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Intellectual Property Bundling: An A …

Tags: academic health centers, aggregation, alleviated, biomedical field, collaborative research, commercialization, complementary technologies, cross purposes, information and technology, initiatives, instances, intellectual centers, intellectual property, new opportunities, patent pools, patent system, patents, shortcomings, trust issues, ups,
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Language: english
Created: Mon Jul 9 13:32:45 2007
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Intellectual Property
Bundling: An
                             A
                                       recurring issue in efforts to facilitate the
Opportunity for                        sharing of research information and
                                       technology is intellectual property (IP)
Academic Health              bundling, or the aggregation of intellectual
Centers?                     property across multiple institutions for the
                             purpose of licensing to outside parties. Bundling
                             arrangements can be formed to address hold-ups
By Andrew Lyzenga, MPP
                             resulting from patent-related problems or to
                             combine complementary technologies in order to
                             create new opportunities for commercialization. IP
                             bundling is worth considering in light of the
                             growing importance of collaborative research and
Collaborative research       the recognition of certain aspects of the patent
                             system which can work at cross-purposes with
coupled with shortcomings
                             collaborative research. This brief will describe some
in the patent system         problems with the patent system that may be
necessitate the pursuit of   alleviated by patent pooling arrangements,
IP bundling                  examine the application of patent pools to the
                             biomedical field, discuss some other instances of IP
                             bundling, consider some anti-trust issues related to
                             IP licensing arrangements, and present a number of
                             issues that academic health centers may need to
                             address when exploring patent pooling or IP
                             bundling initiatives.



                             PATENT POOLS

                             Patents Promote Innovation
                             Scientific progress is, fundamentally, a collective
                             and cumulative endeavor. It has always been
                             thought that the successes of modern science are
                             based to a great extent on "cumulative
                             innovation." That is, new discoveries are enabled
                             by and built on the foundation of previous
                             findings, which in turn were built on findings prior
                             to those, and so on.1 Accordingly, science depends
                             vitally on information exchange. It is essential that
                             new ideas and innovations are divulged and
                             disseminated, rather than kept secret by their
                             proprietors. The patent system exists, at least in
                             part, in order to promote this process of cumulative
                             innovation, providing incentives for scientists or
                             inventors to develop new discoveries and then to
                             publicly disseminate those discoveries so that
                                           ASSOCIATION OF ACADEMIC HEALTH CENTERS


               others can build on their developments.                 Patent Pools May Help in Overcoming
                    Patents encourage this process by giving           Patent Barriers
               innovators ownership of their work--i.e., endowing
                                                                       One proposed solution to the problem of patent
               them with intellectual property (IP) rights--thus
                                                                       thickets is the creation of patent pools or other
               assuring that these innovators will benefit from
                                                                       kinds of cross-licensing agreements. The U.S.
               any commercialization of their discoveries and
                                                                       Department of Justice defines pooling
               preventing the products of their labor and
                                                                       arrangements as follows:
               investment from being stolen by others. The Bayh-
               Dole Act of 1980 allowed universities, non-profit           Cross-licensing and pooling arrangements are
               institutions, and small businesses to claim                 agreements of two or more owners of different
                                                                           items of intellectual property to license [to] one
               ownership of the results of federally-funded                another or third parties. These arrangements
               research. This legislation led to a dramatic increase       may provide procompetitive benefits by
               in patent filings, and has been extremely successful        integrating complementary technologies,
               in stimulating the commercialization of research            reducing transaction costs, clearing blocking
               and the promotion of innovation, particularly in            positions, and avoiding costly infringement
                                                                           litigation. By promoting the dissemination of
               the biomedical field.                                       technology, cross-licensing and pooling
                                                                           arrangements are often procompetitive.4

