1. AN OVERVIEW OF PATENT PROTECTION IN ZIMBABWE DOMESTICATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES IN ZIMBABWE 22 – 23 JANUARY 2014

2. Structure of Presentation Brief background of Patent protection History of patent protection in Zimbabwe The Patents Act Licensing Challenges Way forward

3. What is a patent?  Means letters patent for an invention granted for Zimbabwe.  It grants the proprietor of that patent the right to stop other people doing things in relation to that product or process (e.g. making the product or using the process).  Exclusive right wmushayi@gmail.com

4. HISTORY OF PATENT LAW  Some records exist of a patent type system being used in ancient Greece  The first known patent for an invention was granted in 1236 for woven fabrics with multicolour patterns.  The first known English Patent was to John of Utynam in 1449 for the making of stained glass (according to the UK Intellectual Property Office) or 1440 to John of Shiedame for manufacturing salt (according to Wyndham Hulme). wmushayi@gmail.com

5. Brief Background  Intellectual property laws in Zimbabwe are administered by the Zimbabwe Intellectual Property Office under the Ministry of Justice and Legal Affairs  ZIPO is a Government office responsible for registration and maintenance of intellectual property records and administration of the various IP laws  There is only one IP office in Zimbabwe based in Harare

6. History of ZIPO  Intellectual property protection dates back as far as 1890 whereby the laws enacted in South Africa (Cape Colony) applied to Zimbabwe (then Rhodesia)  Both were British colonies  Applications for registration of Industrial property were accepted in Zimbabwe, examined in South Africa and registered in Zimbabwe wmushayi@gmail.com

7. First Patent record 22/10/1897 wmushayi@gmail.com

8. Invention: How complex is creativity? wmushayi@gmail.com

9. INVENTION  Means 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;

10. wmushayi@gmail.com Patent Filing  Form of application  Complete provisional specifications A provisional specification shall fairly describe the invention A complete specification shall fully describe the invention and the manner in which it is to be performed  Claims Relate to a single invention Clear and succinct Based on matter disclosed in the specification

11. wmushayi@gmail.com Examination: Grounds for Refusal Sections 11, 17(1)  Examination is to ascertain whether the application complies with the provisions of the Act.  Application can be refused where  Invention is deemed obvious, has no inventive step and is anticipated by prior art  Does not relate to an art capable of being applied in trade or industry  The invention is not useful  Contrary to established natural laws  Contrary to public order and morality

12. Exceptions and Limitations  Diagnostic, therapeutic or surgical methods for the treatment of human beings or animals; or  Plants and animals, other than micro- organisms; or  Essentially biological processes for the production of plants or animals, other than microbiological processes wmushayi@gmail.com

13. PATENTS IN THE PUBLIC DOMAIN Too public is some cases  Those rights that have expired after 20 years  Patents that have been forfeited  Have become inapplicable

14. wmushayi@gmail.com Licencing of right  Section 29 At any time after the sealing of a patent the patentee may apply to the Registrar for the patent to be registered as one in respect of which licences may be issued as of right:  Such license maybe according to any terms of agreement entered into or  Upon terms settled by the Registrar

15. wmushayi@gmail.com Section 30A Compulsory licence in respect of dependent patents Where the working of a patent without infringement of a prior patent is dependent upon the obtaining of a licence under that prior patent, the proprietor of the dependent patent may, if agreement cannot be reached as to such licence with the proprietor of the prior patent, apply to the Registrar for a licence under the prior patent, and the Registrar may grant such a licence on such conditions as he may impose, including a condition that such licence shall be used only for the purpose of permitting the dependent patent to be worked and for no other purposes

16. wmushayi@gmail.com Inventions relating to food or certain other commodities  For any invention capable of substantially improving the technological, social and economic development of the country.  The Tribunal shall, on application made to it by any person interested, order the grant to the applicant of a licence under the patent on such terms as it thinks fit, unless it appears to the Tribunal that there are good reasons for refusing the application.

17. wmushayi@gmail.com Section 31 Compulsory licence in case of abuse or insufficient use of patent rights Subject to subsection (15), any person interested who can show that he has been unable to obtain a licence under a patent on reasonable terms may, within a period of six months from the initial request for a voluntary licence, 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. wmushayi@gmail.com Section 34 Use of patented inventions for service of the State  Notwithstanding anything in this Act, any department of the State or any person authorized 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 this section

19. wmushayi@gmail.com Section 35 Special provisions as to State use during emergency  During any period of emergency the powers exercisable in relation to an invention by a department of the State or a person authorized by the Minister under section thirty-four shall include power to make, use, exercise and vend the invention for any purpose which appears to the Minister necessary or expedient

