upset a longstanding practice by the academic community to not concern itself with others' patents when performing research with no clear commercial goal, assuming an "experimental use" exception. Without that shelter, however, patent holders may more actively sue universities for infringement.
Among its recommendations, the NAS said Congress should consider exempting research from patent infringement if the research seeks to find novel methods of making or using the patented invention or create novel alternatives, improvements, or substitutes. The National Institutes of Health should require government-funded research centers to deposit protein-structure data in the public Worldwide Protein Data Bank, overseen by a consortium of international research groups. Moreover, researchers should avoid seeking patents on genes and proteins whose functions are not known.
"The goal is to ensure that public investments in genomics and proteomics bring about the greatest public good," says Shirley Tilghman, president of Princeton University and NAS committee cochair, in a statement accompanying the report's release in November. "Researchers, policy- makers, and other stakeholders must recognize that achieving an appropriate balance between protecting research discoveries and granting access to them is critically important to fostering scientific progress and enhancing public health."