A southern Brazilian pharmaceutical company called Prati-Donaduzzi obtained in July 2020 a two-decade patent for virtually all CBD (cannabidiol) diluted in oil in Brazil. The patented concentration, from 20 to 250 mg/ml, comprises almost all product possibilities, which eventually created a monopoly in the country.
However, the benefiting company did not invent any product. It obtained the patent thanks to privileges with Jair Bolsonaro’s government. And it was thanks to the mobilization of society that the patent fell, but not before the pharmaceutical company signed a five-year pact with a government foundation, which can make the company profit hundreds of millions of reais from the Single Health System, SUS.
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The Brazilian Patent and Trademark Office (Inpi) granted the company a 20-year patent for an invention that was not theirs
The political current that governs Brazil, Bolsonarism, has a very moralistic position on customs. Both adult and medicinal cannabis use are persecuted. The rulers are mobilizing strongly against Bill 399/15, which legalizes medicinal cultivation and will be voted on by December. The government’s counterproposal is to provide CBD in SUS, and politicians started to openly lobby for Prati-Donaduzzi, such as the then Minister of Citizenship, Osmar Terra. Electoral and economic interests came together. And then came the privileges. For more than a year, the pharmaceutical company’s cannabidiol was the only one sold in pharmacies. Otherwise, it would have to be imported. And more: the Minister of Health mobilized officials to do a study to incorporate this drug in SUS. However, as cultivation is forbidden and the raw material is imported, the oil costs about 400 euros a 30 ml bottle. The technicians of the Brazilian Institute of Industrial Property (Inpi) calculated that to attend only one thousand patients in five years would cost more than 66 million euros and the proposal was vetoed.
The impasse would be easily solved if the product was patented and there was no other option on the market. This is what happened! The Brazilian Patent and Trademark Office (Inpi) granted the company a 20-year patent for an invention that was not theirs. A 1993 study by the University of São Paulo, almost three decades earlier, already proved what Prati claimed as its invention: that CBD is best diluted in corn oil. Another claim, regarding preservatives and antioxidants, was demonstrated in a 2009 study.
With the – fraudulent – patent in hand, Prati and the government signed a pact under industrial secrecy for five years. The partnership is with the Oswaldo Cruz Foundation (FioCruz), which will produce a clone of Prati’s product to make it available at SUS, since the foundation cannot engage in commercial activity.
However, after the patent frauds were revealed by the press in February, society mobilized. A congressman, a religious leader, a lawyer, and a phytotherapic company appealed to the Inpi against the monopoly. After some months of analysis, the institute’s technicians accepted the appeals and recommended the annulment of the patent.
“It is an understanding of this collegiate that merely altering the concentration of CBD and adding excipients, such as antioxidants, sweetener, flavoring and preservative, in order to provide a liquid CBD oral composition (…) is a trivial modification that is within the ordinary abilities of a subject matter technician in the area of pharmaceutical technology. Thus, the solution cannot be considered an inventive activity,” concluded the technicians. In July, the president of the Inpi annulled the patent.
“Patients were almost held hostage by a company with unethical practices”
For Brazilian neuroscientist Fabrício Pamplona, a doctorate in cannabinoid pharmacology and one of the greatest references in Brazil on the subject, the patent was only overturned thanks to the mobilization of society.
“Why was the argument of lack of inventiveness not accepted at the time the patent was granted? These technical issues could no longer be neglected, but evidently, they were only appreciated because there was mobilization,” highlighted the scientist.
“It was very close that millions of Brazilians were not held hostage to an expensive oil produced by a pharmaceutical company that has already revealed unethical practices. But even if the patent has fallen, the company’s objective was achieved, which is this agreement with FioCruz. Now we need to fight against this pact, or the pharmaceutical company will swallow millions of reais of public money thanks to this false patent,” warned Pedro Sabaciauskis, president of the Santa Cannabis patient association in Florianópolis, which serves 500 families. The activist argues that the Brazilian government should indeed supply CBD in SUS, but that this oil should be produced through patient associations, which cultivate cannabis – some legalized, others outside the law – and produce medicine 10 times cheaper.
“We advocate that patients be able to grow their own medicine at home, and if they don’t want to grow it, that they can associate themselves with NGOs, like Santa Cannabis, which will grow and produce it at a much more affordable cost and even for free, if that associate cannot afford it,” Sabaciauskis explained.
Bill legalizes cultivation by companies, not by patients
Bill 399/15, which legalizes the cultivation of cannabis for medicinal and industrial purposes in Brazil, should be voted on in the second semester in the Brazilian Congress. The text allows companies and the government itself to cultivate cannabis for medicine production or hemp for veterinary, food, textile, etc. purposes. An access considered fundamental, however, was vetoed: cultivation by adult patients and users.
Even though cultivation is forbidden, some associations and more than 300 patients have already obtained in court the right to grow cannabis at home. For the president of the cannabis commission in Congress, Paulo Teixeira, who is the same congressman who filed that appeal against the Inpi, the project would never be approved if it allowed self-cultivation.
“There are segments in Congress that agree to regulate for medicinal use, but they want all the guarantees so that there is no window for personal use. There is no correlation of forces to approve if personal use is included,” he believes.
Neuroscientist Sidarta Ribeiro, one of the most respected researchers on cannabis and psychedelics in Brazil, defends all avenues of access: “It is not possible that this great market is going to be regulated without the communities that have paid the most for the war on drugs, which are the vulnerable communities, being properly repaired by being part of this market. It is important that they have cannabis startups in the favelas, where there are people who have suffered abuse of state coercion,” he said.
Prati-Donaduzzi, the Oswaldo Cruz Foundation, and the INPI declined to comment.
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