Strategic Deployment of Third-Party Pre-Grant Submissions in Brazil's Patent Examination: A Comprehensive Guide for Life Sciences Practitioners

Brazil's patent landscape presents a dynamic environment for pharmaceutical and biotechnology innovators navigating an increasingly important Latin American market. Among the procedural mechanisms available during patent prosecution, the submission of third-party observations—referred to in Brazilian law as "subsidies" (subsídios) to the examination—under Article 31 of the Brazilian Industrial Property Law (Law No. 9,279/96) represents a valuable strategic tool that remains underutilized by many life sciences practitioners. This mechanism allows any interested party to submit prior art documents and arguments during the examination of pending invention patent applications, potentially preventing problematic patents from being granted or narrowing their scope to mitigate competitive threats.

Introduction: The Strategic Value of Third-Party Pre-Grant Submissions

In the pharmaceutical and biotechnology sectors, where patent protection serves as the cornerstone of commercial viability and return on research investment, the ability to influence the patent landscape during examination rather than waiting for post-grant opposition or nullity proceedings carries substantial strategic and economic advantages. Brazil's third-party submission framework operates within a procedural context that differs meaningfully from analogous mechanisms in other major jurisdictions, including China's third-party observations under Rule 54 of the Implementing Regulations, the European Patent Office's third-party observations, and the United States Patent and Trademark Office's third-party pre-issuance submission program.

The Brazilian National Institute of Industrial Property (INPI, Instituto Nacional da Propriedade Industrial) receives and considers third-party submissions as part of the substantive examination process. Examiners are obligated to consider all materials in the file wrapper, although they retain considerable discretion regarding their weight and ultimate influence on examination outcomes. Understanding the nuances of this system—including optimal timing, permissible grounds, submission requirements, and strategic considerations—is essential for practitioners advising clients on comprehensive freedom-to-operate strategies and portfolio management in Latin America's largest pharmaceutical market.

Brazil's patent system has undergone significant evolution in recent years, particularly affecting pharmaceutical applications. Most notably, the elimination of the Brazilian Health Regulatory Agency's (ANVISA, Agência Nacional de Vigilância Sanitária) prior consent requirement in August 2021 has streamlined pharmaceutical patent examination, reducing average prosecution timelines and creating new strategic opportunities for third-party intervention. This transformation, combined with INPI's ongoing efforts to address examination backlogs and modernize guidelines, has enhanced the relevance and potential effectiveness of well-crafted third-party submissions.

Legal Framework and Procedural Basis

The legal foundation for third-party submissions in Brazil is derived from Article 31 of the Industrial Property Law (Law No. 9,279/96), which provides that "from the publication of the application until the end of the examination, the INPI may receive documents and information from interested parties to subsidize the substantive examination." This provision establishes a framework with several distinctive characteristics that practitioners must be aware of.

First, third-party submissions apply exclusively to invention patents and utility model applications, not to design applications. This limitation reflects the substantive examination process required for invention patents, which undergo rigorous assessment of novelty, inventive step, industrial applicability, sufficiency of disclosure, and other patentability criteria. Second, the submission window extends from the publication date of the application (typically 18 months from the filing or priority date, though accelerated publication can occur earlier) until the "end of examination". INPI has interpreted this phrase to mean the date of issuance of the notice of allowance, rejection, or definitive dismissal (Article 50, Ordinance No. 14/2024).

Third, the official fees for filing third-party submissions are lower than those for filing a post-grant opposition (R$290.00 for third-party submissions (e.g., about USD $54.00) and R$1580.00 for filing a post-grant opposition (e.g., about USD $293.00), making this an economically attractive option compared to post-grant opposition proceedings or judicial nullification actions. This represents a significant advantage for parties monitoring multiple competitive applications or conducting systematic freedom-to-operate analyses in crowded therapeutic areas.

INPI places third-party submissions in the examination file for the examiner's consideration during substantive examination. However, crucially, INPI is not obligated to notify the submitting party of the handling, consideration, or outcome of the submissions. The submitting party does not become a formal party to the examination proceedings and has no right to respond to the applicant's arguments or participate in subsequent procedural stages. This "observer" status distinguishes Brazilian pre-grant submissions from more formalized opposition proceedings available in some jurisdictions.

INPI will not notify the applicant that a third-party submission has been filed, though the submission becomes part of the file wrapper and is accessible through file inspection mechanisms. This confidentiality during the examination process contrasts with post-grant opposition proceedings, where the opponent and patent owner engage in a formal adversarial exchange with notifications published in the Official Gazette (Revista da Propriedade Industrial, RPI).

Temporal Considerations and Strategic Timing

The strategic timing of third-party submissions represents a critical consideration that can significantly impact their likelihood of influencing examination outcomes. While the statutory window extends from publication through the "end of examination," practical considerations favor earlier submission, ideally before the issuance of the first office action.

Several rationales support this timing preference. First, examiners conducting initial substantive examination possess greater flexibility to incorporate relevant prior art and arguments into their preliminary assessment of patentability before formulating initial rejections. Once an examiner has committed to a particular examination position in a first office action, institutional and procedural factors may reduce receptivity to third-party submissions that would require substantial reconsideration of that position. Second, early submission allows the examiner adequate time to review potentially voluminous prior art references and associated claim charts or comparative analyses, rather than encountering them late in prosecution when examination momentum may favor resolution. Third, submitting before the first office action maximizes the opportunity for observations to shape the examination trajectory from its inception, potentially leading to rejection or requiring claim amendments that narrow the scope of protection.

