RESTRICTEDWORLD TRADE
ORGANIZATIONIP/Q3/DNK/1
21 January 1998
(98-0101)
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
Denmark1
The present document reproduces the questions put to the delegation of Denmark and the
responses given in the review of legislation on patents, layout-designs (topographies) of integrated
circuits, protection of undisclosed information and control of anti-competitive practices in contractual
licences at the Council's meeting of 26-30 May 1997.2
_______________
I. REPLY TO THE GENERAL QUESTION ON PRIORITY RIGHTS3
Does your country recognize a right of priority on the basis of an earlier patent
application filed in any other WTO Member by a national of a WTO Member?
Yes.  Section 6(2) of the Danish Consolidated Patents Act No. 824 of 13 September 1996
authorizes the Minister of Business and Industry to lay down the particulars of the right to claim
priority.  This mandate has been used in the Order No. 77 of 30 January 1997 Concerning Patents and
Supplementary Protection Certificates, Section 10a.  According to this provision, priority for
applications filed in a state which has ratified or has acceded to the Agreement Establishing the World
Trade Organization is recognized.  The provision was introduced in the Order Amending the Order
Concerning Patents and Supplementary Protection Certificates, No. 22 of 19 January 1996.
                                                     
1As regards laws and regulations relevant to the areas under review as notified by Denmark under
Article 63.2 of the Agreement, reference is made to documents IP/N/1/DNK/1/Rev.1, IP/N/1/DNKP/1-4,IP/N/1/DNK/L/1-3.
2The minutes of the meeting have been circulated in document IP/C/M/13.
3At the meeting of the TRIPS Council of 27 February 1997, Members agreed to respond to this
question in the context of the present review (document IP/C/M/12, paragraph 18).IP/Q3/DNK/1
Page 2
II. REPLIES TO QUESTIONS POSED BY JAPAN
Preliminary remarks
The implementation of the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) has led to changes in the Danish legislation concerning patents.  The Patents Act was
amended by Act No. 900 of 29 November 1995, which was implemented in the consolidated Patents
Act No. 824 of 13 September 1996, and the Order Con cerning Patents and Supplementary Protection
Certificates was amended by Order No. 22 of 19 January 1996.4
1. In your country, are the following subject matters protectable by patent:  (1) plants andanimals, and (2) plant and animal varieties?
According to the Danish Patent Act Section 1( 4) both plant and animal varieties are excluded
from being patented.  Essentially biological processes for the production of plants or animals are also
excepted from patentability.
Plant varieties may however be protected under the Danish legislation on breeders' rights.
The Danish legislation on plant varieties is based on the UPOV Convention of 1991, which Denmark
has ratified.  Plants as such which are not described as a plant variety, as well as elements of plants
including cells and genes, may be patented in Denmark.
Animals as such, as well as elements of animals, cannot be patented in Denmark.  This
follows from a decision made by the Danish Parliament in 1991.  The reason for this interpretation isprimarily that the Danish Parliament finds that it is unnatural to distingu ish between animals and
animal varieties in connection with patents and that grant of patents on animals is considered to be
unethical.
Patenting of cells and genes isolated from the animal body or produced by a technical process
is allowed to a certain extent.
Section 1(4) does not exclude microbiological processes for the production of plants or
animals from patentability.  Also technical processes are allowed.
2. In your country, is the act of offering for sale included in the exclusive rights of patent?
According to the Danish Patents Act Section 1(1) a proprietor of a patent obtains an exclusive
right to exploit the invention commercially.
Section 3(1)(i) of the Patents Act states that the exclusive right implies that the proprietor can
prohibit others from offering the patented product for sale.
However, the fact that an invention is patented does not automatically give the proprietor the
right to offer the product for sale.  This will, e.g. be relevant if the patented product is against any
other regulation in Danish law, e.g. concerning protection of the environment.
                                                     
4According to the Danish delegation, the order was replaced by Order No. 77 of 30 January 1997.IP/Q3/DNK/1
Page 3
3. In your country, what kinds of acts are rec ognized as exceptions to the exclusive rights
conferred by a patent right?
The Patents Act lists exceptions to the exclusive right of a patent in Sections 3(3), 4, 5 and
45-50.
Section 3(3) provides that the exclusive right does not extend to acts done for non-
commercial purposes, acts concerning products put on the market in the EC area by the proprietor of
the patent or with his consent, acts done for experi mental purposes relating to the subject-matter of the
patented invention, and preparation in a pharmacy of a medicinal product according to a prescription
in individual cases or act concerning the pharmaceutical product so prepared.
It follows from Section 4 of the Patents Act th at any person who, at the time when the patent
application was filed, was exploiting the invention commercially may, notwithstanding the grant of a
patent, continue such exploitation retaining its gene ral character, provided that the exploitation does
not constitute an evident abuse.
