RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/278/Add.2
14 November 2001
(01-5763)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Responses from Egypt to follow-up questions posed by Switzerland and the United States
By means of a communication from the Permanent Mission of Egypt dated 8 November 2001,
the Secretariat has received the following responses  to follow-up questions posed by Switzerland and
the United States, as circulated in documents IP/C/W/263/Add.1 and 268/Add.2.1
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SWITZERLAND
A. PATENTS
Ad response to question 2:
In your answer, you mention that under Article 2 of your new IPR law (currently in
draft form) living organs, tissues, cells, DNA and genomes are excluded from patentability. Does
this mean that inventions relating to such subj ect matter even if fulfilling the conditions of
patentability, i.e. novelty, inventive step and i ndustrial applicability are nevertheless excluded
from patentability according to your law? If s o, please explain how this complies with the
obligation of Article 27.1 of the TRIPS Agreement prohibiting discrimination as regards
patentability between different fields of technology.
Our response to question 2 reflects the conventional wisdom behind the patent system in that
the subject matter of the invention is the fruit of human ingenuity and hence, to be patentable, it
should fulfil the three criteria of patentability as provided in Article 27.1 of the TRIPS Agreement.
The Agreement introduced or enlarged the possibility of patent protection of certain life forms andprocesses.  A distinct flexibility, however, has been the right of Members to exclude from
patentability certain other life forms and processes: Article 27.3(b).  Such exclusion is permitted
without specifically requiring that the subject matter is  to be a "whole" or a "part".  It is difficult to
think of an entire living organism, plant or animal, being unpatentable while a part of it is patentable.
As it is well known, this matter is hotly debated worldwide and the contents of sub-paragraph 27.3(b)are open for review in a future WTO function.
Ad response to question 7:
It does not resort clearly from your answer whether a patented product needs to be
produced in your country in order to satisfy the requirement of the use of the invention. Please
confirm whether, according to your new legislat ion, importation is considered as working the
patent and satisfies therefore the requirement of use/exploitation of the patent. If this should not
                                                     
1 Egypt's responses to many initial questions posed by Switzerland and the United States have been
circulated in document IP/C/W/278.IP/C/W/278/Add.2
Page 2
be the case, please explain how this complies wi th the obligations contained in Article 27.1 of the
TRIPS Agreement, requiring patent rights to be enjoyable without discrimination as to whether
products are imported or locally produced.
Our response to question 7 reflects unambiguously the basic tenets of the patent system as
related to the issue of working the invention.  Th e spirit and letter of Article 5(A) of the Paris
Convention have been expressed in the answer gi ven.  The action (compulsory licensing) allowable,
accordingly, in a situation of non-working is pronounced in the new IPR law (currently in draft form),
however, does not say that importation is considered as  working the invention.  It is clear also in the
language of Article 25 of the new draft law that, in the issuance of compulsory licences, each due will
be given consideration on its individual merits, precisely in compliance with Article 31(a) of the
TRIPS Agreement.
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 9:
In your answer, there is no mention of legal provisions providing protection against
unfair commercial use for confidential test data submitted to the Egyptian authority responsible
for market authorization. Please explain how your new legislation will provide protection
against unfair commercial use of test data as required by Article 39.3 of the TRIPS Agreement.
Will the responsible state authority require the sa me amount of data for market authorization
from the second applicant as from the first applicant?
Our response to question 9 clearly indicates that there are legal provisions providing (in
compliance with Article 39.3 of the TRIPS Agreemen t) protection against unfair commercial use for
confidential test data submitted to the Egyptian authority responsible for marketing authorization.
These provisions, as stated in our previous response, are contained or covered in:
a) Article 57 of the new IPR legislation (currently in draft form);
b) Prime Minister's Decree No. 2211 of the year 2000;  and
c) Egypt's formal notification (document IP/N/1/EGY/Add. 1, dated 8 May 2000)
communicated to the WTO Council for TRIPS.
As to the second point in the question, the governing law and procedure require the same
amount of data, for market authorization, from the second applicant as from the first applicant.
UNITED STATES
A. PATENTS
1. Please explain whether a known enzyme that was isolated from an animal and used as a
contact lens cleaner would be patentable under the Egyptian draft law if this method of use is
new, has an inventive step and industrial application.
A strict reading, that is presumably also a fair reading, of Article 27.1 of the TRIPS
Agreement would lead to the following understandin g: the method of use of the contact lens cleaner
in connection with a specific health problem is in itself not patentable; cf. Article 27.3(a) of the
TRIPS Agreement.IP/C/W/278/Add.2
Page 3
2. Article 19(1) of the draft law appears to mandate that all applications directed to
inventions in the pharmaceutical field not be granted until approval has been provided by the
Egyptian Ministry of Health.  How would the cr iteria that are to be used in evaluating such
applications by this Ministry be established?
The issue contained in the first paragraph of the draft law Article 19 has been the subject of
much controversy with widely different positions held  by different parties.  The latest draft text that
emerged (early June 2001) from the latest deliberations step does not contain this paragraph.
Receiving and examination of patent applications in all fields of technology remain the function andduty of the Patent Office.
3. Draft Article 11 appears to provide that patent rights are "exhausted" if the patent
owner has marketed the invention anywhere in the world.  Please explain whether this authority
is limited to products voluntarily placed on th e market by the patent owner without restriction.
The patent rights are "exhausted" if the patent owner has marketed the invention (i.e. actually
put the protected product on the market for circulation in the normal channels of commerce) anywherein the world.  The practical effect of this exhaustion is that the patent owner cannot prevent third
parties from using, selling, importation, or other distribution of goods which constitute the subject
matter of a valid patent. The language in the draft law Article 11 clearly refers to the action taken by
the patent owner in marketing by himself or th rough authorizing the marketing of the goods in
question.
