1. DOMESTICATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES IN ZAMBIA PROPOSED PATENT BILL AND ITS RELEVANCY TO PUBLIC HEALTH George Mpundu Kanja mkanja@live.com

2. STRUCTURE OF PRESENTATION Introduction Justification for Public Health Provisions in the Patent Bill Public Health Provisions in the Patent Bill Conclusion

3. Introduction Zambia’s IP regime or regulatory framework dates back from the Zambia’s pre-independence era, in particular 1958 when the IP laws namely  Patents Act, Cap 400;  Trade Marks Act, Cap 401;  Registered Designs Act, Cap 402;  Merchandise Marks Act, Cap 405; and Copyright and Performance Rights Act, Cap 406, were enacted.

4. Introduction From the time Zambia attained its independence in 1964 to date, it has continued with the same Patent Act it inherited at independence. Besides Zambia is a party, or has ratified a number of 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. Introduction TRIPS Agreement requires WTO Members such as Zambia to provide for the minimum standards for the protection of intellectual property rights in their respective legislation or laws by 2013 and 2016 for public health (pharmaceuticals) matters.

6. Introduction In 2010 the Ministry of Commerce, Trade and Industry adopted the National Intellectual Property Policy which called for the amendment of the Patents Act, and domestication of international obligations related to intellectual property that are beneficial to Zambia.

7. Justification for Public Health Provisions in the Patent Bill (1) IP Policy The National Intellectual Property Policy calls for legal reform, in particular, the amendment of the Patents Act and domestication of international obligations related to intellectual property such as TRIPS Agreement that are beneficial to Zambia.

8. Justification for Public Health Provisions in the Patent Bill (2)WTO Doha Declaration on TRIPS Agreement and Public Health – adopted on November 14, 2001 Clause 4 of Doha Declaration states as follows: “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can

9. Justification for Public Health Provisions in the Patent Bill and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”

10. Justification for Public Health Provisions in the Patent Bill (3) Extension of the Transition period under Article 66.1 of the TRIPS Agreement for LDC Members for certain obligations with respect to pharmaceutical products – Decision of the Council Trips of June 27, 2002 The TRIPS Agreement exempts the LDCs Members of WTO to give patent protection for pharmaceutical patents or products.

11. Justification for Public Health Provisions in the Patent Bill The WTO Council for TRIPS decision states as follows: “LDC country Members will not be obliged, with respect of pharmaceutical products, to implement or apply sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these sections until January 1, 2016.

12. Public Health Provisions in the Patent Bill The public health provisions in the proposed patents bill can be grouped into three categories namely: (1) Preventive Provisions (2) Remedial Provisions (3) Enforcement Provisions

13. (1) Preventive Provisions The preventive provisions that are provided in the proposed Patent Bill in relation to public health are as follows: (i) exclusion from patentability of Pharmaceutical Products (ii) Exclusion from patentability new uses or second use of medicine (iii) exclusion from patentability methods of treatment

14. (1) Preventive Provisions (iv) Pre-Grant Patent Opposition (v) ARIPO Patents

15. (1) Preventive Provisions The Patent Bill excludes from Patentability the following: (i) Pharmaceutical Products Section 14 provides as follows: Pharmaceutical products and processes shall not be patentable until the year 2016 or until the expiry of such later period of extension as may be agreed upon by the World Trade Organization for least developed countries.

16. (1) Preventive Provisions (ii) New uses or second use of medicine Section 15 provides: New uses of a known product or process including public health related methods of use of any substance such as the second use of a medicine shall not be protected by a patent.

17. (1) Preventive Provisions (iii) Methods of treatment Section 15 provides: Diagnostic, therapeutic and surgical methods for treatment of humans shall not be protected by a patent.

18. (1) Preventive Provisions (iv) Pre-Grant Patent Opposition The Patent Bill allows any interested person including the State to challenge the grant of a patent to an applicant on various grounds including on public health matters.

19. (1) Preventive Provisions (V) 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.

20. (1) Preventive Provisions Section 64 provides: (1) A patent, in respect of which Zambia is a designated state, granted by ARIPO by virtue of the ARIPO Protocol shall have effect in Zambia as a patent granted under this Act except where the Registrar objects or communicates to ARIPO, in respect of the application thereof, a decision in accordance with the provisions of the Protocol, that if a patent is granted by ARIPO, that patent shall not have effect in Zambia.