Section 5(1) states that persons other than the proprietor of the patent may exploit the
invention by the use of a foreign vehicle, vessel or aircraft, notwithstanding the grant of a patent,
when it temporarily or accidentally enters the country.  Section 117 of the Order Concerning Patents
and supplementary Protection Certificates provides that, notwithstanding a granted patent, spare parts
and accessories for aircraft may be imported and used for the repair of aircraft belonging to a foreignstate being a party to the Convention of 7 December 1944 on International Civil Aviation and either
being a party to the Paris Convention for the Protection of Industrial Property of 20 March 1883 or
having a patent legislation which recognizes inventions made by nationals of another state which is
party to the first-mentioned Convention and protects such inventions by a legislation which is in
principle in conformity with the Paris Convention.
Furthermore the provisions in Sections 45-50 of the Patents Act providing possibility of
issuing of compulsory licences under special circum stances are considered to be exceptions to the
exclusive right of a patent holder.
4. In your country, in which case is use wi thout the authorization of the right holder
permitted, including use by the government or by third parties authorized by the government?
Permission to use the patented invention without authorization from the right holder is only
allowed in rare instances and under exceptional circumstances.  The provisions just mentioned in the
Patents Act Sections 45-50 contain the circumstances under which a compulsory licence can be
issued.
5. In your country, how is the obligation under Articles 34.1 and 34.2 of the TRIPS
Agreement regarding the shift of the burden of proof in civil proceedings for patent
infringement related to a process patent implemented?
It follows from Section 64a
5 of the Patents Act that if the subject-matter of a patent is a
process for the manufacture of a new product, the same product shall, when manufactured by any
other person than the proprietor of the patent, be deemed to be manufactured on the basis of the
patented process, unless evidence to the contrary is submitted.
                                                     
5 The Danish delegation explained that this provision was introduced in the Act Amending the Patents
Act No. 1057 of 23 December 1992 (cf. the Consolidated Patents Act No. 824 of 13 September 1996).IP/Q3/DNK/1
Page 4
6. Please explain how undisclosed information is protected in your country, as required by
Article 39.2 of the TRIPS Agreement.
General rules on access to undisclosed information
(a) the Danish Access to Public Administration Files Act
(1) General Rule
It is the general rule of the Danish Access to Public Administration Files Act that any person
may demand that he be apprised of documents received or issued by an administration authority as
part of casework performed in the course of its activity (cf. Section 4(1) of the Danish Access to
Public Administration Files Act).
The person requiring access to documents is not required to demonstrate a locus standi  in
being apprised of the documents requested.
Access can be refused only if the material requested for disclosure is subject to the exceptions
as provided by the act.  In practice, the rules of exceptions are narrowly construed, thus allowing the
widest possible application of the general rule of access to files.
Generally, the fact that the information is subject to a duty of non-disclosure does not provide
sufficient grounds for refusal of access.  Therefore, access can be refused only if the material is
subject to one or more of the exceptions specifically listed in the act.  If the particular information is
subject to a specified duty of non-disclosure, the latter will, however, defeat the right of access.
(2) Exceptions to the Rights of Access to Administration Files
The Access to Public Administration Files Act contains several exceptions to the general rule
of right of access.
First of all, certain classes of matters are exempt.  Thus the act does not apply to matters
relating to criminal justice.  Also, the right of access is barred in matters of employment and
promotion of public servants.
Legislative matters are generally excepted from the right of access until the time for
introduction of the bill in the Folketing.  After that point in time the general rules of the Access to
Public Administration Files Act will determine whether the right of access shall apply to documents
relating to a legislative matter, including documents issued prior to the introduction of the bill(cf. correspondence between ministries regarding legislation below).
Secondly, the Access to Public Administration Files Act excepts certain documents.
As such internal documents are excepted from access.  Basically, internal case material is
exempt from disclosure, however, only as long as  it remains in the possession of the authority
preparing the documents in question.  If an internal document is forwarded to another authority, orpassed on to a third party, the document usually loses its internal character.
Several documents are subject to disclosure, though they may be internal case material.
These may for instance be documents which render exclusively the substance of the authority's final
resolution on its decision in a matter (agreed minutes).IP/Q3/DNK/1
Page 5
Certain documents are exempt from disclosure, though they may have been exchanged
between authorities.  These documents could be records of meetings of the Council of State, minutes
of meetings of ministers and documents prepared by an authority for use at such meetings.
Correspondence between ministries on legislative matters is similarly exempt.  Particularly,
this provision carries independent importance as regards bills which have been introduced.  Prior to
such introduction, a request for access to administration files is generally refusable in legislativematters (cf. above).  The provision is assumed to relate only to correspondence in connection with
considerations whether to prepare and/or implement legislation rather that correspondence regarding
the construction of existing legislation.
The exceptions listed with regard to documents are modified by a provision on a duty of
extraction which implies that factual information in  said documents of material importance to the
matter shall be disclosed pursuant to the general provis ions of the act.  The authority's internal opinion
is not subject to the duty of extraction.  The duty of extraction considerably limits the scope of theprovisions for exceptions specified.
