Science, intellectual property, taxpayer funding, and the law

Taxpayers, whether they know it or not, fund a huge proportion of scientific research across a breadth of fields. Fruits borne of such investigations subsequently often become the highly valuable "intellectual property" (IP) of academic institutions and private parties.

to wit, from a recent issue of my AAAS Science Magazine:

Racing for academic glory and patents: Lessons from CRISPR
Arti K. Rai, Robert Cook-Deegan

The much-publicized dispute over patent rights to CRISPR-Cas9 gene-editing technology highlights tensions that have been percolating for almost four decades, since the U.S. Bayh-Dole Act of 1980 invoked patents as a mechanism for promoting commercialization of federally funded research. With the encouragement provided by Bayh-Dole, academic scientists and their research institutions now race in dual competitive domains: the quest for glory in academic research and in the patent sphere. Yet, a robust economic literature (1, 2) argues that races are often socially wasteful; the racing parties expend duplicative resources, in terms of both the research itself and the legal fees spent attempting to acquire patents, all in the pursuit of what may be a modest acceleration of invention. For CRISPR, and future races involving broadly useful technologies for which it may set a precedent, the relationship between these competitive domains needs to be parsed carefully. On the basis of legal maneuvers thus far, it appears that the litigants will try for broad rights; public benefit will depend on courts reining them in and, when broad patents slip through, on updating Bayh-Dole's pro-commercialization safeguards with underused features of the Act,
       
Science, Commerce, CRISPR
The University of California (UC) and the Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard University are tangling over U.S. patent rights to CRISPR technology. In June 2012, Doudna of UC, Charpentier, and others demonstrated in vitro that a system comprising a Cas9 DNA endonuclease could be programmed with a single chimeric RNA molecule to cleave specific DNA sites (3). Six months later, in January 2013, Zhang of the Broad Institute reported genome editing in mammalian cells using CRISPR-Cas9 (4). The research underlying both of these seminal publications was supported by the U.S. National Institutes of Health (NIH) and thus were funded for public benefit and subject to terms of the Bayh-Dole Act (3, 4).
       
From the outset, CRISPR science has been intertwined with commercial considerations. UC filed its provisional patent application in May 2012, one month before publication of the research findings. Some of UC's initial claims swept very broadly, encompassing any DNA-targeting RNA containing a segment complementary to the target DNA and a segment that interacts with a “site-directed modifying polypeptide” (5). Although UC subsequently restricted its claims to a type II CRISPR-Cas9 system, it continues to claim this system in any species as well as in vitro.
       
The Broad Institute began filing patent applications in December 2012. Broad paid for expedited examination, with the result that its patents began to issue in April 2014. The relevant Broad patents claim alteration of eukaryotic cell DNA by using type II CRISPR-Cas9 systems.
       
After the Broad patents began to issue, UC asked for a legal proceeding known as an interference, arguing that because the subject matter of its application, which had not yet been granted, overlapped with that of the Broad patents, the U.S. Patent and Trademark Office (USPTO) had to declare who was the “first to invent.” In February 2017, the USPTO ruled that the overlap did not exist (6). Specifically, USPTO held that the Broad team's success in eukaryotes was not scientifically “obvious” in light of UC's demonstration of success in vitro…
       
Patent Races, Scientific Credit
As histories of key technologies such as the telephone demonstrate (12), and as studies of patent records have documented on a large scale empirically (13), patent races are common. Moreover, legal rights can get confused with scientific credit (12). It is important to get the rules right, not only for the patent system but also for academic science.

Whatever the outcome of the patent interference proceeding, scientific and patent priority are not the same. The rules for securing a patent should differ in important ways from the rules for scientific credit and recognition. Although current rules for academic credit may seem murky or unfair to some individuals who feel left out, winner-take-all scenarios for important patents, which confer legal exclusivity over inventions, are more pernicious because they confer powerful rights to exclude…
       
Shifting Roles of Universities
The problem of inefficiency in races is exacerbated if the racing parties believe they can, via an overly broad patent, make the race a winner-take-all fight: the bigger the prize at the end of the race, the more likely we will see inefficiency. So, overly broad patents that emerge from winner-take-all races are not only likely to hamper downstream development, they are also likely to encourage upstream duplication. In contrast, to the extent that racing parties have engaged not in wholesale duplication but have pursued valuable divergent paths (14), narrow patents can be awarded to multiple racers, allowing diversity to be rewarded…

Improving Bayh-Dole
A first-best result in the CRISPR race would be narrow patents that both diminish incentives for wasteful future racing and prevent any player from imposing substantial control over downstream innovation. But to the extent broad patents that impede development nonetheless slip through, presumably because CAFC does not choose to follow its admittedly controversial precedent on written description, the CRISPR controversy suggests the need for renewed attention to prior literature that highlights avenues for improving Bayh-Dole's pro-commercialization safeguards. Regulatory improvements that have been suggested in the literature include clarifying government-use rights, extending them to grantees and contractors; recognizing situations in which patenting is not the shortest or best path to widespread application; and simplifying procedures for “march in” to compel additional licensing when health and safety needs are not being met by those with exclusive rights (25).

To our knowledge, none of these academic proposals for improvement have been investigated seriously by the U.S. Department of Commerce, which is responsible for administering Bayh-Dole. The CRISPR controversy may be a catalyst for action. Improving pro-commercialization safeguards would be prudent even if narrow rights were ultimately at stake. But, improvement could prove particularly critical in the event that courts let overly broad rights emerge.

'eh?

Ahhh... patent actions.

