System of patent protection
1. Is patent protection provided for pharmaceutical products?
Yes/No
a) If yes, how long ago was patent protection introduced?
b) If yes, is this a process or product patent (circle as appropriate)?
Process/Product/Both
c) What is the duration of the patent term?
Please add any comments on the product/process patent issue that may be relevant to your country
________________________________________________________________________
________________________________________________________________________
2. If the country is a WTO Member, has national legislation been modified to implement the TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights)? yes/no
a) If yes, when did it take effect?
b) If not, when is this likely to take place?
c) Is the country availing itself of the transition period provided by Article 65 of the TRIPS Agreement?
d) If the country is a least-developing country (LDC), has it availed itself of the transitional period accorded to LDCs in Article 66 of the TRIPS Agreement?
3. Have parallel importing provisions been incorporated into national legislation?
Yes/No/Currently being discussed
a) If yes, have these parallel importing provisions been applied for pharmaceuticals?
Yes/No
b) What regime of exhaustion is incorporated into national legislation?
International/Regional/National
4. Have compulsory licensing provisions been incorporated into national legislation?
Yes/No/Currently being discussed
a) If yes, have these compulsory licensing provisions been applied for pharmaceuticals?
Yes/No
b) If yes, under what conditions?
National emergency/Public non-commercial use/Remedying anti-competitive practices/Other (please specify)/Don’t know
5. Are generic pharmaceutical manufacturers allowed to use patented inventions for the purpose of obtaining marketing approval prior to patent expiration; i.e has a Bolar provision been incorporated in national legislation? (see definitions page 38-39)
Yes/No/Currently being discussed
6. Are there provisions granting a minimum term of data exclusivity for the protection of test data submitted for the marketing approval of a pharmaceutical product? (see definitions page 38-39)
Yes/No/Currently being discussed
Table F: Patent and/or data exclusivity status |
Product |
Dates of patent expiration
(if applicable) |
Date of data exclusivity expiration
(if applicable) |
Erythromycin |
|
|
Ciprofloxacin |
|
|
Rifampicin |
|
|
Doxycycline |
|
|
Cyclophosphamide |
|
|
Hydrochlorothiazide |
|
|
Atenolol |
|
|
Salbutamol |
|
|
Candesartan |
|
|
Celecoxib |
|
|
Orlistat |
|
|
Sildenafil |
|
|
Olanzapine |
|
|
Levofloxacin |
|
|
Atorvastatin |
|
|
Montelukast |
|
|
Esomeprazol |
|
|
Fluconazole |
|
|
Zidovudine |
|
|
Nevirapine |
|
|
Azithromycin |
|
|
Didanosine (ddI) |
|
|
Indinavir |
|
|
Lamivudine |
|
|
Ofloxacin |
|
|
Lamivudine + Zidovudine |
|
|
Zidovudine + Lamivudine + Abacavir |
|
|
Pre-marketing authorization
1. Which authority is responsible for granting marketing approval (registration)?
________________________________________________________________________
________________________________________________________________________
2. What is its affiliation with the Ministry of Health?
________________________________________________________________________
________________________________________________________________________
3. Is there any linkage between the processes of drug registration (Ministry of Health or Drug Regulatory Authority) and the grant of patent (National Patent Office)?
Yes/No
4. What is the average length of time required for approval of a new pharmaceutical product? (Please indicate with reference to any given year)
| |
Year |
|
Length of time (in months) |
5. What is the average length of time required for approval of a generic pharmaceutical product upon patent expiration? (Please indicate reference to any given year)
| |
Year |
|
Length of time (in months) |
6. How many pharmaceutical products are approved by the health registration authority in 2001?
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