Moreover, certain information is exempt from access.
The right of access to administration files does not apply to, e.g. information on the private
circumstances of individual persons, including their finances.  Information on operating or business
procedures is also exempt from disclosure.
The right of access to administration files may furthermore be subject to limitation where
protection is essential with regard to, e.g. the security of the State or the defence of the realm, the
protection of Danish foreign policy or of Danish external economic interests, including relations with
foreign powers or international institutions.
Where the information of a document is exempt from the access to administration files only in
part, the person requesting disclosure shall be apprised of the rest of the contents of that document.
(3) Increased Access to Administration Files
The Access to Public Administration Files Act is a minimum act.  Even if he material is
subject to a provision for exception, so that people do not have a claim on access to administration
files, an administration authority may allow wider acc ess to administration files, always subject to the
rules in relation to secrecy, etc. (increased access to administration files).
In its practice notes on the Access to Public Administration Files Act the Ministry of Justice
has repeatedly emphasized the desirability of authorities demonstrating open government and
providing increased access to administration files.
(b) The Patents Act
Section 22 of the Patent Act deals with publicati on of patent applications.  The more general
rules are to be found in Section 22 (1) and (2).
Section 22(1) states that the patent application shall be available to the public from the date of
which the patent is granted.
Section 22(2) provides that even if a patent is not granted the application shall be made
available to the public when 18 months have elapsed from the date of application or, if priority hasIP/Q3/DNK/1
Page 6
been claimed, from the date on which priority is claimed, unless a decision has been made to shelve or
refuse the application.
Section 22(5) concerns documents which do not relate to an invention for which the patent is
applied for or has been granted.  According to this provision, the Danish Patent Office may, on
request, decide that such documents shall not be available to the public or only in part available to the
public.
III. REPLIES TO QUESTIONS POSED BY THE UNITED STATES
Preliminary Remarks
The implementation of the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) has led to changes in the Danish legislation concerning patents.  The Patents Act was
amended by Act No. 900 of 29 November 1995 which was implemented in the consolidated Patents
Act No. 824 of 13 September 1996, and the Order Con cerning Patents and Supplementary Protection
Certificates was amended by Order No. 22 of 19 January 1996.6
1. Section 2(iii) of the Danish Patents Act provides that "computer programs" are not to
be regarded as "inventions." Please explain whether, under this provision, inventions within the
categories specified below are not eligible to be patented under Danish law, notwithstanding the
fact that the invention is novel, involves an inventive step, and is useful:
(a) process inventions which, in whole or in part, consist of steps that are performed
by a computer and are directed by a computer program;
(b) product inventions consisting of elements of a computer-implemented invention,
including in particular:
(i) machine-readable computer program code stored on a tangible medium
such as a floppy disk, computer ha rd drive or computer memory; and
(ii) a general purpose computer whose novelty over the prior art arises
primarily due to its combination with a specific computer program.
If any of these types of inventions are excluded from eligibility to be patented, please
explain how Danish patent law complies with the obligations of Article 27 of the TRIPS
Agreement, which mandates patent eligibility for all categories of invention withoutdiscrimination.
It follows from the Danish Patents Act Section 1(2)(iii) that computer programs are not
regarded as inventions.  Excluded from patentability are thus computer programs as such.  The reason
for this is that we find that a computer program as such is an algorithm like other mathematical
methods in Section 1(2)(iii).  A computer program as  such is thus not considered to be an invention
and it is for that reason not patentable.
Software related inventions are however regarded as patentable as they have a technical
character.
The main issue when deciding patentability regarding software is the question of industrial
applicability or the usefulness of the invention.
                                                     
6According to the Danish Delegation, the Order was replaced by Order No. 77 of 30 January 1997.IP/Q3/DNK/1
Page 7
In principle, the examples mentioned in (a) and (b) are patentable in Denmark.7
(a) If the subject-matter claimed makes a technical contribution to the prior art
patentability will not be denied in Denmark merely because a computer program is
involved in its implementation.
(b)(i) and (ii) When deciding on the patentability of product inventions we find it important
to consider the invention as a whole.  The medium itself is not the decisive matter.  Anew program including both an algorithm and some specific software related to the
specific use could be patentable on any medium.
The requirement of industrial application is fu lfilled when the invention is brought to use in
an apparatus as a (known, general purpose) comput er, robot, laboratory equipment etc., and thereby
having the necessary technical character, just as an  any mechanical improvement that is added to the
apparatus can be patentable.
We thus find that the Patents Act fulfils the requirements of Article 27 of the TRIPS
Agreement.  It should finally be mentioned that computer programs are eligible for obtainingcopyright protection in Denmark as required in Article 10 of the TRIPS Agreement.
