A Hybrid Game: Of the Blessed Intellectual Property & the Bastardized Biodiversity Srividhya Ragavan University of Oklahoma Law Center

The presentation posits that the international regime for protection of plant varieties threatens food security.

The presentation posits that the international regime for protection of plant varieties threatens food security by: Over protecting hybrid varieties Under protecting genetic materials Not addressing issues arising from the interaction of all of the regimes

International Regime for Plant Variety Protection TRIPS UPOV CBD – Convention on Biological Diversity Agreements on Agriculture & Agreements on Subsidies & Countervailing measures

Basis for protection

The TRIPS requirement for plant variety protection

Article 27 (3)(b) of TRIPS “…members shall provide for the protection of plant varieties either by patents or an effective sui generis system or by any combination thereof”

An effective sui generis system Article 31 of the Vienna Convention: Treaties be read in the light of the objectives Objective based reading in the Doha Ministerial Declaration Also the Declaration on public health

An objective based reading of TRIPS posits that effectiveness is dependent on the individual member’s requirements in embracing the international trade regime

Objective Based Reading Article 1: Nature and Scope “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” Members can adopt protection best suited for national legal system and practices

Art. 7 of TRIPS: Objectives The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Article 7 of TRIPS The protection and enforcement of intellectual property rights should contribute to the promotion of …. to the mutual advantage of producers and users … in a manner conducive to social and economic welfare, and to a balance of rights and obligations of members

Art. 8 of TRIPS: 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, provided that such measures are consistent with the provisions of this Agreement.

Surely, the article cannot mean that where inconsistent members need not: “Protect public health and nutrition, and to promote the public interest in sectors of vital importance” Thus, member’s public health & public interest situations form an adequate exemption under art. 27 (3) (b) of TRIPS.

Article 7 & 8 + Doha Declaration: Lends a national rather than a global objective Members have to adopt TRIPS in a way that balances their rights & obligations Members can make adequate exceptions in a manner protecting public health and interest.

So, what is an effective protection Developed nations: Efficiency depends on the sufficiency of protection for new varieties When read with the objectives, the efficiency is measured using a national rather than global standard Has to balance social & economic factors Reiterated in the Doha Decl: PBR protection should take biodiversity and TK issues

Types of effective protection Patents sui generis system or a combination of patents and sui generis systems Uniqueness of article 27(3): Lack of harmonization Flexibility

Uniqueness of Article 27.3 Lack of harmonization Flexibility Members can adopt any one of the 3 alternatives available as long as it is effective

Malnutrition and need to improve access to food Benefits of PBR WTO weighed costs & benefits of PBR Hence middle ground for PBR provisions Reasons for the uniqueness

Art 27 (3) meant to be flexible Language of article 27 (3) History of Article 27(3)

History of Article 27.3 EU and US/ Japan differed Developing nations went with EU Increased dependence of population on agriculture Hence, economy’s dependence on agriculture More biodiversity Marginal participation in international trade in commodities No studies specific to developing nations The inevitable process of privatization

Whether UPOV can be an effective sui generis system

UPOV as an example of over- protection for hybrids

Whether UPOV can be an effective sui generis system UPOV is neither mandatory nor the minimum standards in TRIPS First, flexibility in article 27(3) is lost if UPOV is mandatory Second, UPOV is an ineffective sui generis system

UPOV is an ineffective sui generis system Diluted Eligibility requirements Excessive Scope for breeder’s rights Inadequate limitations on breeder’s rights

UPOV’s Eligibility Requirements Protection under UPOV for: New Useful Distinct & Stable varieties

Diluted Eligibility Requirements Protection under UPOV for: New - diluted Useful Distinct – highly lowered standard Need not be nonobvious Stable varieties

Novelty Requirements Commercial Novelty: Art. 6 of UPOV The variety shall be deemed to be new if, at the date of filing of the application for a breeder's right, propagating or harvested material of the variety has not been sold or otherwise disposed of to others, by or with the consent of the breeder, for purposes of exploitation of the variety Excludes cultivation, reference collection, publication etc,. Allows the breeder to claim protection over genetic varieties that have been cultivated for centuries but never sold.

Distinctiveness Requirement Article 7 of UPOV: “The variety shall be deemed to be distinct if it is clearly distinguishable from any other variety whose existence is a matter of common knowledge at the time of filing the application.” Application materials that are a matter of common knowledge can pass the test of distinctiveness if it can be distinguished from another material that is a matter of common knowledge.

Art 14: A variety is “a matter of common knowledge,” under article 14 of UPOV, if it has been subject “of an application for the granting of a breeder's right” or has been entered in the official register of varieties, in any country”

Distinctiveness: Ability to distinguish from another variety entered in the official register or, for which an application has been made. Varieties already cultivated, being cultivated, well known, and are indistinguishable from well known varieties will continue to qualify as “distinct” so long as close cousins of the variety have not been subject to an application for breeder’s rights.

