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It is premature to assess the overall impact of the first unilateral recognition of equivalence. Any negative effects of the resolution must be carefully considered before COFEPRIS issues similar resolutions covering medicaments or other health-related products manufactured in Mexico.


Mexico must improve the quality of its regulatory agencies so that their decisions are recognised internationally. Tis will


facilitate reciprocal


homologation schemes that do not leave Mexican companies at a disadvantage and smother their aspirations for international expansion.


Unfortunately, the speed of globalisation imposes conditions that threaten to cause a steady growth of the technological, economical and social gap between industrialised countries and nations such as Mexico that aspire fruitlessly to join them.


In the meantime, the equivalence resolutions issued by COFEPRIS and their claimed statutory basis disrupt the national legal order by ignoring the primacy of international treaties over federal regulations and the principle of reciprocity that these treaties embody.


Hedwig Lindner heads the patent litigation department and is consistently a top tier ranked lawyer. She also has been active in IP legislative reforms. Lindner is a past president of AMPPI (Mexican IP Association/ AIPPI National Group) and teaches at the Universidad Panamericana. She holds master’s degrees in intellectual property law from George Washington University and in constitutional and administrative law from the Universidad Nacional Autónoma de México. She is a graduate of the Universidad Panamericana, with honours.


Hedwig Lindner is a partner at Arochi, Marroquín & Lindner, S.C. She can be contacted at: hlindner@aml.com.mx


Manuel Morante is an associate at Arochi, Marroquín & Lindner, S.C. He can be contacted at: mmorante@aml.com.mx


Manuel Morante practises intellectual property, international, administrative and advertising law. He also is director of the firm’s library. Morante has extensive experience as an academic. Currently, he is an adjunct professor of comparative law at the Universidad Panamericana, where he earned his doctorate and law degrees.


www.worldipreview.com


Life Sciences Intellectual Property Review 2011


75


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