Patent rights follow-up: from the FPR to BD–1

Posted on February 27, 2019 by Gerald Barnett

Here’s some advice in the Federal Procurement Regulations (1975) with regard to the operation of the patent rights clause covering subject inventions. Bayh-Dole is built from the ruins of the IPA program and the FPR by the same folks who built and ruined the IPA program and the FPR. Their changes, then, are instructive.

1-9.109-1 Patent rights follow-up.

It is important that the Government and the contractor know and exercise their rights in inventions conceived or actually reduced to practice in the course of or under Government contracts . . .

This advice is sound, and applies to any federal invention policy. It is not only important that contractors know and exercise their rights, but that the federal government also know and exercise its rights. We may go so far as to argue that the contractor’s exercise of rights in inventions made in projects deemed worthy of federal support depends on the federal government exercising its rights in those same inventions. If the government fails to exercise its rights, then contractors will be encouraged not to exercise their rights–they may not be diligent in identifying inventions, using the patent system, developing inventions to the point of practical application, or making the benefits of those inventions reasonably accessible or on reasonable terms.

Worse, if the government does not exercise its rights, contractors may do things that they have no right to do–they may take inventions they have no right to take, they may do deals that they have no right to make, they may offer products to the public on terms they have no right to offer, they may prevent others from having access when they have no right to prevent that access. We might then argue that the fundamental public protection in federal invention policy is that the government exercise its rights. If the government fails to exercise its rights, then the rest of the public protection apparatus, whatever it might be, fails. Continue reading →

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A null hypothesis for the ITIF panel on Bayh-Dole

Posted on February 27, 2019 by Gerald Barnett

The Information Technology & Innovation Foundation, a  self-described think tank based in Washington DC, will have a panel soon featuring Joe Allen and representatives from BIO and AUTM. Here’s the topic of the discussion:

Join us on March 7 for a discussion of the Bayh-Dole Act’s key role in catalyzing American leadership in life sciences and why implementing march-in rights would harm research universities and limit further innovation.

Folks of course are free to discuss whatever they want, even folks who lead pressure groups. But there’s so much nonsense here, it’s worth at least a comment on it.

Null hypothesis: Bayh-Dole has catalyzed virtually nothing in American life sciences, march-in cannot harm universities nor limit further innovation. Whatever has been happening during the Bayh-Dole era has been happening despite Bayh-Dole, despite the gross misrepresentation of Bayh-Dole, despite the wholesale non-compliance with Bayh-Dole and non-enforcement of Bayh-Dole and Bayh-Dole’s patent rights clauses.

First, we might ask exactly what evidence there is that Bayh-Dole has catalyzed anything having to do with the life sciences or played any role in “American leadership.” Bayh-Dole makes use reports a government secret. The AUTM licensing survey does not break out federally supported subject inventions nor ask about outcomes for these inventions. If Bayh-Dole catalyzed the life sciences, why didn’t the decade-long revived NIH IPA program do this as well? The IPA program was shut down as ineffective. Bayh-Dole was based on the IPA program, drafted by Norman Latker, the same NIH attorney who revived the IPA program. What made Bayh-Dole such a catalyst and the IPA not? Perhaps the panelists will inform us.  Continue reading →

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Research, Nonresearch, and CDC Policy 557

Posted on February 25, 2019 by Gerald Barnett

The Centers for Disease Control has a document–Policy 557–that lays out when Institutional Review Board involvement is necessary with regard to distinctions between patient care and the involvement of patients in research.

Here’s the basic policy:

CDC has an ethical and legal obligation to ensure that individuals are protected in all public health research activities it conducts. All CDC activities must be reviewed to determine whether they are research involving human participants. When an activity is classified as research involving human participants, CDC and its collaborators will comply with 45 CFR part 46 in assuring human research protections.

Policy 557 then distinguishes Public Health Research from Nonresearch. Here’s a bit of the description of Research (my emphasis):

The purpose of the activity is to develop or contribute to generalizable knowledge to improve public health practice;

intended benefits of the project can include study participants, but always extend beyond the study participants, usually to society;

and data collected exceed requirements for care of the study participants or extend beyond the scope of the activity.

Generalizable knowledge means new information that has relevance beyond the population or program from which it was collected, or information that is added to the scientific literature.

Knowledge that can be generalized is collected under systematic procedures that reduce bias, allowing the knowledge to be applied to populations and settings different from the ones from which it was collected.

Research intends to use patients to undertake systematic study that produces knowledge that does not depend on any specific patient and may not even provide a benefit specific to any given patient. That is, patients are used–agree to be used–to ascertain something that is not particular to any given patient. Continue reading →

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Are copyrights considered inventions under Bayh-Dole?

