TRIPS Flexibilities: The importance of Policy Coherence. Presented by Brook Baker, Health GAP, US.

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TRIPS Flexibilities: The Importance of Policy
Coherence
Global Summit on IP and A2M: Pathways to Access
Brook K. Baker, Senior Policy Analyst Health GAP
Professor Northeastern U. School of Law
Honorary Research Fellow, University of KwaZulu Natal, S.A.
Jan. 15, 2018

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TRIPS Included a Key Flexibility
for Least Developed Countries
 Article 66.1 LDC transition periods
 2006>2013>2021: freedom from all TRIPS IP
protections except for national treatment and most
favoured nation
 2003>2016>2033: freedom from all patent [including
market exclusivity and mailbox] and data protection
requirements for pharmaceutical products.
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LDC Policy Coherence
 Several LDCs have adopted the pharmaceutical
waiver/extension, but most have not domestically or regionally,
e.g. OAPI has but ARIPO has not.
 Even though LDCs are included in a limited set of voluntary
licenses and even though patents are not necessarily filed
extensively in LDCs, LDCs are still missing opportunities to
ensure no pharmaceutical patents both to promote affordable
access to medicines and to facilitate local production, e.g.,
Uganda and Bangladesh.
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Standards of Patentability
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Exclusions from Patentability
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Standards of Patentability and
Exclusions - Policy Coherence
 Strict standards of patentability and exclusions from patentability
need to clarified legislatively and by regulations/examination
guidelines and patent examiners need to be trained in stringent
criteria with incentive systems for strict enforcement of standards.
 Strict standards and exclusions dramatically reduce the number of
unworthy patents, especially secondary patents that result in
evergreening of patent monopolies.
 Strict standards and exclusions facilitate successful use of
opposition procedures.
 Strict standards and exclusions result in reduced need for
voluntary or compulsory licenses.
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Required Disclosures, Oppositions,
and Patent Term
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Policy Coherence – Required
Disclosures, Oppositions, and Patent
Term
 Strict standards of disclosure provide better clarity on claims
and scope of patent and thereby promote stringent patent
examination; facilitate follow-on experimentation and
innovation; ease generic entry; allow easier search of patents
covering pharmaceutical products (INNs); and allow updated
and comparative analysis of patent status in other jurisdictions.
 Pre- and post-grant patent oppositions promote quality patent
examination and oversight of patent office performance and
allow for coordinated patent oppositions to priority medicines.
 Limiting patent term extensions allows earlier generic entry.
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Limited Exceptions and Parallel
Importation
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Policy Coherence – Limited
Exceptions and Parallel Importation
 Countries should make full use of well-known limited
exceptions under Article 30.
 Early working allows faster registration of generics both domestically
and abroad.
 A broad research exception allows for follow-on innovation
 Article 30 could be used for an easier-to-use exception allowing
production for export to non-producing countries
 Broadening adoption and use of permissible limited exceptions will
incentivize other countries to also adopt
 Parallel importation can help countries overcome adverse price
discrimination by originators and if used more broadly will allow
importation of licensed generic equivalents. [Note: PI may be
more politically palatable if it doesn’t allow import from lowest
income countries.]
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Compulsory and Government Use
Licenses
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Policy Coherence – Compulsory and
Government Use Licenses
 Compulsory licenses overcome barriers to generic competition
regardless of the merits of the patent and can be widely and
consistently used without violating TRIPS.
 TRIPS allows routine, presumptive compulsory and government
use licenses.
 Most countries haven’t adopted broad grounds and easy-to-use
administrative procedures and few have issued licenses in
multiple therapeutic areas undermining CL credibility.
 Collaboration in timing and issuing of CLs would diminish political
pressure and help aggregate viable markets for generic producers
especially licenses are granted to multiple licensees.
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Competition Policy
Arts. 8 and 40
Competition Policies
Prevent abuse of IP rights by right holders in
licensing or other practices that unreasonably
restrain trade or adversely affect transfer of
technology.
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Policy Coherence – Competition
Policy
 Can be used to require disclosure of voluntary licenses and to
regulate content to achieve competition goals.
 Provides competition-enhancing remedies in addition to those
allowable directly within the TRIPS Agreement, e.g. during
mergers and acquisitions, price controls, etc.
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Policy Coherence More Broadly
 Governments have human rights obligation to ensure equitable
access to affordable medicines and to remove barriers to such
access, including intellectual property barriers.
 TRIPS is by no means a truly balanced system mediating the
interests of government duty holders, people who need
medicines, and innovators, especially in light of global
economic inequality and human development needs.
 TRIPS is inadequate as a policy instrument for needed
innovations, especially those for neglected populations, and
with respect to equitable and affordable access.
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Policy Coherence More Broadly
 However, until true changes in the medical innovation/access
ecology are achieved, every country has a human rights duty to
adopt, use, and protect TRIPS flexibilities at home and abroad.
 In the 23 years since the adoption of TRIPS, most LMICs have
neglected these TRIPS-flexibilities duties with dire
consequences for public health.
 It is hard to argue for the protection of TRIPS flexibilities when
countries are not willing to adopt them, let alone use them –
use them or lose them.
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Policy Coherence More Broadly
 It is more difficult for individual low- and middle-income
countries to act to adopt and use TRIPS flexibilities when other
countries don’t do so – there is greater political strength and
cover in joint and coordinated action. Stronger MICs must take
the lead.
 Voluntary license strategies are substantially weaker when
TRIPS flexibilities are not adopted, used, and protected.
 The generic industry is even more at risk of becoming junior
partners to Big Pharma if TRIPS flexibilities are not adopted
and used to ease generic entry.
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Policy Coherence More Broadly
 Big Pharma and their rich country supporters, especially the US
and the EU, are constantly trying not only to undermine the
adoption and use of TRIPS flexibilities, they have a long term
strategy of strengthening, broadening, and lengthening
pharmaceutical monopolies.
 E.g., Trump say other countries are not paying enough for medicines.
 E.g, demands in ongoing trade agreements.
 We need coordinated CS campaigns – national, regional, and
international – to win TRIPS flexibilities.
 Our own coordination is weak and siloed. We have let a single
issue – voluntary licenses – to foolishly divide weakening our
collective ability to win needed TRIPS flexibility reforms.
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