Following passage of the Organic Code on the Social Economy of Knowledge, Creativity and Innovation, its Regulations for Application were published in Official Registry Supplement No. 9 on June 7, 2017, with a view to implementing and regulating certain articles of the Code.
Noteworthy among the regulations are:
Establishment of the National Intellectual Rights Service (SENADI), as technical knowledge management body, with its own legal standing, to be composed of at least the following areas: i) General Office, ii) Technical Industrial Property Office, iii) Technical Copyright and Related Rights Office, iv) Technical Plant Varieties Office, v) Collegiate Body for Intellectual Rights.
Included are general rules regarding i) Academies of Sciences, Arts or Humanities, ii) the National Commission on Research Ethics, iii) Spaces for Knowledge Development and Innovation Ecosystems, iv) Human Talent Education and Training, v) Responsible Research, and vi) Technology Transfer.
On Patents, a list is included of nonpatentable inventions, primarily with reference to the product of polymorphs and metabolites.
Certain rules are included with respect to "undisclosed information," indicating that it is protected with disclosure in accordance with the rules of the Organic Law on Market Power Regulation and Control, as well as rules in relation to "trial data" protection. To authorize sale of new chemical entities of pharmaceuticals and agrochemicals, any document or evidence making it possible to guarantee their safety and effectiveness can be used.
Additionally, the Regulations incorporate certain rules for observance of intellectual property rights, qualifying such rules as mechanisms for enforcement and penalizing rights violations. Moreover, with a view to avoiding abuse of exclusive and excluding prerogatives, negative observance procedures permit use of third-party intellectual creations without infringing subjective rights.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.