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Patents on basic biomedical research
« on: 2003-03-12 07:59:38 » |
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Razing the Tollbooths
A call for restricting patents on basic biomedical research
By Gary Stix
Scientific American, April 2003
http://www.sciam.com/article.cfm?articleID=00092FBB-6BDC-1E61-A98A809EC5880105&catID=2
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The 14-fold increase far outpaced the overall growth in patents during that period. A few voices in the intellectual-property community have now charged that Bayh-Dole has gone too far. Patents, they claim, have been granted on the fruits of biomedical research that should remain in the public domain. In recent co-authored articles, Arti K. Rai of the University of Pennsylvania and Rebecca S. Eisenberg of the University of Michigan at Ann Arbor have proposed reform of the law, contending that development of new biopharmaceuticals and related technologies has been hindered by extending patent coverage beyond actual products to basic research findings. DNA sequences, protein structures and disease pathways should, in many cases, serve as a general knowledge base that can be used freely by everyone.
Rai and Eisenberg cite the case of a patent obtained by teams at Harvard University, the Massachusetts Institute of Technology and the Whitehead Institute for Biomedical Research in Cambridge, Mass. It covers methods of treating disease by regulating cell-signaling activity involving nuclear factor kappa B (NF-kB), which controls genes for processes ranging from cell proliferation to inflammation in various maladies. Those institutions and Ariad Pharmaceuticals (also in Cambridge), the exclusive licensee of the patent, are now suing Eli Lilly, claiming that two of its drugs--one for osteoporosis, one for sepsis--infringe the patent. Ariad has contacted more than 50 other companies that are researching or commercializing drugs that work through this pathway, asking them for licensing fees and royalties. The broad-based patent does not protect specific drugs. Instead it has become a tollbooth for commercial drug research and development on the NF-kB pathway. "In this case, as in many others, upstream [precommercial] patents issued to academic institutions serve as a tax on innovation, diluting rather than fortifying incentives for product development," the authors wrote in the winter-spring issue of Law and Contemporary Problems. (Their other article on the Bayh-Dole Act appeared in the January-February issue of American Scientist.)
Rai and Eisenberg suggest that the law should be altered to make it easier for the government--in particular, the National Institutes of Health--to specify that such upstream research remain public and not be subject to patents. They also recommend facilitating the government's ability to mandate the nonexclusive licensing of a patent at reasonable rates. Both actions are permitted under the current law but have almost never been exercised; the law makes it cumbersome to do so.
Fiddling with Bayh-Dole does bear risks. For instance, an executive-branch agency such as the NIH could be subject to political pressure in barring patents: an administration opposed to using embryos in scientific investigations might order an agency to withhold patents on such research. But university technology-transfer offices, Rai and Eisenberg contend, cannot be entrusted to make decisions about when to forgo patenting, given that a big part of their mission is to bring in licensing revenues. So more leverage is needed to ensure that basic biomedical research remains open to all.
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