Brazil’s Intellectual Property Law (IPL) determines that a patents’ validity period starts to be counted from the moment its application is filed, being 20 years for inventions, and 15 for utility models. In view of Brazil’s INPI (National Institute of Industrial Property) delay in analyzing applications, IPL’s Article 40 Sole Paragraph grants inventors a minimum protection time so as they can exclusively gain usufructs from their creation’s sale. The constitutionality of this same Paragraph is under dispute and a Direct Unconstitutionality Action (ADI) over it is expected to be voted on by Brazil’s Supreme Court (STF) at any time. 

Interfarma participates in the debates as amicus curiae and has brought relevant facts, data, and other arguments to the attention of the STF Justices, warning on the decision’s impacts on Brazil’s referential pharmaceutical sector. The Association defends the constitutionality of the mentioned paragraph. 

Over the past few months, Interfarma held a series of meetings defending the constitutionality of IPL’s Article 40 Sole Paragraph. In August, the Association filed a petition to ADI 5529 process with legal opinions by jurist and former STF Justice Ellen Gracie Northfleet, and by USP Law Faculty Titular Professor Floriano Marques, alongside with economic opinions from Tendências consulting firm. 

On September 10, in a meeting with Carlos da Costa, Special Secretary for Productivity, Employment and Competitiveness at Brazil’s Ministry of Economy (SEPEC), the Association mentioned the main topics on its position on the subject, highlighting Article 40’s Sole Paragraph as an exceptional compensation mechanism. Also, in the meeting, Interfarma recognized the efforts that have been made by INPI to fight the backlog (reduced 50% in one year). A day later, the Association participated in a meeting with US Consulate representatives, addressing LPI’s Article 40; Previous Consent by ANVISA; Data Protection; National Intellectual Protectio
n Strategy; and Compulsory License. 

Regarding the National Intellectual Property Strategy, in August Interfarma contributed to the public consultation for its formulation, carried out by the Special Secretariat for Productivity, Employment and Competitiveness (SEPEC)’s Secretariat for Development of Industry, Commerce, Services and Innovation (SDIC). The strategy was published on December 11, and can be found (in Portuguese) here.

IPL’s Article 40 Sole Paragraph at a glance   

The paragraph disputed within ADI 5529 defines a minimum validity of 10 years for patents, counting from the grant date. It is a guarantee against the backlog and against any delays in processing patent applications. In 2014, then Prosecutor General of the Republic Rodrigo Janot accepted a questioning from a business association and proposed Direct Action of Unconstitutionality 5529 (ADI 5529). 

In December, STF Justice Dias Toffoli, new rapporteur for ADI 5529, responded to pending requests for including new pending amici curiae, namely the Brazilian Association of Generic Medicines Industries (PróGenéricos); the Brazilian Association of Lawtechs and Legaltechs (AB2L) and the National Association for Research and Development of Innovative Companies (ANPEI). 

Brazil’s Intellectual Property Law (IPL) determines that a patents’ validity period starts to be counted from the moment its application is filed, being 20 years for inventions, and 15 for utility models. In view of Brazil’s INPI (National Institute of Industrial Property) delay in analyzing applications, IPL’s Article 40 Sole Paragraph grants inventors a minimum protection time so as they can exclusively gain usufructs from their creation’s sale. The constitutionality of this same Paragraph is under dispute and a Direct Unconstitutionality Action (ADI) over it is expected to be voted on by Brazil’s Supreme Court (STF) at any time. 

Interfarma participates in the debates as amicus curiae and has brought relevant facts, data, and other arguments to the attention of the STF Justices, warning on the decision’s impacts on Brazil’s referential pharmaceutical sector. The Association defends the constitutionality of the mentioned paragraph. 

Over the past few months, Interfarma held a series of meetings defending the constitutionality of IPL’s Article 40 Sole Paragraph. In August, the Association filed a petition to ADI 5529 process with legal opinions by jurist and former STF Justice Ellen Gracie Northfleet, and by USP Law Faculty Titular Professor Floriano Marques, alongside with economic opinions from Tendências consulting firm. 

On September 10, in a meeting with Carlos da Costa, Special Secretary for Productivity, Employment and Competitiveness at Brazil’s Ministry of Economy (SEPEC), the Association mentioned the main topics on its position on the subject, highlighting Article 40’s Sole Paragraph as an exceptional compensation mechanism. Also, in the meeting, Interfarma recognized the efforts that have been made by INPI to fight the backlog (reduced 50% in one year). A day later, the Association participated in a meeting with US Consulate representatives, addressing LPI’s Article 40; Previous Consent by ANVISA; Data Protection; National Intellectual Protectio
n Strategy; and Compulsory License. 

Regarding the National Intellectual Property Strategy, in August Interfarma contributed to the public consultation for its formulation, carried out by the Special Secretariat for Productivity, Employment and Competitiveness (SEPEC)’s Secretariat for Development of Industry, Commerce, Services and Innovation (SDIC). The strategy was published on December 11, and can be found (in Portuguese) here.

IPL’s Article 40 Sole Paragraph at a glance   

The paragraph disputed within ADI 5529 defines a minimum validity of 10 years for patents, counting from the grant date. It is a guarantee against the backlog and against any delays in processing patent applications. In 2014, then Prosecutor General of the Republic Rodrigo Janot accepted a questioning from a business association and proposed Direct Action of Unconstitutionality 5529 (ADI 5529). 

In December, STF Justice Dias Toffoli, new rapporteur for ADI 5529, responded to pending requests for including new pending amici curiae, namely the Brazilian Association of Generic Medicines Industries (PróGenéricos); the Brazilian Association of Lawtechs and Legaltechs (AB2L) and the National Association for Research and Development of Innovative Companies (ANPEI).