2. Section 45 of the Danish Patents Act permits the issuance of a compulsory licence under
a patent that has not been worked or brought in to use to a reasonable extent in Denmark.  The
provision further provides that the evaluation of whether these standards are met will permit
consideration of whether there ha s been a sufficient working of the invention in a foreign state,
provided that foreign state reciprocates in such an evaluation.  With regard to these provisions,
please explain:
(a) whether importation of a patented product at a level which satisfies Danish
market demands will satisfy the requirement of a patent owner to bring theinvention into use to a reasonable extent in Denmark, and if not, please explain
how this provision complies with Article 27.1 of the TRIPS Agreement, which
precludes discrimination in the enjoyment of patent rights with regard to local
manufacture or importation of the patented invention; and
(b) explain how Denmark evaluates reciprocity if a foreign state does not permit the
possibility of issuance of compulsory licences.
(a) It follows from Section 45(2) of the Danish Patens Act that the Minister of Business
and Industry is authorized to decide that working of the invention in another country
shall be considered equivalent to working in Denmark.  This mandate is used inSection 120(1) of the Order Concerning  Patents and Supplementary Protection
Certificates.
8  It follows from Section 120(1) that in the evaluation of the possibility
of obtaining a compulsory licence under Section 45(1) of the Patents Act, working in
a state which has ratified or has acceded to the Agreement on the Establishment of the
World Trade Organization (WTO) is considered to be equivalent to working inDenmark.  Thus, if a patented invention is not worked to a reasonable extent in a
                                                     
7The Danish delegation informed Members that the Danish Patent Office only receives very few
applications regarding computer programs and there ha ve not been court decisions concerning this subject
matter for many years.
8According to the Danish delegation, the present wording of Section 120 was introduced by Order
No. 22 of 19 January 1996 and is unchanged in the new Order No. 77 of 30 January 1997.IP/Q3/DNK/1
Page 8
WTO Member it might be subject to issuing of a compulsory licence, unless there are
legitimate reasons for failure to work the invention.  The requirement of Article 27.1
of the TRIPS Agreement is thus fulfilled.
(b) The mandate of Section 45(2) of the Patents Act to consider working of the invention
in another country equivalent to working of the invention in Denmark states that such
a provision may be made subject to reciprocity.  It follows from Section 120(1) of the
Order Concerning Patents and Supplementary Protection Certificates that in the
present Danish legislation there is no requirement of reciprocity.
[Follow-up question from the US]
In relation to the answer provided by Denmark to question 2(b) from the United States,
please clarify when the Danish Government would be required to make a determination
regarding whether working in another WTO Member is considered to be equivalent to working
of the invention in Denmark.  In particular, please indicate whether the Government ofDenmark could make this determination during the process of evaluating a request for
compulsory licence, and whether a decision during such a proceeding would be binding on the
applicant for a compulsory licence.
As stated in the answer to the original question No. 2(a) it follows from Section 120(1) of the
Order Concerning Patents and Supplementary Protection Certificates that in the evaluation of thepossibility of obtaining a compulsory licence under Section 45(1) of the Patents Act, working in a
state which has ratified or has acceded to the Agreement on the Establishment of the World Trade
Organization (WTO) is considered to be equivalent to working in Denmark.
Section 50 of the Patents Act states that th e Copenhagen Maritime and Commercial Court as
the court of first instance shall decide whether a compulsory licence shall be granted.  In a caseconcerning the possible issuing of a compulsory licence according to Section 45 of the Patents Act,
the court will have to decide whether the conditions for issuing of a compulsory licence are fulfilled.
Among others the element of whether the invention ha s been worked to a reasonable extent in a WTO
Member shall be considered.  This question is part of the final decision which is binding for the
parties of the case.
3. Sections 45 to 50 of the Danish Law perm it the issuance of involuntary (compulsory)
licences under a patent for a variety of reasons.  Please explain how this regime complies with
the requirements of Article 31 of the TRIPS Agreement, and in particular:
(a) how Section 46 of the Danish Patent Law concerning dependent patent
compulsory licences complies with the re quirement of Article 31(l)(i) that the
dependent patent concern an invention that involves "an important technical
advance of considerable economic signif icance in relation to the invention
claimed in the" dominant patent;
(b) how Sections 45 to 50 comply with the requirement of Article 31(c) of the TRIPS
Agreement, which specifies that licences for inventions in the field of
semiconductor technology may only be justified for public non-commercial use
or to remedy a judicial or administrative finding of anti-competitive practices;and
(c) what factors are used by Danish courts to determine compensation under a
compulsory licence, and whether co urts are required to ensure that
remuneration takes into account the economic value of the authorization.IP/Q3/DNK/1
Page 9
(a) Section 46(1) of the Patents Act, which was introduced by the Act Amending the
Patents Act No. 900 of 29 November 1995 (cf. the Consolidated Patents Act No. 824
of 24 September 1996) provides that the proprietor of a patent for an invention, the
use of which is dependent on a patent which belongs to another person may obtain a
compulsory licence for use of the protected invention of the latter patent "if the
former invention makes up an essential technical progress of substantial economicimportance".  It is stated in the explanatory notes to the Patents Act that this means
that if the owner of a patent (the second patent) cannot exploit the patent without
infringing another patent (the first patent), the owner of the second patent can obtain a
compulsory licence if the invention claimed in the second patent involves an
important technical advance of considerable economic significance in relation to
inventions claimed in the first patent.  Section 46 of the Patent Act therefore complies
with Article 31(l)(i) of the TRIPS Agreement.
