. /.RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/277/Add.2
13 September 2001
(01-4299)
Council for Trade-Related Aspects of
Intellectual Property RightsOriginal:  Spanish
REVIEW OF LEGISLATION
Responses from Honduras to the Follow-up Questions
Posed by Switzerland
Addendum
By means of a communication from the Permanent Mission of Honduras dated
10 September 2001, the Secretariat has received the following responses to the follow-up questions
posed by Switzerland, as circulated  in document IP/C/W/263/Add.1.
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A. P ATENTS
Ad response to question 2:
Please explain in detail how the following excep tion to patentability, foreseen in Article 7
of your Law on Industrial Property, complies with Article 27 of the TRIPS Agreement
prohibiting discrimination as regards patentabil ity between different fields of technology: "[...]
incluyendo los procesos genéticos o relativos a material capaz de conducir su propria aplicación,
por sí mismo o por cualquier otra manera indirecta, cuando consistan en seleccionar o aislar
material biológico disponible y dejarlo que actúe en condiciones naturales".  Does this exception
mean that inventions relating to such subject matter, even if fulfilling the conditions of
patentability, i.e. novelty, inventive step and industrial applicability, are nevertheless excluded
from patentability according to your law?
Pursuant to Article 27.1 of the TRIPS Agreement, the general rule is that patents shall be
available for any inventions, whether products or processes, in all fields of technology, provided that
they are new, involve an inventive step and are capable of industrial application.  However,
Articles 27.2 and 27.3 provide that Members may exclude from patentability certain inventions,
including essentially biological processes for the production of plants or animals other than non-
biological and microbiological processes.  The exception allowed by Article 7 of the IndustrialProperty Law refers to essentially biological proc esses for the production or reproduction of plants,
animals or their varieties, and is therefore consistent with the provisions of Article 27.3 of the TRIPS
Agreement.IP/C/W/277/Add.2
Page 2
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to
the responsible authorities in the procedure for market authorization of a pharmaceutical or of
an agricultural chemical product, please explain in  detail if your legislation explicitly prohibits a
second applicant from relying on, or from referring to, the original data of the first applicant (in
the absence of any disclosure by the State agen cy), when applying subsequently for market
authorization for his own product.  Does your legislation set a specific term of protection for
undisclosed test or other data of the first applicant? Do the responsible authorities require asecond applicant to submit the same amount of data regarding product safety and efficacy as
the first applicant?
 The Honduran Industrial Property Law stipulates that where the submission of secret data or
information is required in a proceeding before a national authority competent to approve themarketing or sale of a pharmaceutical or agricultural chemical product containing a new chemical
component, the data shall be protected against unfair commercial use by third parties.  Honduran
legislation does not set any specific term of protection for such data, nor does it include any special
provision that prohibits a second applicant from relying on, or referring to, information supplied by
the first applicant when applying for authorization to market his own product.
 In conformity with the country's sanitary regulations, however, information regarding the
safety and efficacy of the product is required where a pharmaceutical product consists of new
molecules not recognized in pharmacopoeias or accepted compendia of proprietary pharmaceuticals
and where an agricultural chemical product contains an unknown active ingredient.
The submission of test data is not required where information on the efficacy and safety of,
and adverse reactions to, the active ingredients is set forth in pharmacopoeias and accepted compendia
of proprietary pharmaceuticals;  the same applies to agricultural chemical products containing known
active ingredients.
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