A while ago, Research Enterprise argued that the “manufactured substantially” requirement in Bayh-Dole, for all its gesture toward American manufacturing, is a nearly empty requirement. Absurdly narrow, easy to circumvent, waivable by federal agencies (“we tried and failed” or “we didn’t bother even to try”–both okay excuses), unenforced, backed by march-in procedures so narrow and convoluted that no agency has ever marched-in for non-compliance.
In a nutshell, section 204 reflects the characteristics of Bayh-Dole in general. Bayh-Dole exists to permit the federal government to subsidize the patent medicine industry by means of patent monopolies on publicly funded research.
This claim is clear from the history of federal patent policy. We may start with the pharma boycott of the Public Health Service in the early 1960s, move to the NIH use of the Harbridge House report to restart the IPA program in 1968, note the fact that the IPA program itself was an end-run around executive branch patent policy (and PHS policy). When the NIH was blocked trying to expand the IPA program to all government agencies and the IPA program shut down in 1978 for doing sweetheart exclusive licenses with pharma, we get Bayh-Dole doing much the same thing, introduced in 1979, passed in 1980, effective mid-1981.
We can also see the pipeline in the mechanics of Bayh-Dole. For all the rainbows that appear to be about “protecting” the public, the rainbows end up being political fantasy to dissuade anyone from challenging the pipeline by which publicly funded inventions are assigned (under the cover of exclusive patent licenses that in fact assign) to pharmaceutical companies or to companies formed by speculative investors to sell out, eventually, to pharmaceutical companies.
Bayh-Dole’s rainbows don’t operate. Continue reading