(b) Section 49(4) of the Patent Act
9 explicitly states that a compulsory licence concerning
semiconductor technology only can be issued for public, non commercial use or for
terminating an anti-competitive practice, which has been established by judgement or
administrative decision.  The Danish law is thus in compliance with Article 31(c) of
the TRIPS Agreement.
(c) The Patents Act does not specify factors to be taken into consideration when
determining the amount of compensation under a compulsory licence.  The Danish
courts10  will therefore determine compensation based on an evaluation of the
concrete case.  The presumption is that the proprietor of the patent as a general rule
should obtain full compensation and that the question of compensation normally canbe based on customary contractual practice concerning voluntary licences.
[Follow-up question from the US]
Please explain whether Section 48(1) of the Patents Act conditions the application for a
dependent patent compulsory licence on a showing that the owner of the dependent patent has
made efforts to obtain authorization from the owner of the dominant patent on reasonablecommercial terms but has not succeeded in obta ining such authorization within a reasonable
time.
We consider the question to be a follow-up question to the original question No. 3(a) which
concerns dependent patent compulsory licence.  Such compulsory licences are specifically dealt with
in Section 46 of the Danish Patents Act.
The Patents Act, Section 49(1), which regards compulsory licences in general, states that a
"compulsory licence shall only be granted to persons who by agreement have not been able to obtain
licence on reasonable terms".  This provision also covers dependent patent compulsory licences.
It is explicitly stated in the explanatory notes to the Patents Act that Section 49(1) is intended
to fulfil the obligations of Article 31(b) of the TRIPS Agreement whereby a compulsory licence only
may be granted if the proposed user in advance has ma de efforts to obtain authorization from the right
                                                     
9 The Danish delegation explained that this provision was introduced by the Act amending the Patents
Act No. 900 of 29 November 1995 (cf. the Consolidated Patents Act No. 824 of 13 September 1996).
10 According to the Danish delegation, the Copenhagen Maritime and Commercial Court decides as the
court of first instance (cf. Section 50 of the Patents Act).IP/Q3/DNK/1
Page 10
holder on reasonable commercial terms and conditions and that such efforts have not been successful
within a reasonable period of time.
4. Please indicate how many compulsory licen ces on a yearly basis have been granted in
Denmark since 1 January 1993.
 Compulsory licences are granted very rarely in Denmark.  The most recent cases concerning
compulsory licences are dated back to 1966 (judgement of the Danish Supreme Court 1966, page 566)and 1972 (judgement of the Danish Supreme Court 1972, page 325).
5. Please indicate whether Denmark has no tified the Consolidated Patents Act (of
13 September 1996) to the TRIPS Council, and when the Act became effective in Denmark.
Denmark has notified the Consolidated Patents Act including the Patents Act and the later
amendments to the TRIPS Council.
11
The Consolidated Patents Act (No. 824 of 13 September 1996) is a compilation of the Patents
Act No. 479 of 20 December 1967 and the later amendments to the Act.
When an act is passed through the Danish Parliament the act itself contains provision on the
entry into force.  Thus the Patents Act from 1967 and the later amendments each contain such
provisions.
Since the Consolidated Patents Act is just a compilation of the Patents Act and the later
amendments, the Consolidated Patents Act does not have a date of entry into force.
6. Please explain how undisclosed information is protected in Denmark, and the legal basis
for such protection.
The answer given by the Danish delegation to this question is an exact reproduction of the
language and in its answer to question No. 6 from Japan.
[Follow-up questions from the US]
 In its response to the US question regarding the protection of undisclosed information,
Denmark has provided considerable detail reg arding the protection of such information
contained in public documents.  Please explain in detail how, under Denmark's law, a party in
control of undisclosed information meeting the cr iteria indicated in Article 39.2 of the TRIPS
Agreement may prevent unauthorized persons from disclosing, or acquiring or using suchinformation contrary to honest commercial practices.
Section 10 of the Danish Marketing Practices Act sets out the following:
"1. No person employed by, co-operating with, or performing work or providing
services for a commercial enterprise shall, in an improper manner, acquire or attempt
to acquire knowledge or possession of the trade secrets of such enterprise.
