Industrial Property Protection for products derived from Cannabis in Brazil

With the regulation, it is expected that various patents filed with the Brazilian Patent and Trademark Office [National Institute of Intellectual Property] and that are currently in abeyance will return to being prosecuted, ensuring the development of a domestic market and the very access of the population to the medication.

As one of the foundations for building and progressing a competitive economy, the protection of industrial property is an essential requirement for the development of a nation. In Brazil, this protection is even mentioned in the Federal Constitution in Article 5, item XXIX, ensuring owners of this right a temporary privilege to use and economically exploit their creations[1] with exclusivity, bearing in mind the social interest and the technological and economic development of the Country.

With the entry into force of Law 9,279/96 (IPL), which was formulated precisely to incorporate the resolutions contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) into Brazilian legislation, the legal prohibitions that had hitherto existed that prevented the granting of patents in the chemical and pharmaceutical sector were revoked, paving the way for companies operating in this sector and enabling the granting of patentes related to pharmaceutical products and processes in the country.

However, despite the revocations that enabled the granting of patents in the chemical and pharmaceutical sector, the granting of patents in this sector is prosecuted in a different manner from the conventional, since, to grant these patents, prior consent from the National Health Surveillance Agency (ANVISA) must be obtained, as set out in Article 229-C[2] of the IPL.

It should be noted that the legislator chose to adopt a more thorough procedure for analysing these patents, precisely because of the direct relationship that these products have with consumer health, giving the agency the power to ensure that medicines present safety, efficacy and quality.

Accordingly, ANVISA’s role in granting chemical and pharmaceutical patentes goes beyond verifying the patentability requirements for such products, since the agency carries out the role of observing the aspects that are relevant to public health, aiming to comply with the national policy for access to the medicine[3].

Having said that, in recent years ANVISA has initiated a regulatory process for the consideration of Cannabis[4] for medicinal purposes, which consists of the analysis of technical and administrative requirements for the cultivation of this plant in the production of medicines, for use in scientific research and also for the regularisation of pharmaceutical products made from the exploitation of Cannabis in the country.

Currently the planting, cultivation, harvesting and exploitation of Cannabis is prohibited and constitutes the crime of drug trafficking under law 11.343/06, so any activity involving the plant must be preceded by a prior license from the competent authority.

However, since 2017 the debates on the subject have intensified, ANVISA had already changed the category of Cannabis to a plant with the possibility of medicinal use, putting the plant again on the list of therapeutic substances due to the various studies that attest to positive results for health, specifically for the treatment of diseases such as epilepsy and multiple sclerosis.

The São Paulo State Court of Appeal itself has adopted a position guaranteeing the sick access to medication based on substances derived from Cannabis, whenever it is proven that patients need this medication for their treatment. In this regard, an excerpt from the vote handed down on 17 December, 2018, by the Honourable Justice Heloísa Martins Mimessi of the 5 th Chamber of Public Law, in Interlocutory Appeal 2222365-06.2018.8.26.0000 should be highlighted:

“Moreover, in the case under discussion, the lack of a registration for the medicine at ANVISA must be revealed in order to preserve the physical and psychological integrity of the petitioner, once the need for its use has been demonstrated as the most effective drug to inhibit or mitigate the effects caused by the pathology that affects him. If this were not enough, the substance in question is no longer prohibited and will be controlled by ANVISA from 2015 onwards, which has instituted a simplified procedure for the importation of medicines based on Canabidiol, under the terms of RDC 17/15”

It should be noted that the regulation of this sector is of interest not only to patients who need to use drugs made from the cultivation of Cannabis, but also to companies that operate in the research & development sector of these chemical compounds, because it signals positively for the sector.

Faced with this scenario on 3 December, 2019, the ANVISA Collegiate Board of Directors approved a new regulation for products derived from Cannabis. The text lists the necessary requirements for the regularisation of these products in the country, establishing quality parameters and will come into force 90 days after its publication in the Official Federal Gazette.

In his vote, the Director of ANVISA Mr. Fernando Mendes Garcia Neto, alleged it was difficult to regulate the sector, as can be noted below: “Finally, it is not easy to understand the social, scientific, clinical and regulatory problems that arise when considering making cannabis products available for medicinal purposes. However, this learned collegiate always seeks to modernise itself, to create mechanisms and innovative strategies to favour regulation, enabling a more dynamic performance, bringing the regulatory system closer to the reality of universal access to quality health products.

