Depositary Center of Microorganisms for Patent Purposes

Law No. 9,279/96 (Industrial Property Law), which came into effect on May 15, 1997, in its Article 24, sole paragraph, includes the condition that, “(…) In the case of biological material essential for the invention, which cannot be described and has not been accessible to the public, the new patent applicant shall deposit the material in an institution authorized by the BPTO or indicated in an international agreement.”

This Article of the Brazilian IP Law is founded on the international agreement for the Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or the Budapest Treaty. Although Brazil is not a signatory to the Treaty, like the signatory countries it recognizes deposits made in any International Depositary Authority (IDA), which are regulated by the Treaty.

Some initiatives have been made toward establishing a biological material depositary center, but currently there is no such institution authorized by the Brazilian Patent and Trademark Office (BPTO), in Brazil or in Latin America . This scenario may be on the verge of changing, however.

In the first International Symposium on Intellectual Property and Innovation in the Biotechnology Field, held in Belo Horizonte in April of 2008, the BPTO announced a project for building and opening a Brazilian Center for Biological Material (CBMB). Efforts are aimed at establishing within the country a depositary center facility for biological material for patent purposes and an evaluation system to support development and activities of the country’s culture collections. The CBMB, in accordance with the Budapest Treaty, will store biological material designated for patent purposes in the area of biotechnology and make it available following the nondisclosure period. Additionally, it will maintain copies of animal cultures and microorganisms considered strategic for the country, stored in Brazilian collections, in accordance with international security and record-keeping requirements. Lastly, a program will be developed for evaluating biological material compliance.

According to BPTO representatives, the new facilities will be built on the Inmetro campus in Xerém, in the city of Duque de Caxias , Rio de Janeiro . The CBMB will be divided into two departments: the microorganism department, which will include bacteriology and mycology laboratories as well as support labs, such as those for molecular biology and material preparation; and secondly cell culture departments. The two primary preservation methods will be cryopreservation (liquid nitrogen), for all types of microorganisms and cell cultures, and lyophilization, for microorganisms.

However, additional steps must be taken before the World Intellectual Property Organization (WIPO) recognizes the Brazilian Center for Biological Material as an International Depositary Authority. Acquiring IDA status requires official approval of the microorganism collection the country proposes, and the country must assume responsibility before the WIPO for the collection’s activity. But even more problematic than collection approval is the fact that IDA status is granted only depositories located in countries party to the Budapest Treaty, and this is not the case with Brazil at the present time. As such, unless Brazil signs the Treaty, the CBMB may not be recognized as an IDA, and consequently the depositary center will be destined only for deposits related to national applications; international applications will still require depositing in an IDA.

The Brazilian Center for Biological Material is a joint effort by the BPTO, Inmetro and the Ministry of Science and Technology, with completion of its engineering design scheduled for June 2008. Construction is projected to begin later this year, and commencement of CBMB activity in the second half of 2009.