Last updated: December 17, 2025
Executive Summary
Brazil's patent framework for biopharmaceutical inventions is governed primarily by its Industrial Property Law (Law No. 9,279/1996) and aligned with the TRIPS Agreement. Patentability criteria demand novelty, inventive step, and industrial applicability, with particular sensitivities around biological materials and methods. Enforceability hinges on robust patent prosecution processes, compliance with disclosure requirements, and diligent patent maintenance. The scope of claims in biopharmaceutical patents often faces challenges related to patentable subject matter coverage, especially around nature-based inventions and biotechnological processes. This report consolidates essential insights and strategic considerations for stakeholders aiming to secure, enforce, and optimize biopharmaceutical patents in Brazil.
What Are the Patentability Criteria for Biopharmaceuticals in Brazil?
1. Patentability Requirements
| Criterion |
Details |
Relevant Laws & Guidance |
| Novelty |
The invention must be new. Prior disclosures, publications, or uses bar patentability. |
Art. 11, Law No. 9,279/1996 |
| Inventive Step (Non-Obviousness) |
The invention should not be obvious to a person skilled in the field, considering state of art. |
Art. 8 & 15, Law No. 9,279/1996 |
| Industrial Applicability |
The invention must have a specific, substantial, and credible utility. |
Art. 10, Law No. 9,279/1996 |
| Patentable Subject Matter |
Biological materials may qualify only if they meet the criteria of novelty and inventive step; naturally occurring substances are excluded unless modified. |
Art. 10, Item VIII, Law No. 9,279/1996 |
2. Biological Materials and Biotech-Specific Challenges
- Brazil adheres to the European Approach: naturally occurring biological substances are not patentable unless they involve a technical invention, such as a new method of production, a recombinant DNA, or a purified or isolated form that demonstrates industrial utility.
- The 2019 Brazilian Patent Office (INPI) examination guidelines clarify that isolated genetic material may be patentable if the invention involves a significant human intervention or technical contribution.
- Key point: Claims must include clear definitions, chemical structures, sequences, or detailed methods demonstrating the invention's distinctiveness.
3. Exclusions and Limitations
- Section 3 of Law No. 9,279/1996 excludes from patentability:
- Discoveries, scientific theories, or mathematical methods.
- Methods for doing business or playing games.
- The mere presentation of information.
- Natural phenomena or natural products as they are found in Nature, unless modified or isolated with demonstrable invention.
How Enforceable Are Biopharmaceutical Patents in Brazil?
1. Patent Enforcement Pillars
| Aspect |
Details |
| Registration & Maintenance |
Patents granted by INPI are valid for 20 years from the filing date, subject to annual maintenance fees. |
| Legal Actions |
Patent lawsuits are handled by specialized federal courts, with enforcement focusing on infringement, undue use, or patent nullity actions. |
| Infringement Criteria |
Use or manufacturing of a patented invention without authorization constitutes infringement, provided the patent is valid and enforceable. |
| Post-Grant Oppositions & Nullity |
Patent validity can be challenged through nullity suits on grounds including lack of novelty, inventive step, or infringement of exclusions. |
2. Challenges in Enforcement
- Brazil’s judiciary is protective of patent rights but demands rigorous proof of infringement, especially in biopharma, where product-specific distinctions may be nuanced.
- Patent invalidity claims are common, often based on prior art or non-compliance with patentability criteria.
- Courts have upheld patent rights for biopharmaceuticals, yet issues around evergreening and data exclusivity are under ongoing debate.
3. Data Exclusivity and Market Dynamics
- Brazil lacks formally codified data exclusivity for pharmaceuticals, relying instead on patent protection. However, the BMS & Teva case (2014) signaled judicial sensitivity to patent term extensions and patent linkage.
- Market entry barriers often hinge on patent validity and enforceability, with regulatory approvals requiring patent status affirmations.
What Is the Scope of Claims for Biopharmaceutical Patents in Brazil?
1. Types of Claims
| Claim Type |
Description |
Strategic Utility |
| Product Claims |
Cover the active pharmaceutical ingredient (API) or biological product. |
Central to core patent coverage. |
| Process Claims |
Cover methods of manufacturing or producing the invention. |
Crucial for biotech inventions involving recombinant methods. |
| Use Claims |
Cover specific therapeutic uses or indications. |
Extend patent scope beyond the product. |
| Formulation Claims |
Cover specific compositions or formulations. |
Supplement to core claims to broaden protection. |
| Structural Claims |
Cover sequences, structures, or modifications, e.g., amino acid sequences. |
Highly relevant for biotech and genetic inventions. |
2. Claim Drafting Strategies
- Emphasize specific chemical structures, sequences, and intermediates.
