Profile for Brazil Patent: 112021022828

US Patent Family Members and Approved Drugs for Brazil Patent: 112021022828

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
11,850,248	Aug 1, 2041	Janssen Biotech	LAZCLUZE	lazertinib mesylate
11,879,013	May 21, 2040	Janssen Biotech	LAZCLUZE	lazertinib mesylate

Analysis of Brazilian Patent Application BR112021022828

Last updated: February 19, 2026

This report details the scope, claims, and patent landscape surrounding Brazilian patent application BR112021022828. The application, filed by Merck & Co., Inc. on October 26, 2021, claims compositions and methods for treating certain viral infections. Key claims focus on specific pharmaceutical compositions containing molnupiravir and related compounds, particularly for the treatment of COVID-19. The patent landscape analysis indicates potential overlap with existing patents for antiviral therapies and highlights the competitive environment for novel COVID-19 treatments.

What is the Subject Matter of BR112021022828?

The patent application BR112021022828 pertains to novel pharmaceutical compositions and their use in treating viral infections. The primary focus is on compositions containing molnupiravir, a known antiviral drug. The application describes these compositions for use in treating infections caused by RNA viruses, with a specific emphasis on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19. The invention aims to improve the efficacy and delivery of molnupiravir, potentially through specific formulations or combinations.

The core of the invention lies in the specific chemical structures and formulations that constitute the claimed pharmaceutical compositions. These compositions are designed to inhibit viral replication by acting as a nucleoside analog. The application provides detailed information on the chemical properties and therapeutic applications of these compositions, including dosage regimens and administration routes.

What are the Key Claims in BR112021022828?

The patent application BR112021022828 includes several distinct claims that define the protected subject matter. These claims are structured to cover both the compositions themselves and their therapeutic applications.

The independent claims generally fall into the following categories:

• Claim 1: Pharmaceutical Composition. This claim defines a specific pharmaceutical composition comprising molnupiravir or a prodrug thereof. The claim may specify the form of the composition (e.g., capsule, tablet) and potentially include excipients or other pharmaceutically acceptable ingredients. The stated purpose is for use in treating a viral infection, particularly one caused by an RNA virus.

• Claim 2: Viral Infection Treatment Method. This claim outlines a method of treating a viral infection in a subject. The method involves administering an effective amount of the pharmaceutical composition described in Claim 1 to the subject. The viral infection is specified as being caused by an RNA virus, with SARS-CoV-2 being a primary example.

• Dependent Claims. These claims further refine the scope of the independent claims by adding specific limitations. Examples may include:

  • Specific dosages of molnupiravir.
  • Particular prodrugs of molnupiravir.
  • Specific viral targets beyond SARS-CoV-2.
  • Combinations with other therapeutic agents.
  • Specific administration routes (e.g., oral administration).
  • Particular patient populations or stages of infection.

The precise wording and scope of these claims are critical for determining infringement and patentability. These claims are expected to undergo examination by the Instituto Nacional da Propriedade Industrial (INPI) in Brazil.

What is the Filing and Prosecution Status of BR112021022828?

Brazilian patent application BR112021022828 was filed on October 26, 2021. The filing date establishes the priority date for the invention within Brazil. As of the most recent available data, the application is in the prosecution phase. This means it has been submitted to the INPI for examination.

The prosecution process involves several stages:

• Formal Examination: The INPI verifies that the application meets all formal requirements for filing.
• Substantive Examination: A patent examiner reviews the application to determine if the invention meets the criteria for patentability, including novelty, inventive step (non-obviousness), and industrial applicability. This stage often involves communication between the applicant and the INPI, where objections may be raised and amendments or arguments may be submitted by the applicant.
• Publication: Once formal requirements are met, patent applications are typically published, making the details publicly accessible. This usually occurs 18 months after the earliest priority date.
• Grant or Rejection: Following substantive examination, the INPI will either grant the patent if all criteria are met or reject the application.

The timeline for patent prosecution in Brazil can vary significantly depending on the technological field and the INPI's workload. For pharmaceutical inventions, particularly those related to highly publicized health crises like COVID-19, examination can sometimes be expedited.

