September 2006
Contents
> Philosophy:
striking a balance
> Obligations
and exceptions
> What
does “generic” mean?
> Developing
countries
This
fact sheet has been prepared by the Information and Media
Relations Division of the WTO Secretariat to help public
understanding. It is not an official interpretation of
the WTO agreements or members’ positions |
GENERAL back to topDeveloping
countries and economies in transition from central
planning did not have to apply most provisions of the
TRIPS Agreement until 1 January 2000. The provisions
they did have to apply deal with non-discrimination. Article 65.2
and 65.3
Least-developed
countries were given until 1 January 2006. Article 66.1. On 30 November 2005, members agreed to extend the deadline to 1 July 2013, or
to the date a country is no longer “least-developed”, if that is
earlier.
For pharmaceutical patents this is extended to 2016 under the Doha
Declaration on TRIPS and Public Health.
Most
new members who joined after the WTO was created in 1995
have agreed to apply the TRIPS Agreement as soon as they
joined. Determined by each new member’s terms of
accession
PHARMACEUTICALS
AND AGRICULTURAL CHEMICALS back to top
Some
developing countries delayed patent protection for
pharmaceutical products (and agricultural chemicals)
until 1 January 2005.
This was allowed under provisions that say a developing country
that did not provide product patent protection in a
particular area of technology when the TRIPS Agreement
came into force (on 1 January 1995), has up to
10 years to introduce the protection. Article 65.4
However, for
pharmaceuticals and agricultural chemicals, countries eligible to use
this provision (i.e. countries that did not provide protection on
1 January 1995) had
two obligations.
They had to allow inventors to file patent applications from
1 January 1995, even though the decision on whether
or not to grant any patent itself need not be taken until
the end of this period — Article 70.8.
This is sometimes called the “mailbox”
provision (a metaphorical “mailbox” is created
to receive and store the applications). The date of
filing is significant, which is why the mailbox
provisions were set up. It is used for assessing whether
the application meets the criteria for patenting,
including novelty (“newness”).
And
if the government allowed the relevant pharmaceutical or agricultural
chemical product to be marketed during the transition period, it had to — subject to certain
conditions — provide the patent applicant an exclusive
marketing right for the product for five years, or until a decision
on a product patent was taken, whichever was shorter. Article 70.9
Which
countries used the extra transition period under Article 65.4, wholly or
partially? The answer is not entirely straightforward. Thirteen WTO
members — Argentina, Brazil, Cuba, Egypt, India, Kuwait, Morocco,
Pakistan, Paraguay, Tunisia, Turkey, United Arab Emirates and Uruguay —
notified “mailbox” systems to the TRIPS Council, indicating that at the
time they did not grant patent protection to pharmaceutical products. It
is possible that a few other members should have notified the WTO but
did not do so.
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The
TRIPS Agreement
Article 65
Transitional Arrangements
1.
Subject to the provisions of paragraphs 2, 3 and
4, no Member shall be obliged to apply the
provisions of this Agreement before the expiry of
a general period of one year following the date
of entry into force of the WTO Agreement.
2.
A developing country Member is entitled to delay
for a further period of four years the date of
application, as defined in paragraph 1, of the
provisions of this Agreement other than Articles
3, 4 and 5.
3.
Any other Member which is in the process of
transformation from a centrally-planned into a
market, free-enterprise economy and which is
undertaking structural reform of its intellectual
property system and facing special problems in
the preparation and implementation of
intellectual property laws and regulations, may
also benefit from a period of delay as foreseen
in paragraph 2.
4.
To the extent that a developing country Member is
obliged by this Agreement to extend product
patent protection to areas of technology not so
protectable in its territory on the general date
of application of this Agreement for that Member,
as defined in paragraph 2, it may delay the
application of the provisions on product patents
of Section 5 of Part II to such areas of
technology for an additional period of five
years.
5.
A Member availing itself of a transitional period
under paragraphs 1, 2, 3 or 4 shall ensure that
any changes in its laws, regulations and practice
made during that period do not result in a lesser
degree of consistency with the provisions of this
Agreement.
Article
66
Least-Developed Country Members
1. In view of the special needs and
requirements of least-developed country Members,
their economic, financial and administrative
constraints, and their need for flexibility to
create a viable technological base, such Members
shall not be required to apply the provisions of
this Agreement, other than Articles 3, 4 and 5,
for a period of 10 years from the date of
application as defined under paragraph 1 of
Article 65. The Council for TRIPS shall, upon
duly motivated request by a least-developed
country Member, accord extensions of this period.
[…]
Article
70
Protection of Existing Subject Matter
[…]
8.
Where a Member does not make available as of the
date of entry into force of the WTO Agreement
patent protection for pharmaceutical and
agricultural chemical products commensurate with
its obligations under Article 27, that Member
shall:
(a) notwithstanding the provisions of
Part VI, provide as from the date of entry into
force of the WTO Agreement a means by which
applications for patents for such inventions can
be filed;
(b) apply to these applications, as
of the date of application of this Agreement, the
criteria for patentability as laid down in this
Agreement as if those criteria were being applied
on the date of filing in that Member or, where
priority is available and claimed, the priority
date of the application; and
(c) provide patent protection in
accordance with this Agreement as from the grant
of the patent and for the remainder of the patent
term, counted from the filing date in accordance
with Article 33 of this Agreement, for those of
these applications that meet the criteria for
protection referred to in subparagraph (b).
9.
Where a product is the subject of a patent
application in a Member in accordance with
paragraph 8(a), exclusive marketing rights shall
be granted, notwithstanding the provisions of
Part VI, for a period of five years after
obtaining marketing approval in that Member or
until a product patent is granted or rejected in
that Member, whichever period is shorter,
provided that, subsequent to the entry into force
of the WTO Agreement, a patent application has
been filed and a patent granted for that product
in another Member and marketing approval obtained
in such other Member.
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