Brazil's patent prosecution timeline presents both opportunities and constraints for third-party submissions. The average examination timeline for pharmaceutical patent applications granted between 2020 and 2022 was approximately 10.25 years, though recent reforms aim to reduce this to an ambitious target of four years. Current average prosecution times range from five to nine years. This extended timeline creates a substantial window for third-party intervention; however, recent initiatives to accelerate examination, including Patent Prosecution Highway (PPH) programs, preliminary office action programs, and prioritized examination for certain pharmaceutical applications, can significantly compress the available window.​

Practitioners monitoring competitor activities must remain vigilant for signals of accelerated prosecution. Several fast-track mechanisms exist for pharmaceutical applications:

Prioritized Examination Programs: Since 2013, prioritized examination has been available for patent applications claiming pharmaceutical products and processes, particularly those related to HIV/AIDS, cancer, neglected diseases (including tuberculosis, dengue, malaria, and others), and more recently, rare diseases and applications deemed strategic to Brazil's public healthcare system (SUS, Sistema Único de Saúde). Third parties (including competitors) or the Ministry of Health can request prioritized examination in certain circumstances, creating scenarios where prosecution accelerates unexpectedly.

Patent Prosecution Highway (PPH): Brazil participates in PPH programs with multiple patent offices, allowing applicants to request expedited examination based on allowances or favorable examination results in partner jurisdictions. PPH applications undergo significantly faster examination, with 91% of PPH participation requests approved and 87% of PPH applications granted. Brazil's PPH program expanded to be "tech neutral" in 2019, meaning pharmaceutical and biotechnology applications are now eligible.

Preliminary Office Action Program: Launched in 2019 to address examination backlogs, this program involves the issuance of simplified preliminary office actions listing prior art cited during the examination of counterpart applications in other jurisdictions, without detailed analysis. Applicants have 90 days to respond; failure to do so results in a lapse with no right to appeal. Notably, applications for which third-party submissions have been filed are not eligible for the preliminary office action program.

Permissible Grounds for Third-Party Submissions

Unlike some jurisdictions that limit third-party submissions to citation of prior art documents without substantive arguments (such as the pre-2015 U.S. system), Brazil's third-party submission framework permits challenges on any ground that would constitute a basis for rejection under the Industrial Property Law. This comprehensive scope encompasses the full range of substantive and formal patentability requirements, though in practice, submissions focusing on prior art and patentability criteria receive the greatest examiner attention.

Novelty (Article 11 of Law No. 9,279/96): Third parties may submit prior art references demonstrating that the claimed invention lacks novelty because all features of a claim are disclosed in a single prior art reference. Article 11 defines the state of the art broadly as "everything made accessible to the public before the filing date of a patent application, by written or oral description, by use or any other way, in Brazil or abroad". For pharmaceutical and biotechnology inventions, novelty challenges often involve identifying earlier publications disclosing the same compound, biological molecule, composition, formulation, or method of treatment. Brazil provides a 12-month grace period for disclosures made by the inventor or by INPI (regarding applications filed without the inventor's consent), or by third parties based on information obtained from the inventor.

For chemical compounds, Brazilian examination guidelines specify that to be considered novel, the claimed compound may not have been specifically disclosed in the prior art in the form of examples, tests, results, lists, tables, nomenclature, individualized structural formula, or method of preparation. Generic disclosure of a compound class does not necessarily destroy the novelty of a specific compound within that class. For stereoisomers, novelty is attributed when the prior art does not describe the claimed enantiomer, atropisomer, or diastereoisomer. However, the disclosure of racemic or stereoisomeric mixtures is considered to anticipate both stereoisomers, making it possible to claim solely compositions with a specific enantiomeric excess.

Inventive Step (Article 13 of Law No. 9,279/96): Perhaps the most frequently invoked ground, a lack-of-inventive-step argument asserts that the claimed invention would have been obvious to a person skilled in the art in view of the prior art. For pharmaceutical inventions, this may involve demonstrating that a claimed compound represents a predictable structural modification of a known compound, that a claimed combination of known active ingredients would have been obvious to try, or that claimed pharmacological properties would have been expected based on structural similarities to known compounds.

Brazilian examination guidelines for chemical inventions provide detailed criteria for assessing inventive step, emphasizing the need for unexpected technical effects or advantages. Selection inventions—where a subgroup is selected from a broader genus—must demonstrate that the selected compounds possess unexpected or superior properties not predictable from the prior art disclosure. For pharmaceutical combinations, an inventive step analysis considers whether the combination would have been obvious based on known therapeutic effects and the lack of a synergistic effect.

For second medical use claims (use of a known compound for a new therapeutic purpose), inventive step represents the most challenging requirement. INPI considers five specific factors: (1) the mechanism of action of the compound; (2) the etiology of the disease; (3) structure-activity relationships; (4) side effects; and (5) symptoms of the disease to be treated. If the mechanism of action or disease etiology differs from what is known in the prior art, inventive step may be established. Third-party submissions targeting second medical use claims can effectively challenge inventive step by providing prior art that demonstrates the predictability of the new therapeutic application based on known pharmacological properties or mechanisms.

