We are dealing with when an invention becomes a subject invention under Bayh-Dole. An invention must meet every element of Bayh-Dole’s definition at 35 USC 201(e) to become a subject invention and cause Bayh-Dole to preempt most other federal law and executive branch patent policy with its own clumsy additional layer of administrative fussiness. We are dealing with the problem of patentability, and in particular with the necessity that an invention must be sufficiently documented to meet the requirements of federal patent law for patentability as one of the conditions set down by the definition of “invention” within the definition of subject invention. Again, if an invention has not been documented at the level required to obtain a patent, it is not patentable. We would say that the invention has not been “enabled.” Nothing in Bayh-Dole requires an inventor to document an invention so as to make it (all other things aligned) become an invention that is or may be patentable. Bayh-Dole doesn’t even come into effect for merely patentable inventions, anyway–even those made within the scope of a federal funding agreement. The invention must be a subject invention for Bayh-Dole to preempt other law and impose its own clunky, mostly useless administrative layer.
Bayh-Dole’s implementing regulations attempt to add some structure to the law–mostly by introducing stuff not in the law but dragged in from past executive branch policy and regulations. Here, for instance, is 37 CFR 401.14(c)(1), on invention disclosure. It’s stuff not in Bayh-Dole but required anyway. And it’s longish. The point of the disclosure requirement is that the elements in the disclosure by a contractor (having come to own a given invention) to the federal agency are those that would provide the necessary documentation that makes (everything else aligned) an invention patentable (is or may be) and a subject invention (only if it is owned by a party to a federal funding agreement).
The contractor will disclose each subject invention to the Federal Agency within two months after the inventor discloses it in writing to contractor personnel responsible for patent matters.
Remember, “contract” here is defined shorthand for “funding agreement” and “funding agreement” includes any assignment, substitution of parties, and subcontract of any kind, and the “performance of work under a funding agreement” means developmental, experimental, or research work, at least some of which has been supported by federal funds.
The disclosure to the agency shall be in the form of a written report and shall identify the contract under which the invention was made and the inventor(s).
The written report meets a requirement for constructive reduction to practice of an invention and provides the information necessary to demonstrate that the invention indeed is a subject invention.
It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electrical characteristics of the invention.
For a subject invention to be disclosable, it must already meet every element of the definition of subject invention. This disclosure requirement applies only to subject inventions. If a disclosure sent by a contractor to a federal agency fails to provide the information necessary to satisfactorily document a given invention, it is not that the report is defective–it is that the invention, until it is satisfactorily documented, cannot be a subject invention because without such documentation it is not patentable.
The enabling information has to be provided to contractor personnel responsible for patent matters. That is, this information demonstrates that the invention is directed to patentable subject matter, and has been described in sufficient detail that, other things also conforming, the invention is or may be patentable. If this description is not “sufficiently complete,” then the invention is not a subject invention. Inventors may supply a sufficiently complete description–but there’s nothing in Bayh-Dole that requires them to do so, or for a contractor to demand such a description. Even here, in the standard patent rights clause, the contractor’s obligation begins when an invention is a subject invention, not before. There’s nothing in Bayh-Dole that forces contractors to act so that Bayh-Dole comes into effect. The law does not force itself on contractors. The law is entirely conditional on the contractor doing those things that bring Bayh-Dole into effect to preempt the operation of other law and executive branch patent policy.
There is a widespread presumption that contractors should desire Bayh-Dole to preempt other law. That presumption is borderline crazy stupid. Only in universities and nonprofits does one find such a thing. Why? Because if Bayh-Dole preempts other law, then university administrators can prevent inventions from the horror (from their perspective) of entering the public domain or royalty-free non-exclusive licensing by federal agencies (Bayh-Dole also aims to preclude federal agencies engaging in royalty-free non-exclusive licensing–so perhaps the university administrators are desperate to own inventions to prevent federal agencies from bungling their efforts at exclusive licensing). There are a host of reasons why federal open access is not a horror, and why it doesn’t happen now anyway–but the short of it is that university administrators are not, for the most part, particularly good at reasoning, and so they presume it is a good thing to do whatever they can to trip Bayh-Dole into effect.
