Some highlights in cannabis legislation in Brazil

26 June 2020

Study of the protection of cannabis-based products in Brazil. The cannabidiol.

26 June 2020

As we informed in our previous post: Cannabis legislation opens the door for pharmaceutical brands in Argentina the importance of the new regulations in Latin America regarding the Cannabis-based medical products opens an important door for pharmaceutical industry giants like Sanofi, Pfizer or Merck, which have included patents and trademarks protecting their discoveries about cannabis and marketable medicines in their IP portfolios.

These are now relevant selections of the article published at WTR written by our colleague Daniela Lin, Director of H&A Brazil where specifies different policies in Brazil in this respect.

Government authorities in Brazil are beginning to make strides towards establishing a solid regulatory framework for the medical use of cannabis-based products. Although there is still a long way to go, analysis of IP activity in the field reveals that some rights holders are already staking a claim in the emerging market.

The use of cannabis sativa derivatives as an input generator of innovations in the pharmaceutical industry has been increasing in recent years, following a number of medical discoveries and destigmatisation in several countries. One of the active components of cannabis is cannabidiol (CBD), which has the potential for use in treatments for anxiety, epilepsy, convulsion and sleep disorders, and which contains anti-inflammatory properties.

Analysis of trademark and patent filings in Brazil either disclosing CBD-based processes or containing similar wordings for pharmaceutical brands – also taking into account the specific results of processes related to pharmaceuticals and companies that invest in innovative compounds derived from cannabis sativa – can provide a thorough IP mapping of CBD innovation in the country.

Searches of the Brazilian Patent and Trademark Office (INPI) patent database reveal that foreign companies own most patent applications for processes related to the pharmaceutical use of CBD. The same applies to trademarks using either cannabis or sative-based phrases.

More specifically, US companies own more than 80% of Brazilian patent applications for substances and processes containing either CBD or THC. German and UK companies also appear to be applying for such patents in Brazil.

In regard to trademarks, no more than 40 applications have been filed containing the term ‘canabi’ or ‘cannab’ for pharmaceutical products – most of which were filed in Brazil after 2018, with the trademark CANABIDOL registered in 2017. Similar trademarks have also been registered in Brazil, including SATIVEX, which was granted in 2017 to designate CBD-based pharmaceutical products. But overall, the commercial evolvement of cannabis brands remains modest, meaning that there is a vast field with huge growth potential waiting to be explored. Since 2006, Brazilian Law 11.343/06 has enabled the federal government to authorise the planting, cultivation and harvesting of the cannabis plant “for medicinal and research purposes at predetermined locations and time limits and through supervision”.

However, only recently the Brazilian National Health Surveillance Agency (ANVISA) waved off the possible legalisation of CBD-derived drugs. In 2015 ANVISA released a list of authorised compounds for importation, namely: CibdexHemp, CBDComplex, HempBlend, Real Scientific Hemp Oil CBD, RevividLLC HempTincture, CBDRX CBDOil, Charlotte Web HempExtract, EndocaHempOil, ElixinolHempOilCBD, EVR HempOilCBD, Mary’s Elite CBD Remedy Oil and PurodiolCBD.

Not coincidentally, the number of CBD-based patent applications has increased considerably at the same time.

Yet despite the agency’s further attempts to regulate the issue, there is now a contradictory situation in the country regarding the medical use of CBD. Although ANVISA has regulated the registration of imported CBD drugs since 2015, any Brazilian company with the expertise to manufacture the same products is not authorised to do so, because the current regulation includes imported products only, excluding the possibility of manufacturing the drugs domestically.

In fact, in 2017 ANVISA approved the registration of a specific drug under the commercial brand Mevatyl (THC, 27mg/mL + CBD, 25mg/mL) – cannabinoids obtained from cannabis sativa as a pharmaceutical oral solution (spray). This was the first drug based on cannabis sativa to be registered in the country.

In May 2019 ANVISA issued the prior consent required by INPI for a pharmaceutical patent application containing a CBD-based compound.

On 3 December 2019 ANVISA approved the registration of cannabis-based drugs, including in relation to manufacturing, but closed the motion for a resolution that provided for the cultivation of cannabis by manufacturing companies. As such, the country is one step closer to decriminalising cannabis-based drugs, as companies can now produce and commercialise cannabis-based pharmaceutical products – although the cultivation of such products remains prohibited.

The approved text establishes the necessary requirements for the product to meet quality standards and be commercialised. The measures are due to enter into force on 9 March 2020 under Resolution 327/2019 of the College Board of Directors.

Although this activity indicates that the CBD-based pharmaceutical industry is beginning to grow in Brazil, the country is still lagging behind the 40-plus jurisdictions around the world that have approved CBD-based pharmaceutical regulations.
Considering the plethora of therapeutic and medicinal applications for CBD-derived drugs, Brazil will need to review its legislation in line with recent developments in the regulatory field, resolving the contradictions between, on the one hand, ANVISA’s initiated drug regulation and approval of CBD as an active ingredient in many pharmaceutical compositions and, on the other hand, the country’s laws prohibiting the cultivation and manufacture of these same approved medicines. This contrast is seen by many as a barrier to the democratisation of treatments for a large number of illnesses, as the price of imported medicines is prohibitive for most patients.

As of 9 March 2020, the manufacture and sale of cannabis-based substances will be permitted in Brazil, enabling the possible development of new industries and even of existing companies in the sector.
Indeed, it is not only the pharmaceutical industry that is likely to be positively affected by the new regulation. A huge range of businesses may arise from the change, including in the fields of cosmetics, food and drink, and tobacco. According to *Forbes* magazine, the cannabis market has grown exponentially abroad at a rate of approximately 15%, with consumer purchases reaching around $40 million per year.

This gives a hint of the real size of the market and the potential for growth, especially considering that Brazil is yet to enter the game. The first entrepreneurs to take a shot on this promising field will be the first to benefit from its profits.

5/5 - (1 vote)

Daniela Lin

Lawyer. Trademarks department. Brasil office Director.


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