Another question on RE: When does Bayh-Dole not apply?–4

Now that you have a better idea about Bayh-Dole and have done some thinking about why someone might want it Bayh-Dole to apply and others might not want it to apply, let’s work the definition of invention (at 35 USC 201(d)):

The term “invention” means any invention or discovery which is or may be patentable or otherwise protectable under this title or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.).

This is actually a problematic definition. Bayh-Dole is part of federal patent law, but federal patent law does not otherwise define invention. The point of federal law is to set out when someone may receive a patent on an invention that meets the law’s requirements for patenting, and what rights a person has who holds a patent. What matters is what is patentable, not the word for whatever it is that is patentable. Patent law concerns *the conditions on which one can get a patent*, not what defines everything  for which one might imagine getting a patent.

Bayh-Dole could be really simple:

If you decide to seek a patent, then specially report the discovery or invention on which you have based your decision.

No definition of discovery or invention is necessary. It’s whatever you define as the subject of your patenting effort. If a contractor doesn’t seek a patent, then the discovery or invention will be disclosed to the federal government as part of findings without any special hoo-haw about patentable inventing. But Bayh-Dole also adds authorization for federal agencies to deal in exclusive licenses–patent monopolies, if you wish–and that provides a motivation for attempting to capture everything that anyone at a federal agency (or someone in a company that has the ear of someone at a federal agency)–more than the inventor, or the contractor–might want the federal government to patent and so control exclusively.

Look at the logic of Bayh-Dole’s definition:

“invention” means both “patentable invention” and “not patentable invention” including “plant varieties” that may be protectable and may not be protectable, and anything else that is “otherwise” protectable under federal patent law (i.e., “this title”–title 35 USC) but not “patentable.”

If an invention “may be patentable” then the “may” also means that the invention might not be patentable, but patentability has not yet been conclusively decided, and so an invention comes within the scope of Bayh-Dole’s definition of invention whenever patentability has not been conclusively ruled out. That is, a final rejection of a patent application from the USPTO or a determination that an invention otherwise fails to meet the statutory requirements for patenting–directed to non-patentable subject matter, application filed after a statutory bar to patenting, and the like. But as long as someone thinks an invention may be patentable and hasn’t bothered to have a determination made otherwise, the invention clearly “may” be patentable–at least in the indecisive, non-authoritative mind of someone.

One further element to this mess. An invention cannot be patentable if the inventive nature of the invention is recognized by the inventor. See the MPEP 2138.04 discussion of conception. While the idea of “conception” does not apply to first to file patent applications, it does apply in Bayh-Dole, which bases its definition of “made” in part on conception. That’s because Bayh-Dole uses conception not to establish a not-earlier-than date for inventing but rather as a way of establishing the scope of federal interest in inventions that have been acquired by a contractor. So, scope of what “is or may be patentable,” not patentability.

If an inventor insists that some thing that’s been done is not inventive, even if that thing would otherwise be at least potentially patentable in someone else’s opinion, the invention cannot possibly meet Bayh-Dole’s definition of subject invention because the inventor rejects the claim that the thing is inventive. In Bayh-Dole, a subject invention–a particular category of invention that Bayh-Dole operates on for its contracting provisions at 35 USC 202(c)–depends on “conception” and conception in turn depends on simultaneous recognition of the invention by the inventor.

There’s really nothing a university administrator or lawyer can do by way of threats–if an inventor says the thing is not inventive, then even if the inventor is wrong, the invention cannot be a Bayh-Dole subject invention, and Bayh-Dole’s contracting provisions do not apply. There’s nothing to disclose to the contractor, nothing for the contractor to disclose to a federal agency, nothing for the contractor to elect to retain title to–even if there is a title.

If an inventor does not accept that what has been done is inventive, then whatever it is is not patentable, since the standard of conception has not been met, and Bayh-Dole simply does not apply since whatever it is is therefore not “protectable” under federal patent law.

Perhaps if a patent application were to be filed anyway, over the objections of the inventor who insists the whatever thing is not inventive–and for that, somehow disclosure happens anyway–and a patent issues, then and only then might someone insist that legally the inventor must have conceived an invention that is or may be patentable–because, clearly, a patent has issued. At that point, and only then, one would have an invention that meets the conception part of Bayh-Dole’s definition of subject invention. But until that point, whatever anyone does has nothing to do with Bayh-Dole, because Bayh-Dole does not apply if a whatever it is is not patentable. No conception, not patentable. Just as, not owned by a party to a federal funding agreement, impossible to be a subject invention, even if “patentable,” and Bayh-Dole does not apply.