Sufficiency of Disclosure (Article 24 of Law No. 9,279/96): Third parties may argue that the specification fails to describe the invention clearly and sufficiently to enable a person skilled in the art to carry it out. In the pharmaceutical and biotechnology context, this ground assumes particular importance where the preparation of the claimed compounds is not sufficiently described, where the claimed biological materials lack proper deposit under the Budapest Treaty, or, for new medical use inventions, where the claimed technical effects (such as therapeutic efficacy) lack adequate experimental support.

Brazilian examination practice requires experimental data to support claimed technical effects, particularly for pharmaceutical inventions. Unlike some jurisdictions that liberally accept post-filing data, Brazil's approach has become increasingly restrictive, particularly for new use claims. Recent proposed guidelines for new use claims specify that in vitro, ex vivo, or in silico studies alone are insufficient to demonstrate therapeutic effects, and that supplemental data will not be accepted, even if intended to corroborate information already disclosed in the specification. This strict enablement standard creates opportunities for third-party submissions that challenge whether the specification adequately supports the claimed therapeutic effects with clinical or in vivo data.

Unpatentable Subject Matter (Article 10 of Law No. 9,279/96): Third parties may challenge applications claiming subject matter not considered inventions, including discoveries, scientific theories, mathematical methods, abstract methods, surgical or therapeutic methods applied to the human or animal body, diagnostic methods, and natural products or living beings.

For pharmaceutical inventions, this ground is relevant when applications impermissibly claim diagnostic or treatment methods rather than properly claiming uses of compounds in the preparation of medicaments. Brazil does not accept process claims for curative therapy or conclusive diagnostic results applied to humans or animals.

However, Brazil does accept Swiss-type claims for medical uses (e.g., "use of compound X in the manufacture of a medicament for treating disease Y"), which are treated as process claims for the preparation of the medicament. Features that do not affect the medicament preparation process—such as dosage regimens, routes of administration, or patient subgroups—do not contribute to novelty or inventive step of such claims. Third-party submissions can challenge improperly drafted use claims that include non-distinctive features or that impermissibly claim therapeutic methods.

Furthermore, third-party submissions can challenge claims referring to natural products or synthetic products undistinguishable from them, or to natural living beings, such as cells and microorganisms. The same applies to pharmaceutical compositions comprising the natural product or living being and a pharmaceutically acceptable carrier, which may be water or saline.

Lack of Support or Clarity (Article 25 of Law No. 9,279/96): This provision requires that claims be based on a description that clearly defines the scope of protection sought. The support requirement becomes critical when applications claim broad genus claims but provide limited working examples in the specification. The clarity requirement relates to claim drafting and interpretation. For pharmaceutical applications, particularly those claiming Markush structures or broad compound classes, third-party submissions can challenge whether the specification provides adequate support for the full scope claimed, or whether claims clearly and unambiguously define the invention.

Recent proposed guidelines for new use claims impose strict clarity requirements for new medical use claims, mandating that claims specify the exact compound used and clearly identify the disease or condition treated. Vague references to disease classes (e.g., "central nervous system disorders") or indirect characterizations (e.g., "serotonin reuptake inhibition") are considered unclear. Markush structures and chemical classes are deemed to be indefinite for use claims. These strict requirements create opportunities for third-party submissions challenging claim clarity.

In the biotechnology field, there are also strict requirements regarding claim language. Biological molecules must be defined by a specific SEQ ID NO, and indirect definition of polynucleotides (i.e., by means of the proteins encoded) is not allowed under the biotechnology guidelines.

Other Grounds: Third parties may raise unity of invention objections where an application attempts to claim multiple independent inventions lacking a single general inventive concept (Article 22), or challenge improper amendments that extend beyond the scope of the original disclosure or set of claims for which examination was requested (Article 32). While the lack of unity of invention grounds receives less attention in pharmaceutical third-party submissions than novelty, inventive step, and sufficiency challenges, it may be relevant in specific circumstances. Regarding the addition of matter (e.g., new matter), examiners tend to analyze this formal requirement very thoroughly, and many cases are rejected based on this ground.

For pharmaceutical and biotechnology practitioners, the most effective third-party submissions typically combine novelty and inventive step challenges, supported by highly relevant prior art and technical analysis that addresses structure-activity relationships, pharmacological predictability, and therapeutic effects.

Documentary Requirements and Submission Format

INPI does not impose extensive formal requirements for third-party submissions, and no official form is required. Submissions may be filed electronically through INPI's e-Patentes platform. The informal nature of the procedure contrasts with the more formalized post-grant opposition proceedings, which require compliance with procedural requirements.

Despite the lack of formal requirements, effective third-party submissions typically include several key components to maximize examiner consideration and impact:

Statement of Grounds: The submission should articulate the specific provisions of the Industrial Property Law with which the application allegedly fails to comply, providing reasoned explanations for each asserted ground of unpatentability. Conclusory assertions without detailed analysis are unlikely to receive substantial weight from examiners. Given that examiners are obligated to consider all materials in the file wrapper but are not required to respond to third-party submissions, the burden falls on the submitting party to present clear and compelling arguments that facilitate the examiner's understanding and adoption.

