Kene Gallois

The use of biological agents in pest and disease control in agriculture has been a growing trend worldwide, and Brazil is no exception. With increasing concerns about sustainability and environmental health, many farmers and agricultural companies are seeking alternatives to conventional chemical products, opting for biofertilizers and other biological control methods. These biological agents include beneficial microorganisms such as bacteria, fungi, and viruses, as well as natural predators of pests, which help control insect populations and diseases that affect crops.

In recent years, the pharmaceutical industry has undergone significant changes in the focus of its innovation, research and development efforts. Historically, oncology and immunology were the primary targets for pharmaceutical companies, with most resources and capital allocated to developing new technologies in these areas.

In an ongoing effort to reduce the backlog of patent applications, Brazil has introduced new appellate stage guidelines that significantly impact how applicants should respond to office actions and file appeals. These changes emphasize thorough and strategic responses to ensure all objections are properly addressed, paving the way for a more efficient patent granting process. The motives behind the appellate stage guidelines can be traced back to around 2018, when the Brazilian Patent and Trademark Office (BPTO) began publishing new rules aimed at streamlining and expediting the examination and reducing the pendency time of patent applications, for example, of so called “preliminary office actions”.

It is not news that cannabis-based medicines have been used for millennia around the world in the treatment of conditions and diseases such as chronic pain; epilepsy; neuropsychiatric disorders; nausea and vomiting related to chemotherapy; symptoms associated with autistic spectrum disorder; amyotrophic lateral sclerosis; rheumatoid arthritis, among others. However, this topic has been the subject of recent discussions due to the progressive dissemination of scientific data proving the efficacy and safety of their uses. New scientific research and clinical studies are expected, not to mention the revision/alteration of legislation in some countries so that the cultivation, production, commercialization and use of cannabis-based medicines becomes more viable and comprehensive.

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.