BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys
• the United States allows the patentability of thera ‑ peutic methods, which in that country includes dosage regimens, as long as they meet the patent ‑ ability requirements (ie, novelty, non-obviousness and industrial application); and • the European Patent Office (EPO) also restricts the patentability of therapeutic regimens, but allows the patentability of dosage regimens even if that is the only new feature, thereby also dispensing the formulation of Swiss-type claims. In some ways, Brazilian patent law is closer to Chi ‑ na’s example. Much like the Chinese model, novelty is not recognised if the claimed invention is based exclusively on characteristics related to the mode of administration of the substance. Therefore, as in Brazil, second-use inventions require the applicant to present Swiss-type claims to the patent office; such claims should demonstrate relevant modifications in the therapeutic indication or the structure of the drug. Throughout the years, the BRPTO has issued some guidance on how to attain patents involving new uses and dosage regimens. First, the BRPTO published Resolution #169/2016, which provides that claims involving the use of chemical-pharmaceutical prod ‑ ucts for the treatment of new diseases must comply with the Swiss-type claim model, linking the chemi ‑ cal substance/compound of interest and its respective dosage to the manufacturing process of a drug used to treat a specific disease. Resolution #208/2017 was published to provide spe ‑ cific guidelines for examining patent applications in the field of chemistry. In particular, Chapter 9 of this Resolution offered guidance on the requirements for assessing patents directed at new uses for known substances. The BRPTO recently published Notice of Public Con ‑ sultation #2/2025, which aimed to gather input from the public concerning changes to the patent office’s guidelines established in Resolution #208/2017, thereby changing interpretations regarding chemistry- related inventions. Notably, along with the notice for public consultation, the BRPTO published an initial draft for changing
examination guidelines for inventions in chemistry. Some of these changes provide important clarification and support for applicants looking to protect inven ‑ tions related to dosage regimens, as follows. • For claims encompassing new uses of known substances, novelty is assessed based solely on the disease. Therefore, there is no novelty in claims related to the manufacturing process of an active pharmaceutical ingredient (API) for the treatment of a disease in which the use of said API is known. • Considering the nature of “use claims”, the enable ‑ ment requirement will only be deemed to be met if the applicant provides “sufficient and unequivocal evidence” of the effectiveness of the new use. This evidence should be attained through in vivo tests. Currently, the draft proposed by the BRPTO still does not allow patents to derive their novelty exclusively from a new dosage regimen. Nevertheless, proceed ‑ ings from the public consultation afforded by the BRPTO may impact the outlook and perception of stakeholders engaged in shaping the BRPTO’s rules in the field of chemistry. On the other hand, litigation has provided a path ‑ way for applicants to fight for the allowance of their patents related to new uses or dosage regimens. One noteworthy case was the judgment of Appeal #1080806-87.2021.4.01.3400 ( BRPTO v Genentech ) by the Federal Court of Appeals for the 1st Circuit (TRF-1). This case concerned Brazilian Patent #BR 12 2019 020930-8, which describes the use of the drug Ocrevus® (ocrelizumab) within certain parameters (eg, dosages of 0.6g administered within 14 days of each other) in the treatment of multiple sclerosis. Although the patent application was drafted in compli ‑ ance with the requirements of the BRPTO, including by making use of Swiss-type claims, the patent office rejected the application by alleging that the patented subject matter covered a therapeutic regimen. This decision was reviewed and invalidated at the trial level, in a decision later upheld by the 12th Panel of the TRF-1. The rationale established by the court emphasised that the applicant complied with the formulation of
36 CHAMBERS.COM
Powered by FlippingBook