PRIVATE PATENTS AND PUBLIC HEALTH

TABLE 7 DATA EXCLUSIVITY PROTECTIONS IN THE TPP NEGOTIATING
PARTIES
COUNTRY PHARMACEUTICALS – BIOLOGICS –
DATA EXCLUSIVITY (YEARS) DATA EXCLUSIVITY (YEARS) *
Australia 5 5
Brunei 0 0
Canada 8 8
Chile 5 5**
Japan 8 8
Malaysia 5*** 5***
Mexico 5 5**
New Zealand 5 5
Peru 5 5**
Singapore 5 5
United States 5 12
Vietnam 5 5
European Union 10 10
PRIVATE PATENTS AND PUBLIC HEALTH
* Excludes further extensions for paediatric approval, orphan designation, new indications,
and other incentives.
** It is uncertain whether data exclusivity will apply to biologics in Chile, Mexico and Peru.
These countries do not specifically grant data exclusivity to biologics.
***Malaysia begins counting data exclusivity from the date a product is approved and given
data protection in its originator country and allows for up to five years of data exclusivity
from that date.
SOURCE
Michael Mezher, “Trade Talks Stumble Over Biologics Data Exclusivity,” Regulatory Affairs
Professionals Society, www.raps.org/regulatory-Focus/ News/2015/02/11/21309/Trade-
Talks-Stumble-over-biologics-Data-Exclusivity
MERITS OF THE MULTILATERAL SYSTEM
It is difficult for countries, in particular developing countries, to push
back on TRIPS-plus demands in bilateral and regional trade talks. And
subsequent trade agreements tend to have a ratcheting up effect on
TRIPS-plus measures, as they each set new norms for IP measures. India,
for example, is not part of the TPP, but norms in the TPP will indirectly
affect India’s patent laws, making it harder for India to resist signing on
to similar legislation in future trade deals.
TRIPS-plus demands undermine the multilateral consensus where
wealthy nations also have to give and take and where the public and the
media can follow the deliberations and offer comment. Norm setting on
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