Intellectual Property Rights Implications for Development Fleur Claessens

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Intellectual Property Rights Implications for Development Fleur Claessens

Intellectual Property Rights Implications for Development Fleur Claessens

What is Intellectual Property? • … books, CD’s, video games, paintings, staplers, bags, fabrics,

What is Intellectual Property? • … books, CD’s, video games, paintings, staplers, bags, fabrics, planes, food/drinks, pharmaceuticals, plant varieties, computer chips, cars, music, broadcasts, sound recordings, etc… • …an IP right provide the right holder with an exclusive right to stop others • . . IP right holder may provide licenses • …IP rights are territorial in nature

Forms of Intellectual property Rights • • • Patents Trade Marks Designs Copyrights Geographical

Forms of Intellectual property Rights • • • Patents Trade Marks Designs Copyrights Geographical Indications Industrial Designs Trade Secrets Utility Models Traditional Knowledge (? )

Patent requirements • New/novel • Inventive step/non-obviousness (not obvious to someone skilled in the

Patent requirements • New/novel • Inventive step/non-obviousness (not obvious to someone skilled in the art) • Industrial Applicability • Patentable subject matter

What is patentable? • “Everything under the sun that is made by man. “

What is patentable? • “Everything under the sun that is made by man. “ Diamond v. Chakrabarty 1980 US Supreme Court • Ideas/inventions are patentable

Exclusions from patentability • Discoveries are not patentable: Einstein could not patent his celebrated

Exclusions from patentability • Discoveries are not patentable: Einstein could not patent his celebrated law that E = mc^2; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of. . . nature, free to all men and reserved exclusively to none” • Literary, dramatic, musical or artistic works • Schemes, rules, games, computer programs as such • Methods of medical treatment • Contrary to public policy and morality: Those which by publication or exploitation might result in offensive, immoral or anti-social behavior. Current debate life patents/GM Food • Plant and animal varieties (in EU not in US)

How to obtain a patent? • Domestic patent/IP office: filing, obtain priority date •

How to obtain a patent? • Domestic patent/IP office: filing, obtain priority date • European patents: a bundle of patent rights at the European patent office • International level: WIPO PCT Application requirements: • Description as how the invention works • Claim covering the scope of the legal monopoly claimed by the patentee • Examination and publication

Copyright • Copyrights protects the rights of authors of literary and artistic works •

Copyright • Copyrights protects the rights of authors of literary and artistic works • Copyright is in essential a negative right which prevents others from making copies of the work of an author • No copyright in a pure idea/news/simple works/information itself • Expression/idea dichotomy • If sufficient ‘selection, judgment and experience’ or ‘labour/skill and capital’ copyright can be granted, even in a database (so not the content in the data base but the compilation itself), in EU separate database right, not in the US. • Moral rights versus economic rights

Rationale behind IPRs Patents To stimulate innovation/encourage investment the inventor receives an exclusive right

Rationale behind IPRs Patents To stimulate innovation/encourage investment the inventor receives an exclusive right to his invention in exchange for disclosure of the invention in such a way that it allows replication, the inventor receives a limited amount of time to recoup his investment Trademarks Protection of goodwill and reputation Copyright Protection of creativity

Innovation: Methods and Factors “Innovation is the development and implementation of an improved (incremental)

Innovation: Methods and Factors “Innovation is the development and implementation of an improved (incremental) or new (landmark) product or process with success in a business activity / society” • Methods: ü Formal innovation v Scientific method (evidence of efficacy and/or efficiency) v Marketing strategies (new utility, design, process) ü Informal or Traditional v Experience/belief v intergenerational v individual or collective v Functional • Factors: ü Culture, education, inventiveness/creativity, capital, enabling environment, linkages, supplychain management, marketability, etc.

Why are IPRs important? • IPRs allow control over technology, signs and creations •

Why are IPRs important? • IPRs allow control over technology, signs and creations • Original Purpose: to stimulate innovation and creativity by compensating the creator/innovator for their intellectual efforts • Lately: incentive to investment / change in market players --big multinationals

The TRIPS Agreement …sets minimum standards …is part of a package deal – WTO

The TRIPS Agreement …sets minimum standards …is part of a package deal – WTO Agreement …is signed by 153 parties… is subjected to dispute settlement body. . . contains enforcement mechanisms. . . is subjected to National Treatment and Most -favoured-Nation Treatment (MFN) Principles

