RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/294/Add.1
29 November 2001
(01-6096)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Responses from Kenya to a question posed by
the European Communities and their member States and
follow-up questions posed by Switzerland and the United States
Addendum
By means of a communication from the Permanent Mission of Kenya, dated
28 November 2001, the Secretariat has received the fo llowing responses to an initial question posed
by the European Communities and their member States and to follow-up questions posed by
Switzerland and the United States.1
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EUROPEAN COMMUNITIES AND THEIR MEMBER STATES
A. GENERAL
1. Please describe if your legislation includes measures necessary to protect public health and
nutrition, to promote the public interest in sectors of vital importance to your socio-economic and
technological development as mentioned under Arti cle 8 of the TRIPS Agreement. If yes, please
explain how such measures are consistent with the provisions of the TRIPS Agreement.
The Industrial Property Act, 2001 provides measures necessary to protect public health and
nutrition namely:
• Section 58 (2) on parallel importation
• Sections 72-25 on compulsory licence for commercial use
• Section 80 on the government use for non-commercial purposes
Parallel Importation
Parallel importation provision in the Act is consistent to Article 6 of the TRIPS Agreement on
the exhaustion of rights.  Section 58(2) states:
"The rights under the patent shall not extend to acts in respect of articles which have been put
on the market in Kenya or in any other country or imported into Kenya."
As per the draft implementing regulations of the Industrial Property Act, the articles have to
be put in the market by the owner of the patent or through his consent.
                                                     
1 Kenya's responses to all other initial questions were circulated in document IP/C/W/294.IP/C/W/294/Add.1
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Compulsory Licence - Commercial Use
Sections 72-75 of the Industrial Property Act, 2001, published on 3 August 2001, compulsory
licence is provided for non-working of a patent or similar reasons such as high prices for medicineand on interdependence of patents.
Compulsory Licensing for Government Use
Section 80 of the Industrial Property Act, 2001, the Government can exploit patented
invention by itself or by third persons authorized by the government in the case of public interest, in
particular, national security, national emergency, nutrition, health, environment conservation, or the
development of other vital sector if the national economy so requires.
Early working of a patent (Bolar Provision)
The rights conferred on the owner by the patent under section 54(1) of the Industrial Property
Act, 2001, shall not apply to acts by third parties necessary to obtain approval or registration of aproduct from the Institute, for the purpose of commercialising the product after the expiry of the
patent.  This allows experimentation for commercial purposes.  In the case of pharmaceutical patents
it permits the initiation of procedures for the registration of a medicine by a third party before the
expiry dates of the respect patents, so as to speed up the commercialisation of a generic product after
that date.  This exception is usually known as early working or Bolar Provision.
SWITZERLAND
Follow-up to question 6:
You mention that you are currently developing the legislation on protection of undisclosed
information.  Please explain what the draft Bill pr ovides in this regard and when the new legislation
is supposed to enter into force.
Currently, Kenya has no specific legislation on the protection of undisclosed information.
Protection of undisclosed information is provided for in other legislation such as the Pharmacy and
Poisons Act Cap 346, the Pest Control Product Act, Cap 346 of the laws of Kenya, or by the commonlaw.  Kenya, however, intends to legislate a law on the protection of undisclosed information in the
future.  No specific time is set yet to have such a law in place.
Referring to the answers given to the United States original question no.19 during Kenya’s
review of its legislation:
Under the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya, test data submitted to
the Registrar of Drugs and Pharmaceutical products, is handled confidentially.
The Pest Control Products Act, Cap 346 of 1982, revised in 1985 regulates the importation,
exportation, manufacture, distribution and use of products used for the control of pests and of the
organic function of plants and animals and for connected purpose.
Under Sections 3 and 4 of the Pest Control Products Act, the information submitted to the
Secretary of the Board for registration of chemical products is not accessible to any third partywithout the authority of the owner.  Under section 12 of this Act, any person who contravenes the
provisions of Sections 3 and 4 on confidentiality of information shall be guilty of an offence and shall
be liable to imprisonment for a term not exceeding two years.IP/C/W/294/Add.1
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Under the two Acts, the Pharmacy and Poisons Ac t and the Pest Control Products Act, third
parties do not have access to information previously submitted for approval for the marketing of
pharmaceutical or agricultural chemical products.  Kenya intends to review the two pieces of Law to
allow other applicants for the marketing approval for their own versions of a previously approvedpharmaceutical and agricultural products to permit the third party to rely on data submitted by the
earlier applicant, after a certain period of exclusivity given the earlier application before such reliance
becomes possible.  This would encourage research and development including manufacture of generic
medicine to address our national concerns on the public health and food security sectors.
UNITED STATES
A. G
EOGRAPHICAL INDICATIONS
1. Please explain how Kenya ensures that interested parties can prevent the use of a
geographical indication for wines and spirits that do not come from the place indicated in the
geographical indication even when accompanied by expressions such as "kind", "type", "style","imitation" or the like.
Kenya has a draft bill for geographical indications, which has to be tabled in Parliament for
enactment.
Under clause 2(f) of the draft Bill, a geographical indication is defined as a description or a
representation used to indicate the geographical origins in the territory of a country or a region of
locality in that territory where a given quality, reputation or other characteristic, of goods or services
are exclusively or essentially attributable to geographical environment, including natural factors,
human factors or both.
When the Bill becomes law interested parties could prevent the use of a geographical
indication for wines and spirits that do not come from the place indicated in the geographical
indication even when accompanied by expressions such as "kind", "type", "style", "imitation" or the
like.
2. Please explain how Kenya ensures that interested parties can prevent the use of a
geographical indication for wines or spirits that do not come from the place indicated in the
geographical indication, even when the origin of the goods is indicated.
As a follow-up to the answer to question 1 above, any geographical indication for wines and
spirits must indicate the geographical origin, in the territory of a country or a region or locality in thatterritory where a given quality or reputation or other characteristics of goods or services are
exclusively or essentially attributable to geogra phical environment, including natural factors, human
factors or both.
B. C
OPYRIGHT AND RELATED RIGHTS
3. Please explain how the requirement that co pyright owners must apply for authentication
under Article 36 of the proposed Copyright Act of 2000 ("proposed Act") is consistent with
Article 5(2) of the Berne Convention, which states that the enjoyment and exercise of copyright should
not be subject to any formality.
The authentication envisaged under Clause 36 of the Copyright Bill (2001) is an enforcement
measure aimed at curbing piracy of sound recordings, audio-visual works and to a certain extent
software.IP/C/W/294/Add.1
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This requirement is not a device that will confer copyright to right holders and is therefore not
inconsistent with Article 5(2) of the Berne Convention.  It is only applicable to those works where
copyright subsists.
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