The disclosure shall also identify any publication, on sale or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been accepted for publication at the time of disclosure. In addition, after disclosure to the agency, the Contractor will promptly notify the agency of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the contractor.
This added reporting requirement documents that the invention is indeed patentable, all other elements having been met, and identifies any bar date based on publication, sale, or public use after which time the invention would no longer be patentable and therefore no longer a subject invention.
Thus, what a contractor’s designated patent personnel have to get from inventors by way of disclosure is all this stuff that demonstrates that an invention is a subject invention–but for documentation that the invention is owned by a party to the funding agreement. That’s the thing left out that’s material to demonstrating that an invention is indeed a subject invention.
The standard patent rights clause handles it all this way (at 37 CFR 401.14(f)(2)):
The contractor agrees to require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the contractor each subject invention made under contract in order that the contractor can comply with the disclosure provisions of paragraph (c) of this clause, . . .
That is, this disclosure requirement is not the first impression–a report, say, that an invention has been made–but rather the complete documentation of an invention to show that it is or may be patentable. The report is required only for inventions that are already subject inventions–that is, they are already owned by the contractor (a written assignment step here), have been described in sufficient detail to meet the specification requirements for a patent application, and which have been “made under contract” (that funding agreement with all its possible extensions stuff again), plus the information regarding statutory bar by publication, sale, or public use.
You might think this is crocked up. The requirement should be to disclose everything that even remotely smells like an invention “just in case.” Let the contractor paw through things for those inventions that turn out to be patentable, figure out if they were made under federal contract, and report those in some detail. And that’s pretty much what university administrators do, but that’s not the federal law. They might demand inventors comply with their requirements, but it’s sissy fraud for them to ascribe their demands to compliance with federal law.
Think it this way instead. Bayh-Dole pertains here to subject inventions. It does not operate for everything else that someone working at a university, nonprofit, or small company might discover, develop, collect, create, author, or poop out. It applies to a specific, carefully defined, intangible asset–the subject invention. Until there is documented evidence that a subject invention has come into existence–recognized, owned, patentable subject matter, new-useful-non-obvious, under contract, not barred by prior disclosure–Bayh-Dole has no claim, preempts nothing. Thus, there is no authority nor mechanism in Bayh-Dole to compel things to become subject inventions or to compel contractors or inventors to take action to make things become subject inventions.
Imagine if a law that required candidates for public office to disclose their tax returns also required everyone to run for public office on the premise that if it was good that candidates disclose their tax returns, then it must be even better if everyone did so. That’s the level of whooping stupidness at work among university patent administrators when it comes to Bayh-Dole. They want Bayh-Dole to require them to act to bring Bayh-Dole into effect. But it is their own choice that operates, not federal law. They choose to make things become subject inventions and so bring these within the scope of Bayh-Dole. There’s nothing that demands that they do so–and there are even great reasons for not getting bogged down in Bayh-Dole’s kookiness, but try to explain that to the lemmings.
NIST recently added an assignment requirement to this same (f)(2) provision–they did so by requesting comments on how to improve technology transfer from federal labs, and then accepted comments on how to deal with university technology transfer, and then added a requirement that the employees’ written agreements to protect the government’s interest also include a provision that inventors will assign subject inventions to their employer. This is NIST stupidness–NIST’s chief counsel has public talk slides that demonstrate he doesn’t intend to comply with Bayh-Dole. The Supreme Court in Stanford v Roche made clear that Bayh-Dole is not a vesting statute. It does not provide contractors with ownership of inventions or any special privilege to acquire ownership of inventions. NIST ignores the Supreme Court and in effect implements an executive branch policy outside Bayh-Dole’s authority but using Bayh-Dole’s definition.
