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Pharmaceutical
Patent - Extension of Term Provisions Around the World Background
Intellectual Property Rights (TRIPS)
The World Trade Organisation's (WTO) Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) attempts to unify the international rules and narrow
the gaps in the way that intellectual property rights are protected around the world. The
TRIPS agreement covers a wide range of intellectual property, including copyright,
trademarks, geographical indications, industrial designs, patents and the layout designs
of integrated circuits. The TRIPS agreement requires its member countries to give minimum
and adequate protection to intellectual property rights, for example, 20 year terms for
patents. It also addresses how intellectual property rights should be adequately enforced,
and states how disputes over such rights are to be settled at the WTO. The TRIPS agreement
also recognises and provides for special transitional arrangement for developing countries
such as India to implement new intellectual property legislation.
Patent Extensions
A number of countries now provide for extended patent terms for pharmaceuticals. These include Australia, Japan, Korea, Israel, the United States, and many of the member states of the European Union.
Although there are no internationally agreed standards for patent term extension, the provisions for patent term extension in those countries that provide for it contain some common features:
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Extension is not automatic; the patent owner must make a specific application;
- The length of the extension granted depends on the length of time between the date of filing of the patent application and the date of marketing approval;
- A maximum extension of 5 years is provided for; and
- The rights of the patent owner in respect of the patent are usually limited during the extended term compared with the rights available during the original term.
Although some countries do provide for patent term extension for pharmaceuticals, many countries do not. These include Argentina, Brazil, Canada, China, Colombia, Ecuador, Hungary, India, Malaysia, New Zealand, Peru, South Africa and Venezuela.
Bolar Provision
Some countries permit the manufacturers of generic pharmaceuticals to use
the technology of a patented pharmaceutical to perform work that would assist in the
marketing or regulatory approval of the generic product, while the patent is in force.
This "Bolar" provision then allows the generic producer to market and
manufacture their goods as soon as the patent expires. Bolar Provisions have been upheld
as conforming to the TRIPS agreement.
Compulsory Licensing
The TRIPS Agreement allows WTO member governments to produce a patented
product or process without the consent of the patent owner for public non-commercial
purposes (government use). While the agreement does not specify the grounds for compulsory
licensing, it does set a number of conditions that have to be met in order to safeguard
the legitimate interests of the patent owner. These include:
(1) an effort must have been made first, as a general rule, to obtain a voluntary license
on reasonable commercial terms and conditions;
(2) adequate remuneration must be paid to the right holder in each case, taking into
account the economic value of the license.
Parallel Imports
Parallel imports relate to products that have been made and marketed by
the patent owner in one country, which have subsequently been imported by a third party
into another country, without the patent owner's consent.
http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma.pdf
Prepared for IP Organisers by Dr Grace Chan, David Tadgell and Virginia Beniac-Brooks, Phillips Ormonde & Fitzpatrick - November 2007. |
