Patents and Companies Registration Agency
Republic of Zambia

• 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 licenses 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 standard for patentability is provided for under Section 2 of the Patents Act, Cap. 400 of the Laws of Zambia: The invention must be new and useful art (whether, process or product) which is not obvious and capable of being used or applied in trade or industry.

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 Patent Act originates from the British Patent Act, and therefore excludes from Patentability the following: discoveries, scientific theory or mathematical method; a scheme, rule or method for performing a mental act, playing games or doing business or computer programme; literary and artistic work and presentation of information. 

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?

Section 28 (4) provides that the effect of a patent shall be to grant to the patentee, subject to the provisions of this Act and the conditions of the patent, full power, sole privilege and authority by himself, his agents and licensees during the term of the patent to make, use, exercise and vend the invention within Zambia in such a manner as to him seems meet, so that he shall have and enjoy the whole profit and advantage accruing by reason of the invention during the term of the patent.
 

3. Which exceptions and limitations does the applicable law provide in respect to patent rights (please indicate the applicable exceptions/limitations):

Prior use;
Use of articles on foreign vessels, aircrafts and land vehicles;
Acts for obtaining regulatory approval from authorities;
Compulsory licensing and/or government use.

Section 2: Private and/or non-commercial use

4.-6.

[Note from the Secretariat:  response was not provided.]

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):

“Commercial scale” is not defined in the current Patent Act, Cap. 400 of the Laws of Zambia and, therefore, the phrase should be given the ordinary grammatical meaning. 
 

8.-10.

[Note from the Secretariat: response was not provided.]

Section 3: Experimental use and/or scientific research

11.-22.

[Note from the Secretariat:  the applicable law of Zambia does not provide exceptions related to experimental use and/or scientific research.]

Section 4: Preparation of medicines

23.-30.

[Note from the Secretariat: the applicable law of Zambia does not provide exceptions related to the preparation of medicines.]

Section 5: Prior use

31. If the exception is contained in statutory law, please provide the relevant provision(s):

Section 53(4) provides exception for acts of non-infringement where the third party had started making the product before the date of filing the patent application for the invention embodied in the product; and
Section 8 (convention applications).

NB: The above exceptions only apply to the inventor/applicant/ predecessor in title and not to third parties. Any use thereof before filing the application in the Patent Office would destroy the novelty requirement. 
 

32.-37.

[Note from the Secretariat:  response was not provided.]
 

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:

Section 34 (a):
34. In every order restoring a lapsed patent made under section thirty-three, there shall be inserted for the protection of persons who may have availed themselves of the subject-matter of the patent after a lapse of a period of three months from the date on which the renewal fee was due, the following provisions, namely, that the patentee shall not commence or prosecute any action or other proceedings or recover damages:
(a) in respect of any infringement of the patent which has taken place after the lapse of the said period and before the date of the order.
 

39.-41.

[Note from the Secretariat:  response was not provided.]

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):

Section 9 of the Act provides that:
9. (1) where a vessel or aircraft registered in a convention country or a land vehicle owned by a person ordinarily resident in such a country comes into Zambia temporarily or accidentally only, the rights conferred by a patent for an invention shall not be deemed to be infringed by the use of the invention-
(a) in the body of the vessel or in the machinery, tackle, apparatus or other accessories thereof, so far as the invention is used on board the vessel and for its actual needs only; or
(b) in the construction or working of the aircraft or land vehicle or of the accessories thereof; as the case may be. 

43.-44.

[Note from the Secretariat:  response was not provided.]
 

45. The exception applies in relation to:

Vessels
Aircrafts
Land Vehicles
 

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, the applicable law applies such terms as ‘temporarily and/or accidentally’, however, there are no definitions for them in the Act. 
 

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, if invention is used-
(a) in the body of the vessel or in the machinery, tackle, apparatus or other accessories thereof, so far as the invention is used on board the vessel and for its actual needs only; or
(b) in the construction or working of the aircraft or land vehicle or of the accessories thereof;
(As cited under Section 9 of the Act above)
 

48.-50.

[Note from the Secretariat:  response was not provided.]

Section 7: Acts for obtaining regulatory approval from authorities

51.-59.

[Note from the Secretariat: the applicable law of Zambia does not provide exceptions related to acts for obtaining regulatory approval from authorities.]

Section 8: Exhaustion of patent rights

60.-64.

[The applicable law of Zambia does not provide exceptions related to exhaustion of patent rights.]

Section 9: Compulsory licenses and/or government use

Compulsory licenses

65. If the exception is contained in statutory law, please provide the relevant provision(s):

This is provided for under section 37 of the Patents Act. 
 

66. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat:  response was not provided.]
 

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
Anti-competitive practices and/or unfair competition
Public health
National security
National emergency and/or extreme urgency
 

68.(a) What are the public policy objectives for providing compulsory licenses in your country? Please explain:

To protect public interest

(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):

Section 37 (6)(b), the terms non-working or insufficient working have not been defined in the Act . However, the rights in a patent shall be deemed to be abused if the patented invention, being an invention capable of being worked in Zambia, is not being worked therein on a commercial scale and there is no satisfactory reason for such non-working. 
 

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):

No, section (37)(6)(b):
Any person may apply to the Registrar for the compulsory licence if the working of the invention within Zambia on a commercial scale is being prevented or hindered by the importation of the patented article by the patentee or persons claiming under him, or by persons directly or indirectly purchasing from him or by persons against whom the patentee is not taking or has not taken proceedings for infringement; 
 

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?