               Shortcomings of the Patent System                            Pooling arrangements address the problem of
                                                                       patent thickets by bundling related patents together
               However, the patent system has its limitations, and
                                                                       and placing them under the control of a single
               can even work to stifle the sort of information
                                                                       entity, thereby creating a "one-stop shop" for
               exchange that it is intended to promote. The
                                                                       potential licensees. Rather than negotiating
               granting of ownership over technological
                                                                       licensing agreements with each of the respective
               developments can allow patent holders to block
                                                                       patent holders, a user can obtain access to a set of
               continued innovation by obstructing reasonable
                                                                       patents through a single transaction, most likely
               access to their patented developments. For
                                                                       under pre-established terms and conditions. In
               example, patent holders may effectively stifle
                                                                       addition to reducing transaction costs, patent pools
               innovation by refusing to license their discoveries
                                                                       also provide competitive benefits by reducing the
               to others, licensing to only one user exclusively, or
                                                                       probability of litigation for patent infringement,
               charging exorbitant licensing fees. Moreover, even
                                                                       thus increasing the likelihood of continued
               when patent holders are behaving reasonably,
                                                                       innovation.
               problems can arise if a user seeking access to
                                                                            Patent pools have been utilized in many
               previous discoveries must deal with multiple
                                                                       industries as a way to enable the development and
               different patent holders in order to develop a single
                                                                       production of goods that require the use of
               useful product or tool. In such a case, the
                                                                       multiple patented technologies. The Sewing
               "downstream" researcher must negotiate licensing
                                                                       Machine Combination, covering a number of
               agreements with each of the different "upstream"
                                                                       different sewing machine patents, was formed in
               patent holders, a process that may entail
                                                                       1856 and is generally thought to be the first
               transaction costs so excessive that they become
                                                                       instance of a patent pool.5,6 Patent pools were also
               prohibitive.2 This is known as "patent stacking," or
                                                                       created in the emerging automotive and aircraft
               the creation of a "patent thicket." Patent thickets
                                                                       industries in the early 20th century.7 More
               can lead to underutilization of important
                                                                       recently, patent pools have been formed around the
               discoveries and the stagnation of research if
                                                                       basic elements of digital video compression and
               potential users determine that the costs of
                                                                       storage technologies.8
               obtaining rights to the relevant technologies are
               greater than they are willing to bear.3                 Patent Pools in Biomedicine
                                                                       While there are currently no patent pools
               "The granting of ownership over                         comprising biomedical innovations, a number of
               technological developments can allow                    observers have warned of developing problems in
               patent holders to block continued                       the area of biotechnology licensing, including the
               innovation by obstructing reasonable                    formation of patent thickets and high licensing
INTELLECTUAL   access to their patented                                costs.2,9,10 Patent law experts Michael Heller and
    PROPERTY                                                           Rebecca Eisenberg provide an example of the
   BUNDLING    developments."

      2
                                 ASSOCIATION OF ACADEMIC HEALTH CENTERS


"A number of observers have warned                           Along these lines, the Larta Institute, a private
                                                        firm specializing in technology transfer, and the
of developing problems in the area of
                                                        Ewing Marion Kauffman Foundation, an
biotechnology licensing, including the                  organization based in Kansas City that is dedicated
formation of patent thickets and high                   to advancing innovation and entrepreneurship,
licensing costs"                                        have collaborated on an initiative called the
                                                        Technology Bundling Project.16 Recognizing that
problems that may arise from the proliferation of       there is often a lack of coordination in university
biotechnology patents:                                  research and that many institutions do not have
                                                        the resources to pursue tech transfer aggressively on
    To learn as much as possible about the
    therapeutic effects and side effects of potential
                                                        their own, the Technology Bundling Project aims to
    [pharmaceutical] products at the preclinical        identify complementary technologies at multiple
    stage, firms want to screen products against all    institutions, bundle those technologies together,
    known members of relevant receptor families.        and market the bundles to industry.17 However,
    But if these receptors are patented and             this project does not establish a single licensing
    controlled by different owners, gathering the
    necessary licenses may be difficult or
                                                        entity. Rather, participants are encouraged to
    impossible. A recent search of the Lexis patent     develop template agreements laying out licensing
    database disclosed more than 100 issued U.S.        terms in advance, so that licensing agreements will
    patents with the term "adrenergic receptor" in      not need to be negotiated on an ad hoc basis each
    the claim language. Such a proliferation of         time a company expresses interest in the bundled
    claims presents a daunting bargaining
    challenge.11
                                                        technologies.18
                                                             The Technology Bundling Project convened
     The National Academy of Sciences concluded         two expert panels to review university-submitted
that, to date, there is no evidence that patent         technologies and determine which of these
thickets are a severe problem in the areas of           technologies could be bundled together. As of
genomics and proteomics in a report issued last         October 2006, according to Larta, the panel has
year.12 However, the authors suggested that this        reviewed more than 1500 inventions from six
may be the result of a "general lack of awareness or    submitting institutions. From these submissions,
concern among academic investigators about              41 bundles comprising 100 different technologies
existing intellectual property,"13 and cautioned that   have been created.19 In connection with the
licensing issues could become increasingly              Technology Bundling Project, the Kauffman
problematic as genomics and proteomics continue         Foundation has created a website
to develop and institutions become more aggressive      (www.ibridgenetwork.org) where technology
in asserting their intellectual property rights.14      bundles may be posted and searched by potential
     To avoid future problems, proactive efforts to     industry users.
reduce barriers to licensing and dissemination of            In addition, a variety of organizations in New
research results are being considered by some           Mexico, including the University of New Mexico,
experts as a preventive measure to ensure               the National Center for Genome Resources, and
continued innovation and progress in                    other non-profit institutions active in biomedical
biotechnology. Pooling arrangements, which can          research, joined together in 2003 to create the
simplify the process of identifying patents and         Technology Research Collaborative (TRC), a
obtaining licensing rights, may be an appropriate       cooperative venture to promote technology
response to potential problems in biomedical            commercialization and create economic benefits for
research.3,4,15                                         the state of New Mexico.20 In 2005, TRC members
                                                        signed an Inter-Institutional Agreement
                                                        establishing a framework for patents from the
OTHER IP BUNDLING EFFORTS:                              various organizations to be bundled together and
TECHNOLOGY TRANSFER                                     licensed through a single entity.21 However, shortly
                                                        thereafter, TRC shifted its focus from support for
In addition to bundling arrangements that respond       pre-commercial technologies to support for
to patent thickets and other related issues,            developing commercial ventures serving an already-
intellectual property can also be bundled in order      established market or need. Ultimately, given this
to create new prospects for commercialization and       change in direction, there was never any activity by     INTELLECTUAL
                                                                                                                 PROPERTY
to improve marketing opportunities.                     TRC in the area of IP bundling.22 Still, the initial
                                                                                                                 BUNDLING


