Danish Patent and Trademark Office (DKPTO)
- Section 1 General
- Section 2 Private and/or non-commercial use
- Section 3 Experimental use and/or scientific research
- Section 4 Preparation of medicines
- Section 5 Prior use
- Section 6 Use of articles on foreign vessels, aircrafts and land vehicles
- Section 7 Acts for obtaining regulatory approval from authorities
- Section 8 Exhaustion of patent rights
- Section 9 Compulsory licensing and/or government use
- Section 10 Exceptions and limitations related to farmers' and/or breeders' use of patented inventions
- Section 11 Other exceptions and limitations
Section 1: General
1. As background for the exceptions and limitations to patents investigated in this questionnaire, what is the legal standard used to determine whether an invention is patentable? If the standard for patentability includes provisions that vary according to the technology involved, please include examples of how the standard has been interpreted, if available. Please indicate the source of law (statutory and-or case law) by providing the relevant provisions and/or a brief summary of the relevant decisions.
The Consolidate Patents Act (Act no. 91 of 28 January 2009)
Correspondingly, please list exclusions from patentability that exist in your law. Furthermore, please provide the source of those exclusions from patentability if different from the source of the standard of patentability, and provide any available case law or interpretive decisions specific to the exclusions.
The following is not considered as inventions:
a) discoveries, scientific theories and mathematical methods
b) aesthetic creations
c) schemes, rules or methods for performing mental acts, playing games or doing business or programs for computers
d) presentation of information
Patents shall not be granted in respect of:
e) methods for treatment of the human or animal body by surgery or therapy or diagnostic methods practiced on the human or animal body
f) plant or animal varieties (plant variety as defined in EC regulation 2100/94, article 5)
g) essential biological processes for the production of plants or animals
h) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements
i) inventions contrary to ordre public or morality
j) processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, uses of human embryos for industrial or commercial purposes, and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, also animals resulting from such processes
2. As background for the exceptions and limitations to patents investigated in this questionnaire, what exclusive rights are granted with a patent? Please provide the relevant provision in the statutory or case law. In addition, if publication of a patent application accords exclusive rights to the patent applicant, what are those rights?
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 1(1):
“Any person who has made an invention which is susceptible of industrial application, or his successor in title, shall, in accordance with this Act, have the right on application to be granted a patent for the invention and thereby obtain an exclusive right to exploit the invention commercially. Inventions may be patented within all areas of technology.”
3. Which exceptions and limitations does the applicable law provide in respect to patent rights (please indicate the applicable exceptions/limitations):
Private and/or non-commercial use;
Experimental use and/or scientific research;
Preparation of medicines;
Prior use;
Use of articles on foreign vessels, aircrafts and land vehicles;
Acts for obtaining regulatory approval from authorities;
Exhaustion of patent rights;
Compulsory licensing and/or government use;
Exceptions and limitations related to farmers’ and/or breeders’ use of patented inventions.
Section 2: Private and/or non-commercial use
4. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3(3)(i).
5. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None.
6.(a) What are the public policy objectives for providing the exception?
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Alignment with Article 31a in Agreement relating to Community patents, 1989, signed by Denmark.
7. If the applicable law defines the concepts “non-commercial”, “commercial” and/or “private”, please provide those definitions by citing legal provision(s) and/or decision(s):
No definition.
8. If there are any other criteria provided in the applicable law to be applied in determining the scope of the exception, please provide those criteria by citing legal provision(s) and/or decision(s):
None.
9. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes.
10. Which challenges, if any, have been encountered in relation to the practical implementation of the exception in your country? Please explain:
None.
Section 3: Experimental use and/or scientific research
11. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3(3)(iii).
12. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None.
13.(a) What are the public policy objectives for providing the exception?
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Alignment with Article 31b in Agreement relating to Community patents, 1989, signed by Denmark
14. Does the applicable law make a distinction concerning the nature of the organization conducting the experimentation or research (for example, whether the organization is commercial or a not-for-profit entity)? Please explain:
No.
15. If the applicable law defines the concepts “experimental use” and/or “scientific research”, please provide those definitions by citing legal provision(s) and/or decision(s):
None.
16. If the purpose of experimentation and/or research is relevant to the determination of the scope of the exception, please indicate what that purpose is:
Experimentation and/or research should aim to:
[Note from the Secretariat: response was not provided.]
