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Biological Material Published on Marcasur International website on March 30, 2011

by Ivan B. Ahlert e Pedro Moreira

March 30, 2011

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In the case of biological material essential for the practical execution of the subject matter of the patent application, which cannot be described and which has not been accessible to the public, the patent application should be supplemented by a deposit of a sample of the biological material in an institution authorized by the Brazilian Patent and Trademark Office or indicated in an international agreement.

The international treaty that addresses the deposit of biological materials for the purposes of patent procedure is the Budapest Treaty, which was created on April 28, 1977 and currently has 73 member countries. One of the treaty’s objectives is to eliminate or reduce multiple deposits of biological materials by means of a single deposit recognized by the local Patent and Trademark Office’s of the signatory countries. This is beneficial in terms of lower costs and greater security. The depositary centers recognized by the treaty are known as "IDA’s" or International Depositary Authorities. Today, the treaty encompasses 39 IDA’s, located in the North America, Europe, India, Asia and Australia.

The IDA’s are impartial, objective institutions that receive the deposit of the biological material for patent and other purposes and supply samples of the deposited material for research purposes after the secrecy period of the patent application. Examples of internationally recognized IDA’s include The American Type Culture Collection – ATCC (USA) and the Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH – DSMZ (Germany). After receiving the material, the depositary centers test same for purity and viability, and then store same for a minimum of 30 years. According to the German DSMZ, on 2009, 3,094 samples of biological materials were deposited only in Asia, North America and Europe, particularly samples of algae, bacteria, fungi, human, plant and animal cells, plant viruses, DNA and protozoa.

Even though Brazil has not yet signed the Budapest Treaty – in fact, the only Latin American member is Peru – the Brazilian PTO recognizes IDA’s deposits made for the purposes of patent procedure as if it was a signatory country. In Brazil and the Latin America, there is no official depositary center recognized by the Brazilian PTO for the deposit of biological materials for patent purposes.

Nowadays, Brazilian researchers, research institutions and companies currently have to send their biological materials overseas before filing their patent applications, in order to comply with the requirements of the Brazilian PTO, and the requirements of foreign PTO’s in the event they apply for patents abroad. The national and international health and customs legislations and the associated logistics drive costs up dramatically and generate considerable red tape, discouraging and hindering the patenting of biotechnological inventions.

Within this context, and also given that biotechnology has become a priority in Brazil’s industrial policy, the Brazilian PTO and the Brazilian federal government are currently considering signing the Budapest Treaty.

On April 2008, in the 1st International Symposium on Biotechnology Innovation and Intellectual Property, the Brazilian PTO launched the project for building and putting into operation the Brazilian Center for Biological Materials (CBMB), a strategic move by the MCT and MDIC ministries, the Brazilian PTO and the INMETRO (the Brazilian institute of metrology).

On December 03, 2010, construction of the CBMB began on the campus of the INMETRO in Xerém (Duque de Caxias/Rio de Janeiro). The groundbreaking was attended by the Presidents of the Brazilian PTO and INMETRO, as well as the Minister of Health. The Brazilian PTO says that construction should be completed in 2011 and the center is scheduled to open in 2012. The CBMB will have researchers from the Brazilian PTO and INMETRO, and will receive biological materials including bacteria, fungi, cell cultures and plasmids having biosafety levels 1 and 2 (BSL I and II).


 

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Ivan B. Ahlert

Partner, Mechanical Engineer, Industrial Property Agent

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Pedro Moreira

Partner, Pharmacist, Industrial Property Agent

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