African nations last week led a push by least-developed countries (LDCs) in
the World Trade Organization that would further delay patent protections on
pharmaceuticals and agricultural chemicals, but the U.S. signaled its
skepticism about the proposal, which would exempt these countries until
2016 from additional obligations under the Agreement on Trade Related
Aspects of Intellectual Property Rights (TRIPS).
The issue surfaced at an informal TRIPS council meeting May 17 in a
discussion on implementing a decision reached by trade ministers in Doha
last November to grant LDCs another 10 years -- until 2016 -- regarding
their obligation to provide patent protection to pharmaceuticals,
pesticides and other chemicals. Some African countries want to tack on an
exemption until 2016 to the obligation to provide “mailbox” protections
under TRIPS articles 70.8 and 70.9.
These articles require countries that do not yet have patent regimes to
allow companies to file for patents, which would be granted once these
countries enact patent protections. Absent such a provision, companies
would have to delay filing for patent protection until 2016, which because
of the length of time between filing for patents and bringing new products
to markets, would effectively delay patent protection for another 10 years,
industry and government sources said.
The mailbox protections would ensure that companies filing for patents on
new products in the period between now and 2016 would benefit from patent
protection starting in 2016. Otherwise, only products developed starting in
2016 would be eligible for patents, and older products would be ineligible,
sources said.
The mailbox provisions also require granting of five years exclusive
marketing rights for these products to the pharmaceutical companies until
patents are granted, although this would not prevent the marketing of
generic copies under a different name, according to trade officials.
The U.S. signaled its unwillingness to automatically accede to the African
countries' request. But the U.S. and other countries like Switzerland with
research based pharmaceutical industries did not come out and outright
oppose the idea, which is a new element in the discussions on TRIPS and
public health.
Instead the U.S. asked the WTO Secretariat to prepare two draft decisions
on the LDC extension for adoption by the TRIPS council, one with and one
without the additional exemptions from mailbox obligations. The secretariat
is expected to present both versions of the draft decision at the June
TRIPS council meeting.
At the meeting, Switzerland also repeated its request for a background
paper from the secretariat on the pharmaceutical production capacity of
developing countries and their levels of patent protection. The information
is relevant to the TRIPS council's discussion of how countries without
production capacity can take advantage of compulsory licensing provisions,
for instance by licensing production in a third country. The TRIPS council
is due to make a decision on the issue by the year's end.
Both the TRIPS Council informal meeting, and a special negotiating session
of the council were dominated by procedural issues in the run-up to the
June formal sessions of both bodies.
The special session, which is tasked with negotiations on the establishment
of a multilateral registry of protected geographical indications for wines
and spirits, saw an effort by the chairman to break the long-deadlocked
discussion with a focus on getting agreement on the key terms. These
definitions would be the focus of discussion at the June meeting.
On the question of broader protection for geographical indications for
other agricultural products, which was under discussion in the regular
TRIPS council, two key demandeurs on this issue, Bulgaria and India, asked
the chairman to invite members to submit proposals on how to provide higher
levels of protection, in order to fulfill the council's mandate to find a
solution to the issue. But the U.S. and Argentina disagreed with this
characterization of the mandate, which only requires a report on
discussions by year's end. Australia, which is allied with the U.S. in
opposing agreement on higher levels of protection, asked the secretariat to
compile information on how members are currently protecting use of such
geographic appellations on products.
Neither the special session nor the regular council could arrive at a
solution to the question of which intergovernmental bodies should be
allowed in on meetings as observers, which has vexed all the negotiating
groups in the new round.
In the regular TRIPS council, the U.S. repeated its opposition to allowing
the Convention on Biological Diversity to sit as an observer, saying the
focus of the group was too narrow. India, the European Union, Peru and
Brazil argued for granting the CBD observer status, since the Doha mandate
calls for discussion of the interrelationship between TRIPS and the CBD
with regard to issues concerning patents on living organisms.
In the special session, India and Egypt balked at a proposal by the chair
to allow all observers in the regular TRIPS council to observe the
negotiating sessions. Egypt said the question of observerships needed to be
resolved at the Trade Negotiations Committee, a reference to the standoff
between Arab countries and the U.S. and Israel over observer status for the
Arab League (Inside U.S. Trade, April 26, p. 1).
Return to: CPTech Home -> Main IP Page -> IP and Healthcare -> WTO Page |