2. Where such person has lawfully acquired knowledge or possession of the
trade secrets of the enterprise, he shall not , without proper authority, disclose or make
use of such secrets.  This provision shall apply for a period of three years after the
                                                     
11 To be distributed as document IP/N/1/DNK/P/1.IP/Q3/DNK/1
Page 11
termination of the employment or of the period of co-operation or the completion of
the work or of the provision of the services, as the case may be.
3. Where a person for the purpose of performing work or for any other business
purpose has been entrusted with technical drawings, descriptions, formulae, patterns,
models or other information, he shall not, without proper authority, make use of or
allow others to make use of such knowledge, information or material.
4. No person carrying on a trade or business shall make use of a trade secret
where knowledge or possession of such trade secret has been acquired in
contravention of the preceding provisions of this section."
Section 22, subsection 4, of the same act contains the following provision:
"Any person guilty of an offence under Section 10 of this Act shall be liable to a fine
or to mitigated imprisonment or to ordinary imprisonment for a term not exceeding
two years.  Proceedings may be instituted only at the request of the injured party."
The provisions in Section 10 only apply to a person with legal access to the business or firm,
for example as a result of employment, co-operation or professional assignment.  Even after the said
relationship has expired, the person is not allowed to use the information mentioned in the Section,
where the knowledge is a result of that relationship.
According to Section 10, agreements concerning non-competition clauses are not excluded.Subsection 4 of Section 22 includes the handling of information.
In the answer to the general question co ncerning how confidential information is
protected in Denmark, the government of Denmark indicated that certain exemptions exist to
prevent access by the public to information held by Danish administrative agencies.  The
examples of information specified included such  things as financial records of a company or
business or operating procedures of a company.  Th eses examples appear to address the spirit of
the requirements of Article 39.2 to the extent that they pertain to Danish government agencies,
but certain related issues remain unclear.  Please explain:
(a) whether a company that has provided in formation can classify the information
as being confidential, and whether this request would result in preventing accessby third parties without their consent to such information held by a Danish
administrative entity;
(b) whether these provisions bind all Dani sh regulatory agencies, including those
responsible for granting marketing approval for new drugs or for agricultural
products.
(a) There is not the legal authority in the legi slation to extend a guaranty in advance to an
applicant regarding confidentiality of information.  However, the rules contained in
the Access to Public Administration Files Act, Section 12, subsection 1,2, impose an
obligation on public authorities not to disclose information which is confidential.
(b) The provisions of the Access to Public Administration Files Act - including
Section 12, subsection 1, 2 are binding on all Danish regulatory agencies, including
the Danish Medicines Agency (responsible for granting marketing approvals forIP/Q3/DNK/1
Page 12
pharmaceutical products) and the National Agency for Environmental Protection
(responsible for granting marketing approvals for agricultural products).
7. Please indicate the nature of measures, if any, that are taken by judicial authorities in
Denmark to protect the confidentiality of undisclosed information furnished by a party to the
court during legal proceedings, when the informat ion has been provided either to enforce rights
in such information, or for other purposes.
Access to documents in civil cases
Cases heard by the courts are not subject to the Danish Access to Public Administration
Files Act.  According to Section 41 of the Administration of Justice Act the parties may demand a
transcript of court records and the documents produced in court.  The court may refuse to deliver a
transcript if it is to be feared that the transcript wi ll be used unlawfully (cf. Section 41(2)).  The right
to demand a transcript is equally granted to any third party provided he is able to prove a locus standi
therein.
Access to attend court hearings
Section 29 of the Administration of Justice Act provides that court hearings shall be public
unless otherwise expressly specified.  In civil cases the court may decide, for instance, that the case
shall be heard in camera when open court hearings would cause undue harm to a person, e.g. when
oral evidence is to be given about business or operating secrets.
Obligation of either party in civil cases to produce documents at the request of the other party
According to Section 298 of the Administration of Justice Act, the courts may order, upon
request made by either party, that the other part y produce documents which are at his disposal and
which he intends to rely upon during the proceedings.  However, a party cannot be ordered to produce
a document if, as a result thereof, information would be disclosed which he would be excluded orexempted from giving evidence about as a witness (cf. Sections 169-171 of the Administration of
Justice Act).
Basically, people like clergymen, doctors, defence counsels and lawyers are excluded from
giving evidence as regards information which has come to their knowledge during performance of
their activities (cf. Section 170(1) of the Administration of Justice Act).  As a general  rule, people ofsuch professions cannot be ordered to produce documents containing information which they have
acquired in the course of duty.  A lawyer in a civil case can never be ordered to give evidence or
produce documents about anything he has learnt in a case entrusted to him for execution or in which
his advice has been sought.
According to Section 171 of the Administration of Justice Act a witness has the privilege to
refuse to give evidence if, in so doing, he would expose himself or his next of kin to punishment or
other material loss.  Disclosure of business or operating secrets fall under the concept of other
material loss.
