Bayh-Dole has to be broad
Bayh-Dole’s scope has to be as broad as the broadest federal statute or regulation pertaining to federal rights to inventions.
In Bayh-Dole, “subject invention” is defined broadly to include conception or first actual reduction to practice, not just what gets patented first
“Contractor” is extended to all parties to funding agreement including those added by assignment, substitution of parties, and subcontract
“Made in the performance of work” applies to the overall project not just the federally funded part
Without this broad scope Bayh-Dole cannot uniformly preempt federal statutes and regulations whenever a contractor acquires ownership.
Consequences
Each party to a federal funding agreement is subject to a patent rights clause and has the right to retain ownership of inventions it acquires–including inventors.
Bayh-Dole requires contractors to make their technical employees parties to the funding agreement, and
when those employees invent, they own their inventions and thus their inventions are subject inventions, and
the patent rights clause that applies to inventors as contractors is the inventor patent rights clause unless the inventor assigns to the contractor.
When nonprofits assign subject inventions to companies:
the companies become parties to federal funding agreements
the companies are subject to the nonprofit patent rights clause
the companies must dedicate income from subject inventions to specified charitable purposes–scientific research and education
inventions made in development of a subject invention by a party to a funding agreement are also subject inventions
Instances
When a university receives federal funds to conduct medicinal chemistry research, the broad purpose is to discover and develop new medicines–even if federal funds support only “early stages” of that research and development and even if the university characterizes its work as “basic or applied” research. The scope must be as broad as the overall purpose, the overall project.
When a university grants an exclusive patent license to make, use, and sell a subject invention, the university necessarily assigns that subject invention and the assignee becomes a party to the federal funding agreement–any inventions the assignee makes to develop the subject invention in performance of the broad purpose become subject inventions when acquired by the assignee.
Enforcement of Bayh-Dole
The march-in public interest apparatus in Bayh-Dole is thin, weak, waivable, unenforced, and designed not to operate. There are no means by which the public can initiate an enforcement action or prevent a federal agency from waiving requirements. Even a failure to achieve practical application–benefits of use available to the public on reasonable terms–only provides a conditional federal agency right to require licensing.
The government license to practice and have practice any subject invention only makes a difference in Bayh-Dole’s operation if the federal government has the will to use that license. Otherwise, it is a wasted federal asset–and fails to bound Bayh-Dole’s operation to non-governmental markets.
The broad scope of Bayh-Dole’s definitions is fundamental to its operation. The enforcement of Bayh-Dole’s definitions is not waivable at federal agency discretion:
non-disclosed subject inventions made in development and other broader projects
nonprofit assignment of subject inventions under cover of exclusive patent licenses
misuse of income by nonprofit assignees–now parties to the funding agreement–that must by law be dedicated to charitable purposes
Avoidance
If a company does not want to devote its income earned with respect to a given subject invention to specified charitable purposes, then it must insist on taking less than an exclusive license to all substantial rights in that subject invention.
If a university wishes to constrain the scope of its federally funded projects, it cannot declare as default policy that it intends to commercialize each invention or discovery it owns–that policy default broadens the supported project.
Avoidance of the consequences of Bayh-Dole’s broad definitions is Bayh-Dole’s necessary public interest outcomes:
use the patent system to promote utilization
maximize the participation of small companies in development
promote free competition and enterprise
promote American industry and labor
These objectives are accomplished when contractors choose to avoid the consequences of Bayh-Dole’s broad definitions–no infringement actions except to protect those using inventions; access to subject inventions on terms that any small company can afford; non-exclusive licensing and standards to promote free competition; availability of subject inventions to all American companies–to industry–not just to one company in an industry.