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THE BLACK HOLE

A brief history of translational research funding in North America

How the Bayh-Dole Act succeeded in kickstarting an explosion of technological innovation.

By JONATHAN THON | SEP 07 2018

There are fundamental difference between discovery and translational research. The former aims to found new knowledge while the latter transforms that knowledge into something practical. The former succeeds if even one person (usually a highly trained scientist over the course of many years) is able to demonstrate that they can validate a theory in a well-controlled experimental study one or more times. The latter requires any technically skilled person (usually a junior research technician) to be able to successfully repeat an outcome every time. Both discovery and translational research are fundamental to achieving the end-goal of improving human health and wellbeing and represent book-ends between which exists a relatively broad spectrum of work. Most of us work in this space in-between, which is precisely the research federal science funding agencies were originally founded to support. It should come as no surprise that conflict (often war) has historically driven scientific discovery, which has therefore always been inexorably linked to translation and application.

In the United States, the National Academy of Sciences was established by an Act of Congress in 1863 (signed by then President Abraham Lincoln) in the midst of the American Civil War. It’s purpose was to unite distinguished scholars within the structure of a private, non-profit society, to provide independent, objective advice to the nation on matters related to science and technology.

The National Institutes of Health in the United States were founded shortly thereafter, in 1887, when a one-room laboratory was created within the Marine Hospital Service. The Marine Hospital Service had been established in 1798 to provide for the medical care of merchant seamen, and in 1880 was charged by Congress with examining passengers on arriving ships for clinical signs of infectious diseases such as cholera and yellow fever to prevent epidemics.

Like the National Academy of Sciences, the National Research Council was founded for the international coordination of scientific and technological research and development in 1916 against the backdrop of the First World War, in response to growing concerns about the lack of American preparedness.

In Canada, the Medical Research Council was established as a federal granting council in 1960 from the National Research Council Associate Committee on Medical Research (est. 1936). The Medical Research Council’s mandate was to “promote, assist and undertake basic, applied and clinical research in Canada in the health sciences…” and served as an advisory body to Canada’s Minister of Health. In June 7, 2000, the Canadian Institutes of Health Research in Canada was created under the authority of the Canadian Institutes of Health Research Act to succeed the Medical Research Council of Canada. Its purpose is to create new health knowledge AND to translate that knowledge from the research setting into real world applications.

Likewise, university-based natural science and engineering research was supported through the National Research Council until May 1, 1978 when the Natural Sciences and Engineering Research Council of Canada was created as a result of a report of the Senate Special Committee on Science Policy.

In 1980 the United States Congress passed the Bayh-Dole Act (Public Law 96-517, 98-620) in an effort to respond to the economic malaise of the 1970s. The major question being addressed in this legislation was how best to manage inventions that had been created with the more than $75 billion a year invested in government sponsored R&D (a post-World War II issue other countries had been struggling with as well). Prior to the enactment of Bayh-Dole, the U.S. government had accumulated 28,000 patents, but fewer than five percent of those patents were commercially licensed (and presumably being translationally developed). These patents had accumulated because after World War II, the government under then President Harry S. Truman had decided to continue actively supporting research and development presumably on the basis of a contemporary report by Vannevar Bush’s entitled, “Science The Endless Frontier“, which stated that: “Scientific progress is one essential key to our security as a nation, to our better health, to more jobs, to a higher standard of living, and to our cultural progress.”

The Bayh-Dole Act aimed to incentivize commercial translation of basic research discoveries by rewarding academic institutions for promoting their application. It accomplished this by legislating that intellectual property (IP) that results from research funded by the federal government is owned by the institution that performs the research. The federal government retained limited rights to this IP, including, but not limited to:

  • The non-exclusive right to use for government purposes
  • The right to claim ownership if ownership is waived by institution
  • The right to claim ownership if commercialization does not proceed fast enough

In the shadow of Bayh-Dole, universities evolved to focus on discovery research for IP creation, and established tech transfer offices to leverage financial incentives resulting from the out-licensing of this IP to private industry. Independent financing was solicited to help support translational research, with the expectation that commercialization should be driven by the licensor. In Canada, no uniform federal regulation on IP ownership derived from federally-funded programs exists, which has resulted in university and government research facilities all having varying policies regarding intellectual property management.

Nevertheless, the Bayh-Dole Act succeeded in kickstarting an explosion of technological innovation that has increasingly become driven by huge profits on impactful scientific discoveries. My next post will focus on the ramifications of these incentive structures, and how this is shaping scientific research in the present day.

ABOUT JONATHAN THON
Jonathan Thon
Dr. Thon is the CEO and chief scientific officer of Platelet BioGenesis, and a faculty member in the hematology division at Brigham and Women’s Hospital, and Harvard Medical School in Boston.
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