RESTRICTEDWORLD TRADE
ORGANIZATIONIP/Q3/POL/1/Add.2
13 September 2000
(00-3531)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION IN THE FIELDS OF PATENTS, LAYOUT-DESIGNS
(TOPOGRAPHIES) OF INTEGRATED CIRCUITS, PROTECTION OF
UNDISCLOSED INFORMATION AND CONTROL OF
ANTI-COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
POLAND1
Addendum
The present document reproduces further questions put to the delegation of Poland in relation
to its legislation on patents and protection of undisclosed information and the responses given.
_______________
I. RESPONSES TO QUESTIONS POSED BY SWITZERLAND2
A. PATENTS
1. Does your law make compulsory licences subject to the conditions enumerated in
Article 31 of the TRIPS Agreement?
In general, yes.  Under the present Law of 19 October 1972 on Inventive Activity compulsory
licensing is regulated in Article 49, which provides for a possibility of granting a compulsory licence
(in litigation proceedings), where:
- it is necessary to prevent or eliminate a state of national emergency;  or
- the patentee, without justified reasons, does not offer or prevent offering of the
products manufactured by means of the invention on terms meeting the social
demand (three years after the grant of the patent).
The above provision fails to directly provide for the requirement of making efforts to obtain a
voluntary licence, referred to in Article 31(b) , however, since 1 January 2000 the said Article is
directly applicable by virtue of the Constitution.
                                                     
1 As regards laws and regulations relevant to the areas of patents and undisclosed information as
notified by Poland under Article 63.2 of the Agreement, reference is made to documents IP/N/1/POL/1/Rev.1,
IP/N/1/POL/2, IP/N/1/POL/P/1 and 2.
2 In consideration of reservations made by Poland during the 1997 review with regard to certain areas
of its intellectual property legislation at that time in force and under review as well as of the announcement byPoland in 1997 of new legislation being drafted and to enter into force soon, Switzerland posed these follow-upquestions to Poland in respect of its new legislation.IP/Q3/POL/1/Add.2
Page 2
Follow-up questions:
A. In your answer you explain that, in gene ral, your law makes compulsory licences
subject to the conditions of Article 31 TRIPS Agreement.  If exceptions are provided for, please
describe in detail what these exceptions are and how they apply in Polish law and practice?
(Citations of the pertinent provisions of the res pective act or regulation are requested; if the
texts of these laws or regulations have not yet been notified to the WTO, copies are requested
pursuant to Article 63.2 TRIPS Agreement).
When using the expression "in general" we referred to the present legal status under the Law
of 1972 on Inventive Activity.  The provisions of that Law fail to cover the following conditions from
Article 31:
1. the requirement of making efforts to obtain a voluntary license, referred to in
Article 31(b);
2. the authorization to use semi-conductor technology only for public non-commercial
purposes or to remedy an anti-competitive practice, referred to in paragraph (c);
3. the requirement from paragraph (l)(i) that the invention claimed in the second patent
involve an important technical advance of considerable economic significance in relation to
the invention claimed in the first patent;  and
4. the requirement from paragraph (l)(iii) that the use authorized in respect of the first
patent be non-assignable except with the assignment of the second patent.
Since the Law on Inventive Activity came into force, only one case has been reported where a
compulsory licence was granted in the late 1970s (between Polish entities).  Since then, no single
compulsory licence has been issued.  Therefore, it can be said that the provisions governing
compulsory licensing in Poland are not applied in practice.
The new Industrial Property Law, which will become effective soon, addresses all the
conditions laid down in Article 31;  the following provisions of the new Law correspond to the
individual paragraphs of that Article:
Article 31(a):
Article 84(2):  The Patent Office shall determine the scope and duration of a
compulsory license, the detailed terms and conditions of its exercise, as well as theamount, in proportion to the market value of the license, of the royalty and the
manner of and time limits for making payment.
Article 86:  When reasonable in specific circumstances, the decision on the grant of a
compulsory license may, at the request of the interested party, be changes in part
relating to the scope and duration of the license or to the amount of royalty, two yearsafter it was taken.
Article 31(b):
Article 82(4):  A compulsory licence may be granted, if a person applying for it is
able to prove that it has earlier made, in good faith, efforts to obtain a licence.  ThisIP/Q3/POL/1/Add.2
Page 3
requirement may be waived where a compulsory licence is to be granted for the
purpose of preventing or eliminating a state of national emergency or where it has
been announced that a compulsory licence may be applied for.