Posted on February 23, 2019 by Gerald Barnett

I saw a search show up here at Research Enterprise–“Are copyrights considered inventions under Bayh-Dole?”

Simple answer.

No.

Brief answer.

Copyright is a form of intellectual property. At one time, perhaps, the idea of copyright was itself a social invention. Something neat during the reign of Queen Anne. [See Adrian Johns, Piracy for a good history of how copyright was entwined with patent]. Copyright, then, could never be considered inventive now, so wouldn’t be an invention under Bayh-Dole.

Longer answer. Just because.

But what about the subject matter of copyright–original works of authorship fixed in any tangible medium of expression? Can an original work of authorship also be inventive? Yes, of course. Consider, for instance, software. The Copyright Office classifies software source and object code as a “literary work.” Thus, source code is a work of authorship and can even be original in part. It is not that expression of original work can be inventive, but rather that that expression may also be a mode of implementing an inventive idea. Thus, one can author code (expression, copyright) that when executed performs a new, useful, and otherwise non-obvious function (inventive, patent).

But owning a right in the expression has nothing to do with owning a right to an invention to which the expression is attached. Software code may have many features that are expressive (such as a user interface) and yet have nothing at all to do with a component of the code that is inventive (the implementation of a given algorithm to perform an unanticipated function) that may be invoked by the operation of the code.  Continue reading →

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Another university misrepresents Bayh-Dole

Posted on February 21, 2019 by Gerald Barnett

Here’s another misrepresentation of Bayh-Dole by a university technology transfer office–at Loma Linda University. This statement is typical of what happens when someone relies on the information put out by organizations such as AUTM–information people ought to be able to expect is reliable but it is not:

The Bayh-Dole Act (1980) requires universities to report all inventions arising from federally supported research, and to diligently pursue patent protection and commercialization for new technologies that are commercially promising.

Seven big time problems in a single sentence! Such density!

(1) Bayh-Dole does not require universities to report all inventions arising from federally supported research. Bayh-Dole requires disclosure only of *subject inventions*–inventions that a contractor owns and which were made under contract. If a contractor does not own the invention, then it cannot be a subject invention, and is not therefore subject to the disclosure provision of Bayh-Dole’s standard patent rights clause. 35 USC 201(e). Stanford v Roche.  Continue reading →

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Unhelpful NIAID guidance on Bayh-Dole, 2

Posted on February 19, 2019 by Gerald Barnett

We are working through another unhelpful NIAID document on Bayh-Dole. With such ubiquitous misinformation put out as authoritative, it is no wonder that Bayh-Dole has become an excuse for what amounts to ad hoc law, created by wonderful agreement between federal agencies and university administrators to make a private agreement to disregard the law and do whatever sounds good, so long as paperwork is maintained for appearances and everyone shows mock fear of the consequences of non-compliance, even though there are no consequences to non-compliance (although there certainly are for making a federal agency look bad).

More from NIAID’s misguidance on Bayh-Dole:

you (the inventor with the permission of your employer and the funding federal agency) may be allowed to submit a patent application to the United States Patent and Trademark Office  (USPTO).

Here is the Bayh-Dole provision that mystifies NIAID (35 USC 202(d)):

If a contractor does not elect to retain title to a subject invention in cases subject to this section, the Federal agency may consider and after consultation with the contractor grant requests for retention of rights by the inventor subject to the provisions of this Act and regulations promulgated hereunder.

The Supreme Court cited the “retention of rights by the inventor” to mean that the inventor had ownership of the subject invention. An inventor could not “retain” rights without already having them. The Court’s reading is consistent with the idea that inventors are also parties to the funding agreement. They are, by definition, contractors subject to a patent rights clause authorized by Bayh-Dole. The problem is that “contractor” referenced in 35 USC 202(d) is not the owner of the subject invention. Continue reading →

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Unhelpful NIAID guidance on Bayh-Dole, 1

Posted on February 18, 2019 by Gerald Barnett

[NIAID had this document up for all of 2017, as far as I can tell. They have now removed it, and purged it from Google’s cache. But as far as I know, they have not corrected their misrepresentation nor broadcast that correction to reach anyone who may have seen or retained their 2017 misguidance. If NAIAD  ever decides to provide a correction, Research Enterprise is eager to publish it. This article provides a bunch of free help to anyone at NAIAD who wants to get to work on a correction.]

Previously, we have looked at a thoroughly misinformed NIAID document on Bayh-Dole. Let’s look at another document from NIAID, “Intellectual Property Considerations for Contracts,” published in Funding News, April 2, 2015. The document may come up “Access Denied” in a browser search, but it is still available via the Google cache. Perhaps by the Wayback Machine as well. The document provides guidance for the uninformed with regard to federal contracts for research, apparently with the intent to keep the uninformed uninformed:

When it comes to research and development (R&D) contracts and intellectual property (IP), there are a number of issues you should be aware of, such as rights, regulations, and responsibilities.