Prior Art References: When challenging novelty or inventive step, third parties should submit copies of all prior art references relied upon. While evidence can be submitted in English, Spanish, or Portuguese, Portuguese translations of references in other languages are required.

A practical consideration noted by Brazilian practitioners is that some third-party submissions consist merely of hundreds of pages printed from PubMed or search engines, or scanned pages from textbooks, filed without analysis in comparison to the pending claims. Such voluminous, poorly organized submissions may receive cursory attention from examiners and fail to achieve their intended purpose. Quality and clarity of presentation matter more than quantity of references.

Comparative Analyses: To facilitate the examiner's understanding and maximize persuasive impact, practitioners should prepare detailed charts that map claim elements to prior art disclosures. For pharmaceutical inventions, this often involves element-by-element comparison of claimed compounds to prior art structures, identification of common structural features, analysis of the predictability of modifications, and comparison of claimed therapeutic effects to prior art disclosures. For method claims, charts should map claimed steps to prior art method descriptions. For combination pharmaceutical claims, charts should clearly identify the disclosure of individual components and the rationale for combining them.

Technical Analysis: Particularly for inventive step challenges, submissions benefit from detailed technical analysis that explains why claimed features would have been obvious to a person skilled in the art, identifies motivations for combining prior art references, and addresses any technical effects or unexpected results asserted in the specification. For pharmaceutical applications, this may involve analyzing structure-activity relationships, predicting pharmacological outcomes based on the mechanism of action, optimizing known compound classes, or predicting therapeutic effects based on disease etiology and established pharmacology.

Identification Information: The submission must include the author's name and address, though anonymous submission arrangements are possible. The submission should clearly identify the patent application number and title being challenged.

The low official fees for third-party submissions contrast with the costs associated with post-grant opposition proceedings and judicial nullification actions (which include court fees, INPI's mandatory participation as a co-defendant, and extended litigation timelines). This cost differential makes third-party submissions an attractive first-line strategy for addressing competitive threats, particularly when monitoring multiple applications.​

Anonymous Submissions and Confidentiality

Third-party submissions can be filed through arrangements where the true interested party's identity is not disclosed to INPI or the applicant. As noted in Brazilian practitioner guidance, "the subsidy must include the author's name and address, but if the author wants to remain anonymous, that can also be arranged". This typically involves filing through a law firm or other intermediary or using arrangements that obscure the identity of the true interested party.

This confidentiality feature offers strategic flexibility for parties who wish to challenge a competitor's patent application without disclosing their commercial interests or raising concerns about business relationships. INPI does not publish in its Official Gazette any notification informing a patent applicant that a third-party submission has been filed and placed in the file wrapper. However, examiners are obliged to mention third-party submissions in the technical opinions (a notification of which is published in the Official Gazette). Even when submissions are made under an identified party's name, INPI does not investigate or verify the submitter's standing or interest in the application.​

The procedural approach differs from post-grant opposition proceedings, in which the opponent's identity is published in the Official Gazette, and the patent owner receives formal notification with an opportunity to respond. The confidentiality of pre-grant submissions during prosecution protects business relationships and competitive strategies.

The decision whether to submit anonymously or under an identified name involves several considerations. Anonymous submissions may be preferable when the submitting party maintains business relationships with the applicant (such as contract manufacturing relationships, licensing discussions, or joint ventures in unrelated therapeutic areas), when disclosure of competitive interest could trigger strategic responses or retaliation, or when the submitting party wishes to avoid business complications. Some practitioners suggest that identified submissions may carry slightly greater credibility in certain circumstances, though the absence of examiner feedback and the informal nature of the procedure limit the practical significance of this consideration. For most pharmaceutical and biotechnology applications, anonymous submission through qualified patent counsel represents the predominant practice, balancing effectiveness with strategic discretion.

Examiner Consideration and Impact on Examination

A central practical question surrounding third-party submissions concerns the likelihood that examiners will consider and meaningfully adopt the submitted arguments and references. Brazilian law obligates examiners to consider all documents and information in the file wrapper during substantive examination, including third-party submissions. However, examiners are not required to explicitly address or respond to third-party submissions, either to the applicant or to the submitting party. This creates uncertainty regarding the weight accorded to submissions and necessitates active monitoring to assess their impact.

According to official WIPO documentation, "The documents and arguments presented by interested third parties are considered by INPI patent examiners during the application substantive examination. Examiners usually comment in their opinions on the relevance of third-party observations, taking advantage of the content of the subsidies as appropriate". This suggests that while consideration is mandatory, examiner commentary on relevance and adoption varies.

Available evidence regarding effectiveness, though largely anecdotal due to limited published statistics, suggests that well-crafted third-party submissions can meaningfully influence examination outcomes. When examiners find third-party submissions persuasive, they typically cite the submitted prior art references in subsequent office actions, providing tangible evidence of consideration. Submissions may lead to outright rejection of the application, though more commonly they result in narrowing amendments that limit claim scope to overcome the cited art.

Several factors enhance the likelihood of examiner adoption:

Quality and Relevance of Prior Art: The most critical factors determining effectiveness are the quality and relevance of the cited prior art. Highly relevant references that clearly anticipate or render obvious the claimed invention receive greater weight than marginally relevant citations. For pharmaceutical applications, prior art disclosing the same compound structure, similar structural modifications with predictable properties, known combinations, or known therapeutic effects for related compounds proves most effective.

