1. DOMESTICATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES IN ZAMBIA AN OVERVIEW OF PATENT PROTECTION IN ZAMBIA George Mpundu Kanja mkanja@live.com

2. STRUCTURE OF PRESENTATION Introduction Definition of Patent Substantive Provisions relating to Public Health ARIPO Patents Conclusion

3. Introduction Zambia’s Patent regime or regulatory framework dates back from the Zambia’s pre-independence era. The Zambian Patent Act, Cap 400 was enacted in 1958. From the time Zambia attained its independence in 1964 to date, Zambia has continued with the same Patent Act it inherited at independence.

4. Introduction In addition to the Patents Act Zambia is a party, or has ratified international conventions or treaties dealing with patents notably the Paris Convention and World Trade Organization (WTO) Trade Related Aspects of Intellectual Property (TRIPS Agreement).

5. Definition of Patent A patent is defined as an exclusive right granted to an inventor to prevent others from making, selling, distributing, importing or using the invention, without licence or authorisation, for a fixed period of time. In return the inventor or patentee discloses the invention to the public.

6. Definition of Patent In order to be protected a patent has to fulfill three requirements for patentability namely:  Novelty or new  Inventive Step or non-obviousness and  Industrial Applicability.

7. Definition of Patent The patent grants the following rights to the owner: (a) Where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling or importing for these purposes that product.

8. Definition of Patent (b) Where the subject matter of the patent is process, to prevent third parties not having the owner’s consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.

9. Substantive Provisions relating to Public Health The main features of the Patents Act as they relate to public health are as follows: (i) Product Patent vs Process Patent (ii) Pharmaceutical Patents (iii) Exclusion from Patentability of substance capable of being used as food or medicine (iv) Compulsory licenses

10. Substantive Provisions relating to Public Health (v) State use of the Patents (vi) Special provisions as to State use of Patent during emergency

11. (i) Product Patent vs Process Patent The Patent Act protects both the Product Patent or Invention and the Process Patent or Invention. The product patent protects the physical or object of product such Panadol. The process patent protects the method of making such product such Panadol.

12. (i) Product Patent vs Process Patent Section 2 of the Patents Act defines invention as any new and useful art (whether producing a physical effect or not), process, machine, manufacture or composition of matter which is not obvious, or any new and useful improvement thereof which is not obvious, capable of being used or applied in trade or industry and includes an alleged invention. Why India Pharmaceutical industry developed?

13. (ii) Pharmaceutical Patents The Patent Act protects both the product patent and process patent for pharmaceuticals. Section 2 of the Patents Act defines invention as any new and useful art (whether producing a physical effect or not), process …

14. (iii) Exclusion from Patentability of substance capable of being used as food or medicine The Patents Act empowers the Registrar to refuse or grant a patent of an invention a substance capable of being used as food or medicine.

15. (iii) Exclusion from Patentability of substance capable of being used as food or medicine Section 18 of the Patents Act provides: If it appears to the Registrar in the case of any application for a patent that it claims as an invention a substance capable of being used as food or medicine which is a mixture of known ingredients possessing only the aggregate of the known properties of the ingredients, or that it claims as an invention a process producing such a substance by mere admixture, he may refuse the application.

16. (iv) Compulsory licenses The Patents Act empowers the Registrar to grant a compulsory license in case of abuse or insufficient use of patent rights

17. (iv) Compulsory licenses Section 37 of the Patents Act provides: any person interested who can show that he has been unable to obtain a licence under a patent on reasonable terms may, 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.

18. (v) State use of the Patents The Patents Act empowers the Minister to authorize a Government department or any person to use or exercise any invention granted or disclosed at the Patents Office

19. (v) State use of the Patents Section 40 of the Patents Act provides: Notwithstanding 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.

20. (vi) Special provisions as to State use of Patent during emergency The Patents Act empowers the Government to make, use, exercise and vend the invention for any purpose which appears to the Minister necessary or expedient.

21. (vi) Special provisions as to State use of Patent during emergency Section 41 of the Patents Act provides: 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- (b)for the maintenance of supplies and services essential to the life of the community;

22. (vi) Special provisions as to State use of Patent during emergency (c)for securing a sufficiency of supplies and services essential to the well-being of the community; (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

23. ARIPO Patents Zambia a party to the Protocol on Patents and Industrial Designs within the Framework Of African Intellectual Property Organization (ARIPO) (1982) Any patent granted by ARIPO where Zambia has been designated and if Zambia has not objected to the grant of the patent that patent has an effect or is binding on Zambia.

24. ARIPO Patents Section 10A of the Patents Act provides: Where a patent has been granted by ARIPO under section 3 (7) of the ARIPO Protocol and the Registrar has not objected, under section 3 (6) of the Protocol, to the patent having effect in Zambia, the patent shall for all purposes be deemed to have been granted under this Act. A patent shall not be deemed to have been granted under this section if, under section 3 (6) of the ARIPO Protocol, the Registrar objects to its having effect in Zambia.

25. Conclusion The Patent Act does not contain adequate and elaborate provisions relating to public health and access to medicine and as such must be amended to take into account the flexibilities and access to medicines provisions.

26. THANK YOU