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November 07, 2018


Hey Kevin,

I'm very leery of creating the research exemption you propose as I seen no data to support the need for such an exemption. I remember seeing during the Madey case (which I view more as a "spiteful" assertion by a disgruntled former university director/employee at Duke) that there was concern that, without such an exemption, research would be stifled, for example, biotech. But tens of thousands of biotech applications were being filed every year, so obviously biotech research was not being stifled. I've heard that same tired theory that patenting "can inhibit future research" by SCOTUS in Mayo but without any data to suggest that's true.

Frankly, patent owners are not going to assert their patents willy-nilly simply because someone engages in research that might arguably infringe unless there's a monetary reason to do so. So until I see a reliable study that says future research is truly inhibited by patents, it's all speculation. In fact, the anecdotal evidence suggests that the opposite happens as others develop competing technologies to avoid such infringement.

In many ways, EG, perception is everything. The legal academy has been touting the Swedish Alzheimer mouse model (and abuses of the patents therefor) as evidence of the propensity for university-derived patents to be abused. Rather than see this for what it is (the exception that probes the rule) they make it into the rule. And they are very persuasive to zealous legislative aides and judges of particular persuasions, who for their own political reasons believe universities shouldn't be patenting, regardless of the data that shows the societal benefits of Bayh-Dole. They are very fond of imagining a world without patents, where all of the benefits to innovation that have accrued in the world we actually inhabit would have also arisen in the patentees world.

So if something like what I proposed would help ameliorate this particular siren song regarding patenting it would be worth it, even if (or perhaps especially if) it doesn't actually change anything.

Thanks for the comment.

"inequity visited", or did you mean to write "iniquity visited"?

Could be either, I suppose but I meant "inequity" (could have been "inequities" but didn't want to overstate it.

Thanks for the comment

Two other thoughts. First, I wonder whether this could be accomplished by rule under Bayh-Dole, i.e., whether an administrative agency (HHS for NIH research grants, for example) could make this license happen by regulation? That would comport with the District Court's footnote. But it would run the risk of Justice Gorsuch's ire regarding overreach of the judiciary.

Second, if Congress enacted such a provision could it amount to a taking to be recompensed? Would in some instances be problematical but unversities wouild have standing on the question I think.

University researchers who, for example, experiment on a patented drug to improve its activity (as by making derivatives) would be shielded from liability by the safe harbor of 271(e)(1). They would be using the patented drug "solely for uses reasonably related to the development and submission [of an NDA, to the FFDA]. I think that such activities would fall within the safe harbor even if the university researcher did not have support by a commercial entity.

Sorry, I meant to say "overreach of the administrative state" above.

Methods that result in new and useful information need an eligibility check. If the utility and infringing acts arise from the information being consumed by persons, the method should not be eligible.

That's how we protect research and the passing of an economic culture from hand to hand.

Information consumed by non-humans cannot be abstract. No human mind, no abstraction. Information used to help machines work are machine parts.

35 U.S.C. § 204 seems about as clear as can be that researchers should have access to the government's license- certainly for activities that are not directly commercial.

Hey Kevin,

Those who "believe universities shouldn't be patenting, regardless of the data that shows the societal benefits of Bayh-Dole" are living in a utopian "dream world" untethered to any sort of reality. It's well documented that, prior to Bayh-Dole, failure to allow universities to retain patent rights in government-sponsored research resulted in little, if any commercialization of the technology created by such research. Or put differently, expecting altruism to motivate others to commercialize university research which is unpatented is a "pipe dream."

I cannot agree with this characterization:

"This decision cabined the (common law) experimental use exemption to activities akin to the Victorian practice of observing with crude microscopes rotifers in a drop of pond water as an after-dinner amusement amongst gentlemen."

I think this avoids the recognition that modern day universities may NOT be performing activities that PROPERLY earn the experimental exception label. Cozying with industry does not -- and should not -- obtain the research exception on any type of "per se" notion. As to the "label" of non-profit or for profit, that label really has little to do with money-making activities of the type for which the research exception simply should not apply.

I "get" that the GENERAL BUSINESS MODEL has morphed from corporations having their own think tanks and product development experimentation set-ups to basically "out-sourcing" this TO universities. But a rose by any other name still is a rose, and what the "pure research" aspect that had earned the research exception had to do with simply evaporates with the morphed business model.

Martin: I think 35 U.S.C. § 204 just says there can be no exclusive license granted on university technology "unless such person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States." I don't read a grant back license provision in that part of the statute.

Skeptical: of course commercial activities should not be exempt. I read the Madey decision as saying that the normal research activities of a university - devoid of any frank commercial partnership or license - is itself commercial activity:

"major research universities, such as Duke, often sanction and fund research projects with arguably no commercial application whatsoever. However, these projects unmistakably further the institution's legitimate business objectives, including educating and enlightening students and faculty participating in these projects."

So I think when the Court goes on to say

" so long as the act is in furtherance of the alleged infringer's legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense"

it is in that context, hence the rotifer analogy.

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