IPR in the post CBD and WTO regime

P. PushpangadanNational Botanical Research Institute

(Council of Scientific & Industrial Research),Lucknow-226001,INDIA

World Trade and Economies: The Paradigm

Shift• “Resource – based economies’ to ‘Knowledge –based economies’

• 21 st Century will be the Century of Knowledge”……

“A nation’s ability to convert knowledge in to wealth and social good through the process of innovation will determine its future” ( R A Mashelkar, 2001)

• Era of knowledge engineering knowledge societies and knowledge industries.

Intellectual Property Rights (IPR)

Intellectual Property (IP) means the creative products emanating from human mind/brain and IPR are the legal rights governing those rights granted to individual(s) or corporate bodies to have monopolistic ownership or control over. Such IP exercise of human brain such as thoughts, invention, processes, ideas having innovative and inventive steps capable of industrial applications.

The holder of IPR gets an exclusive right over the use.

Features of IPR

• It is intangible

• Has the character of a property

• Recognized by international and national laws

• Can transformed or sold or licensed like any other property

• Protected against wrongful expropriation

• Innocent use can be interpreted as an infringement.

Patent

Patent is a set of exclusive rights granted by a government to an inventor or applicant for a period time-normally 20 years from filing date. It is essentially a monopolistic rights i.e a negative right as it excludes others from making, using, selling, or importing patented invention.

IPR Power……

TOP 10 Patent Infringement Damages Awards in U.S. ($ M)

0 100 200 300 400 500 600 700 800 900

Polaroid v Kodak 91

City of Hope v Genetech '02

Coca cola v Mexican

Hughes Tool v Smith '86

Exxon v Mobil '98

Hughes Aircraft v US '94

Chronology of Patent/Monopolistic Rights

700 B.C. Greece Idea of Monopolistic Rights/Privilege

15th Century

Italy Patent introduced

1421 Republic of Florence

First known patent grant by a “State” to an inventor

1474 Venice Patent Ordinance

  Great Britain

Granting rights and privileges to inventors by Queen Elizabeth I

1623* Great Britain

Statute of Monopolies proposing grant of exclusive rights to inventors for new inventions for a period of 14 years.

* In 1623, Great Britain proposed granting exclusive rights for new inventions with a term of 14 years through an act of the Parliament, known as the Statute of Monopolies Act of 1623. It was only towards the end of the eighteenth century and during the nineteenth century that comprehensive patent statutes got formalized in various countries, including France and USA.

World Intellectual Property Organization (WIPO) & World Trade Organization (WTO)

1883 A.D. Paris Convention for the Protection of Industrial Property

1886 A.D. Berne Convention for the Protection of Literary and Artistics Works

1891 A.D. Madrid Agreement Concerning the International Registration of Trademarks

1947 A.D. Formation of General Agreement on Tariffs & Trade (GATT)

1958 A.D. Lisbon Agreement for the Protection of Apellations of Origin and their International Registration

1961 A.D. Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations

1967 A.D. Decision to form World Intellectual Property Organization (WIPO) by UN

1970 A.D. Patent Cooperation Treaty (PCT)

1994 A.D. WIPO established WTO which administered the TRIPs

2005 A.D. (1st Jan.)

TRIPs came into full force

History of Indian Patent System

1856 The Act Vi of 1856 on Protection of Inventions based on the British Patent Law of 1852. Certain exclusive privileges granted to inventors of new manufacturers for a period of 14 years.

1859 The Act modified as Act Xv; Patent Monopolies called Exclusive Privileges (making, selling and using inventions in India and authorizing others to do so for 14 years from date of filing specification).

1872 The Patents & Designs Protection Act.

1883 The Protection of Inventions Act.

1888 Consolidated as the Inventions & Designs Act.

1911 The Indian Patents & Designs Act.

1972 The Patents Act (Act 39 of 1970) came into force on 20th April 1972.

1999 On March 26, 1999 Patents (Amendment) Act, 1999 came into force from 01.01.1995.

2002 The Patents (Amendment) Act 2002 was passed in June 2002.

2003 The Patents (Amendment) Act 2002 came into force from 20th May 2003-work started on further amendment to the Patents Act.

Status of IPR Laws in India

• Patents – Amendment Act 2002 Passed – Rules finalized and Patents (Amendment) Bill 2003 introduced.