Article 82(5):  Where it has been announced that a compulsory licence may be
applied for, waiver of the requirement referred to in paragraph (4) shall not beapplicable in respect of applications for the grant of a licence submitted after the
expiration of a period of one year counted from the date of that announcement.
Article 31(c):
Article 84(2):  The Patent Office shall determine the scope and duration of a
compulsory license, the detailed terms and conditions of its exercise, as well as the
amount, in proportion to the market value of the license, of the royalty and themanner of and time limits for making payment.
Article 82(2):  The grant of a compulsory licence for the exploitation of an invention
in the case referred to in paragraph (1)(iii), shall be conditional upon ascertainment
that the exploitation of the invention that is the subject matter of the dependent patent,
where the both inventions concern the same subject matter, involves an importanttechnical advance of considerable economic significance. In case of an invention
concerning semi-conductor technology, a compulsory licence may only be granted to
counteract unfair anti-competitive practices.
Paragraph (1)(iii) referred to above reads as follows:
1.  The Patent Office may grant authorization to exploit a patented invention of
another person (a compulsory licence), where:
(i) (…)
(ii) (…)
(iii) it has been established that the patent holder enjoying the right of priority
of an earlier application (an earlier patent) prevents, by refusing to conclude a
licence contract, the meeting of the home market demand through the
exploitation of the patented invention (the dependent patent), whose
exploitation would encroach upon the earlier patent; in such case the holder
of the earlier patent may demand that an authorization be given to him for the
exploitation of the invention that is the subject matter of the dependent patent
(cross-licence).
Article 31(d):
Article 83:  The compulsory licence shall be non-exclusive.
Article 31(e):
Article 85:  A compulsory licence may only be transferred together with the
enterprise or with that of its part, in which it is worked. A compulsory licence relating
to the earlier patent may only be transferred to a third party together with the
dependent patent.IP/Q3/POL/1/Add.2
Page 4
Article 31(f):
Article 82(1)  The Patent Office may grant authorization to exploit a patented
invention of another person (a compulsory licence), where:
(i) (…)(ii) (…)
(iii) it has been established that the patent holder enjoying the right of priority
of an earlier application (an earlier patent) prevents, by refusing to conclude a
licence contract, the meeting of the home market demand through the
exploitation of the patented invention (the dependent patent), whose
exploitation would encroach upon the earlier patent; in such case the holder
of the earlier patent may demand that an authorization be given to him for theexploitation of the invention that is the subject matter of the dependent patent
(cross-licence).
Article 68(1):  The patent holder or the licensee may not abuse his rights, in particular
by preventing the invention from being exploited by a third party, if such exploitation
is necessary for the purpose of meeting home market demands.
Article 31(g):
Article 86:  When reasonable in specific circumstances, the decision on the grant of a
compulsory license may, at the request of the interested party, be changes in part
relating to the scope and duration of the license or to the amount of royalty, two yearsafter it was taken.
Article 31(h):
Article 84
1.  The person exploiting the invention under a compulsory licence shall be obliged to
pay a royalty to the patent holder.
2.  The Patent Office shall determine the scope and duration of a compulsory licence,
the detailed terms and conditions of its exercise, as well as the amount, in proportion
to the market value of the licence, of the royalty and the manner of and time limits for
making payment.
Article 31(i) and (j):
Article 258:  Decisions taken and orders issued by the Patent Office shall be subject
to complaint to the Supreme Administration Court.
Article 31(k):
Article 82(2):  The grant of a compulsory licence for the exploitation of an invention
in the case referred to in paragraph (1)(iii), shall be conditional upon ascertainment
that the exploitation of the invention that is the subject matter of the dependent patent,
where the both inventions concern the same subject matter, involves an important
technical advance of considerable economic significance.  In case of an inventionIP/Q3/POL/1/Add.2
Page 5
concerning semi-conductor technology, a compulsory licence may only be granted to
counteract unfair anti-competitive practices.
Article 68
1.  The patent holder or the licensee may not abuse his rights, in particular by
preventing the invention from being exploited by a third party, if such exploitation isnecessary for the purpose of meeting home market demands.
