TRIPS obligations and flexibilities regarding life forms and plant varieties, and the effects of FTAs By Chee Yoke Ling Third World Network Asian Regional Workshop on Bilateral FTAs (26-28 August 2005, Kuala Lumpur) Session 9

Domestic policy space When there are no international treaties, national governments can decide on the scope of intellectual property claims Before the TRIPS Agreement, the scope of patents in developing countries was restrictive. Thus life forms (plants, animals, microorganisms), food products and pharmaceuticals were not patentable

Patents on “life forms” Ethical, religious and legal aspects re: private ownership claims over biological resources, human genetic resources, parts thereof (including DNA sequences) US has broadest patent scope over life forms, parts of life forms (including DNA sequences) - the distinction between “invention” and “discovery” European Union law on patents over “biotechnological inventions” Canada - no patents over higher life forms (Onco mouse case) Developing countries - from no patents (majority) to varying scope of patents allowed since 2000

WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPs) “Minimum standards” based on standards of developed countries in the late 1980s-early 1990s First international legally binding agreement on intellectual property rights: no choice for WTO Members Patent, copyright, trademark, geographical indication etc Provisions for review and amendment Grounds for exclusion are not exhaustive under TRIPs.

WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPs) (contd) Article 7 on Objectives: IPR protection and enforcement “in a manner conducive to social and economic welfare, and to a balance of rights and obligations” Article 8 on Principles: Members may “adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development” Article 71.1 “TRIPs Council shall be guided by the objectives and principles of Articles 7 and 8 of the TRIPs Agreement and shall fully take into account the development dimension”

WTO-TRIPS Agreement Article 27 What can be patented? Process and product Criteria for patentability New/Novel Inventive step Capable of industrial application Definitions left to national law BUT an “invention” can be excluded from patentability, if it is necessary to protect ordre public or morality Grounds include: to protect human, animal or plant life or health To avoid serious prejudice to the environment Exclusion can be made in national law Grounds not exhaustive in TRIPS.

WTO-TRIPs Agreement Article 27 (contd) May exclude from patents … Essentially biological processes for production of plants or animals Diagnostic, therapeutic and surgical methods for treatment of humans or animals It is illogical to exclude patents on biological processes but mandate patents on microbiologcial processes (concession to the biotech industry) Mandatory to patent … non-biological and microbiological processes for production of plants and animals “microorganisms” (interpreted by many countries to exclude naturally-occuring microorganisms; term is not defined in TRIPs)

“Biopiracy” Misappropriation of biological resources Misappropriation of associated knowledge (public domain, traditional knowledge of indigenous peoples and local communities) Through use and commercialisation without prior informed consent of resource owners or knowledge holders Increasingly through “intellectual property claims” especially patents that confer exclusive/monopolistic rights for a minimum of 20 years

Convention on Biological Diversity (CBD) Recognises that IPRs may be a problem Article 16(5): CBD Parties to ensure that IPRs are “supportive of, and do not run counter to” the CBD objectives Alternative legal framework for benefit sharing systems outside current intellectual property regimes

CBD and WTO-TRIPs relationship WTO Ministerial Declaration (Doha 2001) on reviewing life form patents provision Article 27.3(b) - positions range from no patents to patents Relationship between TRIPs and CBD to be clarified in TRIPS Council - 3 “Disclosure requirements” to be added to patent applications involving genetic resources (proposal of a group of developing countries) Source and country of origin Prior informed consent under relevant national regimes Benefit sharing under relevant national regimes

CBD and WTO-TRIPs relationship (contd) Ongoing WTO TRIPs Council review of Article 27.3(b) on patents on life forms - amendment called for by Africa Group to limit patents on life forms Harmonising Convention on Biological Diversity (CBD) and TRIPs Agreement - main goal to prevent biopiracy in order to meet CBD objectives - TRIPS amendment called for by a group of developing countries to include “disclosure requirements” International Regime on Access and Benefit Sharing under the CBD - negotiations began in February 2004 - alternative to patents and other exclusive intellectual property claims?

FTAs erode flexibilities Removes right to exclude from patentability plants and animals and essentially biological processes for the production of plants and animals (US-Singapore FTA) Must become Party to the 1991 International Convention for the Protection of New Varieties of Plants (UPOV 1991) that confers rights to formal plant breeders that are almost as strict as patents, at the expense of small farmers’ rights. FTA partners forego the option of sui generis system allowed by TRIPS Article 27.3(b) (US-Singapore FTA; US-Chile) Such provisions will worsen “biopiracy”

Neem patent revoked by European Patent Office After a 10 year battle, one of 65 patents given to various products derived from the neem tree was revoked by the European Patent Office, in an appeal by the patent holder against the revocation decision at the first instance Indian NGO, European NGO and European Green Party parliamentarian filed the opposition against W.R. Grace and the US Secretary of Agriculture (joint patent holders) Ground of revocation: no novelty as the use was in the public domain already THUS THERE MUST BE CAUTION AGAINTS FTAs FACILITATING BROAD AND INVALID PATENTS

FTAs creating “patent police” FTAs with developed countries especially the US, contain lengthy provisions on enforcement - increases obligations and burden of national governments to protect IPR holders Recent trend in royalty collection - Monsanto pressured Brazil and Paraguay governments to enter into contractual agreements to collect payments for use of genetically engineered soya at the point of exit Negotiations with Argentina are controversial - no patent on Monsanto’s GE soya; Argentina refuses to be collector; Monsanto sues in Denmark and Holland (importers of Argentine soya)

FTAs should not include TRIPs Plus provisions on biodiversity and plant varieties Maintain TRIPS flexibilities Limit the scope of patentability of life forms Apply the 3 criteria of patentability strictly to maintain the distinction between a “discovery” and “invention” Do not undertake new agreements such as UPOV 1991