[Ip-health] "Recent Experiences In Policy Implementation Of Socially Responsible Licensing In Select Universities Across Europe And North America"

Juliana Veras veras.ju at gmail.com
Thu Sep 13 05:20:38 PDT 2018


Dear all,

I am happy to share with you the article entitled "Recent Experiences In
Policy Implementation Of Socially Responsible Licensing In Select
Universities Across Europe And North America: Identifying Key Provisions To
Promote Global Access To Health Technologies"
<https://poseidon01.ssrn.com/delivery.php?ID=243069124094101108021095100118116007000076081034060007022067079097005097122018087119005102039099016121119028112080098068075097020045006069064005106081003081066123076040065013111093116031009112084030119122116010005070122070018071106067095027004122020085&EXT=pdf>,
that my colleagues Thi-Yen Nguyen, Mohammad Shahzad and I wrote on behalf
of the Universities Allied for Essential Medicines.

The article was published in the September issue of les Nouvelles journal
of the Licensing Executives Society International. Please, let us know if
you if you find any trouble accessing the full version.

Kind regards,

Juliana Veras

*__*

*Membre du Conseil d'Administration de UAEM Europe*
Universités Alliées pour les Médicaments Essentiels
Universities Allied for Essential Medicines

OUR LABS. OUR DRUGS. OUR RESPONSIBILITY. *|||* www.uaem.org

*Abstract*

*Introduction*

Intellectual property (IP) management at universities and public research
institutions (PRIs) has the potential to enable or restrict access to
university-derived health technologies in all countries, but most notably
low-resource settings. Given their fundamental role in research as well as
their responsibility to prioritize public interests in research and
innovation, several leading universities across the United States, Canada
and Europe have adopted socially responsible licensing (SRL) policies for
the industrial development of their biomedical research.



This study aimed to:

1. Assemble experiences of universities and their Technology Transfer
Offices (TTOs) in implementing SRL policies and

2. Identify key provisions and clauses adopted within universities’ legal
frameworks to promote global access to licensed health technologies derived
from publicly-funded research.

*Methods*

In order to assess how universities and PRIs can best manage their IP in
accordance with public health objectives, our research team conducted a
phenomenological qualitative study that involved a survey of experiences in
policy implementation of SRL in select universities. Our methodology
consisted of semi-structured interviews with licensing officers at TTOs of
nine universities including Harvard, Yale, and Oxford.

Between September and December 2015, questionnaires were designed, and
conducted with technology transfer officers from nine universities that
implemented an SRL policy. These universities are located across United
States, Canada and Europe.



*Significant findings*

We found that all these universities were able to develop their own SRL
policies with specific aims around promoting societal impact of
university-derived health innovations and promote equitable distribution of
these technologies in low- and middle-income countries. Furthermore, our
findings showed that the interviewed TTOs have gained experience with
incorporating SRL language in contracts with third party licensees in order
to better monitor the downstream development of their intellectual property
and to ensure it benefits public health. We identified several SRL terms
and provisions incorporated by TTOs into licensing agreements with industry
partners to ensure global access of their health technologies. These
provisions were noted under the following sections of licensing agreement
contracts: Recitals, Definitions, Exclusive vs. Non-exclusive Licensing
Requirements, Royalties, Obligations of Parties, and Breach and Termination.

Noteworthy examples of equity-based contractual obligations and provisions
to promote global access included: University’s right to require due
diligence in downstream development, Monitoring licensee's product
development plan, Licensee’s obligation to sell final products at-cost,
Licensee’s obligation to secure global access provisions in sublicenses,
and Licensee’s concurrence that the University will not file patents in
LMICs, and the Licensee’s agreement to not pursue infringement action in
developing countries.



*Conclusions*

Our findings show that, by implementing an SRL policy, universities
strengthen their ability to incorporate global access provisions into
licensing agreements with industry partners. Significantly, these results
were presented at the recent United Nations High-level Panel on Access to
Medicines in 2016 and incorporated into the Panel’s final report under
section 2.6.2: ‘intellectual property generated from publicly-funded
research’. This reflects an ethical awareness and willingness on the part
of these institutions to align their IP management practices with public
health targets to facilitate access to the end product health technology in
low-resource settings. However, there remains an overall lack of guidance
for universities and PRIs worldwide regarding successful implementation of
socially responsible IP management and licensing practices. Therefore, we
hope that dissemination of current SRL policies and sharing of experiences
across institutions will promote recognition and widespread adoption of
equity-based provisions and formal SRL policies for technology transfer of
publicly-derived health technologies across universities and PRIs worldwide.


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