• Industrial Designs – New Law Brought into Force – May, 2001

• Trade Marks – New Law/Subordinate Legislation in force from 15.09.2003

• Geographical Indication – New Law/Subordinate Legislation in force from 15.09.2003.

• Copy Right and Related Rights – Laws Enacted – Handled by Ministry of HRD.

• Layout – Designs (Topographical) of Integrated Circuits – Act Passed – Yet to be operationalized – Handled by Ministry of IT.

• Protection of Undisclosed Information – No New Law needed.

• Plant Varieties & Farmers Protection Act – Law Enacted – Yet to be operationalized – Handled by Ministry of Agriculture.

• Intellectual Property Appellate Board – Operationalized from 15.09.2003

UN-CBD i.e. Convention on Biological Diversity – is an international regulatory instrument of UN, signed by the countries of the world – 1992 at Rio de janerio

CBD for the first time affirmed i.e. Biodiversity of a nation is its sovereign property and nobody can access it with our prior informed consent of the holder(s) of the biodiversity.

Genesis of the Global Concern on Biodiversity

First discussed in 1972 U. N. Conference at Stockholm U. N. General Assembly by a resolution on 15th

December 1972 established UNEP. . First Governing Council of UNEP met in 1973

identified Conservation of Nature, Wildlife and Genetic Resources as Priority areas.

The World Commission on environment and Development (WCED) was constituted in 1983.

WCED submitted its report ‘Our Common Future’ in 1987 called for Conservation of Biodiversity for Sustainable Development.

Genesis of the Global Concern on Biodiversity (Contd..)

UNEP constituted an ad-hoc Working Group of Technological and Legal experts to prepare an international legal instrument for conservation and sustainable use of Biodiversity which resulted in ‘CONVENTION ON BIOLOGICAL DIVERSITY’ (CBD).

•171 countries signed CBD in June 1992 during the Earth summit at Rio de Janeiro.

CBD came - into force as an International Law on 29th Dec. 1993.

Genesis of the Global Concern on Biodiversity (Contd..)

India ratified CBD on 18th February 1994 and came into force from 19th May 1994

188 countries are now parties to CBD (as on Aug. 2004)

OBJECTIVES OF CBD– Conservation of Biological Diversity– Sustainable use of its components– Fair and equitable use of the benefits arising

out of the utilization of genetic resources

The fundamental conflicts between CBD and WTO

CBD recognizes the sovereign rights of nations over their biological resources and associated knowledge systems.

WTO do not recognize any informal knowledge/ innovations of traditional communities for intellectual property rights.

Do not insulate Traditional Knowledge (TK) from intellectual piracy.

IPR & TK

IPR: The prime driving force behind industrial growth and development in the 19th & 20th centuries.

WTO do not recognize the informal system of innovation of indigenous people.

WTO do not provide mechanism for compensation or benefit sharing with indigenous people.

IPR & TK (Contd..)

IPR laws in general ignore the interest of traditional/local communities-

• because their concept of intellectual property and resource rights are different from those of the advanced societies of developing countries and the developed North countries.

But there are ways in which these laws can serve the interests of these communities.

However, acquiring and defending IPR protection require access to information, good legal advice and financial resources-which are mostly beyond the reach of most of the indigenous people.

International Movements for Protection of TKS

First International Congress on Ethnobiology at Belem, 1987, came out with the ‘Declaration of Belem’.

The declaration recognized a basic obligation that procedures to be developed to compensate native people on their knowledge and on their biological resources.

Second International Congress on Ethnobiology at Kunming, China in 1990 resolved to establish a Global Action Plan, The “Kunming Action Plan” for

Specific and urgent action to stop the destruction of biological and cultural diversity as mandated in the ‘Declaration of Belem’.

Global Coalition for Biocultural Diversity to unite the indigenous people, scientists and environmentalists concerned with the protection of indigenous/ local people rights.

CBD – Bonn Guidelines.

Relevant Provisions of CBD

Article 3 recognizes the sovereign rights of States over their biological resources.

Article 8(j) underlines the need to protect TK and points to the potential benefits to be realized from such knowledge through involvement of its holders and equitable benefit-sharing.

Article 15 states that when access to genetic resources is granted, it shall be on mutually agreed upon terms and subject to Prior Informed Consent.