To help you acquaint—or reacquaint—yourself with the essentials, we’ll cover them in this and future issues. We begin with one key type of IP: inventions.

So far, so good.

According to 35 U.S.C. 201 of the U.S. Patent law as implemented by the Federal Acquisition Regulation (FAR) 52.227-11 Patent Rights-Ownership by the Contractor , an invention is “any invention or discovery that is or may be patentable or otherwise protectable under title 35 of the U.S. Code.”

Well, not quite. Here’s 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.).

Our NIAID document leaves out the PPVA extension for invention. PPVA protection is not within federal patent law. Bayh-Dole extends to PPVA apparently through a slip or cleverness with regard to the treatment of plants as patentable subject matter. In any event, the point of the definition is to limit the scope of “invention” in federal funding agreements to patentable elements plus the PPVA. An invention cannot be broader than its patentable elements. That’s interesting. And includes PPVA stuff which is not patentable. That’s interesting. But perhaps this is all just being picky. Read on.  Continue reading →

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Oh wow–short form

Posted on February 16, 2019 by Gerald Barnett

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. Continue reading →

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Oh wow. Implications of Bayh-Dole’s broad scope

Posted on February 15, 2019 by Gerald Barnett

For Bayh-Dole’s preemption to operate “uniformly,” Bayh-Dole’s scope has to be as broad as any federal statutes and executive branch patent policy that claim any federal interest in inventions arising from federally supported research or development. Since those statutes and executive branch patent policy do not worry who actually has ownership of any invention “arising from federally supported research or development,” or “made under contract,” then Bayh-Dole, if it is to preempt such statutes and policy, also must extend to any owner of any such invention. If the federal government could claim an ownership interest in the invention, Bayh-Dole must be there to preempt that federal interest for any owner of any such invention and substitute Bayh-Dole’s apparatus–if indeed it has been Congress’s intent to preempt all such statutes and policy. And it’s arguable that Bayh-Dole’s scope should be broad enough to preempt even federal claims of a license interest in such inventions–otherwise, even if ownership claims were made uniform, federal license claims would not be uniform, and that would be just as much a problem as ownership.

We can distinguish four sorts of owners of an invention made with federal support: inventor, contractor, subcontractor, and assignee. Bayh-Dole’s patent rights clause, then, must reach to each of these four sorts of owners. Here’s how Bayh-Dole does this.

First, the definition of funding agreement (35 USC 201(b)) is expressly extended:

Such term includes any assignment, substitution of parties, or subcontract of any type entered into for the performance of experimental, developmental, or research work under a funding agreement as herein defined.

When a contractor makes any assignment, the funding agreement necessarily extends to include the assignee. The assignee becomes a party to the funding agreement. By definition (35 USC 201(c)), each party is a “contractor.” As a party to the funding agreement, each party is necessarily bound by a patent rights clause. The same is true for substitution of parties (inventors, mainly) and for subcontracts.  Continue reading →

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Reagan’s Executive Order 12591-4

Posted on February 14, 2019 by Gerald Barnett

In the implementation of Bayh-Dole, then, employee-inventors own unless they assign rights, such as to an institutional Contractor. We can use “Contractor” with a capital “C” to follow the usage in the Federal Procurement Regulation’s patent rights clause that implements the Nixon patent policy.

If employee-inventors assign to the Contractor, then the standard patent rights clause at 37 CFR 401.14 applies. If they do not assign, then the inventor patent rights clause at 37 CFR 401.9 applies. If they are not contractors–that is, not parties to the funding agreement–then they are not subject to the funding agreement, and neither 37 CFR 401.14 or 37 CFR 401.9 applies to them or their inventions. Bayh-Dole provides no compulsory mechanism for inventions to become subject inventions other than the standard patent rights clause’s requirement that Contractors require employee-inventors to make a written agreement that makes those employee-inventors parties to the funding agreement. Inventions become subject inventions in Bayh-Dole compliant practice because inventors agree to become parties to the funding agreement, not because Contractors force them to assign their inventions.

It’s just that Contractors do not comply with the (f)(2) written agreement requirement, and so employee-inventors are routinely not parties to federal funding agreements, their inventions made with federal support are not subject inventions, and due to the fine mess of amendments and presidential memos and executive orders demanding Bayh-Dole rather than a more general policy, there is no other mechanism by which the federal government has an interest in such inventions–not by specialty statutes, and not by the now superseded Nixon patent policy, and not by federal regulation, since the Federal Procurement Regulation was abandoned in favor of the Federal Acquisition Regulation, which implements only Bayh-Dole and not executive branch patent policy for inventions made under contract that are not subject inventions. Continue reading →

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