Contemporary Challenges in IPR negotiations. . . • 1. 2. 3. GIs Creation of

Contemporary Challenges in IPR negotiations. . . • 1. 2. 3. GIs Creation of a multilateral register for wines and spirits Extending the higher level of protection beyond wines and spirits Linkage between GIs and the agriculture negotiations – clawback for terms in common usage • Disclosure of Origin Measure 1. Legal consequences: Voluntary or not, administrative or patent ability requirement (revoke or criminal sanction) 2. Linked to CBD concepts ABS and PIC 3. Linked to WIPO or WTO • • • Implementation of the WIPO Development Agenda Enforcement (WTO US versus China Panel Report) Ongoing norm setting activities / FTAs Technology Transfer Technical Assistance and Cooperation

Why are IPRs controversial? IPRs • … create semi-monopolies also covering goods that might

Why are IPRs controversial? IPRs • … create semi-monopolies also covering goods that might be essential to society (e. g. pharmaceuticals and environmentally sound technologies) /raises prices (higher than production costs) • …limit access to textbooks, educational material, information • …impacts on reverse engineering and imitation • …exceptions are pushed to the limit/scope is widened: – – – extension of subject matter - - patentability of life / software; extension of term of protection -- 70 years of copyright protection; creation of new rights -- non original databases; over relaxation of granting of patents -- lack of adequate description; inclusion of IP in trade, investment and stand alone agreements; primacy of private rights of public rights

Some facts • Swift pace of technological transformation technology has become important in all

Some facts • Swift pace of technological transformation technology has become important in all economic activities • International collaborations have led to the globalization of all economic and technological activities • Much more regulation! ü 3 countries concentrate around 60% of applications ü 5 countries account for above 80% of royalties and fees recipients of which above 70% relates to intrafirm payments

The Public Interest • Promotion of innovation • Public health and access to medicines

The Public Interest • Promotion of innovation • Public health and access to medicines • Nutrition and Food security • Technology transfer • Competition policy • • Human rights Development Fight against poverty Environmental protection • Education “Whenever there is a conflict between human rights and property rights, the former must prevail” Abraham Lincoln

Socio-economic development • Stages of development • Sophistication of their industrial base, including cultural

Socio-economic development • Stages of development • Sophistication of their industrial base, including cultural creative industries • Coherence with related policies (national innovation systems; industrial, trade, competition, FDI policies) • Sectoral policies: health, education, infrastructure

IPRs and Development an integrated model LEVELS OF DEVELOPMENT LOW LEVEL INTERMEDIATE LEVEL INTELLECTUAL

IPRs and Development an integrated model LEVELS OF DEVELOPMENT LOW LEVEL INTERMEDIATE LEVEL INTELLECTUAL PROPERTY RELEVANCE HIGH LEVEL LOW LEVEL HIGH LEVEL IMITATION APPLICATION INNOVATION LEARNING CURVE

Development IPR Solutions • WTO Doha (Development) Round Doha Round Declaration 14 November 2001

Development IPR Solutions • WTO Doha (Development) Round Doha Round Declaration 14 November 2001 Doha Declaration on TRIPS and Public Health • WIPO Development Agenda (adopted September 2007) 2004 Initiative by group of developing countries lead by Brazil and Argentina / development component in WIPO as UN agency – Use of flexibilities – Transparency in technical assistance activities – Development aspect in all norm-setting activities

Doha Ministerial Declaration 14/11/2001 • “implementation and interpretation of the TRIPS in a manner

Doha Ministerial Declaration 14/11/2001 • “implementation and interpretation of the TRIPS in a manner supportive of public health, by promoting both access to existing medicines and research and development into new medicines” (par 17) • “the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension” (par. 19) • Separate Declaration on the TRIPS Agreement and Public Health

Technical Assistance • The Doha Declaration reconfirmed that technical cooperation and capacity building are

Technical Assistance • The Doha Declaration reconfirmed that technical cooperation and capacity building are core elements of the development dimension of the multilateral trading system. • 29/11/2005 TRIPS Council Declaration: …requests LDCs to supply technical and financial cooperation needs in order to implement TRIPS

Sierra Leone and Uganda - communications to the WTO TRIPS Council, titled ‘Priority Needs

Sierra Leone and Uganda - communications to the WTO TRIPS Council, titled ‘Priority Needs for Technical and Financial Cooperation’ Overview of needs in terms of … ü Administrative reform ü Short and long term goals ü IP policy and regulatory framework ü Administrative reform ü Development of IP curriculum and general public training ü Positive IPR agenda

ü Promotion of traditional knowledge (museums, national gallery etc, formalization of music industry etc…)

