Kene Gallois

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Kene Gallois 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.

In 2015, she joined Daniel Legal & IP Strategy, where she coordinates the Life Sciences Division, providing several services related to the patent practice, such as drafting, filing and processing patent applications, performing searches, providing technical assistance in Court actions, preparing legal opinions and freedom-to-operate reports, analyzing the client’s portfolios and providing assistance on commercial strategies. She also attends meetings with clients and the Brazilian PTO examiners and trains newly-hired professionals, amongst other responsibilities.

Cargo: 
Head of Life Sciences
Formação: 
Master’s Degree in Molecular and Cellular Biology from the Oswaldo Cruz Foundation (Fiocruz). Graduation in Biological Sciences from the Fluminense Federal University (UFF).
Área Atuação: 
Biotechnology Patents Pharma Chemistry
Afiliações, comissões e colegiados: 
Member of the Brazilian Intellectual Property Association – ABPI. Member of the Regional Council of Biology - CRBio-02.
Imagem: 
É um sócio ?: 
Não

Área:

Phase II of USPTO-BPTO PPH: new requirements and extension of the covered technical field

The Brazilian PTO published on May, 9th Rule # 218/2018, which establishes the second phase of the Patent Prosecution Highway (PPH) between the Brazilian PTO and the USPTO. The period for receiving fast-track examination requests within this PPH is between May 10, 2018 and April 30, 2020. In this new phase, some modifications were performed in the requirements to participate in this program. The main aspects can be summarized as follows:

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Updates on the requirements concerning access to components of Brazil's genetic heritage or traditional Knowledge

Since November 26, 2015, Applicants declare, when filing a patent application in Brazil, if the claimed invention derives or not from access to Brazilian genetic heritage or traditional knowledge. The Brazilian PTO used to issue Office Actions of code 6.6 for those applications filed prior to November 26, 2015 inviting Applicants to confirm whether access to Brazilian genetic heritage or traditional knowledge occurred or not. 

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BRPTO’s establishes guidelines for examining chemical patent applications

The Brazilian PTO published in January 2nd Rule 208/2017, which provides guidelines for the examination of patent applications related to the chemical field. As informed by our firm on 03/31/2017 (click here), a draft version of these guidelines was submitted to public consultation in March 2017. This new Rule is supplementary to the contents of BRPTO’s Rules 124/2013 and 169/2016 (Guidelines for the Examination of Patent Applications – Parts I and II, respectively).

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Bridging the great divide

Since 2001, the grant of pharmaceutical-related patent applications in Brazil has come to depend on a prior approval analysis by the Brazilian National Health Surveillance Agency (ANVISA).

ANVISA and the Brazilian Patent and Trademark Office (INPI) initially agreed that pharma applications should be forwarded to ANVISA to receive prior approval after the INPI’s examination.

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BRPTO and ANVISA's role regarding the examination of pharma patents application

On April 12, 2017, Brazilian PTO and ANVISA signed the Joint Ordinance # 1/2017, which establishes the procedures to be adopted concerning the analysis of pharmaceutical patent applications

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BRPTO launched a public consultation inviting comments on chemical patents application

The Brazilian PTO published a draft guidelines for the examination of patent applications related to the chemical field.

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