TRIPS Agreement

27.3(b) Members may also exclude from patentability:...

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes...

TRIPS flexibilities: article 27.3(b)

...However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

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Possible exclusions from patentability

Plants (even if genetically modified)  Plant varieties  Parts and components of plants ?

 What’s a microorganism? ‘Natural’ microorganisms  Essentially biological processes, including the use of marker-assisted selection (MAS)

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Proposals on biotech patents in WTO

Report of the UN Special Rapporteur on the right to food (2008)

 Extending patents to plant varieties in particular would accelerate the “verticalization” of the food production chain, as agricultural producers would become dependent on the prices set by companies for the seeds…

Report of the UN Special Rapporteur on the right to food

 …and would be denied the traditional right to sell and exchange seeds among themselves, as well as to save part of their crops in order to retain seeds for the next planting season…

African Group

 Artificial distinction between plants and animals and micro-organisms  Plants and animals, microorganisms and all other living organisms and their parts, and natural processes that produce plants, animals and other living organisms should not be patentable

Bolivia

 To prohibit the patenting of all life forms, including plants and animals and parts thereof, gene sequences, micro-organisms as well as all processes including biological, microbiological and non-biological processes for the production of life forms and parts thereof

Convention on Biological Diversity (1992)

    Objectives: conservation and sustainable use of biological diversity Recognition of countries ’ genetic resources sovereign rights over Fair and equitable benefit sharing of the benefits deriving from the use of genetic resources Article 8(j): Recognition of traditional knowledge and equitable sharing of benefits (ABS) from its utilization

Article 2 of the CBD

 “Genetic resources” means genetic material of actual or potential value, and  “Genetic material” means any material of plant, animal, microbial or other origin containing functional units of heredity.

 “Biological resources” includes genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity.

CBD

  Article 15: Prior Informed Consent (PIC) procedures Article 16.5: .. recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, [Contracting Parties] shall cooperate .. in order to ensure that such rights are supportive of and do not run counter to its objectives.

TRIPS-CBD Relationship CBD Bonn Guidelines on ABS:

encourage disclosure of the country of country of origin of GRs and associated TK in applications for intellectual property rights

TRIPS

Article 29. Conditions on Patent Applicants 1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.

CBD-TRIPS Relationship

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Paragraph 19-WTO Doha Ministerial Declaration 2001

We instruct the TRIPS Council to examine

... the relationship between the TRIPS

Agreement

dimension.

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and the Convention on Biological Diversity, the protection of

traditional knowledge and folklore.... 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

Need for an International Disclosure Requirement

TRIPS allows the granting of patents for inventions that use genetic resources and associated TK without requiring compliance with the provisions of the CBD. TRIPS does not contain provisions to ensure that patent applicants have acquired prior informed consent (PIC) of the owners of the biological resources and associated TK or complied with national ABS regimes.

Disclosure of origin of biological materials

 Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge…

Disclosure of origin of biological materials

 …patent applicants shall disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin.

Disclosure of origin of biological materials

 Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing...

 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (October 2010)

Objective

 The objective of this Protocol is the fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components.

Definitions

   (c) “Utilization of genetic resources” means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention… (e) “Derivative” means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity.

Article 15. COMPLIANCE WITH DOMESTIC LEGISLATION OR REGULATORY REQUIREMENTS ON ACCESS AND BENEFIT SHARING

   1. Each Party shall take appropriate, effective and proportionate legislative, administrative or policy measures to provide that genetic resources utilized within its jurisdiction have been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the other Party. 2. Parties shall take appropriate, effective and proportionate measures to address situations of non-compliance with measures adopted in accordance with paragraph 1 above. 3. Parties shall, as far as possible and as appropriate, cooperate in cases of alleged violation of domestic access and benefit-sharing legislation or regulatory requirements referred to in paragraph 1 above.

Article 17. MONITORING THE UTILIZATION OF GENETIC RESOURCES

   1. To support compliance, each Party shall take measures, as appropriate, to monitor and to enhance transparency about the utilization of genetic resources. Such measures shall include: (a) The designation of one or more checkpoints, as follows: (i) Designated checkpoints would collect or receive, as appropriate, relevant information related to prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilization of genetic resources, as appropriate;

 (ii) Each Party shall, as appropriate and depending on the particular characteristics of a designated checkpoint, require users of genetic resources to provide the information specified in the above paragraph at a designated checkpoint. Each Party shall take appropriate, effective and proportionate measures to address situations of non-compliance;