[Ip-health] New publication: Moderating the impact of patent linkage on access to medicines

Deborah Gleeson deborah at gleeson.net
Fri Oct 26 09:03:23 PDT 2018

 Son K-B, Lopert R, Gleeson D, Lee T-J. (2018) Moderating the Impact of
Patent Linkage on Access to Medicines: Lessons from Variations in South
Korea, Australia, Canada, and the United States. *Globalization and Health*,
(open access)

The inclusion of patent linkage mechanisms in bilateral and plurilateral
trade and investment agreements has emerged as a key element in the United
States’ TRIPS-Plus intellectual property (IP) negotiating agenda. However,
the provisions establishing patent linkage mechanisms in several agreements
appear to reflect a degree of ambiguity, potentially enabling some
flexibility in their implementation. In this study, we reviewed the
features of the prototypic patent linkage mechanism established by the
Hatch-Waxman Act in the United States, and compared these with the
implementation of systems in three countries whose agreements with the US
include patent linkage obligations. From these analyses, we draw lessons
for moderating the impact of these mechanisms on access to generic

We reviewed the features of the patent linkage mechanism in the US, and
undertook a detailed analysis of relevant treaty provisions and the manner
of implementation in Canada, Australia, and South Korea.

A key difference between the US implementation of patent linkage and that
of its trading partners is the disparate treatment afforded to biologics.
Because of the significant differences in the regulatory frameworks
applying to small molecule and biologic medicines in the US, the Hatch-
Waxman provisions do not apply to biologics and they are not subject to
patent linkage. By contrast, the regulatory frameworks in Canada, Australia
and South Korea do not reflect similar distinctions and thus patent linkage
mechanisms also capture biologics. Additional variations in implementation,
mainly the result of constructive ambiguities in the respective treaty
texts, offer potential opportunity for mitigating the adverse impact of
patent linkage provisions on market entry of generic medicines. Practical
measures include ensuring the availability of an accessible, transparent
and easily searchable database of patent information; avoiding automatic
stays of generic marketing approval where possible; and requiring
certification by rights holders to prevent abuse of the system.

Where countries accept treaty obligations to establish patent linkage
mechanisms, the impact on access to generic medicines may be moderated to a
degree by retaining and exploiting constructive ambiguities in the treaty
text and addressing practical aspects of implementation.

Deborah Gleeson MPH PhD
Senior Lecturer
School of Psychology and Public Health
La Trobe University VIC 3086

T: +61 3 9479 3262
M: +61 423 209029

More information about the Ip-health mailing list