8. Please explain the measures, if any, that have been implemented in Denmark to protect
against unfair competition those parties that ha ve provided confidential test or other data
concerning a pharmaceutical or agricultural chemical product to Danish regulatory authorities
pursuant to a request for marketing approval and how such measures are consistent withArticle 39.3 of the TRIPS Agreement.  Please explain whether the information is protected
against  disclosure indefinitely, or is only protected for a specific period of time.IP/Q3/DNK/1
Page 13
Protection of undisclosed information concerning a pharmaceutical product
The Danish Ministry of Health has issued a regulation which will exempt documents in cases
concerning applications for marketing approvals for pharmaceutical products from public access.,
The legal authority for this regulation is the generally applicable law regulating public access to file,
i.e. the Danish Access to Public Administration Files Act.
The regulation will enter into force on 15 May 1997 and the question of protection of
undisclosed information has so far been regulated by the above mentioned act.  The new regulation
will provide companies with even greater certainty that documentation which has been submitted by
them for purposes of their applications will not be accessible for competing companies.
Pursuant to the new regulation, documents related to applications for marketing approvals for
pharmaceutical products are exempted from public access.
However, the exemption does not cover the approval as such, or the accompanying resume of
the product indicating the composition and characteristics of the product.
Information concerning the exporting country of a parallel imported pharmaceutical product
is exempted from public access, unless the immediate distributor of the pharmaceutical product is able
to bar the parallel import on the basis of the EEA or the accession agreements between the EC and
Finland, Portugal and Spain respectively.
The time period during which the documents are exempted from public access under the
regulation is unlimited.
Protection of undisclosed information concer ning an agricultural chemical product
In connection with the negotiations on and subsequent implementation of
Directive 91/414/EEC concerning the placing on the market of plant protection products (i.e.
agricultural chemical products in the TRIPS Agreement) detailed rules have been enacted at bothCommunity and member State levels.
The above mentioned Directive sets out rules on data protection in Article 13 concerning
plant protection products.  Theses rules have b een implemented in Denmark by way of the Danish
Chemical Substances and Products Act. Section 35a, and take effect when active ingredients - new
and old - are entered on the EC list.
The main applicable rules are:
For plant protection products, as regard new active ingredients (i.e. active ingredients
marketed in the EC after 26 July 1993) a 10-year data protection period applies as a main rule.
For plant protection product, as regards old active ingredients (i.e. active ingredients marketed
in the EC before 26 July 1993) no EC data protection applies to the active ingredient.  However,supplementary documentation submitted in connection with the inclusion in the EC list may be
afforded a 5-year data protection period, related, however, to previous national legislation in the field.
The EC Commission is presently preparing Guidelines to assist members states in the administration
of theses rules.
For new products containing old active ingredients, documentation concerning the product
will be protected for a 10-year period following inclusion in the EC list.IP/Q3/DNK/1
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[Follow-up question from the US]
Please clarify whether Danish regulatory authorities charged with the granting of
marketing approval for new chemical entities to be used as pharmaceutical or agricultural
products are prohibited from disclosing test  data provided by an original applicant for
marketing approval to third parties, and whether third parties can at any point in time rely on
the test data to support their own marketing ap proval requests in relation to the same chemical
entity.
Marketing approvals by the National Agency of Environmental Protection responsible for the granting
of marketing approvals for new chemical entities to be used as agricultural products
The National Agency of Environmental Protection considers applications for approval of
pesticides according to the Order on Act on Chemical Substances and Products (Ministry of
Environment and Energy Consolidated Act No. 21 of 16 January 1994) and Order on Pesticides
No. 768 of 23 August 1994.
The Act covers all pesticides, i.e. plant protection products as well as biocides.  Plant
protection products are EU regulated in directive 91/414.  Biocides - wood preservatives, products for
control of rodents, certain insecticides, slimicides, and similar - are not yet regulated in the
Community but the adoption of a proposed biocide directive may be expected shortly, the EU
Parliament having approved on 13 may 1997 the common stand with just a few amendments.
Pursuant to the Order on pesticides, requirements have been established for all pesticides for
submission of documentation to be used for the case administration on approval.
This documentation may generally be divided into two groups:
(a) Documentation containing information about the actual chemical, i.e. its chemical
composition , synthesis ways, content of impurities, etc.  This information is regardedby the National Agency of Environmental Protection as being confidential business
secrets pursuant to Section 12 of the Access to Public Administration Files Act.
(b) Documentation containing information on the effects of the substance/product on
health (cancer studies, studies on teratogenicity, acute toxicity, etc.) and the
environment (studies on the potential of the substance of polluting the groundwater(mobility and persistence), effect to non-target groups, etc.).
The documentation is further used for the following purposes:
(1) According to practice on parallel registration and me-too registration.
(2) According to the rules on open files, documentation shall be released upon request
unless after a review the material must be characterized as being confidential,(cf. Section 12 of the Access to Public Administration Files Act (documentation
under item (a) above)).
