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Amendments to Trademark Laws

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Sep 27, 2012 (Newsletter Issue 14/12)
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Similar and Generic Veterinary Medicines Introduced

The Law No. 12.689/2012 introduces two new modalities of veterinary medicines: the similar and the generic ones. The Law is effective as of October 17, 2012.

The similar and generic veterinary medicines can only be produced after the expiration of the patent of the reference veterinary medicine, so as not to infringe the rights of the patent owner, whether a product or a process.

Similar veterinary medicines must bear the owner's trade name or the trademark and should contain the same active principle, pharmaceutical concentration and form as the reference medicine.

Generic veterinary medicines must be designated by the Brazilian Common Denomination (DCB) or by the International Nonproprietary Name (DCI). They must contain the same active ingredient, concentration and form, administration, dosage and therapeutic indication as the reference medicine. Bioequivalence to the reference medicine, its efficacy and safety must be demonstrated by means of pharmaceutical studies with the Ministry of Agriculture, Livestock and Supply (MAPA).

Rights that may not be protected by a patent, but which allow the exclusive ownership, such as those that grant the exclusive right to use the clinical trials and related dossiers (data protection) provided by Brazilian Law 10,603/2002, should be taken into consideration, for they could eventually delay the launching of some similar and generic veterinary medicine in the market.

MAPA shall shortly publish an ordinance in order to regulate the simplified proceeding of registration of the generic veterinary medicines.

Source: Di Blasi, Parente & Associates, Brazil,
Moeller IP Advisors, Argentina