This is a big problem with Bayh-Dole’s approach. The statute gives the impression that it applies to stuff prior to there being something patentable (that “may be” stuff, implying “may not be”), but in its contracting provisions, it simply cannot dictate control of research anythings until there’s a determination by the USPTO that claims are allowed. Until then, there’s no imperative that anyone have an opinion that some whatever “may be patentable.” If some whatever “may be patentable” it also “may be unpatentable.” The point is, patentability is not the issue. The issue is who gets to decide whether to find out–the inventor, the contractor, or the federal government.

Yeah, strange stuff. But it’s really essential to the architecture of Bayh-Dole, which goes out of its way to protect inventor rights–even though in practice the interpretation of Bayh-Dole has been manipulated by folks (including, unfortunately, the late Senator Bayh) who do not respect inventor rights and consider inventor rights to be somehow in the way of the proper success of the law. Other elements of Bayh-Dole’s genuine interest in inventors include that Bayh-Dole does not require inventors to use the patent system (it’s not there–go look!) and does not require inventors to assign their inventions–even ones made in work supported by the federal government–to their employers or to the federal government (again, not in the statute–whatever you might make of the NIST change in the standard patent rights clause, you have to admit that there’s nothing in Bayh-Dole that requires or authorizes or mandates or even encourages assignment by inventors. If NIST claims that assignment is necessary to somehow “fix” a defect in the law, then NIST is making up law on its own rather than accepting that what it views as a defect is in fact the intended public policy. Which is just how the Supreme Court read Bayh-Dole in Stanford v Roche–you can’t justify a reading of the law just to make it conform to your preference for what the law should do, even if the words of the law don’t support that preference. )

Inventors of inventions made with federal assistance come within the scope of Bayh-Dole (and specifically 35 USC 202(a)) only when they become parties to a federal funding agreement (by any assignment, substitution of parties, or subcontract of any type) or when they assign their inventions to a contractor–someone who is a party to a federal funding agreement.

Contemplate that. Bayh-Dole’s contracting provisions do not apply to inventions made with federal assistance under a funding agreement unless a contractor makes the inventor a party to the funding agreement or obtains assignment of the invention from the inventor.

Nothing in Bayh-Dole compels an inventor to become a party to a federal funding agreement–that’s a matter of mutual consent–and nothing in Bayh-Dole compels an inventor to assign an invention. Furthermore, if one chases this down through the standard patent rights clause for inventors–37 CFR 401.9–even if an inventor becomes a party to a federal funding agreement, the inventor’s requirements are not the same as those that apply to other small business contractors or to nonprofit contractors. Folks who do not want inventors to have any rights in the “technology transfer” process misread Bayh-Dole in the ways the Supreme Court condemned–ways the Court found “deeply troubling” but for the saving that the portion of Bayh-Dole dealing with contracting for research and the like applied only after a contractor had acquired an invention made with federal assistance.

Furthermore, patentability alone is not the only criteria–even if an invention is not patentable, it may–according to the definition–still be “otherwise protectable” under the federal patent statute. It’s not clear just what this “otherwise protectable” means, nor even what it means to “protect” an invention as distinct from using a patent right to exclude others from practicing a claimed invention.

“Protectable” is even more puzzling in the context of Bayh-Dole’s statement of policy–“use the patent system to promote the utilization of inventions.” Here, Bayh-Dole institutes a working requirement on inventions made in research or development work receiving federal support. Where “protection” suggests preventing others from using an invention in favor of the patent holder, Bayh-Dole’s primary purpose is for the patent system to be used in a particular way so that inventions are worked–that there is a benefit of use available to the public on reasonable terms. If Bayh-Dole applies, an invention must be worked, and the implication is that the use of the patent system is only meaningful for those inventions that cannot be worked unless they are “protected.” If an invention would be worked without “protection,” then it is counter to Bayh-Dole’s policy (and therefore counter to federal patent law and therefore not within the patent property rights of the owner of a covered invention) to use the patent law to exclude practice of any given invention. If a patent retards or suppresses use rather than promotes use, that puts the exploitation of that patent at odds with Bayh-Dole.

Just to make the logic of Bayh-Dole clear, such as it is. If an invention will be used without any patent, then no patent is justified under Bayh-Dole. Only if no one will use an invention unless there is a patent, is use of the patent system authorized. The test of this proposition, clearly, is to offer each invention to the public for a period of time–say, 10 months. If no one makes any effort to use the invention, then that’s a sign that patenting might be indicated. But it also may be that no one uses the invention because the invention is not worth using–it may be just another variation on what already is in use. It may be so difficult to use that no one can afford to use it. It may require so many other changes and miracles to take place that it is outside anyone’s power to force all those other changes. It may take so long to develop into something actually practical that the patent will expire before anyone has done all the other developing and inventing needed to use the invention.