17. If any of the following criteria is relevant to the determination of the scope of the exception, please indicate:
Research and/or experimentation must be conducted on or relating to the patented invention (“research on”)
Research and/or experimentation must be conducted with or using the patented invention (“research with”)
Please explain by citing legal provision(s) and/or decision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3(3)(iii).
18. If the commercial intention of the experimentation and/or research is relevant to the determination of the scope of the exception, please indicate whether the exception covers activities relating to:
The commercial intention of the experimentation and/or research is not relevant.
19. If the applicable law makes a distinction between “commercial” and “non-commercial” purpose, please explain those terms by providing their definitions, and, if appropriate, examples. Please cite legal provision(s) and/or decision(s):
No distinction.
20. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
None.
21. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes
22. Which challenges, if any, have been encountered in relation to the practical implementation of the exception in your country? Please explain:
None
Section 4: Preparation of medicines
23. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3(3)(V).
24. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None.
25.(a) What are the public policy objectives for providing the exception? Please explain:
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Alignment with Article 31b in Agreement relating to Community patents, 1989, signed by Denmark.
26. Who is entitled to use the exception (for example, pharmacists, doctors, physicians, others)? Please describe:
Pharmacists making the preparation in a Pharmacy upon medical prescription.
27. Does the applicable law provide for any limitations on the amount of medicines that can be prepared under the exception?
No.
28. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
None.
29. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes, but it is hardly used since nearly no preparations take place at pharmacies any longer in our country.
30. Which challenges, if any, have been encountered in relation to the practical implementation of the exception in your country? Please explain:
None.
Section 5: Prior use
31. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 4(1)
32. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None
33.(a) What are the public policy objectives for providing the exception? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
[Note from the Secretariat: response was not provided.]
34. How does the applicable law define the scope of “use”? Does the applicable law provide for any quantitative or qualitative limitations on the application of the “use” by prior user? Please explain your answer by citing legal provision(s) and/or decision(s):
Qualitative limitation: “Use” must not constitute an evident abuse in relation to the applicant or his legal predecessor
35. Does the applicable law provide for a remuneration to be paid to the patentee for the exercise of the exception? Please explain:
No
36. According to the applicable law, can a prior user license or assign his prior user’s right to a third party?
Yes
37. In case of affirmative answer to question 36, does the applicable law establish conditions on such licensing or assignment for the continued application of the prior use exception?
Yes
If yes, please explain what those conditions are:
The “use” right provided for shall only be transferred to others together with the business in which it has arisen or in which the exploitation was intended.
38. Does this exception apply in situations where a third party has been using the patented invention or has made serious preparations for such use after the invalidation or refusal of the patent, but before the restoration or grant of the patent?
Yes
If yes, please explain the conditions under which such use can continue to apply:
[Note from the Secretariat: response was not provided.]
39. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
[Note from the Secretariat: response was not provided.]
40. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes
41. Which challenges, if any, have been encountered in relation to the practical implementation of the exception in your country? Please explain:
None
Section 6: Use of articles on foreign vessels, aircrafts and land vehicles
42. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 5(1)
43. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None
44.(a) What are the public policy objectives for providing the exception? Please explain:
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Implementation of article 5 ter in the Paris Convention
45. The exception applies in relation to:
Vessels;
Aircrafts;
Land Vehicles;
Spacecraft.
46. In determining the scope of the exception, does the applicable law apply such terms as ”temporarily” and/or “accidentally” or any other equivalent term in relation to the entry of foreign transportation means into the national territory? Please provide the definitions of those terms by citing legal provision(s) and/or decision(s):
Yes, ”temporarily” or “accidentally”
47. Does the applicable law provide for any restrictions on the use of the patented product on the body of the foreign vessels, aircrafts, land vehicles and spacecraft for the exception to apply (for example, the devices to be used exclusively for the needs of the vessel, aircraft, land vehicle and/or spacecraft)? Please explain your answer by citing legal provision(s) and/or decision(s):
Yes, devices used exclusively for the needs of the vessel, aircraft, or land vehicle.
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 5(2).
48. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
None.
49. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes
50. Which challenges, if any, have been encountered in relation to the practical implementation of the exception in your country? Please explain:
None.
