RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/136
10 March 1999
(99-0948)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
IMPLEMENTATION OF ARTICLES 70.8 AND 70.9
The present document reproduces the replies from Egypt to the questions posed by the United
States and distributed in document IP/C/W/113, as communicated by the delegation of Egypt to the
Secretariat at the meeting of the Council for TRIPS of 17 February 1999.
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1. In addition to the information provided in y our notification concerning the filing of patent
applications directed to pharmaceutical or agricultural chemical product inventions, please:
(a) identify the basis in your law that governs the handling of patent applications by the
responsible Government agency in situations where the application is directed to subject-matter that
is not eligible to be patented.
The Patent Office of Egypt is committed to the provisions of the TRIPS Agreement in
handling the patent applications in accordance with the criteria for patentability of subject-matter
established in the TRIPS Agreement.
Article 1 of the Egyptian Patent Law, No. 132 in 1949, had stipulated the requirements and
criteria of patentability which are in conformity with the provisions of Article 27.1 of the TRIPSAgreement.
Article 2 of the new draft patent law is consis tent with the provisions of Article 27.2 of the
TRIPS Agreement.
(b) confirm that the measures specified in your notification will ensure that any patent
application directed to pharmaceutical or agricultural chemical product inventions that was filed on
or after 1 January 1995, can serve as the basis for a grant of a patent with a term that expires no
earlier than 20 years from the date of its filing, once your Government extends patent protection to
inventions consistent with the scope of Article 27 of the TRIPS Agreement.
Since the first of January 1995, Egypt has established a special mechanism as a mailbox to
file the patent applications directed to pharmaceutical or agricultural chemical products according to
the provisions of Article 70.8 of the TRIPS Agreement.
Article 52 of the new patent draft law which is under discussion before the legislative
committee of the cabinet will take into consideration the above-mentioned mechanism, in addition to
the amendments concerning the term of protection of all kind of patents to become 20 years from the
date of application.IP/C/W/136
Page 2
The number of the patent applications related to pharmaceutical or agricultural chemical
products which have been dealt with in the mailbox during the period January 1995/December 1998 is
439:  32 in 1995;  93 in 1996;  91 in 1997;  223 in 1998.
2. Please identify the provisions of your law that govern the granting of exclusive marketing
rights for products covered by Articles 70.8 and 70.9 of the TRIPS Agreement.
Article 53 of the new draft patent law will include provisions to grant the exclusive marketing
rights for the above-mentioned products in accordance with the provisions of Article 70.9, provided
that a patent application has been filed and a patent granted for a product in another Member and
marketing approval obtained in such other Member, based on the application submitted after
1 January 1995, and upon the provision of the documents which prove the above-mentionedrequirements.
Upon the issuance of the marketing approval in Egypt, the applicant will enjoy the exclusive
marketing rights for a period of five years or until a decision by the Patent Office of Egypt to grant or
reject it, whichever period is shorter.
3. Please provide the identity and address of the government authority that is responsible for the
granting of exclusive marketing rights.
The government authority which is or will be responsible for the granting to eligible parties of
exclusive marketing rights in the pharmaceutical field is:
The Central Administration for Pharmaceutical Affairs
(Ministry of Health and Population)
22, El Falaky Street, CAIROTelephone:  +20 2 3549227
Fax:  +20 2 3542627
This is the government authority which has until now been, and will continue to be,
responsible for all matters related to pharmaceutical registration and subsequent steps leading up to
the issuance of ordinary marketing approval.
4. Please explain the procedures to be followed  by a private company or individual wishing to
obtain exclusive marketing rights for a pharmaceutica l or agricultural chemical product that fulfils
the requirements of Articles 70.8 and 70.9.
In accordance with Article 70.9 of the TRIPS Agreement, an applicant for exclusive
marketing rights in the pharmaceutical field will be required to submit substantiated and documented
evidence regarding:
(a) The existence of a product patent application which is filed on or after 1 January 1995
with the mailbox facility at the Egyptian Patent Office, and kept in custody of thatfacility for examination at a later date as stipulated under TRIPS Article 70.8 (a), (b),
(c).
This documented evidence will be obtained from the Patent Office and it should show
the filing and, where applicable, the priority date, as well as clear indication that theinvention subject-matter is identical with or covers the pharmaceutical product for
which exclusive marketing rights are sought.IP/C/W/136
Page 3
(b) The prior filing of a patent application and granting of a patent for the same
pharmaceutical product in another WTO Member country, provided that both the said
filing and granting occurred after 1 January 1995.
(c) The prior award of marketing approval for the same pharmaceutical product and its
actual field marketing in the same WTO Member country.
(d) The award of marketing approval for the same product in Egypt by the competent
authority, as identified above under the answer to question 3.  The procedures to be
followed by a private company or individua l wishing to obtain exclusive marketing
rights for a pharmaceutical product will almost certainly be similar in their essential
elements, if not identical to those currently required in the common practice ofobtaining pharmaceutical registration and marketing approvals.  These procedures
start with the key step of applying for registration requiring submission of a number
of prescribed documents.  The latter are listed in the two-page information sheet,
annexed hereto, prepared by the concerned authority for the guidance of applicants.
