1. Master of Laws in Intellectual Property Geneva, October 22, 2014 Marco M. Aleman, Acting Director, Patent Law Division The WIPO Standing Committee on the Law of Patents WIPO and the University of Turin in cooperation with ITC-ILO

2. 2 The Standing Committee on the Law of Patents (SCP) http://www.wipo.int/meetings/en/topic.jsp?group_id=61

3. 3 Member States’ Committee (IGOs and NGOs: observers) Established in 1998 Forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law SCP

4. Progressive International Development of Patent Law Does it mean the same for developing and developed countries? Developed countries’ preference is to progress in the work of the SCP towards harmonization. Developing countries’ preference is to analyze and understand –through concrete studies- how different features of the international patent system work. The International Patent System’s progressive development should consider the issues that are convenient to nowadays economy. Current differences in patent law and practice from country to country is an important challenge in getting protection for inventions at the international level. 4

5. How to Conciliate Countries Perspectives (1) Policy makers in developed countries are aware of the limited role that patents play in a number of developing countries and LDCs, primarily due to constraints in the implementation and/or design of innovation and transfer of technologies policies. Policy makers in developed countries are sensible to the difficulties that certain developing countries and LDCs face in the implementation of the national patent system. But also are committed to find out mechanisms that allow patentees getting adequate protection in other jurisdictions. 5

7. How to Conciliate Countries Perspectives (2) Policy makers in developing countries are aware of the key role that patents play for the recovery of investments on research and development carried out by innovators companies. Policy makers in developing countries are sensible to the difficulties that innovators face in getting protections for their inventions at the international level, primarily due to the differences in national patent laws and practices. But they also are concerned about how to conciliate patent policy and development goals. 7

8. Source: IFPMA 8

9. Meaning of Progressive Int. Development at the SCP It is about the identification of current best practices and the analysis of the impact of a given choice. providing papers/documents to experts/policy makers to assist them in making informed decisions. MS driving the Committee work on: which subjects to consider (agenda); how to deal with discussions (documents, sharing sessions, seminars, etc.); giving direction to the discussion (fact finding/no harmonization), etc. IP offices’ and patent users’ appreciation of the patent system and policy, and interest in how to improve them for the benefit of all stakeholders. Geneva-based diplomats’ negotiations in “building the route” for this work. 9

10. Meaning of Progressive Int. Development at the SCP (2) It is not about A “tradeoff on technical features” of the patent system. An exercise with the exclusive objective of increasing the level of protection. A common law v. civil law system; developed v. developing countries; weak v. strong patent system; local v. foreign interests. 10

11. 11 SCP since 2010 2010: agreement on five issues for future work (i) exceptions and limitations (ii) quality of patents (iii) patents and health (iv) transfer of technology (v) client-patent attorney privilege SCP/20: January 27 to 31, 2014 SCP/21: November 3 to 7, 2014

12. Exceptions and Limitations to Patent Rights Questionnaire responded by 82 Member States and a Regional Office (i) p olicy objectives; (ii) legal provisions and implementations; and (iii) challenges Five types of E&L discussed during SCP/20 (i) private/non-commercial use; (ii) experimental/research use; (iii) extemporaneous preparation of medicines; (iv) prior use; (v) use of articles on foreign vessels, aircrafts etc. A half-day Seminar on E&L Chief economist’s panel with two external speakers Presentations by Member States of case studies on the implementation Proposal by Brazil (  non-exhaustive E&L manual) 12

13. Quality of Patents Concerns about heading to harmonization No one definition of “quality of patents” “Quality of patents” and “quality of the patent system” (i)Use of foreign search and examination work (Denmark) (ii)National goals of a patent system and metrics for measuring quality of patents and examiners’ work (US) (iii)Questionnaire on the definition(s) of “quality of patents” and elements in (i) and (ii) (Canada & UK) (iv)Work sharing programs (US) (v)Study inventive step (Spain) (vi)Study sufficiency of disclosure (India) 13 Information on work sharing activities and use of external information for search and examination collected and discussed.

14. Patents and Health Balanced and evidence-based approach not denied The role of patent systems in supporting innovation not denied Concerns about duplication of work within WIPO and with other IGOs (i)Increase capacity for a full use of flexibilities (studies, sharing experiences and information, DB on the patent status of medicines and diagnostic tools, technical assistance programs) (AF-G&DAG) (ii)Study on the positive impact of the patent system in providing lifesaving medicines in developing countries; non-patent barriers and effects of falsified medicines to the availability of medicines (US) 14 Sharing session on countries use of flexibilities Active participation of African countries Patent law “flexibilities” to facilitate/expedite the marketing of generic drugs (US)

15. TRIPS Agreement implementation Art. 27 and some of its flexibilit ies 15 Explicit obligation to give protection Inventions -whether products or processes- in all fields of technology. Micro-organisms Explicit permission to exclude from patent protection Plants and animals Diagnostic, therapeutic and surgical methods Implicit permission not to give protection Discoveries Substances existing in nature Incremental innovation

16. Client-Patent Attorney Privilege Concerns about limiting disclosure of evidence and harmonization Doubt about further discussions in the SCP (a matter of law of evidence - national issue) (i)Elaboration of non-binding minimum standards (a voluntary guide for national authorities) (CH, CEBS) (ii)A dedicated web page; a seminar with patent advisors and clients (Group B) 16 How to preserve confidentiality of advice from patent advisors, particularly across the national border? Comprehensive compilation of the subject Policies, legal provisions and analysis

17. Transfer of Technology How to further facilitate ToT for development? Broader questions (ex. absorptive capacity) The gap between theory and practice underlined – constraints to use ToT tools by developing countries Some ideas to move forward: Sufficiency of disclosure and ToT (India) Further experience sharing and better understanding of the role of the patent system (AF-G) Compilation of voluntary licensing practices (India ) 17 Patent-related incentives and impediments to transfer of technology – practical examples and experiences

18. Future work SCP 21 Studies and documents Documents on exceptions and limitations: acts for obtaining regulatory approval from authorities; exhaustion of patent rights; compulsory licensing and/or government use; and exceptions and limitations relating to farmers’ and/or breeders’ use of patented inventions study on the disclosure of International Nonproprietary Names (INNs) study on the role of patent systems in promoting innovative medicines, and in fostering the technology transfer necessary to make generic and patented medicines available Seminars and sharing sessions Half day seminar on exceptions or limitations (same above) Half-day seminar on the confidentiality of advice from patent advisors and practical experiences of clients as well as patent advisors An information sharing session among Member States regarding experiences on international work sharing and collaboration Other activities The Secretariat will improve the WIPO webpage (PCT-PPH) on work sharing initiatives The Secretariat will publish the information contained in document SCP/20/9 (CAP) on the SCP electronic forum website in more accessible and user-friendly format The Secretariat will collect further practical examples and experiences on patent-related incentives and impediments to transfer of technology from members and observers of the SCP 18

19. 19 marco.aleman@wipo.int Thank you