- Maximize method claims around manufacturing or use, which are less susceptible to prior art invalidation.
- Incorporate product-by-process claims to encapsulate unique manufacturing techniques.
3. Claim Limitations and Considerations
| Limitation |
Impact & Best Practice |
| Dependent Claims |
Clarify scope and provide fallback positions. |
| Scope of Broad Claims |
Risk of rejection if claims are overly broad; should be supported by detailed description. |
| Claim Amendments |
Post-filing amendments are allowed but limited; must be justified during prosecution. |
4. Patent Term & Supplementary Protection
- Patent term is 20 years from the priority date.
- Brazil has a data protection period of 10 years for new chemical entities, but this does not replace patent exclusivity.
Comparison with International Standards
| Aspect |
Brazil |
United States |
Europe |
| Patentability of Biotech |
Isolated, purified products patentable with contribution |
Similar, with specific exceptions |
Similar, often more permissive |
| Patent Term |
20 years from filing |
20 years from filing |
20 years from filing |
| Enforcement |
Patent courts, specialized judiciary |
Federal courts, Patent Trial & Appeal Board |
Court of Justice & EPO enforcement systems |
| Scope of Claims |
Broad, if properly supported |
Broad, with clear definitions |
Similar, with emphasis on clarity |
Regulatory Landscape & Policy Environment
- Brazilian Agency of Sanitary Vigilance (ANVISA) oversees drug approvals, which interact with patent rights.
- The Brazilian Patent Office (INPI) plays a critical role in examining and granting patents, with recent enhancements in biotech patent examination quality.
- Brazil’s participation in TRIPS obligates it to uphold standards for patentability but also allows for public health safeguarding measures.
Key Challenges & Opportunities
Challenges
- Navigating the exclusions for natural substances and ensuring claims meet inventive step criteria.
- Overcoming biotech patent opposition based on prior art or non-patentable subject matter.
- Ensuring adequate claim scope without risking invalidation or non-enablement.
Opportunities
- Strategic drafting of product, process, and use claims to extend patent protection.
- Leveraging biotechnological modifications to patent naturally occurring molecules.
- Exploiting Brazil’s robust enforcement mechanisms to deter infringement and protect market share.
Key Takeaways
- Brazil’s patent system allows patenting of biopharmaceuticals that involve significant human intervention, such as isolated genetic material or recombinant proteins.
- Patentability hinges on demonstrating novelty, inventive step, industrial utility, and ensuring claims do not encompass natural phenomena.
- Enforceability is well-established but requires diligent default of patent prosecution, robust claim drafting, and active enforcement in courts.
- Claim scope should balance broad protection with specific language supported by detailed disclosure, encompassing product, process, and use claims.
- Ongoing legal, regulatory, and policy developments make Brazil an attractive yet complex market for biopharmaceutical patent protection, demanding tailored strategies.
FAQs
1. Can naturally occurring biological substances be patented in Brazil?
Generally no, unless they are isolated, purified, or modified substantially to meet inventive and industrial applicability criteria. Brazil excludes natural phenomena from patentability.
2. What are the typical patent term limitations for biopharmaceuticals in Brazil?
Patents are valid for 20 years from the filing date, with maintenance fees due annually. No supplementary data exclusivity is granted apart from patent protection.
3. How does Brazil handle patent disputes in biopharmaceuticals?
Disputes are litigated in federal courts, with possible nullity actions based on validity and infringement suits. The judiciary emphasizes prior art and patent scope compliance.
4. How should claims be drafted to maximize protection for biotech inventions?
Focus on precise structural, method, and use claims, with detailed descriptions of sequences, processes, and modifications to withstand challenges.
5. Are there specific policies incentivizing biopharmaceutical innovation in Brazil?
While no dedicated patent-specific incentives exist, Brazil's regulatory environment and participation in international treaties encourage biotechnological advancements and patent filings.
References
[1] Brazilian Industrial Property Law (Law No. 9,279/1996)
[2] INPI Guidelines for Patent Examination (2019)
[3] TRIPS Agreement (1994)
[4] Brazilian Supreme Court Decisions on Patent Rights (2014 onward)
[5] World Intellectual Property Organization (WIPO) reports on Brazilian patent system