4. Draft Article 11 appears to exempt any "scientific activities" from the possibility of
being patent infringement.  Please explain in detail the "scientific activities" that are envisioned.
The exemption of "scientific activities" is standard in many, if not most patent laws.  It refers
to acts done for purposes of scientific research, not for commercial purposes, regardless of the scale of
the experimentation activities.  This also means that a university or a research institution will not
commit an infringement by carrying out the patented invention if that operation is only undertaken for
the purposes of scientific research.  The first practical benefit that can be derived from this activity is
learning from the experience of the inventor in the manner that enables local researchers to build upon
work already done, thereby increasing the pace of innovation.
5. Draft Article 14 appears to require that applications related to biological matter include
proof that the materials in the application were ob tained legally in the country of origin.  Please
explain in detail the nature  of the proof envisioned.
It is not clear what the question (in fact a statement) seeks to clarify.  However, it is true,
according to the current wording of draft Article 14, that where the invention concerns biological
matter of traditional knowledge, the inventor is required to submit proof that the materials in the
application were obtained legally in accordance with the laws enforced in Egypt; cf. Convention on
Biological Diversity Articles 8(j) and 15.5.
B. T
RADEMARKS
6. Draft Article 96 would preclude trademark owners from refusing to terminate or renew
a licensing agreement with good cause.  Please explain in detail how a trademark owner would
be able to ensure that a licence maintained appropriate quality standards and fulfilled
obligations of the licensing agreement.
Under draft Article 99 the parties may set the term of the trademark licensing contract
provided that provisions of Article 96 will be taken into account.IP/C/W/278/Add.2
Page 4
Once the term of licence is indicated, the licensor is not entitled, according to Article 96 (as
amended), to terminate the licence agreement, except for a legitimate reason.
Draft Article 96 (as amended) does not address the question of renewal of the contract.
C. PROTECTION OF UNDISCLOSED INFORMATION
7. No provision appears to give a party that provides confidential test data to an Egyptian
regulatory authority protection from unfair commercial use.  Moreover, the last sentence of the
English-language version of draft Article 57 appears to permit authorities to rely on test data
submitted by another to prove that a similar product was safe and effective without any delay
after the first party obtained marketing approval.  Please explain how Egypt will provide
protection from unfair commercial use of test data as required by Article 39.3 of the TRIPSAgreement.
The response to question 7 concerns the manner in which Egypt's new law on the protection
of IPR ensures that undisclosed test or other data are protected, in compliance with Article 39.3 of the
TRIPS Agreement. The matter is addressed in Article 57 of the new law.
7.a. The term "undisclosed test or other data", which is to be protected against unfair
commercial use, embraces the undisclosed info rmation which (a) concern pharmaceutical or
agricultural chemical products; (b) result from considerable effort; (c ) utilize new chemical
entities; (d) are submitted to the concerned authorities as a condition for approving themarketing of such products; and (e) are required for conducting the tests necessary for the
marketing approval.
7.b. The concerned authorities which receive such information are obliged to protect the
information against disclosure and against unfair commercial use. This obligation starts fromthe date the information is submitted and continues until the information no longer becomes
secret, or until the elapse of no more than five years
, whichever occurs first.  In anticipation of
the formal passing of the law, a Prime Minister's Decree (No. 2211) was issued (dated25 November, 2000) providing for the same obligation. A formal notification of this
commitment was also communicated (under Article 63.2 of the TRIPS Agreement) to the
Council for TRIPS, and is contained in document IP/N/1/EGY/1/Add. 1, dated 8 May 2000.
7.c. The exceptions provided for in Article 57 of the new law are identical to those
allowed in Article 39.3 of the TRIPS Agreement, namely:
7.c.i  Where the disclosure by the concerned authorities is necessary to protect the
public; or
7.c.ii  Where the concerned authorities use the test information in testing or evaluating
other similar products; this being a situation where protection of the public is an issue.
7.d. Additionally, the following must be clarified:
7.d.i. The test and other data, which are required for the testing, examination and
evaluation of the product, are handled by a responsible government authority, the
National Organization for Drug Control and Research (NODCAR) which is an organ
of the Ministry of Health and Population, where all operations are conducted incomplete secrecy and guarded against any form of disclosure to outside bodies except
when required by law, such as by court order.IP/C/W/278/Add.2
Page 5
7.d.ii. A second applicant cannot, therefore, have access to such test data as submitted
by a first applicant. It is only the concerned authority (in this case NODCAR) which
can use the test data for testing the product of the first applicant or, where deemed
necessary, to protect the public. However, the second applicant and indeed any other
applicant is required to submit the requisite test data and other information in supportof his own application.
7.d.iii.Of the undisclosed information submitted by a first applicant, one can
distinguish two types:
(One) The general facts and figures pertaining to the usage of the product (such as
indications, contra-indications, limitations, precautions, interaction with otherproducts, dosage forms, dose levels, etc.) are actually disclosed, to the
medical profession and to the general public, by the applicant himself upon
releasing his product in the local market.
(Two) The qualitative/quantitative analytical test-evaluation (chemical/biological)
data and methods of procedure are kept with and reserved for the restricted
use of the concerned authority (NODCAR).  This authority's functions, to be
sure, are limited to using – certainly not publishing or otherwise disclosing to
any outside body – the test/evaluation methods which either are made
available to the authority by an applicant, or are already in the authority'spossession for the normal discharge of its daily responsibilities.
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