Pharmaceutical Industry: Medicinal Cannabis and Patents

Por Eng. Marcos Toshiro Iwai

Just before we entered the world pandemic stage with the coronavirus, one of the hot topics in the health area was medicinal cannabis. The evolution of the theme must be watched closely by the Intellectual Property professionals, for good opportunities can still be seen in this segment.
After several public consultations and a long way from the total criminalization to the adoption of increasingly flexible measures regarding the theme, such as the opening for importing of medicines for patients with medical prescription, in 2015, the National Sanitary Surveillance Agency (Anvisa) finally approved in December 2019 the regulation of cannabinoid-based products and sales in drugstores with medical prescription.
In order to obtain the registration, the companies need the Good Manufacturing Practices Certificate issued by the regulatory agency, special working permit, knowledge of the concentration of the main cannabinoids present in the product formulation, technical documentation of the product quality and to have operational conditions to perform the quality control analysis of the products within the Brazilian territory.
That opening initiated by Anvisa must open a new field for Industrial Property and a competitive and promising market, as it is already the reality in some countries, which goes beyond the therapeutic use, comprehending a sphere of products including beverages, foods and cosmetics.
The players of that market, starting from those developing medicinal products for sale in Brazil, must seek protections related to their Intellectual Property rights of their products.
Such regulation on the use of medicinal cannabis is very likely to open a beneficial precedent not only for the facilitation of the distribution of medicines based on the medicinal plant to patients who need them to complement their treatment, but also to incentivize research, technology and innovation, which are so important for the nation’s development.

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