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. Universities don’t comply with the standard patent rights clause; federal agencies don’t enforce the patent rights clauses; federal agencies don’t act on the rights provided to the government; federal agencies have no mandate to march-in; inventors, third parties, and the public have no standing to force federal agencies to act (potentially “deeply troubling”–Supreme Court); and Bayh-Dole purports to exempt all university-supplied information from public disclosure. It’s a pipeline. The public interest stuff just covers for the inventions pushed through the pipeline as patent monopolies, for which university patent administrators collect a fee and call it all virtuous, wildly successful, in the public interest.
If one wants to discuss whether such a pipeline is indeed virtuous–and whether “Bayh-Dole” operates at all, beyond this pipeline–that’s fine. But don’t get caught up rainbow chasing. The pipeline says:
the federal government and nonprofits that host federally funded, faculty-led research
have a mandate take inventions from inventors and outside the patent system to re-issue patents (in the form of assignments made to look like exclusive licenses) on those inventions made with federal support
to pharmaceutical companies (and their proxies) for exploitation and
thus share (in a mostly inconsequential way) in the upside of the patent monopolies
used to exploit public suffering for maximum profit.
There it is. The pipeline exists. It depends on federal agencies not enforcing Bayh-Dole, not acting on federal government rights, not publicly reporting what is happening. Defend it if you can. But this is what we are talking about. Not the rainbows.