Marine Genetic Resources: Scientific intellectual property right and patentability. S. Arnaud-Haond

Transcription

1 Marine Genetic Resources: Scientific intellectual property right and patentability S. Arnaud-Haond

2 SMarineGenetic Resources: Scientific intellectual property right and patentability ci Marine Genetic Resources :Definitions and tendencies (exploitation, applications, patenting) New use, new rules: patenting & MGRs, three roads for improvement

3 Definitionof GeneticResources Genetic Resources: Genetic resources are genetic material of plants, animals or micro-organisms of value as a resource for future generations of humanity. (Definition of the OECD, Organisation for Economic Co-operation and Development) The concept of genetic resources was unclear before the Convention for Biodiversity tackled the issue (CBD workshop Ottawa 2009): Genetic resources means genetic material of actual or potential value. Genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity.

4 GeneticResources Nowadays GRs encompass most natural products due to the evolution of Genomics techniques following Moore s law, genetic resources are more commonly used than harvested or cultured ones, at least for marine Organisms Sequencing speed bp.day -1 (log scaled) $ 0.1 $ $ 0.01 $ $ Years Evolution of price per kb (dollars) Credits: AIBiotech

5 Marine Biotechnologies: Anexponentialincrease 1.2 of patented genes reported in GenBank database have a marine origin, but this number is increasing exponentially The use of natural products has also increased dramatically during the last decades (Arrietaet al., 2010, Molinskiet al., 2009, Costa Leal et al., 2012) (from Arrieta, Arnaud-Haond and Duarte, 2010)

6 Medicines Pain killers (Conus; ziconotine) Anti-cancer (tunicates): anti tumor toxins(already commercialized) or cellular division blockers(in test) : a marketof about 1 billion$. year Anti-herpes (237 millions $. Year for Zovirax) AIDS Treatment-Retrovir(23 millions $) Hydrothermal microbial polysaccharids with properties inducing tissus or bone regeneration Anticoagulants

7 Biomedicaland Molecular Biology Bioluminescence used for cellular labelling Enzymes TOTAL market: 50 billions$. year One billion$. Year for applications to DNA extraction

8 Cosmetics In 2005 an estimated TOTAL marketof230 billion $ Marine organismsare richin carotenoids, chlorophyll, antioxydant Collagen

9 Bioremediationet Biofuel Bioremediation: Bacterias degrading contaminants, including some hydrocarbures Ultrathin Valley industry (hydrothermal bacteria used biofuel production): 150 millions $. year

10 The unbalanced ownership of patents claims 10 countries own 90% patent claims, 3 own 70 A typical power law distribution of wealth The rich gets richer effect: oceanographic means or molecular skills? (from Arnaud-Haond, Arrieta and Duarte, 2011) Yet the Areas Beyond National Jurisdiction were excluded from the Nagoya Protocol for CBD on Access and Benefit Sharing Last November

11 The unbalanced ownership of patents claims Same pattern and similar set of countries for patent claims associated to Human sequences Sequences from the 4 crops most cultivated and consumed in the world: wheat, rice, maize, barley. A disequilibrium therefore mostly linked to access to molecular technology Debunking the belief : the status of Common heritage of the Humankind does not prevent patenting (from Arnaud-Haond, Arrieta and Duarte, 2011) (from Arnaud-Haond, Arrieta and Duarte, 2011)

12 A first question: The thin red line separating discovery from invention Challenging Intellectual Property associated with genes? The novelty and non-obviousness requirement holds that, if a hypothetical person skilled in the relevant domain could re-create the invention as a predictable variation of the state of the art, the patent claim is obvious and not worthy of patent protection genescannotbepatentedper se but a listof potentialapplication is required YET, manyprocesses/methodswescreenedin patent claims use the geneto performwhatitdoesin nature (synthesizea molecule/ compound of interest), using molecular techniques widely available. JingyueJu flickr/dee_gee

13 A second question : a governance gap for Access and Benefit Sharing Marine Genetic Resources may fall under a governance framework, or a governance gap: EEZ: Exclusive Economic Zone, with sovereign rights, where CBD and Nagoya Protocol apply The Area, more than 50% of the surface of Earth: SeaBed Water column Conservation and exploitation within EEZ ruled by CBD since Nagoya, but for Areas Beyond National Jurisdiction a Negociation Process started in 2015 to agree on a governance framework: Status of MGRs as the common heritage of the humankind? Sharing of benefits? Conservation?

14 GAPS: the marine realm is a governance puzzle CBD (Art.15, Nagoya Protocol) RFMO s(fao) ISA

15 A third problem: gaps in the law on gene patenting Some are of unknown origin. Species name is not always mentioned Geographic location of collection OR distribution area of species is not a required criteria HOW to trace the compliance to CBD agreements and Nagoya Protocol HOW to apply a framework to MGR beyond national jurisdiction without such information? (from Arnaud-Haond, Arrieta and Duarte, 2011)

16 List of gaps What is patentable is nonobvious (TRIPS, general) Which information allows tracing the respect of international agreements (TRIPS CBD, general) Should the status of MGRs be considered separately within EEZ and in Areas Beyond national Jurisdiction If so, what should be the status of MGRs in Areas Beyond National Jurisdiction, which Mechanism to ensure Access and benefit Sharing?

17 ImprovingAccess and BenefitSharing: Mechanisms For crops: The International Plant Treaty (CBD/FAO) for «conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of benefits derived from their use» Recognition of Traditional Knowledge Improvement of Access and Benefit Sharing through Standard Material Transfer Agreement A benefit Sharing Fund Only 64 species are involved, and a scope different from that of MGRs

18 Improving Access and Benefit Sharing: Mechanisms For Human Genes: UNESCO Common Heritage of the Human Kind, yet subjectto patenting. Limited numberof initiatives, but the UNITAIDS PATENT POOLS is an example. «A mechanism in which various patents held by different entities, such as companies, universities and research institutions are made available to others for production or further development, such as pediatric or fixed-dose formulations. The patent holders are paid a royalty by those using the patents, with the pool managing the negotiations, the licensing arrangements and payments». Patent Pool Companies Universities Knowledge dissemination Research enhancement Generic companies Cheaper products Fair Royalties Improved R&D (from Spicy IP)

19 Scientific Resolving intellectual the Unbalanced property Appropriation right and patentability of Marine Biodiversity through Gene Patents AAAS Concarneau, Meeting October Vancouver 16 th 17/02/ Ethicaland Legal improvements Intellectual Property Regime on Life? Status of MGRs? WTO/TRIPS: An improvement of rules is Needed to support and enhance the efficiency of the Article 15 of CBD setting framework for Access and Benefit Sharing and to the recent Nagoya Protocol Required if the decision was to setup a specific framework for MGRs from areas beyond national jurisdiction A concept such as patent pools to both ensure Access and Benefit Sharing and Research reward? Ruled under international agreements: UNCLOS? By an Authority that may also manage the Conservation / Protection of Marine Biodiversity, an issue apparently impossible to disentangle in international negotiations

20 Thanks! US President LindonB. Johnson in the deep sea and the ocean bottoms are, and remain, the legacy of all human beings Article 241 of UNCLOS: Marine scientific research activities shall not constitute the legal basis for any claim to any part of the marine environment or its resources.