21. (1) Preventive Provisions (2) Notwithstanding subsection (1), where because of the non objection or communication to ARIPO by the Registrar, a patent is granted by ARIPO under the ARIPO Protocol which should not have been granted under this Act, that patent shall be invalid and shall have no effect whatsoever on Zambia.

22. Remedial Provisions The remedial provisions that are provided in the proposed Patent Bill in relation to public health are as follows: (i) Parallel Imports (ii) Compulsory Licenses for non-working of patents or similar reasons (iii) Compulsory Licenses for Products and Processes declared to be of vital importance

23. Remedial Provisions (iv) Exploitation of patented inventions by the Government or by third persons authorized by the Government (v) Manufacture and Export of Healthcare or Pharmaceutical Patents or Products (vi) Exceptions

24. Remedial Provisions (i) Parallel Imports Parallel imports are imports of a patented product from another country once it has been put on the market in that country by the titleholder or owner of the patent or other authorized party.

25. Remedial Provisions Section 82 provides: A patent holder shall not have the right to prevent acts of importation of any product or article covered by a patent that has been put on the market in any country or anywhere in the world by any of the persons stated in section 79(3) of this Act, manufactured under a compulsory license or government use, order or by any party authorized to use the invention or by any other authorized person.

26. Remedial Provisions (ii) Compulsory Licences for non-working of patent or similar reasons Compulsory license is a license to exploit a patented invention granted by the state upon request to a third party, for instance in order to remedy an abuse of rights by the patentee.

27. Remedial Provisions Section 91 provides: At any time any person may apply to the Minister for grant of a compulsory.

28. Remedial Provisions (iii) Compulsory licenses for products or processes declared to be of vital importance The Minister is empowered through a statutory instrument to issues compulsory licenses for products or processes which are considered or declared to be of vital importance to defence, economy or public health.

29. Remedial Provisions Section 93 provides: The Minister may, by statutory instrument, direct that, for patented inventions concerning certain kinds of products or processes for the manufacture of such products declared to be of vital importance to the defence, economic or public health interests of Zambia, compulsory licenses may be granted.

30. Remedial Provisions (iv) Exploitation of patented inventions by the government or by third persons authorized by the government Where public interest requires the Government or third persons authorized by the Government can exploit the patent without authorization or permission from the owner of the patent.

31. Remedial Provisions Section 101 provides: Where the public interest requires that one or more of the acts referred to in section 77 of this Act to be performed in respect of the patent invention with non-commercial purposes, the Minister may determine that the patented invention shall, even in the absence of the authorization of the owner of the patent, be exploited by a government agency or department or by a third party designated by the Minister, subject to compensation of the owner of the patent in accordance with this section.

32. (v) Manufacture and Export of Healthcare or Pharmaceutical Patents or Products The proposed Patent Bill allows the manufacturing in Zambia and export by Zambia to a third country patent healthcare or pharmaceutical invention.

33. (v) Manufacture and Export of Healthcare or Pharmaceutical Patents or Products Section 85 of the Patent Bill provides: (e) to manufacture and export to a third country a patented healthcare invention where the export of the invention addresses a health need identified by the third country, provided that: - (i) the product is not patented in the third country; or (ii) the government of the third country has authorized use of the patent without consent of the patent owner, and that the production for export of the invention is intended only for the market of the third country.

34. (vi) Exceptions The Patent Bill allows anyone to perform the following acts in respect of the patent: (a) To carry out any acts related to the experimental use of the patented invention including scientific, technological or medical purposes; (d) to make use of the patented invention in relation to the preparation for individual cases, in a pharmacy or by a medical doctor, of a medicine in accordance with a medical prescription;

35. (iii) Enforcement Provisions TRIPS Agreement provides both the Criminal and Civil sanctions as well as border measures. The Patent Bill does not provide for border measures as they are costly and do not provide for criminal sanctions. The Patent Bill provides only for Civil Sanctions namely:

36. (iii) Enforcement Provisions (a) an injunction to prevent infringement where infringement is imminent, or to prohibit the continuation of the infringement, once infringement has started; (b) delivery up of any infringing product or any article or product of which the infringing product forms an inseparable part; (c) damages;

37. (iii) Enforcement Provisions (d) account of profits; (e) royalty; (f) destruction or disposal of infringing goods or products outside the channels of commerce in such a manner as to avoid any harm caused to the right holder; or (g) any other remedy provided by the law or the court may deem appropriate.

38. Conclusion The proposed Patent Bill contains adequate provisions relating to public health and access to medicine and as such must be supported to be enacted into law.

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