Exaggerated Scope of protection Breeder’s right covers protected variety and “varieties not clearly distinguishable” from protected variety (art. 14 (5)(a)) and “essentially derived variety”

Art. 14 (5)(b) - Breeder can exercise rights over ‘essentially derived varieties’ ‘Essentially derived varieties’ are: predominantly derived from the protected variety derived from a variety that is predominantly derived from the initial variety, and it is clearly distinguishable from the initial variety Breeder may be able to claim rights of other farmer’s experimented variety although it is clearly distinguishable from the protected variety

Hybrid Protection over ‘clearly indistinguishable varieties’ Protection over clearly distingusishable but essentially derived material

Limitations on Breeder’s Rights Breeder’s rights have few restrictions Art 14(1)(b): “Breeder may make his authorization subject to conditions and limitations” Art 17: “No Contracting Party may restrict the free exercise of a breeder's right for reasons other than of public interest” “Public interest” Similarity with the pharmaceutical patents debate Hunger v. Monopolization of food

Implications of UPOV Privatization

Implications of UPOV Privatization because of the huge benefits for breeding. Breeding is encouraged when several derivatives of protected variety is also protected. B & M report: 4 firms had most certificates Kesan & Janis: (Soya and Corn patents: 1970 – 2002) Half the issued certificates on Soy were owned by 3 companies; and by 4 companies in the case of corn. Increases price discretion of monopoly holder

Privatization Possible benefits Increased R & D as a possible advantage (Pre-1970): R & D increased proportionally with the increase in sale of seeds (Post-1970): Companies spent less on R & D per sales- dollar earned

Concentration of R & D on commercially yielding varieties B & M Report attributes impact of PVPA on Soy in the US on size of the market and expectation of yield Sales in developing nations bound to be lower Analogy with pharmaceutical market Danger of reduced allocation of R and D for developing country crops Privatization

CBD- An example of under protection for genetic materials

Convention on Biological Diversity CBD introduced at the United Nation’s Conference on Environment and Development in 1992 (came into force in 1993)

Art. 3: Sovereign rights of states to exploit their resources “pursuant to their own environmental policies.” Sovereign should, by national legislation, provide for access to genetic resources. Such access has to be made in accordance with the provisions of the CBD. On plain reading, convention mandates access to genetic resources and leaves the operating mechanisms to the sovereign.

However, Art. 15(1): Access subject to national legislation Art. 15(2): Access shall be facilitated by national legislation National legislation shall not run counter to Convention objectives Article 1: Conservation of biodiversity including by “appropriate” access to genetic resources.

Read together, CBD provides access to genetic resources irrespective of national legislation. CBD mandates: national legislation will grant access, narrowed only by a reference to the “appropriateness” of the access. Thus, sovereign cannot, under the CBD, refuse access to genetic resources Sovereignty is subject, by the CBD, to providing access to genetic resources by national legislation.

Only limitation for sharing genetic resources is prior informed consent Art. 15 (5): Access to genetic resources shall be subject to prior informed consent …

Prior Informed Consent Article 8(j): gist of “prior informed consent” before resources are taken from holders. CBD does not define the term; the kind and extent of information It is unclear whether the requirement of having to share knowledge prevails over the need for consent by the indigenous people.

Art. 15 (5) Access to genetic resources shall be subject to prior informed consent …, unless otherwise determined by that Party. Art. 15 (4): Access on mutually agreed terms

The quid pro quo - access to technology - is subject to mutual consent (art 15 & 16) CBD subjects technology transfer to IP protection The relative bargaining powers makes it more difficult for the South to expect any real benefit from the CBD. Holders, sometimes, are not aware of the extent of development to bargain effectively Access to technology

The fact that a transfer of technology agreement can be violated after the genetic resource has actually been transferred CBD has failed to deal with similar breaches in the past No mechanism to deal with circumstances in which the resources have been obtained by misrepresentation or by the communication of inadequate information. The CBD does not display clarity on the future course of action if it is proved that the information was not acquired with “informed consent.” In any case, simply invalidating an information- transferring agreement for its breach—when the crux of the information has already been transferred—acts as neither a deterrent nor as a protective mechanism.

The PBR regimes of all nations interact with: CBD Agreement on Agriculture Implications of TRIPS

UPOV in the context of CBD Loss of genetic diversity CBD article 1 read with 15: Mandatory to share genetic resources Allows breeder to make nonobvious changes and appropriate genetic material

Scope of protection for breeders Genetic Variety Hybrid Nonobvious difference will not defeat protection Protection extended to clearly indistinguishable and distinguishable varieties

PBRs in the context of other policies that impact agriculture

Effect of subsidies on PBR Assuming PBR results in higher yield, newer varieties and better crop Economies will flourish if farmers can sell the produce Farmers will not be able to sell because of the dumping of subsidized products in both local and international markets

Economic effect of PBR PBR (from 2005) will also be subject to operations under Agricultural Agreement Art 13 of AoA precluded challenges for noncompliance with Agricultural liberalization commitments Exceptions to GATT, AoA and SCM permitted developed nations to maintain subsidies of totaling upto $ 150 billion until recently

Dumping caused from the agricultural subsidies of several developed nations Resale in third markets at less than the cost of production in the exporting country; The export subsidies, direct payments and credits bridge the gap between high cost of production, high internal prices and lower world prices.

Effect of PBR on Farming Abundant availability of food becomes inconsequential if majority population (farmers) suffers from lack of trade and hence is unable to afford food Farmer cannot stock and reuse the seed because UPOV prohibits it (art 14)

Bottom Line Intellectual property cannot yield any benefit if the market is blocked by subsidies

And, thus the fear of food insecurity

The World

Suggestions Agricultural liberalization to precede PBR Differential monopoly term Reduction of monopoly term Differential pricing Amendments in case of emergency Definition of public interest Introduction of compulsory licensing Involvement of international organization Exceptions to least developed nations