Clarity of Presentation: Detailed charts, comparative analyses, and technical explanations reduce examiner burden and increase the likelihood of careful consideration. Given that Brazilian examiners face substantial examination backlogs and productivity pressures, submissions that present arguments clearly and facilitate rapid understanding prove more effective than voluminous, poorly organized materials.

Timing of Submission: Submission before the first office action maximizes opportunity for influence. Examiners conducting initial examination possess greater flexibility to incorporate third-party art into their analysis than when reconsidering positions articulated in earlier office actions.

Technical Sophistication: For pharmaceutical and biotechnology submissions, demonstrating understanding of structure-activity relationships, pharmacological principles, mechanism of action, disease etiology, and prior art in the field enhances credibility and persuasiveness. Submissions that engage substantively with the technical merits of the invention, rather than providing conclusory statements, receive greater examiner attention.

Portuguese Translation: Providing Portuguese translations of prior art in foreign languages other than English and Spanish is required.

Monitoring Burden: The lack of examiner feedback creates a monitoring burden on submitting parties. Third parties must track the prosecution file using INPI's electronic file inspection systems or monitoring services to determine whether subsequent office actions cite the submitted references or address the arguments raised. This monitoring enables assessment of whether the submission achieved its intended effect or whether additional intervention may be warranted.

Strategic Considerations for Pharmaceutical and Biotechnology Applications

The decision whether to submit third-party observations, and if so, what content to include, requires careful strategic analysis weighing multiple considerations specific to the pharmaceutical and biotechnology patent landscapes in Brazil.

Cost-Benefit Analysis: Third-party submissions offer substantial cost advantages over post-grant opposition proceedings and judicial nullification actions. Post-grant administrative opposition proceedings before INPI require higher official fees, formal written submissions, and must be filed within six months of patent grant. Judicial nullification actions require court fees, the mandatory participation of INPI as a co-defendant (because INPI is a federal entity that necessitates federal court jurisdiction), extended litigation timelines, and higher professional fees. By contrast, third-party submissions require lower official fees and impose only the costs of prior art searching, translation, and preparation of the submission.

For parties monitoring multiple competitive applications in a therapeutic area, the ability to submit observations on several applications at minimal official cost represents a meaningful economic advantage. However, this cost saving must be weighed against the lower probability of definitive outcomes compared to formal post-grant proceedings, which result in binding administrative decisions subject to judicial review.

Timing Relative to Product Development and Market Entry: Third-party submissions have the most significant strategic value when filed early in the patent's lifecycle, before grant, as they may prevent the issuance of patents that would otherwise require expensive post-grant proceedings or create freedom-to-operate obstacles. For pharmaceutical companies planning product launches in Brazil, early intervention through submissions may prevent later barriers to market entry.

Brazil's pharmaceutical market dynamics create particular urgency for timely intervention. Brazil operates a Bolar-type exemption under Article 43(VII) of the Industrial Property Law, permitting third parties to conduct acts related to an invention protected by a patent for the purpose of obtaining marketing authorization in Brazil or another country, provided that such acts are undertaken to enable exploitation and marketing after patent expiry. This allows generic manufacturers to complete regulatory approval processes before patent expiration without infringing. However, unlike the United States' Hatch-Waxman framework, Brazil lacks a patent linkage system connecting regulatory approval to patent status. ANVISA can grant marketing authorization for generic or biosimilar products regardless of whether active patents exist. Consequently, once a pharmaceutical patent expires (or is invalidated), generic entry can occur rapidly, as regulatory approval may already be in place.

This regulatory environment creates asymmetric risks for innovators and generics. For innovators, preventing the grant of competitor patents that could block their freedom to operate or create hold-up opportunities is critical. For generic manufacturers, invalidating or preventing the grant of patents covering molecules, formulations, or manufacturing processes they intend to commercialize creates commercial opportunities. Third-party submissions represent a cost-effective mechanism for both innovator and generic companies to shape the competitive patent landscape before patents issue.

Brazil's Patent Term Framework and the Supreme Court Decision: Brazil's patent term framework underwent a dramatic transformation in May 2021 when the Brazilian Supreme Court (STF, Supremo Tribunal Federal) declared unconstitutional the sole paragraph of Article 40 of the Industrial Property Law, which had provided that invention patents would be granted with a minimum term of 10 years from the grant date. This provision had operated as an automatic patent term extension mechanism compensating for INPI examination delays, resulting in patents granted more than 10 years after filing receiving protection extending beyond the standard 20-year term calculated from the filing date.

For the third-party submission strategy, this patent term transformation creates several considerations. First, it increases the importance of securing patent grants promptly, as extended prosecution timelines now directly reduce effective patent term rather than being compensated by automatic extensions. This pressure may lead applicants to pursue accelerated examination programs, compressing the window for third-party intervention. Second, it has intensified applicants’ focus on strengthening applications early in prosecution to minimize examination delays and office action cycles. Third parties must recognize that applicants may be more proactive in amending claims and responding to rejections to secure timely grants.

Conversely, eliminating automatic extensions may reduce incentives for applicants to maintain marginal or weak applications, as the cost of extended prosecution (in terms of reduced effective patent term) has increased substantially. This may create opportunities for well-crafted third-party submissions to tip the cost-benefit analysis in favor of not pursuing borderline applications.

