RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/265/Add.5
1 October 2001
(01-4667)
Council for Trade-Related Aspects of
Intellectual Property RightsOriginal:  French
REVIEW OF LEGISLATION
Replies by Morocco to the Questions Posed by the European Communities
and their Member States and by the United States and to the Follow-Up
Questions Posed by Switzerland
Addendum
By means of communications from the Permanent Mission of Morocco, dated
20 and 25 September 2001, the Secretariat has received the following replies to the questions posed
by the European Communities and their member States and by the United States, which were
circulated in documents IP/C/W/274 and 268, respectively, as well as to the follow-up questions
posed by Switzerland, which were circulated in document IP/C/W/263/Add.1.
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EUROPEAN COMMUNITIES AND THEIR MEMBER STATES
I. ENFORCEMENT
58. Please indicate whether or not your legislation provides for a de minimis  imports
exception.
Questions 58 and 59 have already been dealt w ith in Morocco's replies to the check-list of
issues on enforcement (document IP/N/6/MAR/1).
59. Please explain how your legislation implements Article 61 of the TRIPS Agreement.
See the reply to question 58.
UNITED STATES
A. PROTECTION OF UNDISCLOSED INFORMATION
23. Please describe in detail the manner in which protection is provided test data regarding
pharmaceutical and agricultural chemical produc ts submitted to the Government in order to
obtain marketing approval in Morocco and cite to the relevant provisions of law.
No legal text exclusively governs the protection of test data concerning pharmaceutical
products and agricultural chemical products submitted to the competent authorities in order to obtain
authorization for their marketing in Morocco.IP/C/W/265/Add.5
Page 2
However, under the General Civil Service Statute, as supplemented and amended, provision is
made for the protection of confidential data which may be required by the public authorities for the
investigation of a case.
Article 18 of the aforementioned Statute provides that:
"irrespective of the rules on professional secrecy contained in the Criminal Code, every civil
servant is bound by the obligation of professional discretion with respect to any facts or
information of which he becomes aware during or in connection with the performance of his
duties.  Any unauthorized use or communication of official documents to third parties is
strictly prohibited."
24. Are other applicants for ma rketing approval for their own versions of a previously
approved pharmaceutical or agricultural chemical product permitted to rely on data submitted
by the earlier applicant?  If so, how long a period of exclusivity is given the earlier applicant
before such reliance becomes possible.
The file accompanying the application for marketing authorization in Morocco comprises
different parts:
- The first part concerns the chemical molecule.  This is the active starting material for
the medicinal product;
- the second part concerns the manufacturing process;- the third part concerns the clinical, pharmacological and toxicological studies.The information contained in the third part of the file constitutes undisclosed information.
Such information provides evidence of the effectiveness and safety of a given medicinal product and
is usually published in international scientific journals.
A second applicant wishing to register the same product as a generic product is permitted to
use a simplified procedure, i.e.  he is not oblig ed to repeat all the clinical, pharmacological and
toxicological studies, but may refer to the data published in the scientific literature.
Moreover, as was mentioned in the response to question 15, Moroccan legislation provides
for the protection of pharmaceutical products and agricultural chemical products.
Indeed, Article 21 of Law No. 17-97 on the protection of industrial property provides as
follows:
"The invention may relate to products, to processes or to any new application or combination
of known methods, or to the purpose of ob taining a result not previously attained by
state-of-the-art means.
The invention may also relate to pharmaceutical compositions, pharmaceutical products or
remedies of any kind, including processes or devices used to produce them."
Article 17 of the same Law indicates that patents for invention shall be issued for a term of
protection of 20 years from the date of the filing of the patent application.IP/C/W/265/Add.5
Page 3
SWITZERLAND1
A. PATENTS
3. Please confirm whether your law, in ac cordance with Article 27.1 of the TRIPS
Agreement in combination with Article 31 of the TRIPS Agreement, considers importation as"working/utilizing" a patent (and therefore precludes compulsory licensing, if a product is
imported).
Law No. 17-97 on protection of industrial pr operty deals with compulsory licences in
Articles 60-66.
The provisions of those Articles determine the conditions and formalities to be fulfilled for
the granting of a compulsory licence, and stipulate that such licences are granted by the competent
judicial authorities (commercial court) three years after the issue of the patent or four years after the
date of filing of the patent application.
According to the above-mentioned provisions, any public or private law person may, within
the time-limits referred to above, submit an application to the competent court provided that such
application is accompanied by proof that the applicant was unable, by friendly agreement, to obtain a
licence to use the patent from its owner on reasonable commercial terms and conditions, and that he is
in a position to exploit the invention in such a way as to satisfy the needs of the Moroccan market.
Similarly, a compulsory licence can only be non-exclusive and must be granted primarily in
order to supply the Moroccan market.
Thus, the application for a compulsory licence must be submitted in accordance with the
formalities and conditions referred to below, if at the time of the application and in the absence oflegitimate grounds for exemption (Article 60), the owner of the patent or his successor in title:
(a) Has not begun to exploit the patent or is taking effective and genuine preparatory
steps to exploit the patented invention on the territory of the Kingdom of Morocco;
(b) has not marketed the product covered by the patent in a quantity sufficient to satisfy
the needs of the Moroccan market;  or
(c) where the exploitation or marketing of the patent in Morocco has been abandoned for
more than three years.
The provisions contained in (a), (b), and (c) above constitute one of the essential criteria on
which any application to the court for a compulsory licence must be based.
Thus, failure on the part of the patentee or his successor in title to exploit or market the
patented product in Morocco in sufficient quanti ty to satisfy the needs of the Moroccan market
constitutes legitimate grounds for granting a compulsory licence.
Such marketing may be effected by the patentee or his successor in title and may arise from
the importation of a product patented in Morocco or from a local supply link resulting from
exploitation of the patent in Morocco.
                                                     
1 Morocco's replies to the initial questions posed by Switzerland were circulated in document
IP/C/W/265/Add.2.IP/C/W/265/Add.5
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However, in the event of any divergence of views on the interpretation of the provisions of
Law No. 17-97 on compulsory licences, the commercial courts alone have jurisdiction to entertain any
dispute arising from the implementation of that law, pursuant to the provisions of Article 15 thereof.
B. PROTECTION OF UNDISCLOSED INFORMATION
1. Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State agency 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 or iginal data of the first applicant, when applying
subsequently for market authorization for his own product.  Does the responsible State agency require
the same amount of data from the second applicant as from the first applicant?
The file accompanying the application for marketing authorization in Morocco is composed
of different parts:
- The first part concerns the chemical molecule.  This is the active starting material for
the medicinal product.
- The second part concerns the manufacturing process.- The third part concerns the clinical, pharmacological and toxicological studies.
The information contained in the third part of the file constitutes undisclosed information.
Such information provides evidence of the effectiveness and safety of a given medicinal product and
is usually published in international scientific journals.
A second applicant wishing to register the same product as a generic product is permitted to
use a simplified procedure, i.e. he is not obliged to repeat all the clinical, pharmacological and
toxicological studies, but may refer to the data published in the scientific literature.
It should be noted that Moroccan legislation provides for the protection of pharmaceutical
products and agricultural chemical products.
Article 21 of Law No. 17-97 on the protection of industrial property provides as follows:"The invention may relate to products, to processes or to any new application or combination
of known methods, for the purpose of attaining a result not previously attainable by
state-of-the-art means.  The invention may also relate to pharmaceutical compositions,
pharmaceutical products or remedies of any kind, including the processes and devices used toproduce them."
Article 17 of the same Law indicates that patents for invention shall be issued for a term of
protection of 20 years from the date of the filing of the patent application.
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