Thus, maintaining the understanding that Cannabis products for medicinal purposes can be regulated and authorised under special conditions that favour access to patients with refractory therapeutic conditions, I diverge from the guiding vote of the RDC proposal initially presented, I propose a substitute regulation – attached to this vote and known to the members of this DICOL, and I VOTE to approve the RDC proposal reported here as a complete replacement to that proposed by the Director Rapporteur.”

The decision of the Board of Directors establishes that the rule, called a Resolution of the Board of Directors (RDC), shall be reviewed within three years after its publication. Thus, companies will not need to abandon their research strategies to prove the efficacy and safety of their products, since the proposals for products derived from Cannabis resemble the same therapeutic strategies of a medicine.

It is important to highlight that the regulatory framework has created a new category of products that are subject to health surveillance: products based on Cannabis.

The approved RDC sets out the procedures for granting Health Authorisation for the manufacture and importation of these products, as well as establishing requirements for marketing, prescribing, dispensing, monitoring and surveillance of Cannabis products for medicinal purposes.

The approved regulation requires, for manufacturing and marketing purposes, in addition to the specific operating authorisation, the Certificate of Good Manufacturing Practices (CBPF) issued by ANVISA. The requesting company is obliged to have a set of data and technical information, in a version that is always updated, which prove the quality, specification limits and quality control methods, as well as stability studies and periodic usage evaluation reports.

However, the regulation prohibits the manipulation of any product derived from Cannabis. Marketing in the country will take place exclusively in pharmacies and drugstores that do not carry out manipulation and only with a medical prescription.

With the regulation, it is expected that various patents filed with the Brazilian Patent and Trademark Office [National Institute of Intellectual Property] and that are currently in abeyance will return to being prosecuted, ensuring the development of a domestic market and the very access of the population to the medication and fomenting discussion on what is currently in the prior art and what is patentable in this segment.

The considerations of the RDC will also be observed for those interested in applying for a trademark registration for products derived from Cannabis, which hitherto was not possible due to the legal obstacle existing in item III of Article 124[5] and in the first paragraph of Article 128 of the IPL[6].

At this time, with the removal of the legal obstacle existing in the IPL, trademarks related to the segment of medicines derived from Cannabis will be created and may be registered, ensuring distinction from similar products, with it no longer being necessary to use more generic forms such as medicinal plants in the description of products (in these cases allowed by ANVISA) and the BPTO [INPI] must accept products derived from Cannabis, providing a system of fair competition that foments the domestic economy and also adds value to companies qualified to produce these medicines.

In addition, the regulation will enable the economic and technological development of the country, because it is estimated, according to the report published by NewFrontierData[7], that the potential revenue from medicinal cannabis has the potential to reach a value of R$ 4.7 billion in the first three years of the legal sale of compounds produced from the exploitation of Cannabis.

Therefore, it is concluded that the regulation of the medicinal use of Cannabis will be beneficial, not only to facilitate the distribution of medicines based on the extract of this plant to patients who depend on the use of these drugs and who are currently undergoing a procedure controlled by ANVISA, which consists of the importation of the drug, but it will also foment the technological and economic sector in the country, providing the necessary means for research and development.

Finally, production of new chemical and pharmaceutical products based on Cannabis without the need to import these drugs, creating and developing na internal market for the product and contributing to the collection of taxes from the marketing of this medication.

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[1] In this case, creations are understood to be all patents, utility models, industrial designs, trademarks, plant varieties, technological innovations, industrial secrets and other products, services and methods protected by industrial property.

[2] Article 229-C. The granting of patents for pharmaceutical products and processes will depend on the prior consent of the National Health Surveillance Agency – ANVISA.

[3] Ordinance 3,916, of 30 October, 1998.

[4] Cannabis is a genus of angiosperms that includes three different varieties: Cannabis sativa, Cannabis indica and Cannabis ruderalis. Cannabis has been widely used for making fibres (hemp), for seeds and seed oils, for medicinal purposes and as a psychoactive drug (marijuana, hashish, skunk).

[5] Article 124. The following are not registrable as a trademark: II – expressions, figures, drawings or any other sign contrary to morals and good customs or which offend a person’s honour or image or are an affront to freedom of conscience, beliefs, religious cults or to ideas and sentiments worthy of respect and veneration;

[6] Article 128. Individuals and private limited companies or public corporations can apply for a trademark registration.

§1 Private limited companies may only apply for a trademark registration for a trademark relating to the activity that they actually and lawfully carry out directly or through companies that they control directly or indirectly, and this condition must be declared on the actual application, subject to the penalties of the law.

[7] Available here. Accessed on 14 November, 2019.