2.  Preventing third parties from exploiting the invention within a period of three
years from the date of the grant of the patent shall not be considered the abuse of
rights, referred to in paragraph (1).
3.  The Patent Office shall have the right to request a patent holder or a licensee to
submit any explanations as to the scope of the exploitation of the invention for the
purpose of establishing whether the patent is abused.
4.  The provisions of paragraphs (1) and (2) shall not prejudice the provisions on
counteracting monopolistic practices.
Article 84
1.  The person exploiting the invention under a compulsory licence shall be obliged to
pay a royalty to the patent holder.
2.  The Patent Office shall determine the scope and duration of a compulsory licence,
the detailed terms and conditions of its exercise, as well as the amount, in proportion
to the market value of the licence, of the royalty and the manner of and time limits for
making payment.
Article 31(l)(i):
Article 82(2)  The grant of a compulsory licence for the exploitation of an invention
in the case referred to in paragraph (1)(iii), shall be conditional upon ascertainment
that the exploitation of the invention that is the subject matter of the dependent patent,
where the both inventions concern the same subject matter, involves an importanttechnical advance of considerable economic significance. In case of an invention
concerning semi-conductor technology, a compulsory licence may only be granted to
counteract unfair anti-competitive practices.
Article 31(l)(ii):
Article 82(1) The Patent Office may grant authorization to exploit a patented
invention of another person (a compulsory licence), where:
(i) (…)
(ii) (…)
(iii) it has been established that the patent holder enjoying the right of priority
of an earlier application (an earlier patent) prevents, by refusing to conclude a
licence contract, the meeting of the home market demand through theexploitation of the patented invention (the dependent patent), whose
exploitation would encroach upon the earlier patent; in such case the holderIP/Q3/POL/1/Add.2
Page 6
of the earlier patent may demand that an authorization be given to him for the
exploitation of the invention that is the subject matter of the dependent patent
(cross-licence).
Article 31(l)(iii):
Article 85:  A compulsory licence may only be transferred together with the
enterprise or with that of its part, in which it is worked.  A compulsory licence
relating to the earlier patent may only be transferred to a third party together with the
dependent patent.
B. Please indicate what provisions of Polish law or regulations apply, other than Article 49
of the Law of 19 October 1972 on Inventive Activity.  (Citations of the pertinent provisions of
the respective act or regulation are requested; if the texts of these laws or regulations have notyet been notified to the WTO, copies are req uested pursuant to Article 63.2 of the TRIPS
Agreement).
Under the present Law on Inventive Activity the following provisions, other than Article 49,
are applicable in respect of compulsory licensing:
Article 42 (1) and (2):
1.  The patentee or the licensee may not abuse his rights, in particular by employing
prohibited monopolistic practices.
2.  The Patent Office may request from the patentee of licensee explanations as to the
extent of working of the invention in order to determine how the exclusive right is
used.
Article 46 (5) and (6):
5.  Unless otherwise agreed in the licence contract, the licensee shall have the right to
exploit the invention to the same extent as the licensor (full licence).
6.  The licensee authorised to exploit the invention may grant a sublicense only with
the consent of the owner of the patent; gran ting further sublicenses shall be unlawful.
Article 50
In the cases referred to in Article 49(1), a compulsory licence may also be granted for
the rights deriving from the license contracts (compulsory sublicence). Article 49(6)
shall apply accordingly.
Article 51The provisions in a decision to grant a compulsory licence or sublicence, which relate
to the terms of the licence or sublicence or to the amount of the royalty under the
licence (sublicence) may be amended after two years, at the request of the interested
party or ex officio, if this should prove necessary for reasons of equity owing to
substantial changes in circumstances.IP/Q3/POL/1/Add.2
Page 7
2. What does Polish law consider as:
(a) "reasonable commercial terms"; and
(b) "reasonable period of time"
under Article 31(b) of the TRIPS Agreement?
Lack of experience in this respect (no case law, no requests for the grant of a compulsory
licence) makes impossible to clearly define, what would in practice be considered as "reasonable
commercial terms" or "reasonable period of  time".  In the new Industrial Property Law of
17 March 2000, the requirement of Article 31(b) is met by imposing an obligation on a person
requesting the grant of a compulsory licence to prove that he has earlier made efforts to obtain alicence in good faith.  "Reasonable commercial terms" may be evaluated by reference to the market
value of a licence corresponding to the amount of a licence  royalty, in the case when a compulsory
licence is granted, while "reasonable period of time" - by reference to efforts made in good faith .  The
final consideration is left to a body deciding in an individual case.