Burden of Proof Considerations: During the examination process, the burden of demonstrating patentability primarily rests with the applicant, who must establish that the invention satisfies the requirements of novelty, inventive step, industrial applicability, sufficiency of disclosure, and other relevant criteria. This allocation favors third parties submitting prior art and arguments challenging patentability, as the applicant must overcome the examiner's concerns raised by those submissions. This contrasts with post-grant proceedings, where the burden often shifts to the challenger to prove invalidity. Third-party submissions thus benefit from a more favorable burden-of-proof framework during examination.

Risk of Strengthening the Patent: A commonly cited concern regarding third-party submissions in any jurisdiction is that applicants, by responding to and overcoming challenges based on third-party art, may emerge with patents that are harder to invalidate later because the art has been considered and distinguished during prosecution. This "defensive inoculation" effect may strengthen the patent's presumption of validity in later litigation or opposition proceedings.

However, in the Brazilian context, this risk is mitigated by several factors. First, Brazilian law does not impose formal estoppel doctrines that prevent the re-litigation of prior art considered during examination. This means that art cited in third-party submissions can typically be re-raised in post-grant opposition or judicial nullification proceedings. Second, post-grant administrative opposition proceedings before INPI involve de novo review of patentability, not deference to examination determinations. Third, judicial nullification actions similarly involve independent assessment by federal courts, without a presumption of validity favoring patents that have overcome examination challenges. Fourth, carefully selecting prior art for third-party submissions while reserving the strongest references for potential future invalidation proceedings can mitigate this risk.

Coordination with Post-Grant Opposition and Nullification Strategy: Third-party submissions should be viewed as one component of a comprehensive IP strategy, not a substitute for formal post-grant proceedings when patents issue despite submissions. Parties should plan from the outset for the possibility that submissions will not prevent a grant and that post-grant opposition or judicial nullification may become necessary. This planning may involve strategic decisions about which prior art to cite in submissions versus holding back particularly strong references for post-grant challenges.

Brazil's relatively low patent invalidation rate in post-grant administrative opposition proceedings—16% overall, with lower rates in key life sciences sectors (8% for agrochemicals, 13% for pharmaceuticals and petrochemicals, 25% for biotechnologies)—suggests that post-grant proceedings face substantial obstacles. This lower success rate compared to other jurisdictions may enhance the relative attractiveness of pre-grant submissions, which can prevent issuance rather than attempting to invalidate granted patents.

Freedom to Operate Considerations: For parties developing pharmaceutical products that may face patent thickets or overlapping competitive patent protection, systematic submission of third-party observations across multiple competitive applications may narrow the cumulative scope of issued patents and create greater freedom to operate. This systematic approach requires robust competitive intelligence and patent monitoring capabilities. Still, it can yield meaningful strategic benefits in crowded therapeutic areas where multiple patents potentially cover a single product or indication.

Brazilian patent examination has historically yielded lower grant rates for pharmaceutical applications than in other major jurisdictions, though recent data suggest that trends are evolving. Strategic third-party submissions can help maintain examination rigor and prevent the grant of patents that would unduly restrict competitive innovation.

Confidentiality and Business Relationships: The availability of anonymous submissions provides strategic flexibility for parties maintaining business relationships with applicants, such as contract manufacturing relationships, licensing discussions, technology transfer agreements, or joint ventures in unrelated therapeutic areas. Brazil's pharmaceutical industry involves complex business relationships, including technology transfer partnerships for productive development (PDPs, Parcerias para o Desenvolvimento Produtivo) between public and private entities. These relationships could be jeopardized by public opposition, making anonymous pre-grant submissions particularly valuable.

Evidentiary Development for Later Proceedings: Documentation and evidence developed for third-party submissions may prove valuable in later post-grant opposition proceedings or judicial nullification actions. Detailed charts, prior art analyses, and technical expert opinions prepared for submissions can be refined and expanded for use in later contexts, creating efficiencies even when submissions do not prevent a grant.

Comparison with Post-Grant Opposition Proceedings

Understanding the relationship between third-party pre-grant submissions and post-grant opposition proceedings is essential for strategic planning. These mechanisms serve complementary but distinct functions in the Brazilian patent system.

Timing and Scope: Third-party submissions can be filed only during prosecution, from application publication through the "end of examination" (defined as issuance of notice of allowance, rejection, or definitive dismissal). Post-grant administrative opposition can be initiated only after the grant and must be filed within six months from the grant date (Article 51 of Law No. 9,279/96). Submissions thus provide an earlier intervention opportunity but with less certainty of outcome. Opposition proceedings offer the potential for a definitive resolution through formal binding decisions by the INPI President, subject to judicial review, but occur after the patent has issued and entail greater costs and time commitments.

Procedural Formality: Post-grant opposition proceedings are conducted through formal adversarial procedures. Upon filing of the opposition, INPI publishes notice in the Official Gazette, after which the patent owner has 60 days to file a response. After analyzing the submissions, INPI publishes an intermediate opinion regarding the merits of the opposition. Both the opponent and patent owner may file replies to the intermediate opinion within 60 days of its publication. The matter is then decided by the INPI President in a final opinion, ending the administrative opposition procedure. The proceedings involve formal written submissions, potential oral hearings, and issuance of reasoned decisions binding on both parties, subject to judicial review.

