McLEAN SIBANDA. Senior Patent Attorney Innovation Fund WIPO LIFESCIENCES SYMPOSIUM: PUBLIC SECTOR INTELLECTUAL PROPERTY MANAGEMENT

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FRAMING A NATIONAL POLICY AND LEGISLATION FOR MANAGING IPR RESULTING FROM PUBLICLY FINANCED RESEARCH & DEVELOPMENT McLEAN SIBANDA Senior Patent Attorney Innovation Fund mclean@nrf.ac.za WIPO LIFESCIENCES SYMPOSIUM: PUBLIC SECTOR INTELLECTUAL PROPERTY MANAGEMENT Geneva, Switzerland 15 th December 2008 OVERVIEW BACKGROUND Patenting trends in South Africa R&D Strategy 2002 Systemic challenges POLICY FRAMEWORK LEGISLATION CONCLUDING REMARKS 1

BACKGROUND Patenting by South Africans PCT Applications: SA vs S Korea 4000 3500. Applications 3000 2500 2000 1500 1000 500 SA S Korea 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 Year BACKGROUND Patenting by South Africans PCT patent application trends for comparator countries. applications 1000 800 600 400 200 0 1997 1998 1999 2000 2001 2002 2003 2004 Year of Application SA Spain Ireland India 2

BACKGROUND Life Sciences Patenting SA Inventors US Patents where a South African is listed as an inventor 1996-2002 US Patents by assignation 80 70 60 50 40 30 20 10 0 1976-1980 1981-1985 1986-1990 1991-1995 1996-2002 15% 6% 8% 13% 19% Private Individuals Private Companies Large corporates Universities 39% Number of Patents Government [CSIR, WRC, SAMRC, etc] Overseas companies, HEI's and other entities PATENTS (EPO, USPTO) 1991 2005 (2050 patents) Universities Sasol Mintek De Beers CSIR 3

Publicly financed institutions accounted for about 5% of all patent applications published by the EPO, USPTO, and WIPO, which have a South African priority BACKGROUND National R&D Strategy, 2002 Quality of life Wealth Creation Technical progress (Improvement and Public Financing Domain Innovation) SET Human Capital Business performance IPR Domain Future R&D capacity Current R&D Capacity National R&D Strategy Imported know-how 4

BACKGROUND Systemic Challenges local context National R&D Strategy (approved July 2002). Section 7.6 considers intellectual property issues At present, there is little appreciation of intellectual property as an instrument of wealth creation in South Africa financing of patenting competes with other developmental priorities need for a proper framework and enabling legislation for management of IP when this is in the national interest. Increased public discourse in respect of output and impact of publicly financed research and development BACKGROUND Systemic Challenges local context national policies are in place with negative consequences Loss of intellectual property Locally Off-shore jurisdictions Poor commercial practices balance of incentives and regulation R&D Expenditure per Sector 2003/4 Sector Business Gov R&D Exp 55.5% 21.9% HEI 20.5% Other 2.1% 5

BACKGROUND Systemic Challenges Global context IPR and public funding very dynamic Universities and public research organisations are major players Feature of the knowledge economy Increased intangible content in patents Patents and life forms, genetics and bioresources Patents and software, business methods, etc Geopolitical issues WIPO, WTO, etc Poverty, public health and IPR IPR POLICY FRAMEWORK Approach Consistent approach required to ensure protection of intellectual property developed with public financing Frameworks and legislation benchmarked against good practice globally and contextualised for national and regional efficacy Key functions identified and responsibilities allocate The focus of this framework is patenting of publicly financed research Sensitivities regarding academic work Easier to measure 6

IPR POLICY FRAMEWORK Process Public presentations at LES forums and other public forums increase public awareness Solicit both public and industry concerns Cabinet approval of draft policy framework Extensive public consultation process Publicly financed institutions Industry partners Funding agencies Other government departments with overlapping responsibilities Revised draft policy framework IPR POLICY FRAMEWORK Key Issues 1/2 Intellectual property (patents) must be secured on the outputs of publicly financed research Obligation to disclose potential IP Government can secure IP if institution does not Obligations and benefits are linked Ownership Obligation to commercialise Individuals and institutions have defined rights Ownership Benefit sharing 7

IPR POLICY FRAMEWORK Key Issues 2/2 Certain patents can be secured to protect public interest and will not be licensed on commercial terms Preferences in commercialisation non-exclusive licensing local licensing SMMEs and BEEs as licensors Government has walk-in rights on publicly financed IP in the national interest free licence Revenue to institutions will grow but it is not expected to be a major source of finance at the system level IPR FROM PUBLICLY FINANCED RESEARCH AND DEVELOPMENT BILL Towards an enabling legislative framework IPR Bill: 18 v 2008 IPR Bill: August 2008 Draft IPR Bill: May 2007 IPR Policy Framework 2007 Draft IPR Policy Framework 2006 R&D Strategy 2002 8