3. Does Polish law, in accordance with Articl e 27.1 in combination with Article 31 of the
TRIPS Agreement, recognize importation as "working a patent" (and therefore preclude
compulsory licence)?
Both the present Law on Inventive Activity and Industrial Property Law to become effective
soon makes the grant of a compulsory licence conditional upon unavailability or inadequateavailability of the product on the market, irrespective of whether the product could be manufactured
in the country or be subject of importation.
Follow-up question:
Please indicate the provision of Polish law or regulation that provides for recognizing
importation as "working a patent" and therefore precludes compulsory licence on the grounds
of non-working if the patented product is be ing imported.  (Citations of the pertinent
provisions of the respective act or regulation are requested; if the texts of these laws or
regulations have not yet been notified to the WTO, copies are requested pursuant to
Article 63.2 TRIPS Agreement).
According to the provisions of Article 49(1) subparagraph 2(a) a compulsory licence may be
granted, where "the patentee, without justified reasons, does not offer or prevents the offering of the
product manufactured by means of the invention on terms meeting the social demand".  This
provision is to be understood as preventing the grant of a compulsory licence where the patentee
meets the social demand by putting the product on the market whether by way of local production or
by way of importation.
The same interpretation is to be given in respect of Article 82(1)(ii) and (iii):1. The Patent Office may grant authorization to exploit a patented invention of
another person (a compulsory licence), where:
(i) (…)
(ii)  it has been established that the patent has been abused within the
meaning of Article 68 (cited in reference to Article 31(k))IP/Q3/POL/1/Add.2
Page 8
(iii)  it has been established that the patent holder enjoying the right of
priority of an earlier application (an earlier patent) prevents, by refusing to
conclude a licence contract, the meeting of the home market demand through
the exploitation of the patented invention (the dependent patent), whose
exploitation would encroach upon the earlier patent; in such case the holderof the earlier patent may demand that an authorization be given to him for the
exploitation of the invention that is the subject matter of the dependent patent
(cross-licence).
4. Does Polish law prohibit the transfer of  a compulsory licence, except its transfer
together with the part of the enterprise or it s assets that enjoys such use as required in
Article 31(e) of the TRIPS Agreement?
Yes.  Both the present and the new laws provide for a possibility of a compulsory licence to
be transferred only together with the enterprise (or its part), in which it is worked.
Follow-up question:
Please indicate the provisions of Polish law or regulations which provide for the
additional conditions as required by Article 31(l) of the TRIPS Agreement.  (Citations of the
pertinent provisions of the respective act or reg ulation are requested; if the texts of these laws
or regulations have not yet been notified to the WTO, copies are requested pursuant to
Article 63.2 TRIPS Agreement).
Additional conditions for the grant of a compulsory licence in case of a dependent patent
(Article 31(l) of the TRIPS Agreement) are directly met in the provision relating to cross-licensing,
referred to in subparagraph (ii), i.e. in Article 49(1).2.(b) of the Law on Inventive Activity of 1972,
which reads as follows:
"The Patent Office may grant (...) a compulsory licence (...), where:
(...)
it has been found that the exclusive right has been abused (...), in particular, where:
(...)
the patentee, by refusing to conclude a licence contract, prevents the meeting of the
social demand through the exploitation of the invention that is the subject matter of adependent patent; in such case, the holder of the original patent may demand that an
authorization be given to him for the exploitation of the invention that is the subject
matter of the dependent patent (cross-licence)."
Remaining additional conditions from Article 31(l) will be met in the new Industrial Property Law as
indicated above in the response to the follow-up questions to the response to question 1.
5. Does Polish patent law or procedural la w provide for the principal of the reversal of
burden of proof in a process patent litigation?
Yes.  Article 57(3) of the Law of 1972 on Inventive Activity states the following:
"In the case of a patent for a process for the manufacture of a new product, any product that
can be obtained by means of the patented process shall be presumed to have in fact been
produced by that process".IP/Q3/POL/1/Add.2
Page 9
Consequently, in any case of a process patent litigation it is for the defendant to prove that the process
actually used is not that covered by the patent.
