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of the TRIPS-plus provisions constitute barriers to the entry of affordable generic
medicines on the markets of the signatories.85
There is also a visible trend of the US proposing increasingly protective provisions,
especially to developing countries, who are weaker negotiation partners. For example,
only the most recently concluded FTAs86 include the requirement of patentability of
a new use of a known substance.87 Generally, the US are shifting their focus from mul-
tinational playground to bilateral trade agreements in order to increase their chance to
pursue their negotiation objective.88
VI.a) Are the US Creating a New Harmonized International System
of IP Protection?
Most of the TRIPS-plus rules on patent protection are already covered in the US
law. Therefore, by enforcing them in their FTAs and most recently in the TPP, the
US are creating a new harmonized international system of intellectual property rights
protection, which is consistent with their own law. However, the US law, as well as
their negotiation positions, are largely dependent on the interests of pharmaceutical
corporations.89
The US often propose provisions that put the pharmaceutical companies in the posi-
tion of a regulator. For example, when proposing patent linkage (a system in which the
marketing approval of a generic drug is dependent on the original drug patent), there
are two options. Either the generic drug marketing approval can be forbidden as long
as the original drug patent is valid, or the registration authority notifies the original
drug patentee and the patentee itself decides whether or not allow the generic drug
marketing approval. The second version is consistent with the US law and more often
included in the US-concluded FTAs.
Given that the US concluded FTAs are in the end adding more constraints and
obligations than flexibilities on the signatories, some authors describe them as TRIPS-
minus, rather than TRIPS-plus. With regard to this fact, there is a big debate in the
international trade law about whether or not states can lower their protection in an
FTA. So far, it has been a common practice to lower the protection between states
in a bilateral agreement. However, the question is what would be the situation if the
lower protection resulted in harming the interests of another state.
85 Ibid.
86 Australia-US FTA, Morocco-US FTA, US-Bahrain FTA, in force: 01 Aug 2006, online: .
gov/trade-agreements/free-trade-agreements/bahrain-fta/final-text> [US-Bahrain FTA]. Bahrain-US
87 Morin, Jean-Frédéric, “Tripping up TRIPs debates: IP and Health in Bilateral Agreements” (2006) 1:1/2
Int J Intellect Property Manag.
88 High Price supra note 169 at 2.
89 “The negative impact on public health will be enormous: Statement by MSF on the conclusion of Trans-
Pacific Partnership negotiations in Atlanta” Doctors Without Borders (5 October 2015) online <http://
the-conclusion-of>.