Data and IP Management in a Mess

For university IP management, we must also take note of the situation around the climate emails and software. It is all too easy to stand aside and let compliance and misconduct investigations wend their way through the forensics and spin. IP management doesn’t come clean out of this mess and folks need to understand that. Commercialization interests are every bit also in play with regard to the fabric of public science, and this still will come to roost in IP management as well.

First, we should remind ourselves of some policy, for the US at least. Circular A-110 __.36(d) (now at 2 CFR 215.36) in particular pertains to the management of intangible assets in the form of data involved in studies used for governmental policy making that has the force of law. (d) requires a university (the “recipient”) to provide “the research data relating to published research findings” to be made available to the public. Research data means “the recorded factual material commonly accepted in the scientific community as necessary to validate research findings”. Excluded from data are “trade secrets…and materials necessary to be held confidential by a researcher until they are published….” One can see how a “commercialization” effort involving IP, or a convenient non-disclosure agreement on data with a company if not another institution (even a teaming agreement to pursue further grant work) could create a convenient shield as a defense to a FOIA request for data.

In Bayh-Dole, our old friend, we find in 35 USC 200, the following as one of the objectives of Congress: “to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery;…” [my emphasis]. That is, the efforts to use patent rights to promote use of federally supported inventions should not “unduly” affect research matters. Withholding of data, in this area, amounts to restrain of trade in the conduct of science. One might add to data also the tools of analysis (such as software) by which data are stored, analyzed, and reported. How else can others come to an understanding with regard to validity of published scientific claims?

Even more so, how can anyone even think to make a business investment based on unvalidated (and unvalidatable) claims. It is a terrible form of due diligence to make an investment based on consensus of folks who think something sounds good but no one has been able to confirm independently. And in fact to promote such a claim (whether in the form of discovery or patentable invention) without the prospect of independent validation is at best throwing the dice and at worst, a form of fraud. Certainly for a university dedicated to a public mission, the standard is higher than buyer beware: the standard is built into the fabric of science–that the university results are more than self-interested promotion of hope in technology, but rather have withstood independent review and replication of results. For that, data and tools must be available. Even if one wanted to make an awkward case for holding data back to advance competitive advantages for the next grant, or for degree research, one has to recognize the damage to commercial investment that can be caused by doing so. And it’s not just a bad investment outcome for whomever gets the snooker–it’s laid at the feet of academic enterprise as an instance, with the open question of whether this is systemic or isolated.

The business of IP management of research generated university assets is to ensure that deceptive practices are not systemic. For that, one has to inspect not only IP policies on ownership, but also those involving research compliance, management of data, scientific conduct, conflict of interest (especially of forms that do not relate to corporate influence), and institutional conflict of interest. If this list is irritatingly long, perhaps that is because all of these policies ask, indirectly, that people behave with a degree of intellectual honesty that a public expects of a university and perhaps is not being found as broadly as one might hope. In that case, indifferently or incompetently applied policies in these areas only serve to advance the bad behaviors these policies are established to address, and become a kind of public dress up that serves appearances while deepening the culpability of the university in whatever bad eventually comes to light. Think about it: by claiming ownership outright of a broad class of research assets–inventions, works of authorship, data–a university becomes responsible for the disposition of these assets. This disposition is not simply to extract maximal financial value from them by dealing with industry and investors. This disposition first and foremost is to manage these assets consistent with the demands of public science. Folks lose sight of this to their peril. This obligation is part of the fabric of public science, every bit as much any published (or suppressed) research finding.

A typical university response to all this is: “We do not contract so as to agree to suppress research findings, and we do not contract so as to compel publication. The decision to publish rests with the investigators, not the institution.” This is all fine and good. But it is not neutral in terms of science policy. As soon as some thing is published, there is much more to it: how is access to data and tools to be managed? Again, this is not unrelated to “commercialization” and it is not merely an incidental “service activity” grudgingly provided as a low institutional priority by a technology licensing office. It’s core to even having an IP function attached to university research. If the science doesn’t get out–just the assertions sounding like science, potentially science–then the business side of licensing is hosed. It’s potentially a betrayal of the public trust. At the very least it is running on a big dose of stupid.

What does one make of this, if one wants to institute best practice in university IP management?

1. Default to open with regard to data and software. Here, “open” does not mean “open” in free of rights or sharing with everyone all the time; rather, it means “open” in the sense of “available for the conduct of independent review by anyone with the technical means and reason to review it.” That means, when there is publication, there is also deposit or availability, not just to one’s “friends” and not just to “non-profits” but to anyone who reasonably makes a request. That’s fabric of public science. It falls to an IP policy to make clear this expectation, as it does, also to data policy and institutional conflict of interest policy. The default has to be with the public, not with proprietary withholding.

2. Require a deposit step if published results are intended, or are discovered to be the subject of agency rule-making. The standard for public science is already high, but when science rises to the level of public policy, it is achieving one of its highest callings–one that may carry more import than forming the basis for lucrative products paying a royalty. For these situations, extra diligence is required to show deposit and access. Doing so should be part of the effort to promote use, not seen as external to that effort.

3. Demonstrate with record keeping that policy and practice in this area conform to expectations. Audit concerns itself with documentary records, not expressions of past or present intentions. The aim is not just to support public science in the form of IP management of results, but to produce a record for that purpose. This is a way to support decisions by investigators to make their data and tools available, and to give such decisions standing relative to other choices (or indifference) that may be considered.

4. Broaden reservation of rights language in exclusive licenses to ensure public deposit or access (including research uses by industry) is available upon request. Typically universities in their exclusive licenses reserve rights for institutional use, and may include a general reservation of rights for non-profit research and educational use. These rights are not sufficiently broad to cover legitimate access requests. Nothing in science indicates that the tax standing of an employer is a meaningful basis for discrimination with regard to access. An exclusive license should reserve broader rights both by restricting the scope of rights granted and for ensuring that an exclusive licensee does not have standing to bring an action for infringement or to force the university to take such an action, where the infringement may involve research activity. While “research on” and “research with” may carry some challenges to differentiate, for research purposes, for a university, it may be much better to reserve broader rights and take some limitation on possible sales than to be part of an effort to limit review.

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