This principle is maintained in the new Industrial Property Law in Article 64 which reads as
follows:
1. A patent granted for a process of manufacture shall also cover products directly
obtained by means of that process.
2. In the case of new products, as well as where the right holder proves that he was
unable through reasonable efforts to identify the process of manufacture actually usedby another person, the product which may be obtained by means of the patented
process shall be deemed to have been obtained by that process.
3. In the case referred to in paragraph (2), in the adduction of proof to the contrary, the
legitimate interests of defendants in protecting their manufacturing and businesssecrets shall be taken into account.
Follow-up question:
When will the Act of 17 March 2000 Industrial Property Law enter into force?
The draft of the new Law was adopted by the Polish Parliament on 30 June, 2000 and is
expected to enter into force by the end of this year.
B. P
ROTECTION OF UNDISCLOSED INFORMATION
6. Does the Polish legislation ensure that undisclosed and confidential test data or other
data submitted by an applicant to the respon sible state agency in the procedure for market
authorization of a pharmaceutical product are protected against disclosure and against unfair
commercial use by a competitor, for example by prohibiting a second applicant from relying on,
or from referring to the original data of the first applicant, when applying subsequently for
market authorization for his own product?
Does the Polish legislation provide for excepti ons to this? If yes, under what conditions
would such exceptions apply?
Pursuant to Article 39.3 of the TRIPS Agreement any documentation and data submitted to
the Office for Registration of Pharmaceutical and Medicinal Products for the purposes of obtainingregistration and regulatory approval are kept confidential, they are protected against disclosure and
are not made available to third parties.
The Registration Commission verifies whether a given pharmaceutical or medicinal product
satisfies the requirements of quality, efficiency and safety.
These are common civil courts in Poland, which hear matters involving acts of unfair
competition according to the provisions of the Act of 16 April, 1993 on combating unfair competition.
When ruling in such cases, courts are supposed to apply, as from 1 January 2000, the TRIPS
provisions.  The Registration Commission is bound by the courts' judgements in this respect.IP/Q3/POL/1/Add.2
Page 10
Follow-up questions:
A. Please indicate the provisions of Polish law or regulations which ensure that undisclosed
and confidential test data or other data subm itted by an applicant to the Polish Office for
Registration of Pharmaceutical and Medicin al Products in the procedure for market
authorization of a pharmaceutical product are, for a meaningful number of years, protected
against disclosure and against unfair commercial use by a competitor, for example by
prohibiting a second applicant from relying on, or fr om referring to the original data of the first
applicant, when applying subsequently for market authorization for his own product.
(Citations of the pertinent provisions of the res pective act or regulation are requested, if the
texts of these laws or regulations have not yet been notified to the WTO, copies are requested
pursuant to Article 63.2 TRIPS Agreement).
B. If exceptions are provided for, please descri be in detail, how they apply in Polish law
and practice.
The following legal acts govern in Poland the procedure for market authorization of
pharmaceutical products:
- Pharmaceutical Act of 10 October 1991 on pharmaceuticals, medicinal products,
pharmacies, wholesalers and pharmaceutical administration (O.J. No 105, item 452 of
19 November 1991);  and
- the Decree of the Ministry of Health and Social Welfare on the register of
pharmaceutical agents and medicinal devices (O.J. No 6, item 24 of 17 January
1994).
Neither of these acts contains any provisions addressing intellectual property rights.
Consequently, since 1 January 2000, Article 91(1) and (2) of the Polish Constitution apply, by
virtue of which the provisions of an international agreement ratified by Poland constitute part of the
national legal order, are directly applicable and prevail over other domestic regulations to the extent to
which they remain discordant with the TRIPS Agre ement.  Any parties to which this Agreement's
provisions are addressed, are bound by them and obliged to observe them.
In meeting the requirements from Article 39.3 of the TRIPS Agreement, any documentation
and data submitted to the Office for Registration of Pharmaceutical and Medicinal Products for the
purposes of obtaining registration and regulatory approval are kept confidential, they are protected
against disclosure and are not made available to third parties.  The Registration Commission verifieswhether a given pharmaceutical or medicinal product satisfies the requirements of quality, efficiency
and safety.