                                                                                                                       3
                                          ASSOCIATION OF ACADEMIC HEALTH CENTERS


               agreement to lay the groundwork for IP bundling,      distribution of risks and benefits among
               which was approved by a diverse array of research     participating institutions, and less time and effort
               organizations, demonstrates the potential for         devoted to negotiating licensing agreements.
               aggregating intellectual property across multiple          A sticking point may be in the pre-valuation of
               institutions.                                         patents in the bundle. Participants will need to
                                                                     determine the relative value of each contributed
                                                                     patent and negotiate in advance the distribution of
               ANTITRUST CONCERNS                                    royalty revenues that would result from any
                                                                     licensing agreement. It is typical of pooling
               Pooling and cross-licensing arrangements can raise    arrangements to retain an independent expert or
               anti-trust concerns in some cases. The Department     board to evaluate patents, in order to eliminate the
               of Justice (DOJ) and Federal Trade Commission         tendency of participants to over-value their
               (FTC) have outlined a number of circumstances in      respective contributions. Furthermore, in the case
               which patent pools can have anticompetitive           of patent pools, an entity is typically designated to
               consequences and thus may be deemed unlawful.23       execute licensing transactions involving the
               According to the agencies, pooling agreements are     bundled IP.
               anticompetitive if they result in price-fixing,            Additional questions that will need to be
               exclusion of competitors from the market, or the      addressed include the following:
               deterrence of innovation.24 The DOJ and FTC have      ·     Do the academic health centers have IP that is
               indicated that most intellectual property licensing         suitable for pooling or bundling with IP from
               arrangements will be evaluated under the "rule of           other academic health centers?
               reason"--that is, arrangements will be evaluated on   ·     What rates will licensees pay for access to the
               a case-by-case basis, with the agencies making a            pool?
               judgment in each case as to whether the               ·     Should licensing of bundled patents be
               arrangement and resulting restraints on licensing           compulsory?
               are procompetitive or anticompetitive in their        ·     Should members retain individual licensing
               effects.25                                                  rights?
                    A series of hearings on antitrust enforcement    ·     Should free use of bundled IP among members
               and intellectual property resulted in a 2007 joint          of the pool be allowed?
               report from the DOJ and FTC that identified several
               specific issues of competitive concern with regard    As collaborative research continues to grow in
               to patent pools.26 Of note were the agencies'         importance and the biomedical field expands,
               findings that (1) pooling arrangements should be      concerns surrounding patents and licensing will
               composed of complementary patents rather than         come increasingly to the forefront. Academic
               substitute patents in order to reduce the risk of     health centers should remain aware of these
               price-fixing;27 and (2) in most cases, participants   emerging issues and pursue creative ways of
               should retain the right to license their patents      sustaining the innovation and information
               outside of the pool to encourage continued            exchange that are so vital to scientific progress.
               innovation.28                                         Intellectual property bundling is one strategy that
                                                                     may be worth exploring to address problems in
                                                                     this area.
               ISSUES FOR ACADEMIC HEALTH
               CENTERS: FINDING ECONOMIC                             Andrew Lyzenga, MPP, is a program associate at the
               VALUE                                                 Association of Academic Health Centers.


