. "4 Trends in the Patenting and Licensing of Genomic and Protein Inventions and Their Impact on Biomedical Research." Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health. Washington, DC: The National Academies Press, 2006.
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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health
There are, however, reasons to be concerned about the future in addition to the earlier observation that the patent landscape is becoming more complex in many domains of research. First, the lack of substantial evidence for a patent thicket or a patent-blocking problem is associated with the general lack of awareness or concern among investigators about existing intellectual property.20 That could change dramatically and possibly even abruptly in two circumstances. Institutions, aware that they currently enjoy no legal protection, may become more concerned about their potential patent infringement liability and take more active steps to raise researchers’ awareness or even to try to regulate their behavior. The latter could be both burdensome on research and largely ineffective because of researchers’ autonomy and their ignorance, or at best uncertainty, about what intellectual property applies in what circumstances. It is much easier for corporations to exercise due diligence in the context of research that is centralized and directed than it is for universities, where research is highly decentralized and decisionmaking is fragmented.
On the other hand, patent holders, equally aware that universities are not shielded from liability by a research exception, could take more active steps to assert their patents. The latter may not extend to more patent suits against universities—indeed, established companies may be reluctant to pursue litigation against research universities—but it could involve more demands for licensing fees, grant-back rights, and other terms that raise transaction costs that are burdensome to research. More assertions would, in all likelihood, prompt more defensive behavior on the part of institutions that traditionally are risk averse. Whether proactively in planned research or defensively in response to claims of infringement, established companies typically go to great lengths and considerable expense to determine what constitutes a “valid” patent. If necessary, the in-house legal department will consult outside counsel to verify its views. The resources necessary to conduct patent literature searches and arrive at validity judgments on a frequent or routine basis probably are beyond the capacity of most nonprofit research institutions and a wasteful diversion, in any case. Nevertheless, failure to perform due diligence could limit research institutions’ ability to approach demands for licenses by distinguishing between patents that probably are valid and patents that likely would be held invalid in litigation.
According to information collected from 66 research universities by the American Association for the Advancement of Science,21 there was an increase in patent infringement notifications received in the aftermath of the Madey deci-
The two conditions likely reinforce each other. The absence of thicket or blocking problems encourages ignorance or inattentiveness and vice versa.
The survey was sent to 240 institutions, with a low response rate of just over 25 percent. It was conducted in association with the Association of American Medical Colleges, the Association of American Universities, the National Association of State Universities and Land-Grant Colleges, and the Council on Government Relations.