Taxpayers, recall, paid for the initial development of the internet itself -- U.S. commercial control of which is soon to be handed over to a handful of major corporations courtesy of the Trump Administration's FCC.

apropos, from the bracingly iconoclastic Yves Smith (re: "Net Neutrality"):

The Trinet
The internet will survive longer than the web will. GOOG-FB-AMZN will still depend on submarine internet cables (the “Backbone”), because it is a technical success. That said, many aspects of the internet will lose their relevance, and the underlying infrastructure could be optimized only for GOOG traffic, FB traffic, and AMZN traffic. It wouldn’t conceptually be anymore a “network of networks”, but just a “network of three networks”, the Trinet, if you will. The concept of a workplace network which gave birth to the internet infrastructure would migrate to a more abstract level: Facebook Groups, Google Hangouts, G Suite, and other competing services which can be acquired by a tech giant...

Ya gotta spend serious time at #Naked Capitalism. I do daily. You comment there with care. They do not suffer fools gladly.
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Regarding digital IP broadly, recall my prior post citing apparent "patent troll" Robert Budzinksi, "NLP, meet NPE: the curious case of Robert Budzinski."

CLIMATE SCIENCE IN COURT

From Public Radio's KPBS:

Climate Paper At Center Of Scientist-Versus-Scientist Legal Dispute

A Stanford University climate scientist has taken the unusual step of suing another scientist, arguing that a rebuttal paper critiquing his work amounted to defamation.

Two years ago, Stanford professor Mark Jacobson published a scientific paper that quickly grabbed national attention: in it he said that a completely renewable energy grid could be possible by 2050, as new ways to store energy would allow the system to keep up with demand even in moments when winds slow down or clouds cover solar panels. The paper was mentioned by Sen. Bernie Sanders and was named one of the best of 2015.

But this June, a group of researchers published its own paper, which said Jacobson ignored important costs, making the type of system Jacobson envisioned theoretically possible, but likely too expensive to be realistic. The lead author was Christopher Clack, a former researcher at the University of Colorado Boulder and now CEO of the nonprofit Vibrant Clean Energy. UC San Diego professor David Victor was one of 20 other authors.

Jacobson sued Clack and the National Academy of Sciences, which published the paper, in late September. He said Clack’s work defamed him…

Audio interview here:

Interesting stuff, all of it.

NEW READING

Stay tuned. About 10% through, very nice thus far. Written by one of the Principals in San Francisco's M34 Capital, Inc. There's a specific reason for my interest in these people.

UPDATE

More "AI" news...

November 27, 2017 - Depending on who is making the statement, artificial intelligence is either the best thing to happen to healthcare since penicillin or the beginning of the end of human involvement in the medical arts.

Robot clinicians are coming to take over every job that can possibly be automated, warn the naysayers.

That might not be such a terrible thing, say the enthusiasts. The sooner the healthcare system can eliminate human error and inefficiency, the safer, happier, and healthier patients will be.

In reality, artificial intelligence is still many, many years away from replacing the clinical judgement of a living, thinking person, says Dr. Joe Kimura, Chief Medical Officer at Atrius Health. And it may not ever do so.

While AI and machine learning hold enormous potential to improve the way clinicians practice, AI proponents should try to temper their expectations, and cynics worried for their jobs can relax for the moment – there is a great deal of work to be done before providers can or should trust computers to make reliable decisions for them…

Interesting. See my prior post "AI vs IA: At the cutting edge of IT R&D." See also "The future of health care? "Flawlessly run by AI-enabled robots, and 'essentially' free?"

All warrants continued attention.

MORE

Amid the Monday morning news, from THCB:

Could Artificial Intelligence Destroy Radiology by Litigation Claims?
By HUGH HARVEY, MD

We’ve all heard the big philosophical arguments and debate between rockstar entrepreneurs and genius academics – but have we stopped to think exactly how the AI revolution will play out on our own turf?

At RSNA this year I posed the same question to everyone I spoke to: What if radiology AI gets into the wrong hands? Judging by the way the crowds voted with their feet by packing out every lecture on AI, radiologists would certainly seem to be very aware of the looming seismic shift in the profession – but I wanted to know if anyone was considering the potential side effects, the unintended consequences of unleashing such a disruptive technology into the clinical realm?…

Read all of it.

ANOTHER BOOK TO READ?

Ran across this title. Looks interesting, given the amount of thought and blogging I've given to AI issues (mostly, albeit not exclusively, pertaining to health care).

"Artificial Intelligence helps choose what books you buy, what movies you see, and even who you date. It puts the "smart" in your smartphone and soon it will drive your car. It makes most of the trades on Wall Street, and controls vital energy, water, and transportation infrastructure. But Artificial Intelligence can also threaten our existence.

In as little as a decade, AI could match and then surpass human intelligence. Corporations and government agencies are pouring billions into achieving AI's Holy Grail—human-level intelligence. Once AI has attained it, scientists argue, it will have survival drives much like our own. We may be forced to compete with a rival more cunning, more powerful, and more alien than we can imagine..."

Dunno, my daughter's illness continues to hamper my reading pace. I have about four books in process at the moment, including this one:

First cited it here.

James Barrat's's website here.

"Intelligence, not charm or beauty, is the special power that enables humans to dominate Earth. Now, propelled by a powerful economic wind, scientists are developing intelligent machines. Each year intelligence grows closer to shuffling off its biological coil and taking on an infinitely faster and more powerful synthetic one." 

The Mark 13

We'll see. So much to continue to learn.
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More to come...