In discussions about the proper scope and strength of intellectual property (IP) protection, commentators frequently note that robust IP rights for medical technology developers are necessary to offset the costs of regulatory scrutiny by the U.S. Food and Drug Administration (FDA). This observation, while true, fails to capture important nuances in the relationship between IP and FDA regulation. Ostensibly conflicting IP and regulatory systems actually are overlapping, complementary components of a composite legal scheme governing information production and distribution. Both systems create incentives to produce intangible goods, albeit different types of goods at different points in technology development timelines. IP pulls inventions into the commercial arena, and public health regulation pushes developers to move nascent discoveries downstream along innovation pathways. Importantly, interplay between IP and regulation creates feedback loops of cumulative technological innovation.
This Article highlights the functional relationships between IP and regulatory laws to advance a holistic approach to medical innovation policy. It introduces the term “regulatory property” to describe how administrative oversight gives rise to the creation of valuable information resources. Regulatory takings and givings involve government redistributions of preexisting goods that transfer wealth among affected members of society. By contrast, regulatory property refers to the process whereby government regulation leads to the production of new information goods. As regulatory property is generated, interacting federal and state laws manage its allocation across private and public domains. The Article proposes strategies to address the unique challenges raised by innovation that is not tied to the creation of new tangible things, such as diagnostic algorithms and newly discovered uses for known products. More broadly, it suggests that understanding the dynamics between intellectual and regulatory property aids in developing coherent governance schemes for all potentially beneficial, risky medical technologies.The delicious 'How not to clone a mammoth' by Steve Jones in (2015) 386(9989) The Lancet 125, in reviewing Beth Shapiro's How To Clone A Mammoth, comments
The first line of the US mule-training manual is said to read: “First gain the animal's attention by striking it smartly between the ears with a stout stick”. For authors, their book's title does the same job. I got some odd glances on the tube a while ago when I was reading a work provocatively labelled (in sixty-point capitals) The Wisdom of Whores which, despite the empty seats that opened up on both sides of me, is in fact an enthralling account of the epidemiology of HIV/AIDS. The most recent Diagram Prize for Oddest Book Title of the Year at the Frankfurt Book Fair was won by Strangers Have the Best Candy, which should also guarantee a seat on a crowded train. How to Clone a Mammoth, too, might be a contestant for the titular crown.
However, this is a book that waves a stout stick but never really gets round to using it. It is full of attention-grabbing speculations about the potential scientific process of “de-extinction”, but its ultimate response to its own front cover is that “You won't be able to” and, yes, there it is, in the author's own words on page 99: “Mammoth cloning is not going to happen”. The elephant in the room is not, it seems, a mammoth. ....
There's not much hope of inserting the mammoth genes for thick hair and cold-resistant haemoglobin into a modern elephant. Another idea, Shapiro explains, is to cut and paste your pachyderm; to compare the most mammoth-like sections of a number of elephant genomes and then to assemble a simulacrum of the extinct proboscid that is really an elephant in disguise. Rather more rational (albeit needing several lifetimes' work) is the idea of breeding from hairy elephants with dumpy legs until an individual emerges hirsute and squat enough to withstand the arctic cold. Other schemes include the possibility of finding frozen sperm in a mammoth carcase and fertilising an elephant with it, but that idea is fantastical indeed. If the spurious Mammoth ever does appear the creatures could move to Pleistocene Park in Siberia, a recent attempt to simulate what the tundra looked like in the days when it was grazed by their extinct relatives.
The mammoth steppe was the largest single block of habitat ever seen, far larger than the tropical rainforest, and those great beasts were what ecologists call a “keystone species”: a creature whose activities determine the fate of many others. Wolves are the same: when they were introduced into the USA's Yellowstone National Park 15 years ago, they reduced elk numbers by half, so that ground cover increased, sheltering voles that were eaten by hawks, and so on and on. A Russian enthusiast has already fenced off a section of Siberian tundra and filled it with wild horses, bison, and deer. Shapiro describes how the effect has been dramatic; a great increase in rich grassland as the animals trample the soil and recycle nutriments and, less predictably, less snow cover in winter as their hooves sweep it away. That, in turn, means that the permafrost gets colder than before, and—an unexpected bonus—releases less carbon dioxide. A new behemoth might then play a part in keeping the whole planet cool.
Another approach to populating Pleistocene Park is simpler: why not get the conservationists of the world to knit great woolly suits for the animals to keep them warm and comfortable in wintry Siberia?