ü Promotion of traditional knowledge (museums, national gallery etc, formalization of music industry etc…) ü Train police and judiciary ü Improve cooperation between players (government departments, private sector, farmer organisations, music industry, police, customs…) ü Value edition in food and drinks>GI protection (market branding and marketing efforts) ü Provide management services to SMEs ü Use public domain knowledge, avoid reinventing the wheel ü Find niche / comparative advantage, “specialization is the need for civilization”

Declaration on the TRIPS Agreement and Public Health 14/11/2001 • “we recognize the gravity

Declaration on the TRIPS Agreement and Public Health 14/11/2001 • “we recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics” (par 1) • “ we recognize that IP protection is important for the development of new medicines. We also recognize its effects on prices” (par 3) • “we agree that the TRIPS does not and should not prevent members from taking measures to protect public health, TRIPS should be interpreted and implemented in a manner supportive of public health and promote access to medicines” (par 4)

 • “Each member has the right to grant compulsory licences and the freedom

• “Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted” (par 5 b) • “each member has the right to determine what constitutes a national emergency or other circumstance of extreme urgency (par 5 c) • “leave each member free to establish its own regime for exhaustion without challenge, subject to the MFN and national treatment” (par 5 d)

Compulsory license: Right to use the patent without permission of the patent holder subject

Compulsory license: Right to use the patent without permission of the patent holder subject to certain conditions (Art. 31 TRIPS)

Compulsory Licensing Article 31 TRIPS (a) (b) authorization of such use shall be considered

Compulsory Licensing Article 31 TRIPS (a) (b) authorization of such use shall be considered on its individual merits; such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.

Article 31 TRIPS (c) the scope and duration of such use shall be limited

Article 31 TRIPS (c) the scope and duration of such use shall be limited to the purpose for which it was authorized (d) such use shall be non-exclusive; (e) such use shall be non-assignable (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;

Paragraph 6 TRIPS Declaration of TRIPS and Public Health addressed the difficulties WTO Members

Paragraph 6 TRIPS Declaration of TRIPS and Public Health addressed the difficulties WTO Members with limited pharmaceutical production capacity have in making effective use of the compulsory licensing: “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002”

Contentious points: --countries eligible to export the generic medicine --the limited scope of the

Contentious points: --countries eligible to export the generic medicine --the limited scope of the diseases being allowed for CL --anti-diversion measures to prevent parallel import of medicines to other countries rather than the intended beneficiary

 • Waiver Decision: 30/8/2003 • Article 31 bis TRIPS Agreement : 6/12/2005 (first

• Waiver Decision: 30/8/2003 • Article 31 bis TRIPS Agreement : 6/12/2005 (first TRIPS amendment) allowing countries with inadequate production facilities to import medicines produced under compulsory license in third countries. . . under certain cumbersome conditions

 • Compulsory licenses are controversial but… • • 1000 United States 600 Europe

• Compulsory licenses are controversial but… • • 1000 United States 600 Europe 300 Japan 1 -5 Developing countries

Transition Periods • Developed countries had 1 year (1/1/1996) • Developing countries had 4

Transition Periods • Developed countries had 1 year (1/1/1996) • Developing countries had 4 additional years (1/1/2000) to apply the TRIPS provisions following date of entry into force (1/1/1995) plus 5 additional years to comply with the TRIPS Agreement provisions on pharmaceutical patents (1/1/2005) • In view of special needs of LDCs, they had till 1 January 2006 to apply TRIPS with possible extension to allow them to “create a viable technological base”

 • The Decision of the Council for TRIPS of 29 November 2005 called

• The Decision of the Council for TRIPS of 29 November 2005 called ‘Extension of the Transition Period Under Article 66. 1 For Least-Developed Country Members’ provides under paragraph 1 that: • “LDCs shall not be required to apply the provisions of the Agreement, other than Articles 3, 4 and 5, until 1 July 2013, or until such a date on which they cease to be a least-developed country Member, whichever date is earlier. ” • Par 7 Declaration on TRIPS and Public Health extends till 1/1/2016 for pharmaceutical protection

Need to… • • • rebalance innovation incentives and the public interest realize that

Need to… • • • rebalance innovation incentives and the public interest realize that IPRs will not solve all problems (neither will TK prot) balance public and private rights at the international level promote coherence among different international agreements and FTAs expand civil society participation/consultations in national, regional and international rules setting processes on IPRs focus on implementation of WIPO Development Agenda, link with WTO negotiations implement flexibilities, let IPRs work for you! build on Disclosure of Origin Momentum avoid adopting new IPRs before implementing existing ones carry out cost-benefit analysis of GI extension and register

MERCI Fleur. claessens@unctad. org

MERCI Fleur. claessens@unctad. org