20. wmushayi@gmail.com State Emergency Includes  the efficient prosecution of any war in which Zimbabwe may be engaged; or  the maintenance of supplies and services essential to the life of the community; or  securing a sufficiency of supplies and services essential to the well-being of the community; or  for promoting the productivity of industry, commerce or agriculture; or

21. wmushayi@gmail.com State Emergencies continued  fostering and directing exports and reducing imports or imports of any classes and for redressing the balance of trade;  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;  for assisting the relief of suffering and the restoration and distribution of essential supplies and services

22. wmushayi@gmail.com Zimbabwe compulsory Licence  In 2002 in view of the HIV/AIDS pandemic affecting Zimbabwe a notice of declaration of Period of emergency was issued by the Minister of Justice, legal and Parliamentary affairs  The notice was intended to allow the state or a person authorised by the state to: Make or use any patented drug including ARV drug Import any generic drug used in the treatment of persons suffering from HIV/AIDS

23. wmushayi@gmail.com Zimbabwe compulsory Licence Continued  The period of emergency was first extended to 31 December 2008 by way of Statutory Instrument 32 of 2003  During this period the state or any person authorized by the Minister of Justice would be able to manufacture or use patented medicines or import any generics used in the treatment of persons suffering from HIV/AIDS

24. wmushayi@gmail.com Zimbabwe compulsory Licence Continued  Varichem Pharmaceuticals (Private) Limited among others was granted the authority to produce ARVs and supply three quarters of its produced drugs to State owned health institutions  Varichem produced its first ARV in October 2003 and has seven generic versions of ARVs

25. Graph illustrating Patent application trends in Zimbabwe wmushayi@gmail.com

26. Existing IP Laws  The Patents Acts Chapter 26:03  The Trade marks Acts Chapter 26:04  The Copyright and Neighbouring rights Act Chapter 26:05  The Industrial Designs Act Chapter 26:02  The Integrated Circuits Layout-Designs Act Chapter 26:07  The Geographical Indications Act Chapter 26:06  Intellectual Property Tribunal Act (Chapter 26:08)

27. wmushayi@gmail.com International and Regional obligations  The Berne Convention  Paris Convention  PCT  WIPO  TRIPS Agreement  ARIPO  Madrid Agreement

28. Role of the IP Office  To receive, process and register IP applications  To maintain a register of records and any update, renewals and subsequent changes  To advise, liaise and cooperate with stakeholders on all matters pertaining to IP  Presiding over hearings  To promote and publicize IP wmushayi@gmail.com

29. First Industrial design record D1/1958 wmushayi@gmail.com

30. Trademark record ( 4/1897) 17/08/1897 wmushayi@gmail.com

31. FILING wmushayi@gmail.com

32. Index room wmushayi@gmail.com

33. Index card wmushayi@gmail.com

34. The Registers wmushayi@gmail.com

35. Federation Period  At one time in history Zimbabwe was part of the Federation of Rhodesia and Nyasaland consisting of Southern Rhodesia (now Zimbabwe), Northern Rhodesia (now Zambia) and Nyasaland (now Malawi)  The Federation lasted for ten years from 1 August 1953 to 31 December 1963  The capital of the Federation was Salisbury (now Harare) and all trademark and patent applications were registered in Harare

36. Interface with stakeholders  Stakeholder committee to fight piracy and counterfeit products  Regular seminars and workshops  Out reach and advocacy  Periodic meetings with the Patent and trademarks agents wmushayi@gmail.com

37. Challenges  Executive ignorance by policy makers  Lack of political urgency to commercialize the office  General disrespect for intellectual property in the society  Lack of awareness  Perceived necessity to infringe  Criminal intent  Lack of capacity by the office carry out effective outreach wmushayi@gmail.com

38. Challenges continued  The rigid Public Service structure and management system of the IP office  The manual processing system which is already overwhelmed  Manual tracking system which is difficult to supervise  Missing files and missing records  No consistent sending out of notices wmushayi@gmail.com

39. Challenges continued  Depressed filings especially of local applications. Most patent applicants prefer to file with ARIPO  Lack of National IP policy and strategy  Weak ICT infrastructure  The weakened position of the Patents Office

40. What are we doing about this? wmushayi@gmail.com

41. What we are doing  Political decision to restructure ZIPO as a separate Department  Human resources development through training programs such as the Masters program in Intellectual property (MIP)  Partnership with other stakeholders to improve awareness  Digitization and Data capture of records wmushayi@gmail.com

42. Thank You Business Card 38 Nelson Mandela Avenue 1 st Floor Century House East Harare Phone:+263 4 775544-6, 777373 Fax:+263 4 777 372 Direct: +263 4 775162 Cell: +263 773 560 284, +263712 868084 E-mail: wmushayi@gmail.com wmushayi@gmail.com