NIST, like university patent administrators, cannot comprehend how Bayh-Dole fails to compel people to bring Bayh-Dole into effect. NIST seeks to force inventors to turn their inventions into subject inventions–or, more nuanced, to make contractors make their inventors parties to the funding agreement and then force them to hand over their subject inventions. But the moment inventors who are parties to a funding agreement invent, they are also contractors and the general principle of Bayh-Dole is that all contractors have the same basic rights, and each contractor is prohibited from using its position as a contractor to obtain an interest in the inventions of other contractors. NIST screws all this up.
It doesn’t matter for university and nonprofit practice because no one complies with the written agreement requirement anyway. All they see is that there’s an assignment requirement, and they shake that in front of inventors as if it is a federal threat–Bayh-Dole must be used, and contractors must be compelled to compel inventors to turn over their subject inventions to the organizations that hosted the federally supported research. It’s weird. It’s wrong. It runs against the federal government’s constitutional authority to secure to inventors their exclusive rights in inventions. It runs against the Supreme Court’s ruling in Stanford v Roche. And the practice that results, if one wants to argue in some strange Robin Hood style that illegal actions by nonprofits can still result in public good, are terrible–the metrics on outcomes (to the extent these leak out, since Bayh-Dole claims the federal government must keep them secret) are terrible. A handful of mostly outrageously priced drugs, Google’s original page rank algorithm, other odds and ends, for a trillion dollars of federal research funding over nearly 40 years.
Anyway, once an invention is a subject invention, inventors must disclose all the elements but for their assignment or status as parties to the funding agreement, that demonstrates that their invention meets all the elements of the definition of subject invention. That’s the short of it. Shish.
or otherwise protectable
I have no idea what this phrase means at all. The “title” referred to is Title 35, which pertains to patents. So what might be “protectable” in an invention that’s not patents but is in patent law is quite beyond me.
Here’s the definition of “Subject Invention” in the Federal Procurement Regulations–the source for Bayh-Dole’s definition. In the FPR, the definition of subject invention includes the definition of invention (1-9.107-5):
“Subject Invention” means any invention or discovery of the Contractor
qualifying the scope–first the invention must be patentable, and then specified aspects of the activity that constitutes making an invention must be identified–the earliest thing (conception) to the thing that completes the act of inventing, even if not necessary for patentability (first actual reduction to practice)…
conceived or first actually reduced to practice
and adding a limitation…
in the course of or under this contract, and
to anchor the definition in patent law, a list of patentable subject matter…
includes any art, method, process, machine, manufacture, design, or composition of matter, or any new and useful improvement thereof, or any variety of plant, which is or may be patentable under the Patent Laws of the United States of America or any foreign country.
The FPR definition itself is clumsy. Bayh-Dole is even clumsier. A subject invention could be defined as any invention “which is or may be patentable under U.S. or foreign patent law”–there’s really no need to then itemize patentable subject matter. There’s nothing in the FPR definition, however, that suggests that there’s anything else that might be protectable, other than patentable subject matter, under whatever patent law that might apply. Bayh-Dole’s even clumsier definition, by contrast, removes reference to foreign patent law, and substitutes plant variety protection for “any variety of plant” in the FPR definition–it’s almost like someone doing the Bayh-Dole drafting had no clue that there were plant patents under federal patent law and decided that since plant varieties were subject to a separate form of certificate protection (not patent law), these plant varieties had to be included in Bayh-Dole’s definition of invention.
More consequential changes by Bayh-Dole to the FPR definition, however, have to do with ownership and the scope of the contract. In the FPR patent rights clause, contractors are required to have patent agreements with their employees that “effectuate” the requirements of the patent rights clause–including assigning inventions (either to the contractor so that the contractor can fulfill its obligations to the government, or to the government directly). In Bayh-Dole, there’s no mention of contractor ownership or patent agreements. Thus, the FPR’s use of “of the Contractor” comes in a context in which the contractor is also required to have a patent agreement under which the contractor has the contractual right to take ownership of conforming inventions, and if it does not exercise this right, the contract secures on behalf of the federal government the right to take ownership.