Caterina fazenda aguardar para colocar

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Membros da Comissão - http://www.ctnbio.gov.br /index.php /content/ view/2251.html 


Como funciona

O funcionamento da CTNBio é definido pela Lei de Biossegurança (Lei 11.105), regulamentada em 2005, segundo a qual a “CTNBio, composta de membros titulares e suplentes, designados pelo Ministro de Estado da Ciência e Tecnologia, será constituída por 27 (vinte e sete) cidadãos brasileiros de reconhecida competência técnica, de notória atuação e saber científicos, com grau acadêmico de doutor e com destacada atividade profissional nas áreas de biossegurança, biotecnologia, biologia, saúde humana e animal ou meio ambiente...”

Além disso, a lei dá, entre outras providências, a determinação de que “a decisão técnica da CTNBio deverá conter resumo de sua fundamentação técnica, explicitar as medidas de segurança e restrições ao uso do OGM e seus derivados e considerar as particularidades das diferentes regiões do País, com o objetivo de orientar e subsidiar os órgãos e entidades de registro e fiscalização, referidos no art. 16 desta Lei, no exercício de suas atribuições”.

  • Caterina fazenda aguardar para colocar

    1. 1. Legal Aspects of Bio Fuels Partnerships<br />Caterina Fazenda - Partner at Koury Lopes Advogados<br />
    2. 2. Brazil<br />Opportunity<br />Complexity<br />Uncertainty<br />
    3. 3. Brazil Legal Overview<br />Constitutional / Codified System<br />Complex Tax and Labor Systems<br />Importance of having FTO<br />Legal / Regulatory Framework<br />
    4. 4. Biofuels Legal Framework<br />Land Acquisition Rules for foreign entities<br />New Forest Code (4.771/65)<br />Intellectual Property Law (9.279/96)<br />Seed and Seedlings Law (10.711/03) <br />Plant Variety Protection (“PVP”) Law (9.456/97)<br />Bio Safety Law (11.105/03)<br />Provisional Measure on Access to Genetic Heritage (2186-16/01)<br />
    5. 5. 2010 opinion from Attorney General restricted land acquisition by foreign companies<br />Registration services have to inform “INCRA” on a quarterly basis<br />On going discussion involving Congressmen, Ag. Ministry and Attorney General (AGU)<br />Final report to be approved by the end of October - changes<br />By the end of the year a new Draft Bill <br />Law will be general but further regulations should take into account needs of land intense sectors<br />Ethanol<br />Cellulose<br />Forests<br />Land Acquisition<br />
    6. 6. New Forest Code<br />Approved by lower House and under discussion at the Senate<br />If approved President has to sanction it, but may use veto power <br />Main areas of debate<br />reduce the strip of land that must be left intact along the banks of rivers and streams<br />exempt small landowners from requirement to preserve 80% forest<br />give an amnesty to landowners who cleared forest before 2008<br />
    7. 7. Seeds and Seedlings Law<br />Establishes requirements for production and commercialization of seeds and seedlings <br />“RNC”<br />Establishes requirements for seed companies certification<br /> “RENASEM” <br />
    8. 8. PVP Law<br />Brazil adopts a “sui generis systems”:<br />Plants and parts of plants can not be patented but may be protected under PVP Law. - 15 years<br />Protected varieties may be used by 3rd parties for breeding<br />PVP law allows farmers to save seeds for own use with some restrictions for sugarcane<br />Current PVP Law is hard to enforce in Courts<br />Draft of New Bill under evaluation<br />
    9. 9. Intellectual Property<br />Patents<br />20 years protection or 10 from grant<br />Living beings or parts of living beings are not patentable<br />New gene constructs (GMO), new methods to make plants tolerant to herbicides may be patentable<br />Differences between US and Brazil Law<br />Favorable enforcement Case Law, criminal sanctions available.<br />Know-how / Trade secrets<br />Need to be protected by contacts (MTA’s and etc).<br />
    10. 10. Biotech Law<br />CTNBIO - multidisciplinary Commission of the Ministry of Science and Development<br />Supports the National Policy on GMO’s<br />Issues Technical Rules and Conclusive Opinions on GMO’s<br /> 27 members with notable scientific background<br />Opinions include technical background, safety measures and restrictions (if applicable)<br />e.g. Coexistence rules for GMO Corn<br />
    11. 11. Access to Genetic Heritage Provisional Measure<br />Prior approval required for research with materials from Brazilian genetic heritage if:<br />Collected “in situ”<br />Kept in collections “ex situ” but collected “in situ”<br />Benefits should be shared through the contract<br /> Patent filings resulting of access to “national genetic heritage” need to have had requested access authorization from CGEN.<br /> In 9 years, CGEN approved only 25 contracts.<br />
    12. 12. Establishing a Biofuel Partnership<br />Start right:<br />Find the right partner<br />Do a proper due diligence<br />Regular IP due diligence X Germplasm/Biotech D.D.<br />Ensure long term success<br />Ensure FTO<br />Develop a Value Capture Model<br />Develop an IP strategy <br />
    13. 13. Regular IP Due Diligence<br />Focus on:<br />IP ownership <br />Licenses / Contracts<br />Patents/Trademarks expiration dates and fees<br />IP litigation<br />
    14. 14. Germplasm Due Diligence <br />FTO of Germplasm banks:<br />Are the materials Registered at the RNC ? Does the company has as RENASEM?<br />Are the materials protected by PVP ?<br />How materials were accessed and how they are kept<br />Lab policies / safety measures ?<br />What was the Status of researchers – Were they members of public universities ? <br />Were Confidentiality / Non – compete agreements put in place?<br />
    15. 15. Biotech Due Diligence<br />If GM are involved:<br />Are the commercial approvals ok ? <br />Does the company has a CIBIO and all the procedures in place? <br />Does the company has the CQB’s ?<br />
    16. 16. Collecting Value with a Bio-fuel JV<br />Developing a Value Capture Model<br />e..g. Delivery Based System - “POD”<br />Soybeans – traders<br />Cotton - cotton mills – “algodoeiras”<br />Sugarcane - Mills<br />Developing an Intellectual Property Strategy<br />Integrated approach:<br />What is the timing of the commercial approval (GMO)<br />Which is the best protection model PVP or Know – How<br />What is the best time to file for patents/where to file<br />
    17. 17. Integrated Approach <br />IP Law<br />PVP<br />Seeds and Seedlings Law<br />Land Acquisition<br />New Forest Code<br />Bio fuels<br />Biodiversity<br />Know-How<br />Bio Safety Law<br />
    18. 18. Thank you !Obrigada!<br />ctfazenda@uol.com.br<br />klalaw.com.br<br />

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