E-mail:
Jack Balkin: jackbalkin at yahoo.com
Bruce Ackerman bruce.ackerman at yale.edu
Ian Ayres ian.ayres at yale.edu
Corey Brettschneider corey_brettschneider at brown.edu
Mary Dudziak mary.l.dudziak at emory.edu
Joey Fishkin joey.fishkin at gmail.com
Heather Gerken heather.gerken at yale.edu
Abbe Gluck abbe.gluck at yale.edu
Mark Graber mgraber at law.umaryland.edu
Stephen Griffin sgriffin at tulane.edu
Jonathan Hafetz jonathan.hafetz at shu.edu
Jeremy Kessler jkessler at law.columbia.edu
Andrew Koppelman akoppelman at law.northwestern.edu
Marty Lederman msl46 at law.georgetown.edu
Sanford Levinson slevinson at law.utexas.edu
David Luban david.luban at gmail.com
Gerard Magliocca gmaglioc at iupui.edu
Jason Mazzone mazzonej at illinois.edu
Linda McClain lmcclain at bu.edu
John Mikhail mikhail at law.georgetown.edu
Frank Pasquale pasquale.frank at gmail.com
Nate Persily npersily at gmail.com
Michael Stokes Paulsen michaelstokespaulsen at gmail.com
Deborah Pearlstein dpearlst at yu.edu
Rick Pildes rick.pildes at nyu.edu
David Pozen dpozen at law.columbia.edu
Richard Primus raprimus at umich.edu
K. Sabeel Rahmansabeel.rahman at brooklaw.edu
Alice Ristroph alice.ristroph at shu.edu
Neil Siegel siegel at law.duke.edu
David Super david.super at law.georgetown.edu
Brian Tamanaha btamanaha at wulaw.wustl.edu
Nelson Tebbe nelson.tebbe at brooklaw.edu
Mark Tushnet mtushnet at law.harvard.edu
Adam Winkler winkler at ucla.edu
Public-private partnerships are critical innovation
strategies for solving problems that are both too important to ignore and too
big for any one actor or sector to tackle alone. These hybrid partnerships form the backbone of current U.S.
strategies to accelerate biomedical innovation in areas where traditional modes
of drug discovery and development have repeatedly failed. While public-private partnerships have
proliferated in major disease areas, and much is riding on their success,
current knowledge of how to make them work more effectively to satisfy public
health goals is inadequate. In Public-Private Partnerships as Innovation
Strategies, which I will be presenting at the Yale ISP’s Innovation Law
Beyond IP conference, I examine the use of public-private partnerships as
vehicles for accelerating biomedical innovation. I focus on how intellectual property rules intersect with
current partnership strategies in ways that may limit their ability to reach
their public health goals.
U.S. government strategies for accelerating biomedical
innovation have focused primarily on “pre-competitive” public-private
partnerships. Public-private
partnerships are generally defined as collaborative arrangements between one or
more public (government) and one or more private entities to combine their
resources, data and knowledge in pursuit of shared goals and mandates. Pre-competitive public-private
partnerships are partnerships where public and private resources and human
capital can be usefully pooled and the results shared broadly and freely
without impinging on the competitive interests of private partners. I argue that this policy focus on
“pre-competitive” partnerships may be misguided for two reasons. First, to ignore the competitive
aspects of these partnerships, particularly those that include fierce market
competitors, may lead to sub-optimal outcomes. Second, the need to support cooperative intellectual
production and the free and open sharing of results in drug discovery and
development efforts extends far beyond the limited areas that private participants
deem to be “pre-competitive.” Greater cooperation and sharing of resources and
knowledge are urgently needed
in stages of drug discovery and development that
are unquestionably driven by market competition.
I suggest that public-private partnership strategies must respond
more directly to the tensions between the cooperative and competitive aspects
of public-private partnerships.
Many of the tools and discoveries that are useful in advancing
biomedical innovation have dual roles as broadly enabling technologies and as
potential sources of competitive advantage. Policy makers may be able to influence the boundaries
between what becomes broadly available as a platform for further innovation and
what is protected as a proprietary asset.
Building on my earlier study of cooperative innovation, I
focus on ways in which patents may disadvantage the cooperative mechanisms upon
which public-private partnerships rely, thus limiting their scope and reducing
their productivity. Where research
tools, data, and early stage research discoveries could serve either as broadly
enabling inputs or as proprietary assets that confer competitive advantages, for
example, patents may tilt the balance towards proprietary innovation. I go on to propose a limited statutory
patent fair use as one way of protecting and expanding the reach of the
cooperative mechanisms on which public-private partnership strategies rely.
To illustrate the potential, as well as the limits, of current
public-private partnership strategies, as well as the role of patents in
limiting these strategies, I draw examples from the current national strategy
to accelerate the discovery of a cure for Alzheimer’s disease. This national strategy relies primarily
on coordinating research and development efforts and promoting public-private
partnerships to achieve its goal of finding a cure for Alzheimer’s disease and
other associated dementias by 2025.
A statutory patent fair use that protects uses of research tools and
other broadly enabling drug discovery technologies, perhaps even
experimentation on early stage drug candidates, where used in furtherance of
the search for a cure for Alzheimer’s disease, might facilitate concerted
public-private efforts to solve this growing public health problem.
Liza S. Vertinsky is an assistant professor of law at Emory. She can be reached at lvertin at emory.edu