               The main question facing academic health centers
               with regard to intellectual property bundling is      "The main question facing academic
               whether institutions will find enough economic        health centers with regard to
               value in a pooling or bundling arrangement to
               participate. Such an arrangement will require
                                                                     intellectual property bundling is
               participants to cede some control over the IP they    whether institutions will find enough
               choose to contribute to the pool in exchange for      economic value in a pooling or
INTELLECTUAL
    PROPERTY   the potential for greater marketability, more equal   bundling arrangement to participate."
   BUNDLING


      4
                                 ASSOCIATION OF ACADEMIC HEALTH CENTERS


1Shapiro C. "Navigating the Patent Thicket: Cross            13   Ibid., p. 3
Licenses, Patent Pools, and Standard-Setting." (2001).       14   Ibid.
Accessed at http://haas.berkeley.edu/~shapiro/ thicket.pdf   15 Grassler F, Capria MA. "Patent pooling: Uncorking a
2 Heller MA, Eisenberg, RS. "Can Patents Deter               technology transfer bottleneck and creating value in
Innovation? The Anticommons in Biomedical                    the biomedical research field." Journal of Commercial
Research." Science 280, 698 (1998).                          Biotechnology. 9(2): 111-118. January 2003.
3 Resnik DB. "A Biotechnology Patent Pool: An Idea           16http://www.larta.org/lavox/ArticleLinks/2006/
Whose Time Has Come?" The Journal of Philosophy,             102006_VBA.asp
Science & Law, Vol. 3 (2003).                                17   Ibid.
4 "Antitrust Guidelines for the Licensing of Intellectual    18   Ibid.
Property." Issued by the US Department of Justice and
the Federal Trade Commission. Section 5.5. April 6,          19   Ibid.
1995. p.30.                                                  20   http://www.nm-trc.org/
5Clark J, et al. "Patent Pools: A Solution to the            21 http://www.sandia.gov/news-center/news-releases/2005/
Problem of Access in Biotechnology Patents?" U.S.            all/inter-inst.html
Patent and Trademark Office (2000).                          22Per a telephone conversation with Andrew
6Merges RP. "Institutions for Intellectual Property          Neighbour, PhD, Executive Director, Technology
Transactions: The Case of Patent Pools." (1999).             Research Collaborative.
Accessed at http://www.law.berkeley.edu/institutes/          23 "Antitrust Guidelines for the Licensing of
bclt/pubs/merges/pools.pdf
                                                             Intellectual Property." Issued by the US Department of
7 Ibid.
                                                             Justice and the Federal Trade Commission. Section
8   Ibid.                                                    5.5. April 6, 1995.
9Campbell EG, et al. "Data Withholding in Academic           24   Ibid.
Genetics: Evidence From a National Survey." JAMA.            25   Ibid., Sections 3.4 & 5.5
2002;287:473-480.                                            26 "Antitrust Enforcement and Intellectual Property
10Baca, MR. "Barriers to Innovation: Intellectual            Rights: Promoting Innovation and Competition."
Property Transaction Costs in Scientific                     Issued by the U.S. Department of Justice and the
Collaboration." Duke L. & Tech. Rev. 0004 (2006).            Federal Trade Commission. April 2007.
11Heller MA, Eisenberg, RS. "Can Patents Deter               27   Ibid.
Innovation? The Anticommons in Biomedical                    28   Ibid.
Research." Science 280, 698 (1998). p. 699.
12National Academies of Science, Board on Science,
Technology, and Economic Policy (STEP), and
Committee on Science, Technology and Law (STL).
(2005) Reaping the Benefits of Genomic and Proteomic
Research: Intellectual Property Rights, Innovation, and
Public Health. Washington, DC: NAS; 2005.




                                                                                                                        INTELLECTUAL
                                                                                                                        PROPERTY
                                                                                                                        BUNDLING


                                                                                                                              5
VISION
To advance the nation's well-being
through the vigorous leadership of
academic health centers.


MISSION
To improve the nation's health care
system by mobilizing and enhancing the
strengths and resources of the academic
health center enterprise in health
professions education, patient care,
and research.


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                         ,
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For more information, contact
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alyzenga@aahcdc.org
© 2007 by the Association of Academic Health Centers