IPR BILL Process Public Comments REVIEW OF PUBLIC COMMENTS CABINET APPROVAL 14/5/08 BILL REDRAFTING CERTIFICATION STATE LAW ADVISORS 6 th June 2008 INTERN. BENCHMARK WORKSHOP WITH STAKEHOLDER GROUP August 2007 - December 2007 February 2008 7March 2008 PUBLIC HEARINGS Joint seating of Portfolio Committee on S&T and Select Committee on Education & Recreation (NCOP) 29 30 th July 2008 PRESIDENT SIGN OFF 25th Sept 2008 (Statement) NCOP NATIONAL ASSEMBLY 21 Aug 2008 Portfolio Committee Responses to Public Hearings and proposed amendments 5 12 th August 2008 18 th vember 2008 IPR BILL Main Object To make provision that intellectual property emanating from publicly financed research and development is: identified; protected; utilised and commercialised for the benefit of the people of the Republic, whether it be for a social, economic, military or any other benefit 9

IPR BILL Guiding Principles 1. Consistent approach in protection of IP developed with public funds 2. Benchmark against good global practice and contextualise for local efficacy 3. Identify key rights, functions & obligations 4. Good balance between incentives and control 5. Certainty in terms of publicly financed IP 6. Must not hinder private-public collaborations IPR BILL IP Ownership RECIPIENT: Universities, Research Institutes, Small Businesses have title to inventions developed with public funds and must obtain statutory protection (where applicable) National IP Management Office (NIPMO) Only where Recipient elects not to take title Only where State will be prejudiced Private Sector partner / IP creator Where NIPMO elects not to take title 10

IPR BILL National IP Management Office (NIPMO) Establishes NIPMO as an agency function under the Department of Science and Technology Administrative Role Facilitating and capacity development Guidelines on transactions and related matters Intellectual property fund management IPR BILL Institutional Arrangements Designated function of Office of Technology Transfer (OTT) at Institutions Regional OTTs may be established Mix of skills and interdisciplinary knowledge and expertise in IP protection, commercialisation, and entrepreneurship Various aspects relating to identification, protection and commercialisation of IP 11

IPR BILL Institutional Arrangements INSTITUTION IP Policy Tech Transfer Capacity (Year Established) INSTITUTION IP Policy Tech Transfer Capacity (Year Established) University of Cape Town Limited (2002) University of Pretoria Limited (1996) University of Stellenbosch (1999) rth West University (2003) Nelson Mandela Metropolitan University Limited (2007) University of the Witwatersrand Limited (2003) Rhodes University University of Limpopo Walter Sisulu Metropolitan University Tshwane University of Technology Limited (2005) Durban University of Technology University of KwaZulu- Natal In process of establishment University of Fort Hare UNISA Cape Peninsula University of Technology University of Western Cape Vaal University of Technology CSIR (2001) University of Johannesburg Limited (2004) Water Research Commission (WRC) Limited (2003) Central University of Technology University of Forthare Mangosuthu University of Technology University of Zululand Vaal University of Technology Agricultural Council (ARC) Research Medical Research Council (MRC) (2004) Mintek Limited From: M Sibanda, Intellectual property, commercialisation and institutional arrangements at South African Publicly Financed Institutions, WIPO Economics of IP, 2008, in print IP creators and heirs at institutions IPR BILL Benefit Sharing Intellectual property creators at an institution and their heirs are entitled to the following benefit sharing: a) at least 20 per cent of the revenues accruing to the institution from such intellectual property for the first one million rand of revenues, or such higher amount as the Minister may prescribe; and b) thereafter, at least 30 per cent of the nett revenues accruing to the institution from such intellectual property 12

IPR BILL IP Transactions IP Transactions: (i) licence; (ii) assignment Recipient empowered to conclude transactions on best terms Assignment - an exception rather than a rule Exclusive licence appropriate performance clauses Off-shore exclusive licence and assignments benefit to the Republic and subject to regulations Preferences to South Africa (priority Black-owned and Small Businesses) IPR BILL Rights of the State Each IP Transaction Agreement to grant the State An irrevocable and royalty-free licence authorising the State to use or have the intellectual property used throughout the world for the health, security, and emergency needs of Republic Walk-in rights - in following circumstances: 1. Failure to disclose Fatal and results in assignment of IP to State 2. n-use: specific consultative process with NIPMO non-exclusive licence to third parties willing and able to commercialise 13

IPR BILL Co-Financed Research Default position - IP owned by the institution Option to an exclusive licence Capacity to manage and commercialize the IP in a manner that benefits the Republic Performance clauses in exclusive licence agreement Could be assigned in exceptional cases Co-ownership of IP requires: joint IP creatorship; and contribution of resources (e.g. include background IP); and appropriate benefit sharing arrangements for IP creators; and agreement for commercialization of IP IPR BILL Full Cost Basis (FCB) Funded Research Research and Development funded on FCB NOT publicly financed Legislation does not apply except to define FCB Full Cost Basis Direct AND Indirect costs of research and development More defined in Regulations NIPMO and Recipient institutions to agree on matrices to be used Variations institution to institution faculty to faculty / business unit to business unit 14

CONCLUDING REMARKS Access and availability of products from publicly financed research Very specific and broad language in IPR Policy Framework Broad language in IP legislation Specific provisions in the legislation By disclosure obligation increasing likelihood that research results could have impact on society Consultative process essential Be patient, understand the concerns use external advice Be less prescriptive, yet clear on ownership, obligations, duties, incentives, consequences, and rights of the State THANK YOU 15