According to the provisions of the Act of 16 April 1993 on combating unfair competition,
common civil courts in Poland are competent to hear and rule in cases involving test data protection.When ruling in such cases, courts are supposed to apply, as from 1 January 2000, the TRIPS
provisions.  Consequently, a drug producer may, in a court proceeding, claim his exclusive right to be
infringed by a producer of a generic pharmaceutical product by way of using the data being his
proprietary information.  The Registration Commission is bound by courts' judgements in this respect.
At present a new Pharmaceutical Law is being under preparation, which is supposed to take intoconsideration the provisions of the TRIPS Agreement, including those of Article 39.  The Law is
anticipated to be accepted by the end of 2000.IP/Q3/POL/1/Add.2
Page 11
II. RESPONSES TO QUESTIONS POSED BY THE UNITED STATES
A. PATENTS 3
1. Please provide a status report on the legislation regarding inventive activity now
pending in Parliament in Poland, including a brief explanation of the changes it will make to
Poland’s patent regime.
The draft of the Industrial Property Law already underwent three readings in Sejm, it was
discussed by the upper chamber of the Parliament – Senat, and now is awaiting voting, on a Sejm’s
plenary session, which is expected to take place in early June, on the amendments proposed for
introduction by Senat.  This is the last phase of the Parliamentary works on the draft.  After the voting
the draft is to be signed by the President of the Republic of Poland to become law.
The new Law makes the following changes to Poland’s patent regime:
1. it provides for the protection for inventions in all fields of technology (exceptions to
patentability no longer include products obtained by nuclear transformation, as
provided for in the Law on Inventive Activity);
2. it permits patent claims to be amended for the purpose of claiming enhanced
protection, which was not earlier available (up to the time of publication of the
application and provided that such alteration may not go beyond what has been
disclosed in the description of the invention as filed);
3. determines detailed conditions for granting compulsory licences along the lines of
Article 31 of the TRIPS Agreement;
4. it provides for the exception concerning th e exploitation of an invention (during the
life of a patent) for the purpose of generating data necessary for obtaining regulatory
approval or registration requisite for certain products to be allowed for putting them
on the market; that is mainly applicable to pharmaceutical products and plant
protection products;
5. it introduces post-grant opposition system (with a six month period from the grant
given for making notice of opposition);
6. it provides for judicial review of Patent Office's decisions , exercised by the Supreme
Administration Court.
2. Article 19 of the Law on Inventive Activity pr ovides that any person with a legal interest
can request an advisory opinion regarding infringe ment from the Patent Office.  Please explain
the legal status of such an advisory opinion.  Can such opinions be appealed to a judicial body
and, if so, how?
Article 19 of the Law on Inventive Activity provides for the establishment by the Patent
Office, in litigation proceedings, that a specified production or intended production is not of a kind as
to infringe another's patent.  In case of an action for infringement of a patent, the court may take such
establishment into consideration, not however being legally bound by it (what is taken into
consideration by the court, these are facts of the case rather than evidence produced by the plaintiff,
                                                     
3 These should be considered follow-up questions to the review of Poland's legislation in the fields of
patents, layout-designs (topographies) of integrated circuits, protection of undisclosed information and controlof anti-competitive practices in contractual licences conducted in 1997 (documents IP/Q3/POL/1 and Add.1).IP/Q3/POL/1/Add.2
Page 12
which is frequently purely hypothetical).  Advisory opinions can be appealed to the Board of Appeals
(composed, among others, of judges of the Suprem e Court) or to the Supreme Court by applying
extraordinary procedure.
The new Industrial Property Law of 17 March 2000 abandons the institution of advisory
opinions and in any case leaves matters of this kind to be decided by common courts.
3. Article 49(2)(ii) provides that, in the event a patentee refuses a voluntary licence to the
owner of a dependent patent, that latter can request a compulsory licence.  Please explain how
the conditions of Article 31(l) are met under the Law on Inventive Activity. How many
compulsory licences have been issued under this provisions since the Law on Inventive Activity
came into force?
Additional conditions for the grant of a compulsory licence in case of a dependent patent
(Article 31(l) of the TRIPS Agreement) are directly met in the provision relating to cross-licensing,
referred to in subparagraph (ii), i.e. in Article 49(1).2(b), which reads as follows:
"The Patent Office may grant (...) a compulsory licence (...), where:
1. (...);
2. it has been found that the exclusive right has been abused (...), in
particular, where:
(a) (...);
(b) the patentee, by refusing to conclude a licence contract, prevents the
meeting of the social demand through the exploitation of the invention that is
the subject-matter of a dependent patent; in such case, the holder of the
original patent may demand that an authorization be given to him for the
exploitation of the invention that is the subject-matter of the dependent patent
(cross-licence).