Any of these reasons would argue against the use of the patent system. We are left, then, with a special subset of inventions–ones that no one takes up for use when offered openly, and ones for which a patent makes no difference because other factors work argue that the invention won’t be used within the term of any patent. Since no one will use inventions that remain, a patent on these inventions does not “protect” anything–there is nothing to exclude if no one will use anyway. Nothing changes with a patent issuing. People don’t say, “I would never use that invention when it was freely available–but now, since there’s a patent on it, then I want to use it so badly but darned, there’s this patent that protects it.” No, that’s not how it works. It is not the invention that the patent “protects” in this case–it is the work that gets done using the invention–it is the work of “practical application” not the work of inventing that gets “protection.”

Again, if anyone with any capability might use an invention with only a modest investment in time and effort–what practitioners with ordinary skill in the art and ordinary resources might do–then again, a patent offers no “protection” within Bayh-Dole because it does nothing to promote use of the invention that won’t happen anyway. On the face of it, denying by patent everyone the opportunity for use in favor of one’s own use or conveying the exclusive right to that use to some chosen company does not promote use–it suppresses use.

So, consider research uses. If one research team has invented a research tool–a method of analysis, a franken rat, a sensor, application of a new or existing compound, whatever–then it stands to reason that other research teams should be able to make their own versions of that research tool–you know, ordinary skill in the art and all. And researchers would have reason to use that tool–to study published findings, to replicate (or dispute) published findings, or to use the tool to do more work of the kind for which it was developed. Similarly, for software that involves inventive algorithms or steps. The software exists and functions–it’s a best mode, say–so others might readily use the software (and hence the invention(s) it enables) simply by gaining access to the software code (or writing their own code that incorporates the inventive algorithms or steps). The move from research to other uses is also no bright line. A popular research use may easily lead to a need for production to meet research demand–a natural pathway by which research technologies become mainstream, all without withholding an invention by means of patent, without a need for “protecting” anything.

We might argue then that Bayh-Dole does not provide anyone that right to withhold inventions from any pathway of to use that is not promoted by a patent–that is, the patent system must do more to create use leading to benefits available to the public on reasonable terms–faster, cheaper, higher quality, broader applications, faster improvement, more robust standards.

What have we got here, then, with the definition of “invention”? First, this is a distinctive definition in federal patent law. It carves out a special category of invention–an invention that includes non-patentable stuff (plant varieties–distinct from patentable plants). Inventions that may be patentable (and therefore some of which are not patentable)–all of which is strange. More strange is the idea that inventions are “protected” by patents when it is clear that patents both publish inventions (how can that “protect” the invention?) and provide a right to exclude others from practicing patented inventions. Excluding from practice does not “protect” an invention. Excluding from practice is intended to “promote the progress of the useful arts.” In this way, a patent “protects” the public interest in the progress of the useful arts by encouraging dissemination of inventions and providing an opportunity for each inventor to first exploit an invention. The patent bestows a privilege to exclude on an inventor in exchange for the publication of an invention.

But a Bayh-Dole subject invention includes a working requirement, and so a patent on such an invention necessarily restricts the privilege to exclude. And patents on subject inventions acquired by  nonprofit under Bayh-Dole’s nonprofit patent rights clause (and especially 35 USC 202(c)(7)) carry a financial limitation that must follow any assignment of the invention–all income after specified expenses must go to support scientific research or education. That, too, restricts the opportunity for a patent holder to make money from the invention–whether through sales or licensing–for itself.

We might say, a patent “protects” the opportunity to make money by excluding those who would otherwise use a given invention. A patent does not “protect” the invention. Except in Bayh-Dole’s definition. Which is part of federal patent law. And screwy.

Basically, if there are patent rights available, then there must be a patentable invention. But how does anyone know there are patent rights available until a patent application has been drafted and claims examined by the USPTO? Until then, it’s all just maybes–for everyone. There’s no “is patentable” until the USPTO says so. The real issue, then, is not “is or may be patentable.” The issue is who gets to decide whether to find out by drafting and submitting a patent application.

Why does Bayh-Dole even bother defining invention? In prior executive branch patent policy–and federal laws pertaining to federal claims to inventions–the government’s policy was to release those inventions for public access either by dedication (via the public domain) or patenting (via publication using the patent system and non-exclusive, royalty-free licensing). If someone wanted an exclusive license from the federal government, they should consider getting an act of Congress to authorize it. Thus, the scope of federal claims–whether to a license or ownership–of an invention made in federally supported work could be broad because that scope was defined on behalf of the public. Whatever the federal government claimed by way of ownership, the public got by way of public domain or non-exclusive, royalty-free license.

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