Carga mental

According to Document WT/TPR/S/284, page 65, paragraph 3.11.3, "regarding animal health and food of animal origin, the Commission stated that EU legislation is largely based on OIE/Codex recommendations, standards, and guidelines".

Question:

4. Considering that in July 2012 the Codex Alimentarius Commission adopted an international standard setting maximum residue levels (MRLs) for ractopamine when used as food additive for cattle and pigs destined for human consumption and also that the WTO SPS Agreement (Article 3.1) provides that "Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist", could the EU explain why the EU does not follow this standard, maintaining its prohibition to imports of meat with ractopamine residues within the MRLs?

EU reply: In line with Article 3(3) of the SPS Agreement, the EU considers that it has a scientific justification for maintaining its measures for ractopamine.

Page 85 - Paragraph 3.223

In March 2012, the EC proposed new legislation to regulate the access of foreign providers to the EU government procurement market, which is currently under discussion in the European Parliament and the Council. Some analysts have seen the proposed regulation as a possible "buy European" law.

Question:

5. How does the EU respond to these critics?

EU reply: Brazil is referring to a Commission proposal which may be modified during the EU's legislative process. The proposal is currently on the table of the EU co-legislators– - the European Parliament and the Council. In the Council, the Member States have worked through a first reading of the proposal at technical level. The European Parliament is likely to express its views in a first reading vote on the proposal in autumn.

Page 90 - Paragraph 3.243

Paragraph 3.243 states that the European Patent Office recorded an increase in patent filings when compared with previous years.

Question:

6. Could the EU please elaborate on the policies put in place in order to address this rising number of patent applications and, if any, its effect on the quality of the examination carried out by the Patent Offices with jurisdiction over EU-members?

EU reply: Please refer to point 3.1. of the Commission Communication (COM(2008) 465 final) on an industrial property rights strategy for Europe outlines the EU policies on quality aspects of patents and the relevant quality study.

http://ec.europa.eu/internal_market/indprop/docs/patent/patqual02032011_en.pdf. Page 96 - Paragraph 3.264

Paragraph 3.264 states that both Spain and Italy have decided not to participate in the enhanced cooperation for the creation of unitary patent protection.

Questions:

7. Could the EU please explain why, in its view, Spain and Italy decided not to participate in the enhanced cooperation?

EU reply: Spain and Italy did not agree with the system of language arrangements which is based on the working languages of the EPO.

8. Is the EU taking any step to ensure that such countries participate in the "unitary patent protection"?

EU reply: Spain and Italy are free to join the enhanced cooperation at any time. Page 96 - Paragraph 3.266

Paragraph 3.266 describes the system in force for granting patents to biotechnological inventions. It is known that such patents are often related to access to genetic resources (GRs), their derivatives and associated traditional knowledge (ATK). Furthermore, it is of note that the European Union signed the Nagoya Protocol to the Convention on Biological Diversity on June 23rd, 2011, and that the Protocol includes provisions regarding the access to genetic resources and associated traditional knowledge and the sharing of benefits arising from their utilization. Lastly, the Protocol stipulates the establishment of checkpoints to, among others, collect and provide relevant information on prior informed consent and mutually agreed terms regarding accessed genetic resources and associated traditional knowledge.

Questions:

9. Could the EU please provide more details on the provisions, if existent, of EU regulations in respect of the disclosure of the origin of genetic resources and traditional knowledge involved in patent applications?

EU reply: There are no EU regulations in respect of the disclosure of the origin of genetic resources and traditional knowledge involved in patent applications.

10. In the absence of such regulations, could the EU please explain which measures are being adopted to fight against the misappropriation of GRs, their derivatives and ATK?

EU reply: On October 2012, the Commission adopted a proposal of Regulation on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union, which is currently under consideration of the Council of the EU and the European Parliament (COM(2012) 576 final)

11. Is the EU planning to establish a checkpoint as provided by Article 17 of the Nagoya Protocol?

EU reply: The Commission proposal (COM(2012) 576 final) implements Article 17 of the Nagoya protocol.

12. Could that checkpoint be, for instance, the European Patent Office, despite the fact that the EU's and the EPO's membership are different?

EU reply: Under the proposal of the Commission, not yet adopted, Member states will decide which checkpoint is appointed for the purposes of Article 17. The proposal of the Commission does not prejudice the role of any existing European authority in relation to Article 17.

13. Does the EU plan to provide, if any, sanctions to patents granted in violation of the Nagoya Protocol?

EU reply: The Commission proposal (COM(2012) 576 final) does not explicitly propose sanctions for patents granted in violation of the Nagoya protocol nor prejudice whether a patent can be granted in violation of the Nagoya Protocol.

14. Does the EU plan to provide a pre-grant mechanism for oppositions in respect of patent- related access to GRs and ATK in violation of the Nagoya Protocol?

EU reply: The Commission proposal (COM(2012) 576 final) does not envisage such a mechanism nor prejudge whether a patent can be granted in violation of the Nagoya Protocol. The document

can be found at the following link: http://ec.europa.eu/environment/biodiversity/international/abs/pdf/PROPOSAL_FOR_A_REGULATI

ON_EN.pdf.

15. What would be the relation of both mechanisms with the unitary patent protection?

EU reply: The Commission proposal (COM(2012) 576 final) does not envisage such mechanisms in relation to patents.