Business Registrations and Licensing Agency (BRELA)
United Republic of Tanzania

  • 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.

(i) Novelty
(ii) Inventive step
(iii) Applicability as provided for under section 8 of the Patents Act.

The provisions of section 7 (2) of the Patents (Registration) Act Cap. 217 R.E. 2002 provides for exclusion from patentable inventions.


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.

Plants and animals varieties;
Methods for treatment;
Discoveries, scientific and mathematical theories;
Mere presentation of information;
Schemes, rules or method for doing business.


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?

Exclusive exploitation of the invention.
The provisions of section 35 and 36 of the Patents (Registration) Act Cap 217 R.E. 2002 so provides.



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;
Use of articles on foreign vessels, aircrafts and land vehicles;
Exhaustion of patent rights;
Compulsory licensing and/or government use.

 

Section 2: Private and/or non-commercial use

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

The provisions of section 38 of the Act limit the rights of the patentee to acts done for scientific research. Patent rights do not extend to scientific research or acts related thereto.


5. 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.]


6.(a) What are the public policy objectives for providing the exception?

An inference may be drawn from the preamble of the Patents (Registration) Act Cap 217R.E. 2002 in respect of facilitation to acquisition of technology on fair terms.

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

[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):

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


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):

Section 37 of the Act provides for the scope of protection to be determined by the terms of the claims in a patent document.


9.-10.

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

 

Section 3: Experimental use and/or scientific research

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

The provisions of section 38 of the Patent Act are an exception in that the rights of the patentee cannot extend to acts done on scientific research.


12. 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.]


13. (a) What are the public policy objectives for providing the exception?

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

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


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, it doesn’t.


15.-17.

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


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:

A non-commercial purpose;
A commercial purpose.


19.-22.

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

 

Section 4: Preparation of medicines

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

Methods for treatment are excluded from patentable inventions in terms of the provisions of section 7 (2) (a) of the Patents Act.


24.-25.

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


26. Who is entitled to use the exception (for example, pharmacists, doctors, physicians, others)? Please describe:

Doctors are most likely to use the exception in so far as prescription of medication is concerned.


27. Does the applicable law provide for any limitations on the amount of medicines that can be prepared under the exception?

No


28.-30.

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

 

Section 5: Prior use

31.-41.

[Note from the Secretariat: the applicable law of the United Republic of Tanzania does not provide exceptions related to prior use.]

 

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 rights under the patent shall not extend to the use of articles on an aircraft, land vehicles or vessels of other countries as provided for under the provisions of section 38 (3) of the Act.


43.-44.

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


45. The exception applies in relation to:

Vessels;
Aircrafts;
Land Vehicles.


46.-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 the United Republic of Tanzania does not provide exceptions related to acts for obtaining regulatory approval from authorities.]

 

Section 8: Exhaustion of patent rights

60. Please indicate what type of exhaustion doctrine is applicable in your country in relation to patents:

National

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

The provisions of section 38 (2) of the Patent Act in respect of articles which have been put on the market by the patentee or with his consent.

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.]


61.(a) What are the public policy objectives for adopting the exhaustion regime specified above? 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.]


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


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:

The provisions of sections 53, 54 and 55 of the Patents Act provide for compulsory licences and government use under section 62. An exception is provided for under section 53 (3) of the Act.

 

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):

Section 53(3)


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;
Dependent patents.


68.-69.

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


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):

The provisions of section 53(1) (c) of the Patents Act to the effect that the working of the patented invention in the United Republic of Tanzania is being hindered by or prevented by the importation of the patented product.


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?

Four (4) years (section 53(1) of the Act.


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”?

Depending on the prevailing circumstances that shall be determined by the court under section 53(3) of the Act.


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):

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


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 53(1)(c)


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:

(i) Serves industrial purposes (section 54 of the Act)
(ii) Constitute substantial technical progress in relation to that last mentioned invention
(iii) If the two (patents) inventions serves the same purpose


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:

Equitable remuneration in circumstances of a case at hand as provided for under the provisions of section 62 (3) of the Act.


77.-79.

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


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 capacity on the part of local industries to produce generic pharmaceutical products should a compulsory licence be issued against a patented invention.


Government use

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

Where a vital public interest requires and or justifies issuance of a compulsory license by Government for Government use in terms of section 62(1).
Where the patentee prefers to appeal against the amount of remuneration fixed by the Registrar of Patents, such appeal shall not suspend the exploitation of the patented invention as provided for under section 62 (1) of the Act.


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):

Public health;
National security;
National emergency and/or extreme urgency.


84.-88.

[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 the United Republic of Tanzania 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 the United Republic of Tanzania does not provide other exceptions and limitations.]


[End of questionnaire]

October 2011