Other conditions are met in the new Industrial Property Law in Article 82(2) and Article 85:
Article 82(2):  The grant of a compulsory licence for the exploitation of an invention
in the case referred to in paragraph (1)(iii) shall be conditional upon ascertainment
that the exploitation of the invention that is the subject-matter of the dependent
patent, where the both inventions concern the same subject-matter, involves an
important technical advance of considerable economic significance.
Article 85:  A compulsory licence may only be transferred together with the
enterprise or with that of its part, in which it is worked.  A compulsory licence
relating to the earlier patent may only be transferred to a third party together with the
dependent patent.
Until the new law comes into force, the TRIPS requirements will be applied directly by virtue
of the constitution.
As regards the number of compulsory licences issued since the Law on Inventive Activity
came into force, it was only one case of this kind reported in late 1970 (between Polish entities).
Since then, no single compulsory licence has been issued.IP/Q3/POL/1/Add.2
Page 13
4. Article 50 of the Law on Inventive Activity appears to authorize compulsory licences for
already existing licences.  Please explain in de tail, how such licences would be granted and the
rationale behind Article 50.
Article 50 of the Law on Inventive Activity would be applicable in a situation of an invention
being exploited in Poland under a licence granted by the licensee of a voluntary licence and thesub-licensee's failing to satisfy, to a necessary extent, the market demand for the product.  This would
constitute a matter in dispute between the licensee of a voluntary licence and a party applying for a
compulsory licence.  In practice, no case of this kind has happened at all.
In the new Industrial Property Law there is no direct provision to that effect; this however
would not prevent a compulsory licence from being granted (on general terms), if such a situation
happened.
5. Article 68(2) provides that the General Public Prosecutor of the Republic of Poland may
request that a patent be declared null and void in the public interest.  Please explain in detail the
circumstances this provision might be invoked and indicate what Article(s) of the TRIPS
Agreement would permit such revocation.
Request by the General Public Prosecutor that a patent be declared null and void may be
based on the same substantive grounds as that of any other person, where the patent was granted in
breach of law.  It is not necessary for the Public Prosecutor to demonstrate his own legitimate interest,
but he may support his intervention with the public interest consideration (in general).  No single caseof this kind has occurred in practice.
The TRIPS provisions do not provide for any limitations on groups of persons eligible to seek
invalidation of a patent granted;  TRIPS only requires provision for judicial review of decisions taken
by the Patent Office and this particular requirement is satisfied in the new Industrial Property Law of17 March 2000, and so far – by way of Office's decision by the Board of Appeals and a possibility of
applying the institution of extraordinary procedure.
6. Articles 121 through 123 of the Law on Inventive Activity provides criminal penalties
for certain activities related to patents and patenting.  Please provide statistics for 1998 and
1999 regarding actions taken under this section, including the penalties imposed.
No statistics in this respect are collected in Poland.
B. P
ROTECTION OF UNDISCLOSED INFORMATION 4
7. Please describe in detail the manner in which the Government of Poland implements the
obligations of Article 39.3 of the TRIPS Agreeme nt to ensure that undisclosed and other data
submitted to obtain marketing approval for pharmaceutical and agricultural chemical products
is protected against unfair commercial use and is protected against disclosure.
Pursuant to Article 39.3 of the TRIPS Agreement any documentation and data submitted to
the Office for Registration of Pharmaceutical and Medicinal Products for the purposes of obtaining
registration and regulatory approval are kept confidential, they are protected against disclosure and
are not made available to third parties.
The Registration Commission verifies whether a given pharmaceutical or medicinal product
satisfies the requirements of quality, efficiency and safety.
                                                     
4 This should be considered a follow-up question to the review of Poland's legislation conducted in
1997 (documents IP/Q3/POL/1 and Add.1).IP/Q3/POL/1/Add.2
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These are common civil courts in Poland, which hear matters involving acts of unfair
competition according to the provisions of the Act of 16 April 1993 on combating unfair competition.
When ruling in such cases, courts are supposed to apply, as from 1 January 2000, the TRIPS
provisions.  The Registration Commission is bound by courts' judgements in this respect .
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