We are working NIH’s not so tasty guidance to participants in its SBIR and STTR programs directed at small businesses. We reach the NIH’s account of the “principal features” of Bayh-Dole, at least with regard to “intellectual property” requirements:
Principal Features of the Bayh-Dole Act
Organizations are required to establish a written agreement with all employees to disclose promptly each subject invention made under a federally sponsored program and to execute all papers necessary to file patent applications.
And here’s the first principal feature–of all things–the written agreement requirement. Well, the written agreement requirement is not in the Bayh-Dole Act. It’s not even in the implementing regulations. It shows up in the standard patent rights clause. There’s some logic to why it is there–we have just been through all that–but the written agreement is most certainly not in the Bayh-Dole Act.
Just to be clear: the principal feature of the Bayh-Dole Act is that federal agencies are limited in the conditions under which they can require a contractor to assign to the federal government an invention made with federal support if a contractor has otherwise acquired ownership of that invention. That’s the essence of 35 USC 202(a).
- pre-empts other laws, but only when the contractor owns;
- provides protocols for federal agencies to vary from the restrictions;
- provides default requirements for contractors to retain ownership of inventions;
- provides requirements for contractors to use inventions for public benefit on reasonable terms, mostly waivable by federal agencies.
The upshot is that Bayh-Dole creates a pipeline of patent monopoly rights in federally supported research to private companies, in secrecy, without public accountability, and with no enforcement of the public protection requirements in the default patent rights clause. Continue reading