Patent Related Flexibilities in the Pharmaceutical Field

1. Patent Related Flexibilities in the Pharmaceutical Field Workshop for the GCC on the Protection of Invention in the Pharmaceutical Sector, Patents, Undisclosed Information and Health Policies Riyadh, Saudi Arabia 15-16 October 2012 Marco Aleman Deputy Director, Patent Law Division, and head, Legislative and Policy Advice Section Giulia Ragonesi Consultant, WIPO

2. WTO/TRIPS • Trips Agreement provides minimum standards of protection of IPRs • WTO members shall provide patents for any invention: • Products (e.g. technical device) • Processes (methods for producing the chemical ingredients for a medicine)

3. Definition of Flexibility • “a range of rights, safeguards and options that WTO Members can exploit in their implementation of the TRIPs Agreement” • Vague international rules, that need to be circumscribed in their content by the national legislation

4. Definition (2) Idea of “alternative ways” for: • Legislative implementation • To accommodate national interests It goes without saying that all these ways must be compatible with the provisions and principles of the Treaty

5. Patents and Public Health How to strike a balance: using flexibilities Early and affordable access to new medicines Stimulus ofInnovation/R&D Generic Drug Patents

6. Public Health related flexibilities • Exhaustion • Transitional period • Research exception • Regulatory Review (Bolar) exception • Compulsory licenses

7. Exhaustion (Art. 6 TRIPs) • Right of the patent holder « exhausted » once the product incorporating the patented invention is put into the market

8. Example of national exhaustion country C Local price $ 1.50 country B Local price $ 0.75 country A Local price $ 1.0 country E Local price $ 0,50 country D Local price $ 2.00

9. Example of international exhaustion Exporting country C Local price $ 1.50 Exporting country B Local price $ 0.75 Importing country A Local price $ 1.0 Exporting country D Local price $ 2.00 Exporting country E Local price $ 0,50

10. Example of regional exhaustion country E Local price $ 0.50 country D local price $ 3.0 country B Local price $ 0.75 country A Local price $ 1.75 country C Local price $ 2.05

11. National exhaustion • UNITED ARAB EMIRATES : Section 17 of the Patent Law No. 44 of 12/10/1992 – 1413 17. The rights conferred by a patent or utility certificate shall cover only acts performed for industrial or commercial purposes. They shall not extend to acts in relation to the protected product once it has been sold in the United Arab Emirates. However, if the patent or utility certificate relates also to a specific use of the product, the owner shall have the right to reserve that use for himself. • OMAN: Article 11 C (4) of theLaw on Industrial Property Rights of 2008 4 - The rights under the patent shall not extend: A) to acts in respect of articles which have been put on the market in Oman by the owner of the patent or with his consent, consequently exhausting the patent owner's rights;

12. International exhaustion • JORDAN: Article 37 of the Law on Patents No. 32 of 1999, as last amended by Law No. 71 of 2001 “The provisions of this law shall not prevent any person from importing any materials or goods from a third party if that party enjoys the legal protection of the same patent protected in the Kingdom and if that importation is lawful, complies with the principles of commercial competition and fairly takes into account the economic value of the protected patent.” • EGYPT :Article 10 (1) of the Law on the Protection of Intellectual Property Rights No. 82 of 2002 A patent shall confer on its owner the right to prevent a third party from exploiting the invention by any means. The right of a patent owner to prevent a third party from importing, using, selling or distributing a product shall lapse when he commercializes the product in any country or authorizes a third party to do so.

13. Transitional Period for pharmaceuticals Art. 66 (1) TRIPS • LDCs: time up to 2016 to provide protection for pharmaceutical inventions (if not yet provided) Art. 65 (4) TRIPS • Developing Countries. Time up to 2005 to provide protection for patents in area of technology not so protectable in the Member territory on the general date of application of the TRIPS Agreement

14. Research and Regulatory Review (Bolar) exception • Not explicitly provided in the TRIPs but possible to adopt them according to the open clause contained in Art. 30 of the TRIPs Agreement • Research exception: “the exception under which use of patented product for scientific experimentation, during the term of the patent and without consent, is not an infringement”* • Regulatory review (Bolar) exception: acts to carry out equivalency tests for the regulatory approval of products such as generic medicines before the expiration of the relevant patent *Canada- Patent protection of Pharmaceutical Product

15. Examples • GCC : Section 14 (1) of the Patent Regulation of the GCC of 1992 (as at 23/04/2002) “The rights under the patent shall not extend to: 1) Acts done particularly for experimental purposes” EGYPT : Article 10 no. 1 of the Intellectual Property Law 82 of 2002 “The following shall not be considered as infringements of that right when carried out by third parties: 1) Activities carried out for scientific research purposes.