By contrast, third-party pre-grant observations involve submission of information and arguments without formal procedural protections, notifications, or mandatory examiner responses. The submitting party does not become a party to the proceedings, receives no notification, and has no opportunity to respond to applicant arguments or intermediate decisions.

Costs: Pre-grant submissions require lower official fees. Post-grant opposition proceedings involve filing fees and professional fees for patent attorneys, as well as potentially incurring costs for technical experts, translations, and other litigation expenses. The total cost differential can be substantial, making pre-grant submissions attractive for initial challenges, particularly when monitoring multiple competitive applications.

Effectiveness and Success Rates: As noted above, Brazil's post-grant administrative opposition success rate is approximately 16% based on the overall invalidation rate. Notably, lower rates are observed in key pharmaceutical and biotechnology sectors. While this represents a meaningful mechanism for challenging granted patents, the relatively low invalidation rate suggests substantial obstacles to invalidation. Pre-grant submissions lack published effectiveness statistics, but anecdotal evidence and case studies from organizations like ABIA suggest they can meaningfully influence examination outcomes when well-crafted.

Strategic Sequencing: Optimal strategy often involves sequential use of both mechanisms—submitting third-party observations during prosecution to potentially prevent grant or narrow claims, followed by post-grant opposition or judicial nullification if the patent issues with problematic scope. This sequencing allows parties to benefit from the low cost and early timing of submissions while maintaining the option for more definitive post-grant proceedings if necessary.

Counter-Reasons to Appeals: A Unique Third-Party Intervention Opportunity

Brazil's patent system provides a unique additional mechanism for third-party participation during the appeal stage, distinct from pre-grant submissions during initial examination. When INPI examiners reject a patent application at first instance, the applicant has 60 days to file an appeal (Article 213 of Law No. 9,279/96). INPI publishes the filing of the appeal in its Official Gazette, opening a 60-day term for any interested party to file "counter-reasons" (contrarrazões) opposing the appeal.

This counter-reasons mechanism provides third parties a formal opportunity to argue against the reversal of the examiner's rejection. The appeal and counter-reasons are considered by the Board of Appeals, which conducts an independent review, including a new prior art search. Notably, the appellant is not formally permitted to file a reply to counter-reasons briefs; if such a reply is filed, INPI does not consider it to be "untimely".

The counter-reasons mechanism differs from pre-grant submissions in several respects. First, it applies only at the appeal stage, after a first-instance rejection has been issued, rather than during initial examination. Second, it contemplates third-party arguments specifically opposing the applicant's appeal brief, rather than general observations on patentability.

During the appeal stage, INPI may issue additional office actions, providing the applicant with a 60-day deadline to respond (Article 214). However, at this stage, only the appellant may file replies; any briefs filed by third parties are dismissed as "untimely". Therefore, third-party participation in the appeal phase is limited to filing counter-reasons to the initial appeal brief.

Recent changes to Brazil's appeal procedures have created additional complexity. Following legal opinions issued in 2023 and 2024, INPI implemented restrictive rules regarding amendments permitted during the appeal stage, including prohibitions on certain types of claim amendments and limitations on the arguments that can be raised. These restrictions aim to address administrative preclusion principles and reduce appeal backlogs, but have proven controversial and are subject to judicial challenges.

For pharmaceutical and biotechnology practitioners, the counter-reasons mechanism provides a strategic opportunity to oppose appeals of rejected applications, reinforcing examiner rejections with additional prior art or arguments. However, the timing constraints (60 days from the publication of the appeal filing) and the prohibition on subsequent third-party participation during the appeal examination limit the utility of this mechanism compared to pre-grant submissions during the initial examination.

Monitoring and Follow-Up

Given the absence of feedback on third-party submissions, monitoring the prosecution file becomes essential to assess the impact and determine whether additional action is warranted. Several monitoring approaches merit consideration.

Official Gazette Monitoring: INPI's Official Gazette publishes information on application status, including publication of applications, office actions, appeal filings, and grant announcements. Systematic monitoring through the RPI or commercial patent database services provides updates on prosecution progress. It enables the identification of procedural developments that may warrant third-party intervention (such as appeal filings that create opportunities for counter-reasons).

Electronic File Inspection: INPI provides electronic file inspection capabilities through its e-Patentes platform and related systems. While the specific systems and access requirements evolve, registered users can access prosecution history for patent applications, including office actions, applicant responses, and prior art citations. Regular monitoring of applications for which third-party submissions have been filed allows identification of examiner consideration, as reflected in citation of submitted references in office actions.

Multiple Submission Strategy: Brazilian law places no limit on the number of third-party submissions that may be filed for a single application. Suppose initial submissions do not appear to influence examination (as determined through file monitoring). In that case, parties may consider filing additional submissions with different or supplemental prior art, refined arguments, or improved technical analysis. This iterative approach allows parties to respond to prosecution developments and increase the likelihood of examiner consideration.

However, practitioners should exercise judgment regarding multiple submissions. As noted in Brazilian practice commentary, some third-party submissions consist of voluminous, poorly organized materials (hundreds of pages printed from databases without analysis) that may receive cursory attention and, without meaningful impact, potentially slow prosecution. Quality and strategic focus prove more effective than repetitive, voluminous submissions.