Directly linked to the process of registration is the step of drug control and testing (at
the National Organization for Drug Control and Research) which has the purpose of
assuring the efficacy and safety of the new product.
Another step in the process in reaching a decision on the pricing of the product,
intended to be launched in the local market, which again is another responsibility of
the same Ministry.  The inclusion of the new product in the drug import plan is
another step which needs to be taken in order to authorize commercial importation.
All these steps require six to 12 months for completion and lead up to issuance of
drug marketing approval which can be enjoyed for ten years.  Upon expiry of this
period the process of registration must be repeated if another term of marketing is to
be obtained.
Law 127/1955 and its amendments, on the practice of pharmaceutical profession, govern all
the procedural and substantive aspects briefly outlined here.
Concerned authorities assure applicants and users of their services, that all information in
respect of registration and drug control data are kept in strict confidentiality both during the
examination period and all through the marketing period.
5. Please identify the fee, if any, for obtaining exclusive marketing rights for a product or family
of products.
The fees as specified in the aforementioned information sheet are:(a) LE 2000 (approximately US$588) to cover registration costs;(b) LE 3000 (approximately US$882) to cover drug analysis costs;(c) LE 50 (approximately US$14.7) to cover the cost of legal medication stamps.
It is to be understood that these fees apply to each one of the dosage forms but include the
different strengths within the dosage form.IP/C/W/136
Page 4
6. Please explain how an entity that has obtained exclusive marketing rights pursuant to
Article 70.9 of the TRIPS Agreement can enjoy the benefit of such rights?  In particular:
(a) Can marketing approval be granted under any circumstances to another party prior to the
expiration of the exclusive marketing rights period defined in Article 70.9?
(b) What remedies or procedures are available to  the holder of an exclusive marketing right to
prevent the issuance of marketing privileges to another party in respect of a product that is the subject
of the exclusive marketing rights?
Since no applications for exclusive marketing rights have been received until the present time
(December 1998), no exclusive marketing rights pursuant to Article 70.9 of the TRIPS Agreementhave been awarded.  The following comments only derive from knowledge and living experience with
the currently common registration and marketing approvals.  It is highly likely that the same situation
would continue to prevail as long as similar conditions prevail essentially as affecting the health and
welfare of Egyptian people.
(a) Negative.  This is not permitted under currently prevailed practice.
(b) In the bona fide exercise of their authority, the registration marketing government
bodies will not allow the issuance of marketing privileges to another party in respect
of a pharmaceutical product, that is new and has the potential of being protectedunder a product patent, and that is already enjoying exclusive marketing rights in
Egypt.  It will expectedly, however, be a responsibility of the holder of exclusive
marketing rights to call attention to any suspected infringement that becomes known
to him.IP/C/W/136
Page 5
Ministry of Health Registration Dept.
Documents required for the registration of Pharmaceutical Specialties
1. Covering letter indicating the documents contained in the file.2. An application form for registration, duly filled in and signed.3. Certificate of origin and free sale issued from the Ministry of Health in the country of origin,
legalized by the Egyptian Embassy or Consulate in that country, including clearly:
(a) Name and address of the manufacturer.(b) Name and strength of the product, name and quantity of active ingredients.(c) That the product is freely sold in its country of origin under the same name and
composition.
(d) Certificate of GMP for the industry manufacturing the pharmaceutical qualities.
4. Five copies of the complete formula, quantitative, qualitative of active and inactive
ingredients, colouring matter, etc . . .
5. Five copies of the method of analysis and assay of the active ingredients in the finished
product, in detail, in English.
6. Seven to ten original samples for analysis.7. Certificate of analysis in two copies, from the manufacturing firm, in which is also clarified
the same batch number of the samples submitted for analysis.  It should also state the dates of
preparation and expiration of the product, if any.
8. In case of antibiotics, another certificate of analysis for each raw material of antibiotic used,
must be submitted.  This should state the dates of preparation and expiration of the rawmaterial.
9. (a) Five original outer labels.
(b) Five original inner labels.(c) Five original inner pamphlets.
10. List of countries where the product is registered and marketed.
11. A full scientific file for the new product in cluding formula, pharmacological, toxicological,
clinical studies and data, etc . . . and stability data.
12. Agency agreement of Authorization for Registration.
This should be granted to an Egyptian citizen or a scientific office in Egypt, and must be
legalized by the Egyptian Embassy or Consulate in the country of origin.IP/C/W/136
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13. A governmental postal order of "The Gene ral Administration of Pharmacy, Ministry of
Health, A.R.E.
14. Prices
The following prices should be indicated for the product in its different packages:(a) Ex. factory price.(b) Public price in the country of origin.(c) F.O.B. price.(d) Expected public price in Egypt.
15. A subsidiary file containing a copy of each document submitted in the original file.
N.B. (a) For pharmacopoeial preparation, all the above documents must be submitted except 
those under nos. 2, 4 and 11.
(b) Official fees:
- Fees of Registration is LE 2000.
- Fees of Analysis is LE 3000.- Medical stamps LE 50.
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