Section 7: Acts for obtaining regulatory approval from authorities
51. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3(3)(iv).
52. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None.
53.(a) What are the public policy objectives for providing the exception? Please explain:
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Implementation of EU directives 2004/27 and 2004/28.
54. Who is entitled to use the exception? Please explain:
Anyone.
55. The exception covers the regulatory approval of:
Certain medicinal products.
56. Please indicate which acts are allowed in relation to the patented invention under the exception?
Acts necessary to obtain marketing clearance for medicinal product, e.g. studies, tests, examination or related procedures to the patented product.
57. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
None.
58. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes.
59. Which challenges, if any, have been encountered in relation to the practical implementation of the exception in your country? Please explain:
None.
Section 8: Exhaustion of patent rights
60. Please indicate what type of exhaustion doctrine is applicable in your country in relation to patents:
Regional.
If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3(3)(ii).
If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None.
61.(a) What are the public policy objectives for adopting the exhaustion regime specified above? Please explain:
A regional exhaustion regime has been determined by the EU Court of Justice and ensure the free trade between member states of the European Union.
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
[Note from the Secretariat: response was not provided.]
62. Does the applicable law permit the patentee to introduce restrictions on importation or other distribution of the patented product by means of express notice on the product that can override the exhaustion doctrine adopted in the country?
No.
Please explain your answer by citing legal provision(s) and/or decision(s):
[Note from the Secretariat: response was not provided.]
63. Has the applicable exhaustion regime been considered adequate to meet the public policy objectives in your country? Please explain:
[Note from the Secretariat: response was not provided.]
64. Which challenges, if any, have been encountered in relation to the practical implementation of the applicable exhaustion regime in your country? Please explain:
None.
Section 9: Compulsory licensing and/or government use
Compulsory licenses
65. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Sections 45-50.
66. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
None.
67. What grounds for the grant of a compulsory license does the applicable law provide in respect to patents (please indicate the applicable grounds):
Non-working or insufficient working of the patented invention;
Refusal to grant licenses on reasonable terms;
Public health;
National security;
National emergency and/or extreme urgency;
Dependent patents.
68.(a) What are the public policy objectives for providing compulsory licenses in your country? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
[Note from the Secretariat: response was not provided.]
69. If the applicable law provides for the grant of compulsory licenses on the ground of “non-working” or “insufficient working”, please provide the definitions of those terms by citing legal provision(s) and/or decision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 45(1)-(2).
“45.-(1) If a patented invention is not worked to a reasonable extent in this country when 3 years have elapsed from the grant of the patent and 4 years have elapsed from the filing of the patent application, any person wishing to work the invention in this country may obtain a compulsory licence to do so, unless there are legitimate reasons for the failure to work the invention.
(2) The Minister of Economic and Business Affairs may provide that for the purposes of the provision of subsection 1 working of the invention in another country shall be equivalent to working in this country. Such a provision may be made subject to reciprocity.”
70. Does the importation of a patented product or a product manufactured by a patented process constitute “working” of the patent? Please explain your answer by citing legal provision(s) and/or decision(s):
See 69.
71. In case of the grant of compulsory licenses on the grounds of non-working or insufficient working, does the applicable law provide for a certain time period to be respected before a compulsory license can be requested?
Yes.
If yes, what is the time period?
3 yrs. from grant of patent and 4 yrs. from filing of patent.
72. In case of the grant of compulsory licenses on the grounds of non-working or insufficient working, does the applicable law provide that a compulsory license shall be refused if the patentee justifies his inaction by legitimate reasons?
No.
73. If the applicable law provides for the grant of compulsory licenses on the ground of refusal by the patentee to grant licenses on “reasonable terms and conditions” and within a “reasonable period of time”, please provide the definitions given to those terms by citing legal provision(s) and/or decision(s):
No.
74. If the applicable law provides for the grant of compulsory licenses on the ground of anti-competitive practices, please indicate which anti-competitive practices relating to patents may lead to the grant of compulsory licenses by citing legal provision(s) and/or decision(s):
No.
75. If the applicable law provides for the grant of compulsory licenses on the ground of dependent patents, please indicate the conditions that dependent patents must meet for a compulsory license to be granted:
Condition: The former invention constitutes a significant technical progress of considerable economic importance.
