267 / 610
265
reducing their twelve-year data exclusivity protection to seven years in order to reduce
costs of the treatment.
78
Biologics were one of the last issues to be resolved in TPP - perhaps the more inter-
esting it is that the US did not get their own way. The reason might have been a firm
opposition on the topic of biologics from Australia, which was clear that it will not
extend the protection period.
79
Australia, for example, offers a data protection period of five years, which applies to
all prescription medicines. During this period, a biosimilars producer cannot rely on
data submitted by the biologics producer while obtaining marketing approval for the
original drug;
80
therefore, the generic manufacturer would have to perform his own
tests, which are too lengthy and expensive. Moreover, the approval agency cannot
begin to evaluate a biosimilar application during the data protection period; therefore,
a follow-on product enters the market at least six years after the originator’s entry.
The final version of TPP shows an enormous compromise from the US. While origi-
nally proposing the data exclusivity period of twelve years, the signed text provides
for minimum of only five years. The TPP signatories can either (1) give an eight years
market exclusivity counting from the date the biologic is approved in the country con-
cerned or (2) give five years market exclusivity and other measures to deliver a compa-
rable market outcome.
81
Some TPP countries have already stated that this provision does not require them
to change their national law.
82
For example Japan and Canada now offer eight years of
data exclusivity for biologicals. Moreover, the TPP provides a five-year transitional pe-
riod for countries to implement the data exclusivity for biologics.
83
As was previously
mentioned, even in the US, who were proponents of a much longer data exclusivity,
have been tendencies to limit the period to seven years. Such a change will bring about
3 billion USD savings on pharmaceuticals for the federal health programs.
VI. Discussion
The TRIPS-plus provisions concluded by the US in FTAs clearly go beyond the
TRIPS agreement.
84
Whereas the TRIPS aimed to protect access to medicines, the US
usually require their trading partners to give up the flexibility offered by the TRIPS.
Almost all FTAs concluded by the US include the patent term extension provisions
(which compensate the marketing approval delays) or patent linkage. However, most
78
Trading Away Health supra
note 151.
79
The Conversation
supra note 144.
80
The Conversation
supra note 144.
81
Biologics supra
note 144.
82
Biologics supra
note 144.
83
TPP
footnote 61.
84
Jean-Frédéric Morin “Tripping up TRIPs debates: IP and Health in Bilateral Agreements” (2006) 1:1/2
Int J Intellect Property Manag.