Coordination with Post-Grant Proceedings: If a patent issues despite third-party submissions, parties should evaluate whether to initiate post-grant administrative opposition (within the six-month window from grant) or judicial nullification proceedings. Evidence of prior art cited in submissions but not adequately addressed by the examiner may strengthen arguments that the patent was improperly granted. Documentation and analysis developed for pre-grant submissions can be leveraged in post-grant proceedings, creating efficiencies.

Key Takeaways for Practitioners

Drawing from the comprehensive analysis above, several key takeaways emerge for pharmaceutical and biotechnology patent practitioners advising clients on Brazilian patent strategy:

1. Early and Strategic Timing: Submit third-party observations as early as possible after application publication, preferably before the first office action, to maximize the likelihood of examiner consideration and influence on examination outcomes. Monitor competitive applications through the RPI and commercial databases to identify candidates for submission before examination concludes or accelerated prosecution programs compress the available window.

2. Comprehensive Grounds with Focus on Prior Art: While any ground for rejection may be raised, challenges based on novelty and inventive step supported by highly relevant prior art references and detailed comparative analyses represent the most effective approach for pharmaceutical applications. Sufficiency-of-disclosure challenges are particularly valuable where applications claim therapeutic effects without adequate experimental support, given Brazil's strict enablement standards for medical-use inventions.

3. Quality Over Quantity: Invest in thorough prior art searching and careful preparation of technical analysis rather than filing cursory or voluminous submissions. Well-crafted submissions with clear comparative charts and reasoned explanations receive greater examiner attention and prove more effective than hundreds of pages of unanalyzed references.

4. Leverage Cost Advantages: The lower official fees make third-party submissions an economically attractive mechanism for monitoring and challenging competitive applications, particularly when tracking multiple applications in a therapeutic area. Use pre-grant submissions as a first-line strategy, reserving more costly post-grant opposition or judicial nullification for situations where patents issue despite submissions.

5. Utilize Anonymous Submission: For most competitive situations, anonymous submission through qualified Brazilian patent counsel provides strategic flexibility while maintaining the effectiveness of the submissions. Anonymous filing protects business relationships and avoids disclosure of competitive interests or strategies that could trigger applicant responses.

6. Active Monitoring: Implement systematic monitoring of prosecution files using INPI's electronic systems, the RPI, or commercial database services to assess whether submissions influence examination outcomes and whether additional submissions or post-grant actions are warranted. Without examiner feedback, monitoring represents the only mechanism for evaluating effectiveness.

7. Integrate with Broader IP Strategy: View third-party submissions as one component of a comprehensive freedom-to-operate and portfolio management strategy, not a standalone solution. Plan for potential post-grant opposition (within six months of grant) or judicial nullification proceedings if problematic patents are issued despite submissions. Coordinate pre-grant and post-grant strategies, potentially reserving the strongest prior art for post-grant proceedings while using good prior art in pre-grant submissions.

8. Consider Burden of Proof Benefits: Recognize that the burden of proof framework during examination favors challengers, as applicants must demonstrate patentability. This makes pre-grant submissions potentially more effective than post-grant invalidation proceedings for borderline cases, particularly given Brazil's relatively low success rates in post-grant opposition proceedings.

9. Presentation: Investing in a clear presentation reduces examiner burden and increases the likelihood of careful consideration. Given examination backlog pressures and productivity requirements, facilitating rapid examiner comprehension through organized comparative charts significantly enhances effectiveness.

10. Pharmaceutical-Specific Considerations: For pharmaceutical and biotechnology applications, particular attention to sufficiency of disclosure, support for claimed technical effects, inventive step based on structure-activity relationships and pharmacological predictability, and proper claim format for second medical use applications can yield effective submissions—leverage Brazil's strict requirements for experimental support and enablement, particularly for therapeutic effect claims.

11. Monitor Accelerated Examination Programs: Stay informed regarding applications participating in PPH programs, preliminary office action programs, or prioritized examination for pharmaceutical applications related to public health priorities. These programs compress examination timelines dramatically, requiring accelerated third-party submission strategies to intervene before the examination concludes.

12. Leverage Counter-Reasons to Appeals: When monitoring reveals that an examiner has rejected a competitive application and the applicant files an appeal, consider filing counter-reasons within the 60-day window after publication of the appeal in the RPI. This formal third-party participation mechanism at the appeal stage can reinforce rejections and oppose reversal.

13. Account for Patent Term Dynamics: Consider the impact of Brazil's 2021 Supreme Court decision eliminating automatic patent term extensions when planning a third-party submission strategy. The increased importance of timely patent grants (to maximize the effective 20-year term from filing) may influence applicant prosecution strategies and responsiveness to examination challenges.

14. Pharmaceutical Market Dynamics: Recognize Brazil's unique regulatory environment, including the Bolar exemption permitting pre-expiration regulatory approval activities and the absence of patent linkage, when assessing the strategic importance of preventing grant versus invalidating granted patents. The ability of generics to obtain regulatory approval regardless of patent status creates asymmetric market entry dynamics that may enhance the value of early intervention through pre-grant submissions.

This post was written by Lisa Mueller and Rob Rodriques, Luiza Cotia, and Yasmin Kronemberger from RNA Law.