Current Situation around the Regulation of Industrial Property and Technological Innovation in the Animal-Health Industry in Mexico

The Linkage Gazette, officially published as the “Industrial Property Gazette in Mexico of Patents in-force liable of being used in allopathic medicaments, art. 162 of the Federal Law for the Protection of Industrial Property (LFPPI)” is a biannual publication by the Mexican Institute of Industrial Property (IMPI) that publicizes Patents related, as its title indicates, to inventions that may be used in allopathic drugs.

In general terms, and in accordance with the Official Mexican Standard NOM-072-SSA1-2012, an allopathic medicament is any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive, or rehabilitative effect […] and that is registered in the Pharmacopeia of the United Mexican States.

In the United States of America, veterinary drugs or medicaments approved by the Food and Drug Administration (FDA) are publicly listed in the so-called Green Book. The Law requires veterinary pharmaceutical companies to provide the FDA with information on Patents and marketing exclusivity of their products in order to be included in said Book.

In Europe, the current Regulation contemplates the rights related to veterinary drug Patents by regulating the conducting of tests, studies and trials necessary to request a marketing authorization for this type of products […], which are not contrary to rights conferred by Patent or their complementary protection certificates.

In this sense, it can be clearly seen that both in the United States of America and in Europe, the legislation ensures that third-party pharmaceutical companies cannot manufacture, nor market generic copies of veterinary medical products protected by Patent.

In Mexico, the regulation of allopathic medicaments for veterinary use is provided by the National Service for Agro-Food Health, Safety and Quality (SENASICA), the National Technical Advisory Council for Animal Health (CONASA), the Veterinary Pharmaceutical Industry (INFARVET), and the National Association of Veterinary Laboratories (ANALAV); none of which is linked to the IMPI for strict surveillance of the corresponding Patent rights.

Surprisingly, to date, there are no examples of drugs for veterinary use listed in the Linkage Gazette, despite fully meeting the criteria of an allopathic drug.

With the existence of this huge gap in the Mexican legislation, the holders of Patent rights for allopathic medicaments for veterinary use are completely unprotected against competition from the generic market.

We, at BC&B, consider it urgent the generation of treaties and legal agreements between the corresponding Authorities so that, through rigorous technical-legal surveillance, technological innovations in the animal health industry in Mexico are not copied, much less marketed when Intellectual Property rights protected by Patent already exist.

Sites Accessed

• https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book

• https://eur-lex.europa.eu/legal-content/ES/TXT/PDF/?uri=CELEX:32019R0006&from=EN

• https://bmeditores.mx/entorno-pecuario/regulacion-de-medicamentos-de-uso-veterinario/