After the expiration of a period of three years subsequent to the date on which that patent was sealed or four years subsequent to the date on which the application in respect thereof was lodged, whichever period last expires, apply to the Registrar in the prescribed manner for a compulsory licence on the ground that the reasonable requirements of the public with respect to the invention in question have not been or will not be satisfied. 
 

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?

Yes

If yes, what are "legitimate reasons"?

Section 37(6) proviso: The application may be refused if the he High Court is of the opinion that the time which has elapsed since the sealing of the patent has by reason of the nature of the invention or for any other reason been insufficient to enable the invention to be worked within Zambia on a commercial scale, the High Court may make an order adjourning the hearing of the application for such period as will in its opinion be sufficient for that purpose. 
 

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):

The phrases are not defined in the Act, however, section 37(6) (d) has used the ‘phrase reasonable terms’. 
 

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):

Section 37(6)(f):
Any person may apply to the Registrar for the compulsory licence if any condition which under the provisions of section forty-nine is null and void as being in restraint of trade and contrary to public policy, has been inserted in any contract made in relation to the sale or lease of or any licence to use or work any article or process protected by the patent. 
 

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:

[Note from the Secretariat:  response was not provided.]
 

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:

Yes, section 37 (11):
(11) The order directing the grant of an exclusive licence under this section shall operate to divest the patentee of any right which he may have as patentee to work or use the invention, and to revoke all existing licences, unless otherwise provided in the order, and may, if considered fair and equitable by the High Court, be made subject to the condition that the licensee shall give proper compensation to be fixed by the High Court for any money or labour expended by the patentee or any existing licensee in developing or working the 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:

Section 41 (1) and (2):The Act provides for the phrase ‘period of emergency’ and not ‘circumstances of extreme urgency’.
41. (1) For the purposes of this section, the expression "period of emergency" means any period beginning on such date as may be declared by the Minister by statutory notice to be the commencement, and ending on such date as may be so declared to be the termination, of a period of emergency, .e.g. a national emergency was declared in 2004 in an effort to respond to HIV and Aids pandemic. 
 

78. Please indicate how many times and in which technological areas compulsory licenses have been issued in your country:

Once in 2004 on the invention relating to pharmaceutical products.
 

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:

No, the circumstances for issuance of compulsory licence have been broadened in the amended Draft law to be enacted.
 

80. Which challenges, if any, have been encountered in relation to the use of the compulsory licensing system provisions in your country? Please explain:

Insufficiency or no manufacturing capacity on the part of the local industries to produce generic pharmaceutical products when the compulsory licence is issued by government.

Government use

81. If the exception is contained in statutory law, please provide the relevant provision(s):

40. (1) Not withstanding anything in this Act, any Government department or any person authorised in writing by the Minister may make, use or exercise any invention disclosed in any specification lodged at the Patent Office for the service of the State in accordance with the provisions of this section.
 

82. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat:  response was not provided.]
 

83. What grounds for the grant of government use 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
 

84.(a) What are the public policy objectives for providing government use in your country?

Public/national interest

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]  
 

85. If the applicable law provides for the grant of government use 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 phrases are not defined in the Act; however, this may be inferred from section 41(2):
(2) During any period of emergency the powers exercisable in relation to an invention by a Government department or a person authorised by the Minister under section forty, shall include power to make, use, exercise and vend the invention for any purpose which appears to the Minister necessary or expedient-
    (a for the efficient prosecution of any war in which the Republic may be engaged;
    (b) for the maintenance of supplies and services essential to the life of the community;
    (c )for securing a sufficiency of supplies and services essential to the well-being of the community;
    (d) for promoting the productivity of industry, commerce and agriculture;
    (e) for fostering and directing exports and reducing imports or imports of any classes, from all or any countries and for redressing the balance of trade;
    (f) generally for ensuring that the whole resources of the community are available for use, and are used, in a manner best calculated to serve the interests of the community; or
    (g) for assisting the relief of suffering and the restoration and distribution of essential supplies and services in any part of Her Britannic Majesty's dominions or any foreign countries that are in grave distress as the result of war; and any reference in that section or in section forty-two to the services of the State shall be construed as including a reference to the purposes aforesaid.
 

86. Please indicate how many times and in which technological areas government use has been issued in your country:

Once in 2004 on the invention relating to pharmaceutical products
 

87. Is the applicable legal framework for the issuance of government use considered adequate to meet the objectives sought (for example, are there any amendments to the law foreseen)? Please explain:

No, the circumstances for issuance of government use licence have been broadened in the amended Draft law to be enacted by including exhaustion of patent rights ( based on international principle).
 

88. Which challenges, if any, have been encountered in relation to the use of the government use mechanism in your country? Please explain:

[Note from the Secretariat: response was not provided.]
 

Section 10: Exceptions and limitations related to farmers' and/or breeders' use of patented inventions

89.-100.

[Note from the Secretariat: the applicable law of Zambia does not provide exceptions and limitations related to farmers' and/or breeders' use of patented inventions.]

Section 11: Other Exceptions and Limitations

101.-103.

[Note from the Secretariat: the applicable law of Zambia does not provide other exceptions and limitations.]

[End of Questionnaire]

March 2012