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Kene Gallois

is Head of the Chemical & Life Sciences Group at Daniel Law. Kene has more than 10 years experience in the field of Biological Sciences. She graduated from the Fluminense Federal University (UFF) and has a Master’s Degree from the Oswaldo Cruz Foundation (Fiocruz) in Cellular and Molecular Biology. She began her career working in research projects in Pathology, Immunology and Pharmacology and has been working with patents in the areas of Biotechnology, Pharmacy, Chemistry, Agriculture, Food and Cosmetics since 2009, providing specialized counseling to clients.

Recent Articles by Kene Gallois

Experimental Data: A Key Element of Brazilian Medical Use Claims

There is no doubt that it is a challenge to design a patent protection strategy for a new medical use (for example, a new disease to be treated or prevented by a known composition, active ingredient or biological). The proper format for claiming such subject matter may vary significantly between patent jurisdictions. In Brazil, besides the accepted format, there are other points that deserve attention in terms of increasing the chances of success in obtaining a patent, such as the need to present experimental data in medical use patent applications in order to meet the sufficiency of disclosure requirements.

Brazil’s Patent System: Latest Statistics on Efforts to Reduce the Backlog and the Road Ahead

Almost two years ago, the Brazilian Patent and Trademark Office (BPTO) launched a plan to reduce the backlog in examination of patent applications, which has had positive results. As part of this important initiative, at the beginning of 2021, the BPTO published its action plan for the year indicating its intentions to increase the efficiency of services offered by the institution via new performance goals. The plan to combat the backlog has already resulted in a reduction of more than 60% of patent applications pending for decision. This has had a positive effect on the credibility of the Brazilian patent system domestically, but also has contributed to the improvement of the national and international attractiveness of the sector, which will possibly provide a greater incentive to protect patents in Brazil.

A Look at BPTO Data on Pharmaceutical Patents Subject to the Minimum Term of Ten Years From Grant

A key issue of discussion with respect to the Brazilian patent system has to do with patents granted by the Brazilian Patent and Trademark Office (BPTO) under the following sole paragraph of Article 40 of the Brazilian IP Law: “Article 40 – The term of a patent for an invention shall be 20 (twenty) years and for a utility model 15 (fifteen) years as from the filing date. Sole Paragraph – The term shall not be less than 10 (ten) years for inventions and 7 (seven) years for utility models, as from the date of grant, except where INPI is prevented from carrying out the substantive examination of the application due to pending litigation or for reasons beyond its control.” This provision guarantees that patentees enjoy a 20-year term from filing and is particularly relevant due to the considerable examination backlog at the BPTO.

Brazilian Ministry of Health Accelerates Examination of Pharma Patent Applications

The Brazilian Patent and Trademark Office (BPTO) presently offers more than 15 programs to speed up examination of patent applications. The prioritization of certain patent applications by means of Patent Prosecution Highway (PPH) programs and other fast-track options has been very effective in reducing pendency. Brazil’s backlog has already been reduced by around 40% and the BPTO estimates an additional 40% reduction by August 2021.