Patent for pharmaceutical cannabidiol-based compound revoked by INPI
Decision enables other pharmaceutical companies to develop and exploit cannabidiol-based products
The National Institute of Industrial Property (INPI) revoked, on July 27th, 2021, patent BR 112018005423-2, concerning “oral pharmaceutical compositions made from cannabinoid, as well as its preparation processes and use.”
First filed in 2016 and granted by the INPI in June 2020, the patent guaranteed Prati, Donaduzzi & Cia Ltda and the University of São Paulo exclusive exploitation rights over the invention for 20 years from the date of filing – that is, until September, 2036.
The product resulting from patent BR 112018005423-2 – based on cannabidiol (CBD) diluted in corn oil – requires a particular prescription to be purchased. It has been prescribed to treat anxiety attacks, epilepsy, Parkinson’s disease and schizophrenia.
In Brazil, the commercialization and importation of cannabis-based products is allowed on exceptional basis and for personal use since 2015, through the Collegiate Board Resolution No. 335/2020 (RDC ANVISA 335/2020) of the Brazilian Health Regulatory Agency’s (Anvisa). In 2020, Anvisa also established procedures and requirements for manufacturing, importing, selling, prescribing, distributing, monitoring and inspecting industrialized cannabis-based products. These products are subject to authorization from Anvisa, must be intended for medicinal purposes, and must exclusively contain plant derivatives or phytochemicals from Cannabis sativa as active ingredients.
Understand the decision
Since the patent was granted, players in the pharmaceutical industry have submitted three administrative nullity proceedings. In short, the applicants claimed the absence of at least one of the patentability criteria, in particular the lack of the inventive step of the product.
According to Article 8 of Brazil’s Industrial Property Law (LPI), the essential requirements for granting patents concern the concepts of novelty, inventive step, and industrial application. The invention must be endowed with an inventive step, representing a sufficient and not obvious development in relation to the state of the art. Finally, the product must be capable of being used or produced within any industry.
Agreeing with the arguments presented by the three petitions for annulment, the INPI’s appellate technical board issued an opinion suggesting the annulment of patent BR 112018005423-2, understanding that the product lacked the inventive step.
Referencing studies published in 1993 (Zuardi et al.) and 2015 that previously mentioned compositions containing CBD and corn oil, the board’s opinion suggested that the product protected by BR 112-18005423-2 did not represent a sufficient advance that could be protected. Therefore, the patent did not present technical characteristics that would not be obvious to an expert in the field – a legally defined characteristic of inventive step – and consequently, patentability.
Thus, the INPI decided to revoke the patent as per its technical board’s opinion. Prati-Donaduzzi may still challenge the INPI’s administrative decision in court, in order to reverse the annulment.
New possibilities for pharmacists and patients
If patent BR 112018005423-2 had been upheld, pharmaceutical companies wishing to commercially exploit compounds resulting from Prati-Donaduzzi’s invention would have had to obtain authorization from the patent holder and pay due royalties.
However, after the decision, other pharmaceutical companies will now be able to produce drugs based on oil-diluted cannabidiol (isolated CBD).
*In collaboration with Lorena Sampaio Pereira.