76. Does the applicable law provide a general policy to be followed in relation to the remuneration to be paid by the beneficiary of the compulsory license to the patentee? Please explain:
“The proprietor of the patent for the invention or of the registered utility model for the exploitation of which a compulsory licence has been granted .. shall on reasonable terms be able to obtain a compulsory licence for the exploitation of the other invention.”
77. If the applicable law provides for the grant of compulsory licenses on the ground of “national emergency” or “circumstances of extreme urgency”, please explain how the applicable law defines those two concepts and their scope of application, and provide examples:
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 47 states, “When required by important public interest, any person who wishes to exploit an invention commercially for which another person holds a patent may obtain a compulsory license to do so.”
According to the preparatory remarks of the Act, such important public interests may concern (non-exhaustive list) national security, the population’s access to medical products and food, power supply, communication lines etc.
78. Please indicate how many times and in which technological areas compulsory licenses have been issued in your country:
[Note from the Secretariat: response was not provided.]
79. Is the applicable legal framework for the issuance of compulsory licenses considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes.
80. Which challenges, if any, have been encountered in relation to the use of the compulsory licensing system provisions in your country? Please explain:
None.
Government use
81.-88.
[Note from the Secretariat: the applicable law of Denmark does not provide exceptions related to government use.]
Section 10: Exceptions and limitations related to farmers' and/or breeders' use of patented inventions
Farmers’ use of patented inventions
89. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3b
90. If the exception is provided through case law, please cite the relevant decision(s) and provide a brief summary of such decision(s):
[Note from the Secretariat: response was not provided.]
91.(a) What are the public policy objectives for providing the exception related to farmers’ use of patented inventions? Please explain:
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Implementation of EU directive 98/44 for the Legal Protection of Biotechnological Inventions.
92. Please explain the scope of the exception by citing legal provision(s) and/or decision(s) (for example, interpretation(s) of statutory provision(s) on activities allowed by users of the exception, limitations on their use, as well as other criteria, if any, applied in the determination of the scope of the exception):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3b (2):
“3b-(2) Notwithstanding the provisions of section 3a(1) to (3), the sale or any other form of commercialisation of breeding stock or other animal reproductive material by the proprietor of the patent or with his consent to a farmer shall imply an authorisation for the farmer to use the animal or other animal reproductive material for the purposes of pursuing his own agricultural activity, but not to sell it within the framework or for the purpose of a commercial reproduction activity. The Minister of Economic and Business Affairs shall lay down provisions concerning the extent and the conditions of the farmer's exploitation of such patents for the purposes of pursuing his own agricultural activity.”
93. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes.
94. Which challenges, if any, have been encountered in relation to the practical implementation of the exception related to farmers’ use of patented inventions in your country? Please explain:
None.
Breeders’ use of patented inventions
95. If the exception is contained in statutory law, please provide the relevant provision(s):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3b.
96. If the exception is provided through case law, please cite the relevant decision(s) and provide a brief summary of such decision(s):
[Note from the Secretariat: response was not provided.]
97.(a) What are the public policy objectives for providing the exception related to breeders’ use of patented inventions? Please explain:
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
Implementation of EU directive 98/44 for the Legal Protection of Biotechnological Inventions.
98. Please explain the scope of the exception by citing legal provision(s) and/or decision(s) (for example, interpretation(s) of statutory provision(s) on activities allowed by users of the exception, limitations on their use, as well as other criteria, if any, applied in the determination of the scope of the exception):
The Consolidate Patents Act (Act no. 91 of 28 January 2009), Section 3b (1):
“3b.-(1) Notwithstanding the provisions of section 3a(1) to (3), the sale or any other form of commercialisation of plant propagating material by the proprietor of the patent or with his consent to a farmer for agricultural use shall imply an authorisation for the farmer to use the product of his harvest for multiplication or propagation by him on his own farm, the extent and conditions thereof being laid down in Article 14 of Council Regulation (EC) No. 2100/94 on Community plant variety rights.”
99. Is the applicable legal framework of the exception considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:
Yes.
100. Which challenges, if any, have been encountered in relation to the practical implementation of the exception related to breeders’ use of patented inventions in your country? Please explain:
None.
Section 11: Other exceptions and limitations
101.-103.
[Note from the Secretariat: the applicable law of Denmark does not provide other exceptions and limitations.]
[End of questionnaire]
September 2011