16. Examples Bolar • EGYPT : Article 10 (5) of the Intellectual Property Law 82 of 2002 “Where a third party proceeds, during the protection period of a product, with its manufacturing, assembly, use or sale, with a view to obtain a marketing license, provided that the marketing starts after the expiry of such a protection period. • JORDAN : Article 21 C of the Patent Act No. 32 of 1999, as last amended by Act No. 71/2001 “Notwithstanding any conflicting provision in this law or any other law, all types of scientific research and development and filing applications for obtaining marketing permits carried out before the elapse of the patent protection period shall not be regarded as infringement neither civil nor criminal

17. Compulsory license (CL) conditions in the TRIPS CL: Authorization granted by the government to a third party to use the invention without the consent of the patent holder. Conditions • Authorization on individual merits • Prior efforts for voluntary license (possibility to waive this requirement in case of national emergency or other circumstances of extreme urgency) • Limited scope and duration

18. CL conditions (2) • Non-exclusive and non-assignable • Used predominantly for the supply of domestic market of the Member authorizing such use • Adequate remuneration to the patent holder

19. CL and local production Problem in case of countries which insufficient or no manufacturing capacities in the pharmaceutical sector: how to use the system of CL?

20. Doha Declaration on TRIPS Agreement and Public Health WTO Members recognized: • the gravity of public health problems…, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics • the importance of IP for the development of new medicines and the concern about its effect on prices WTO Members agreed: • TRIPS shall be interpreted and implemented in a way that supports public-health by promoting ^both access to existing medicines and the creation of new medicines • TRIPS doesn’t and shouldn't prevent members from taking measures to protect public health

21. Doha Declaration on TRIPS and Public Health (2) • Countries shall use flexibilities contained in the TRIPS • Each Member has the right to grant CL and the freedom to determine the ground upon which such licenses are granted • Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency • Each Member is free to establish its own exhaustion regime without challenge • Exemption for LDCs on pharmaceutical patents until 2016

22. Paragraph 6 of Doha Declaration • Problem: • Members lacking manufacturing capacities could issue compulsory licenses for importation • But: Art. 31 (f) requires production “predominantly for the supply of the domestic market of the member” • Under Paragraph 6 of the Declaration, the General Council mandated the TRIPS Council to find a solution to the issue

23. The Decision of the General Council of WTO of August 30,2003 (1) • 3 distinct waivers granted: • Exporting countries’ obligation under Art. 31 (f). Any Member can export drugs made under CL to meet the needs of importing countries • Remuneration is only required on the export side • Exporting constraints are waived

24. The Decision of the General Council of WTO of August 30,2003 (2) • Paragraph 2 of the decision sets out conditions to comply with: • Notification of the TRIPS Council • Confirmation of insufficient or no manufacturing capacities in the pharmaceutical sector (except LDCs) • Determination of expected quantities • Products produced under license shall be clearly identified • Adopting reasonable measures to prevent re-exportation of these products

25. The Decision of the General Council of WTO of August 30,2003 (3) • Eligible importing members: • LDC members automatically eligible • Any other Member eligible, subject to mandatory notifications • But: 44 Members have voluntarily opted out partially or fully • Decision of 30 August 2003 is interim, terminates when amendment replaces it for each member

26. Amendment of the TRIPS Agreement-new Art. 31 bis (December 6,2005) • General Council adopted the Protocol amending the TRIPS Agreement on December 6,2005 • The protocol was opened for acceptance by Members until December 1, 2007 and has been extended until 31 December 2009, to 31 December 2011, and then to 31 December 2013* • The amendment will enter into force if 2/3 of eh WTO Members notify their acceptance Currently 43 Countries + EU have accepted *General Council decisions respectively of 18 December 2007, 17 December 2009 and 30 November 2011

27. First notification • 4 October 2007 Canada has authorized a company to make a generic version of a patented medicine (AIDS therapy drug) for export to Rwanda, which is unable to manufacture the medicine itself

28. Are patents really a barrier to access to medicines in developing countries? • 95% of the products on the WHO Essential Drug List are not patented • Antiretrovirals are not patented in half of the African States • In the other half, only 3 out of 16 antiretrovirals are patented total amount of patents 18%. There is no patent on triple therapies • 12 out of 13 malaria drugs are not patented in Africa total amount of patents 5% • 9 out of 11 tuberculosis drugs are not patented in Africa total amount of patents 1%

29. Access to medicines in developing countries • TRIPS forms part of the solution next to the other important factors: infrastructure, national health systems, procurement regimes, reduction import tariffs, etc. • Extra effort needed to address the problem of neglected diseases as patent as incentive does not work due to lack of market • IP must be protected to trigger R&D and further mechanisms must be developed to trigger R&D into neglected diseases.

30. 6. StatisticsNumber of countries which used Transition Periods

31. Transition Periods %

32. Countries analyzed: Exhaustion

33. Statistics: Exhaustion %

34. Countries analyzed: Research and Bolar exception + EU

35. Statistics: Research and Bolar exception % + EU

36. Countries analyzed: Compulsory Licenses + EU

37. Statistics: Compulsory Licenses (For non-working) %

38. Statistics: Compulsory Licenses (For dependent patent) %

39. Statistics: Compulsory Licenses (To correct patent abuse) %

40. Statistics: Compulsory Licenses (For public interest) %

41. Statistics: Compulsory Licenses (Government use) %

42. Statistics: Compulsory Licenses (Implementation of the Decision of the General Council) %

43. Thank you!