Article 15&16 Incentives to biodiversity-rich countries to conserve and sustainably use their genetic resources, including joint research, access to & transfer of technology.

Relevant Provisions of TRIPs on Biological Resources

Under Article 27, virtually all inventions are to be patented if they are new, involve an innovative/inventive step and are capable of industrial application.

Exceptions to patentability include plants, animals ( other than microbes) and biological processes for the production of the above. However plant varieties must be protected either by sui generis or by patenting (27.3(b)).

TRIPS-CBD Relationship

Absence of explicit compatibility, Difference of approach and priority given to issues which are ultimately related. This has led to violation of the CBD (Articles 8,15 &16).

TRIPs ignores a vast range of valuable, traditional knowledge (TK) because it doesn't meet the standards of patentability.

TRIPS-CBD Relationship (Contd..)

TRIPs undermines CBD in cases of biopiracy, by putting the burden of proof on the source country rather than patentee. Identification of unique source material as required in Art.29 of TRIPs is insufficient. Lack of transparency in the patent application procedure.

TRIPs doesn't require the recognition of domestic laws protecting access to genetic resources and TK and subsequent benefit sharing.

IPR Issues / Benefit Sharing Strategies

Appropriate Procedures for IPR Protection/Benefit sharing

Documentation & Registration of TK – Medicinal plant use & Conservation at local , state and national level.

Contribution to TKDL & TKRC Value addition to TK & Indigenous

Medicinal Plants – Scaling up IPRs Herbal drugs, Pharmaceuticals, Natural

products & byproducts, Nutraceuticals, Functional foods, etc.

International Regulatory Instruments on ABS

Organization Agreement Main FeaturesWorld Trade Organization (WTO)

Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs)

Flexibility of TRIPs Article 27.3 (b) may allow member states to incorporate ABS- “friendly” provisions. Is “legally” binding via the WTO dispute settlement mechanism.

Food and Agriculture Organization (FAO)

International Treaty on Plant and Genetic Resources for Food and Agriculture (IT)

Provides access to 64 crops via a multilateral system, but not for commercial reasons. Legally binding.

World Intellectual Property Organization (WIPO)

Inter-Governmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC); Substantial Patent Law Treaty (SPLT)

Establish Prior Art via the creation of TK database and mirrors the CBD objectives. However, the SPLT potentially could subvert these efforts due to the broad rules for patenting it may present and the asymmetries it has with the Bonn Guidelines.

United Nations Environmental Program (UNEP)

Convention on Biological Diversity (CBD)

Presents best practices for ABS via the Bonn Guidelines. Voluntary; not legally binding, yet expected to be influential in the drafting of domestic regulation.

Strength of India in Biodiversity

Rich in all levels of biodiversity species, genes, habitat

Rich in cultural diversity that generated rich fund of indigenous knowledge systems

Humanity has tapped only a fraction of this nature’s vast genetic library

Over 70-80% genetic resources of India and other South Asian countries are hitherto untapped.

Excellent opportunity for hunting novel genes, drugs, pharmaceuticals, new chemicals/raw materials for new industrial ventures.

Bioprospecting and the new IPR regime

Given the global trends in capturing the intellectual property markets, the Third World nations like India needs to look ahead for the best possible ways and means by which they can generate IPR and build up IPR covered bioindustrial regimes.

Biotechnology (BT), Information Technology (IT) and Herbal Technology (HT) are the three fast emerging and powerful areas of R&D in current century. The rich biodiversity, associated knowledge systems and human resources etc. are the strength of Asia-pacific countries, and therefore have the best opportunity.

Chemical Prospecting Drugs and pharmaceuticals Pesticides Cosmetics Food additives Other industrially valuable Chemical products

Bioprospecting

Gene Prospecting Genetic engineering Crop development Fermentation Cell culture

Bionic Prospecting DesignsSensor technologiesArchitecture Bioengineering Biomodeling

Bioprospecting: Linkages and leads

Biodiversity & IK/TK

Conservation Sustainable use

Benefit sharing

Bioinformatics

IPR

Biotechnology

Information technology

Herbal technology

Bioprospecting

Drug development

Pharmaceuticals

Agrochemistry

Cosmetics

Proteins

Enzymes

New crop varieties

GMOs

GM foods

Designs etc.

THANKS