(3) According to the case administration of applications, documentation is released to
consultants, experts, etc.IP/Q3/DNK/1
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1. Practice on Parallel and Me-Too Registration
Parallel Registration
It is a matter of parallel registration when a producer of a pesticide has already had his
product (the original product) approved in Denmark.  Parallel registration is a quite ordinary approval
according to the rules of the Act on Chemical Substances and Products (and the EU Directive on plant
protection products).  Directive 91/414 on plant protection products does not lay down any rules onparallel imports.  Practice is subject to the interpretation by the particular countries of the Treaty rules
on free competition.
Based on documentation already submitted by the original producer, the National Agency of
Environmental Protection will approve parallel imported products if the parallel importer is in a
position to verify that it is a question of exactly the same product.  The original producer's
documentation material will then fully form the basis for the approval.
Me-Too Registrations
It is a matter of Me-Too registration cases whenever it is a question of products not fully
identical with the original product, or in which the active ingredient or the product has been produced
by another producer.
If the active ingredient is produced by another producer, the National Agency of
Environmental Protection will consider whether the substance is toxicologically identical with the
original one.  In the affirmative, the documentation submitted by the original approval holder may
form the basis of the approval of the new product.
The products will normally not be identical, and in such cases the new applicant will submit
documentation himself.  Only if the products are found to be identical will the documentation for the
original product be used as the basis of approval of the new product.
Approval of plant protection products according to the rules on Me-Too is covered by
EU Directive 91/414 on plant protection products whereas other products are covered by the practice
which applies in Denmark as no EU rules on these products have been adopted yet.
EU regulation lays down rules on data protection in Article 13 of Directive 91/14 on plant
protection products.  These rules have been implemented in Section 35a of the Act on ChemicalSubstances and Products and will take effect when the active ingredients - new as well as old - are
entered in the EU list.
The general rules are:
For plant protection products, new active ingredients (i.e. active ingredients marketed in the
EU after 26 July 1993), are afforded a ten-year data protection-period as a general rule.
For plant protection products, old active ingredients (active ingredients on the market before
26 July 1993), are not afforded any EU data protection-period for the active ingredient.  However,
supplementary new documentation submitted for the purpose of being entered in the EU list may be
afforded a five-year protection-period.  This is, however, related to previous national law in this area.
For new products with old active ingredients , the documentation for the product will be given
a ten-year data protection-period after the substance has been entered in the EU list.IP/Q3/DNK/1
Page 16
For biocides, no data protection applies today but in the proposal for a biocide directive, rules
resembling those applying for plant protection products described above are suggested.
2. Practice on Right of Access to Documents
Pesticides are the subject of much attention by the public so the National Agency of
Environmental Protection receives many requests for right of access to documents on approvals,documentation or other material forming the basis of the consideration of the case.  No special rules
apply pursuant to the Act on Chemical Substances and Products so questions of right of access to
documents are administered in accordance with the Administration Act and the Access to Public
Administration Files Act.
As regards the matter of confidential information in which respect an applicant for approval is
entitled to require that it will not be passed on by the National Agency of Environmental Protection,the agency has applied the provision of Section 12, subsection 1,2.
This provision reads:
"The right of access to documents does not cover information on:
(2) technical devices or procedures or on operating or business matters or similar
in so far as it is of essential financial importance to the person or companythe information concerns that the request should not be met."
There is no legal authority to give an appl icant an advance commitment of confidentiality.
However, pursuant to Section 12, subsection 1,2 of the Access to Public Administration Files Act, the
agency is obliged to exempt information of a confidential nature from the right of access to
documents.
Consequently, the Danish EPA will examine the data documentation and make a concrete
decision about this.  Information about the synthesis, the degree of purity and impurities of the
substance is typically information which can be classified "confidential".  In addition to this, thesections of the laboratory reports which identify the study and certify the formalia of the investigation
(the name of the laboratory, the guideline, the status  for GLP, etc.) are to be kept in the files of the
Danish Environmental Protection Agency and wi ll not be handed over to other parties.
In conclusion, it will not be possible to have a complete set of documentation/data released
for possible use for application(s) in other countries, etc..  The documentation which may be releasedwill be incomplete for such purposes and without any particular commercial value.
The type of information to which right of access to documents is granted is typically that of
studies undertaken and the results of such studies, e.g. a cancer study - information to which the
public is obviously entitled to be granted access (cf. Article 39.3 of the TRIPS Agreement, in fine ).
Similarly the relevant EU regulation also contains a provision according to which the public
shall be afforded general access to information on the harmful effect of a substance/product on human
beings and the environment.
Directive 91/414 on plant protection products sets out rules not only about data protection
(cf. article 13), but also on confidentiality.  Article 14 requires member States and the Commission,once they have accepted an applicant's motivation by application, to keep business secretsIP/Q3/DNK/1
Page 17
confidential.  However, Article 14, subsection 2, sets forth what may not be construed as confidential
information.  The proposed biocide directive aims at similar sets of rules.
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