Latin America General Aspects Estela de Luca Region Latin America • Sub- regions: o o o o North America Central America Caribbean South America Estela de Luca Latin America Trademark Issues Estela de Luca Particularities of Latin America TM law and procedures One trademark application per jurisdiction (Exception: Madrid System: One application filing, through a local or regional PTO. Members: Cuba, Colombia and Mexico). First –to – file – system Attribute system vs. Prior use Principle of territoriality Exceptions: a) b) Well- know trademarks Trade agreements (Subregional Integration Agreement, Cartagena Agreement: Decision 486) c) Other international treaties (Pan American or Washington Convention: CO, CU, GT, HT, HN, NI, PA, PE, US. ) Estela de Luca Principle of territoriality Exception: Well-known TM • Paris Convention Rights of priority (art. 4, six months for trademarks). Exception: Puerto Rico. Art. 6 bis, well-known trademarks. • TRIPS Agreement Art.16: Application mutandis to: a) b) mutatis services, Connectionbetween goods/services. All the countries of the region are members of both agreements. Estela de Luca Principle of territoriality Exception: Andean Community (AC) • Trade agreements: Decision 486 • Bolivia, Colombia, Ecuador and Peru • Andean Opposition (art. 147): owner of a TM in a single country of the AC can oppose to a TM application in any other country of the AC. • Andean Use (art. 165): It is possible to claim the use of a TM in one country of the AC against a third party pursuing a cancellation action in a different country of the AC. • Well-known trademarks: art. 224 and 134 h. Estela de Luca Trademark procedure Filing an application with the local PTO Administrative/ Judicial procedures to adjudicate oppositions Formal examination Publication for opposition purposes (except MX) Substantive examination (ARG: mediation procedure) Estela de Luca Publication of the registration Use requirements Resumption of TM use before the filing of a cancellation claim will keep the TM in force Use made by authorized third parties benefit TM owner Non‐use TMS are «in force» until declared invalid Extent of use :1) Effective local use; 2) Manufacturing for exportation; 3) Mere transit Estela de Luca The main requirement for canceling a mark is the lapse of a particular period of time Public domain Trademark Law • Signs that are ineligible for, or excluded from, trademark protection. • Forms of using trademarked signs that remain unaffected by the exclusive rights of the trademark owner • Signs excluded from registration and protection as trademarks, • Signs which lack of distinctiveness, • Limits to the use of the protected sign. • Direct relationship with the goods or services Generic or descriptive terms to which the sign is or will be applied to Estela de Luca Latin America Regulatory Issues Estela de Luca Latin America No Harmonization Group 1 Group 2 Brand drugs Innovative or original drugs Generic drugs Similar drugs Generic drugs Estela de Luca Group 1 Branded drugs • Identified by brand names Generic drugs • Using INN-DCI recommended by WHO or any other nonpropietary names defined by the country or recognized internationally Estela de Luca Group 2 Innovative or original drugs • Generally distinguished by brand names. Similar drugs/copies • Pharmaceutically equivalent to the proprietary product. • Labelled by brand names or INN. Generic drugs • Products that have been proven to be therapeutically equivalent and interchangeable with the proprietary drug. Estela de Luca Drug Prescribing Use of INN is compulsory ? Private sector Public sector Principle: YES Estela de Luca AR, BO, PA, PE, PY, UY Substitution 1 ) BR: Not for similar drugs. 2 ) Not mandatory AR, BO, CR, CO, EC, PE, UY; (CH: At the discretion of the patient and pharmacist) , Generics/ Prescribe medicine similar drugs 3 ) Mandatory 4 ) MX, BR, PA. Estela de Luca Descriptive signs vs. evocative or suggestive signs AR/BR/MX : Evocative/suggestive signs: Considered “weak TMs”, but registrable (contains elements that gives them a fanciful nature, to some degree). PY : It cannot be registered as trademarks for pharmaceutical specialties, generic names of active principles. If a medicinal specialty is distinguished by a TM or fancy name, same cannot be confusingly similar with a generic name or induce to errors regarding the therapeutic properties or the nature of the proprietary medicinal product. Law 1119, Paraguay ARG: “Lab. Bagó SA c/ Sanofi Synthelabo Cease of TM Opposition” (File N° 1817/2001). Federal Civil and Commercial Chamber, Tribunal II, August 23, 2005 FENDIPRAZOL “Lab. Northia SACIFIA vs Synthelabo ref. Cease of TM Opposition” (File N° 1589/2000). Federal Civil and Commercial Chamber, Tribunal II, April 28, 2005 – GASPRIDE Estela de Luca MERCOSUR Full Member Associate Member Accessing Member (2012) Estela de Luca Mercosur The proposed trademark is evaluated by each Health Authority Resolution GMC N° 23/95. Medicines must be distinguished by the proposed commercial designation and the name of the active substance according the International Common Designation –DCI-“. Estela de Luca Resolution GMC N° 55/96. Trademark is understood as a name that, in contraposition with common generic name, distinguishes one certain medicine, under the property or exclusive use of laboratory and is by law for a specified period of time”. Mercosur No general Resolution GMC N° 54/96 (Validity, modification, renewal and cancellation of the pharmaceutical products registry). guideline / Establishes different criteria for commercial designations: principles a) The name tend to be in accordance with the WHO recommendations b) Use the name INN or the Portuguese version (DCB). referring to the connection between TM and INN. c) The generic name must be added with the name of the laboratory. d) Commercial designation should not suggest therapeutic application e) If trademark issues arise, the marketing of a same product may be done with a different commercial designation or trademark in each of the countries. f) The commercial designation must not induce to mistakes. Particularly: a) The name must not be misleading, such as lead to assume the presence of an active component not present in the formula, b) be similar to the name of another product with different therapeutic indication, c) be similar to another product with the same therapeutic indication, which has different active ingredients. Estela de Luca Estela Mariel De Luca. IP Consulting. [email protected]
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