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largest medical device patent litigation in Brazil, and the European pharmaceutical research based industry in an unfair competition and copyright infringement case against branded generics (similar). In addition, we also assisted The Association of Pharmaceutical Products of the State of São Paulo in a leading case where the pharmaceutical industry recuperated the right to market vaccines with trademarks in Brazil. In a landmark decision, the Court of Appeals for the First Circuit affirmed the district court’s decision and a preliminary injunction, declaring the unconstitutionality of a rule of law that exists in Brazil since the Seventies. Other transactions we have assisted with


include the leading Japanese research based pharmaceutical industry against the Brazilian FDA (ANVISA), where the district court issued a final judgment on a record timing, ordering the ANVISA to grant prior approval to pharmaceutical patents. We also assisted one of the three largest US research based pharmaceutical industries in several cases involving an infringement and validity patent portfolio covering a glaucoma drug, where more than twelve court decisions have been issued in the last 12 months, affirming patent rights and preventing the launch of generics. There are also several more transctions we have been involved in, including the representation of US and European research based industries in government bids and public-private partnerships (PPP).


Q


What are the main challenges and complexities for you and your company regarding business in Brazil?


The recent interest that has been taken by the international community in Brazil as an investment option has attracted the attention of foreign investors with little experience in the country. Historically, Brazil has welcomed FDI by means of local investments requiring lots of local presence. The task of seeking, auditing and implementing investments in Brazil, while changing the historical perspective into new options, while maintaining realistic chronograms, is a complex challenge for the near future.


Q


How will the Brazilian business environment develop over the next 3-5 years and what should foreign investors be aware of?


Brazil still has a closed economy. International standards are not followed and compliance with local regulations is always a challenge. Foreign investors should be aware of the differences between the standards applied in Brazil, the lack of trusted means to evaluate and audit potential investments and the need to establish a good interface with regulators. fi


fi MONTHLY MARCH 2011 Contact Details:


Rua Teófilo Otoni, 63/10º andar Centro - CEP: 20.090-080 Rio de Janeiro/RJ - Brazil


Tel: +55 21-2136-4100 Fax: +55 21-2136-4200 Email: momsen@leonardos.com.br


invest ing & doing business in brazi l


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