Brazil Patent System

Brazil's local working requirement is found in Article 68 of the Industrial Property Law (Law 9,279/1996). It provides that a patent is subject to compulsory licensing if: (1) the subject matter of the patent is not worked (exploited) in Brazil within 3 years of the patent grant date; (2) the working is discontinued for more than 1 year; (3) the marketing of the patented subject matter does not satisfy the needs of the Brazilian market; or (4) the patentee exercises rights over a patent in an abusive manner. 'Working' means local manufacturing in Brazil. Importation alone may be considered sufficient if the patent owner can demonstrate that local manufacturing would be economically unviable (this has been debated in Brazilian courts and policy). Any interested party can request a compulsory license for non-working after 3 years from grant, and the Federal Government issues the license if the requirement is not met. In practice, the local working requirement has most significantly affected the pharmaceutical sector. In 2007, the Brazilian government invoked compulsory licensing for Merck's antiretroviral patent covering efavirenz (an HIV/AIDS drug), citing its high price and the national health emergency posed by HIV. Brazil was the first middle-income country to compulsory-license a non-generic pharmaceutical patent after the Doha Declaration. For practical patent strategy in Brazil: ensure you have a distribution arrangement, licensing agreement with a Brazilian manufacturer, or local manufacturing within 3 years of grant. Document your market presence carefully. For pharmaceutical patents, also ensure the licensed product is priced to satisfy market needs — the government has historically been willing to issue compulsory licenses if supply or pricing fails to meet public health needs.

Before 2021, pharmaceutical patent applications in Brazil required 'prior consent' (anuência prévia) from ANVISA (the Brazilian health regulatory agency) before INPI could grant them. ANVISA had authority to block pharmaceutical patents on substantive grounds — including patentability criteria reviewed through a public health lens. This dual-review system was controversial: it created significant additional delays (often 3–5 additional years on top of INPI's already-long examination backlog) and was criticized as inconsistent with Brazil's TRIPS obligations, which generally permit member countries to regulate pharmaceutical patents but don't require a dual administrative review. Law 14,195/2021 (the Economic Freedom Act), signed in September 2021, eliminated ANVISA's prior consent requirement. INPI now handles pharmaceutical patent examination alone, without ANVISA involvement. ANVISA retains its core regulatory mandate (drug marketing authorization), but no longer reviews or blocks patent grants. The reform brought Brazil's system closer to international norms and removed a significant uncertainty for pharmaceutical patent holders. For practical purposes: (1) pharmaceutical patent applicants in Brazil after September 2021 face INPI examination only — no ANVISA review; (2) historical applications that were stuck in the ANVISA-INPI dual-review pipeline have been processed through INPI following the reform; (3) future pharmaceutical patent prosecution in Brazil follows the same general procedure as other technology areas, without the additional ANVISA layer.

Yes, software inventions can be patented in Brazil, subject to the technical character requirement. Article 10 of Brazil's Industrial Property Law (Law 9,279/1996) excludes 'computer programs per se' from patent protection (along with mathematical methods, business methods, and other abstract categories). The phrase 'per se' is the operative limitation — software that is claimed purely as a program, without any reference to its technical application or effect, cannot be patented. However, software that is claimed as part of a technical system or that produces a technical effect can qualify for patent protection. INPI follows an approach similar to the EPO: if a computer-implemented invention has a technical character — that is, if it achieves a technical result beyond the normal physical interactions of software and hardware, or if it solves a technical problem in a technical way — it can be patented. Examples of patentable software-related inventions in Brazil: embedded systems controlling physical devices; data processing methods that improve the operation of a computer network; signal processing algorithms applied to telecommunications; software-implemented machine learning techniques used for a technical purpose (image analysis, industrial control, etc.); computer-implemented methods in medical devices. Software that cannot be patented: pure algorithms with no technical application; software that merely implements a business method or game rule; programs that only present or organize information without technical effect. The Brazilian approach is somewhat more permissive than the post-Alice USPTO but similar to EPO practice.

Patentes Verdes (Green Patents) is Brazil's accelerated patent examination program for environmentally beneficial inventions. It was launched by INPI in April 2012 — making Brazil one of the first patent offices in the world to establish a dedicated green technology fast-track. How it works: (1) Eligibility: any patent application covering technology with a clear environmental benefit qualifies. Eligible areas include: alternative energy production (solar, wind, biomass, hydroelectric, tidal), energy efficiency, biofuels, sustainable transport, solid and liquid waste management, water treatment, climate change mitigation, sustainable agriculture, and biodiversity conservation; (2) Cost: completely free — no additional government fee beyond standard INPI application fees; (3) Process: the applicant files a request with a brief statement explaining the environmental benefit; INPI verifies eligibility and, if accepted, advances the application for priority examination; (4) Speed: applications accepted into Patentes Verdes receive priority in the examination queue. This has reduced examination times for green technology from the historical backlog of 10+ years to significantly shorter periods. As of 2023, INPI processes thousands of Patentes Verdes applications annually. This program is directly analogous to the UK's Green Channel (free, broad eligibility) and IPO's similar programs in other countries. For startups and companies in cleantech, renewable energy, environmental technology, and sustainable agriculture, requesting Patentes Verdes treatment in Brazil is strongly advisable — there is no cost, and the time savings are substantial.

Brazil protects two types of technical inventions: Invention Patents (Patentes de Invenção) and Utility Models (Modelos de Utilidade). The key differences: (1) Subject matter: Invention patents cover any technical innovation — including products, processes, and compositions of matter — that meets the requirements of novelty, inventive activity, and industrial applicability. Utility models are limited to objects of practical use, or parts thereof, susceptible to industrial application, with a new form or arrangement resulting in functional improvement. Utility models cannot protect pure processes or methods — only physical objects (devices, equipment, mechanisms). (2) Term: invention patents = 20 years from filing; utility models = 15 years from filing. (3) Inventive activity threshold: invention patents require a non-obvious inventive step. Utility models apply a lower 'inventive act' standard (ato inventivo) — the improvement needs to be novel and functional, but the inventive activity requirement is less demanding than for a full patent. (4) Examination: both undergo formal examination by INPI; the substantive examination standard is lower for utility models. (5) Cost: utility model annuities and filing fees are generally slightly lower than invention patent fees. (6) Strategy: utility models are useful for: incremental improvements to existing products; innovations that are clearly novel in form and function but may not meet the full inventive step bar for a full patent; fast protection for physical device improvements where process patents are not needed. The utility model is conceptually similar to Germany's Gebrauchsmuster (though Brazil's version requires 15 years rather than Germany's 10-year max) and the Chinese utility model. The US has no direct equivalent.