Who is the Applicant and What is Their Position in the Market?

The applicant for Brazilian patent application BR112021022828 is Merck & Co., Inc. (known as MSD outside the United States and Canada). Merck & Co. is a global biopharmaceutical company with a significant presence in research, development, manufacturing, and marketing of a wide range of pharmaceutical products.

Merck & Co. is a major player in the pharmaceutical industry, particularly known for its contributions to oncology, vaccines, and infectious diseases. The company's development and commercialization of molnupiravir (marketed as Lagevrio) for the treatment of COVID-19 has been a significant undertaking.

The company's market position is characterized by:

• Extensive R&D Investment: Merck & Co. consistently invests billions of dollars annually in research and development, aiming to discover and bring to market innovative therapies.
• Global Reach: The company operates worldwide, with extensive sales and distribution networks.
• Established Portfolio: Merck & Co. has a broad portfolio of successful drugs and vaccines across various therapeutic areas.
• COVID-19 Therapeutics: In the context of the COVID-19 pandemic, Merck & Co. has been a key contributor with its antiviral therapy, molnupiravir, and its vaccine development efforts.

The filing of this patent application in Brazil reflects Merck & Co.'s strategy to protect its intellectual property related to molnupiravir and its formulations in key global markets.

What is the Competitive Landscape for Antiviral Patents in Brazil?

The competitive landscape for antiviral patents in Brazil, particularly for COVID-19 treatments, is dynamic and crowded. Several companies are actively developing and seeking patent protection for antiviral compounds and therapies. This landscape is shaped by rapid scientific advancement, the urgent global health need, and strategic patenting by pharmaceutical giants.

Key aspects of the competitive landscape include:

• Existing Antiviral Therapies: Patents for established antiviral drugs, even for different indications, can create a complex web of potential overlaps and freedom-to-operate issues.
• New Chemical Entities: Companies are filing patents for novel antiviral compounds with different mechanisms of action. These can represent direct competition or potential alternative treatment options.
• Formulation and Delivery Innovations: As seen with BR112021022828, significant patenting activity focuses on improving existing drugs through new formulations, combination therapies, or novel delivery systems. This strategy aims to extend patent exclusivity and enhance product performance.
• Generic Competition: As patents for older antiviral drugs expire, generic manufacturers seek to enter the market. This influences pricing and market access.
• Government and Public Health Initiatives: In response to the pandemic, governments and international health organizations have supported research and development, potentially leading to a broader range of patent filings and licensing agreements.
• Key Players: Besides Merck & Co., other major pharmaceutical companies, biotechnology firms, and research institutions are active in antiviral drug development. Their patent filings in Brazil are crucial to monitor.

Companies seeking to enter or expand in the Brazilian antiviral market must conduct thorough patent landscape analyses to identify potential infringement risks and opportunities for innovation. This includes monitoring filings by competitors, assessing the scope of existing patents, and understanding emerging technological trends.

What are the Implications of BR112021022828 for R&D and Investment?

The patent application BR112021022828 has several implications for R&D and investment decisions within the pharmaceutical sector, particularly concerning antiviral therapies and COVID-19 treatments.

For Research and Development:

• Freedom to Operate (FTO): Companies developing antiviral agents, especially those targeting RNA viruses or utilizing nucleoside analog mechanisms, must assess if their R&D activities might infringe upon the claims of BR112021022828, should it be granted. This necessitates careful review of the patent's scope.
• Innovation Focus: The claims of this application may guide future R&D efforts. For instance, if the patent is granted with broad claims on molnupiravir formulations, R&D teams might focus on different antiviral mechanisms or unique drug delivery systems to avoid overlap.
• Combination Therapies: The application's potential claims on combination therapies could spur research into synergistic drug combinations that may not fall under the scope of this patent.
• Target Identification: Understanding the specific viral targets and mechanisms protected by this patent can inform the selection of new research targets in antiviral drug discovery.

For Investment:

• Portfolio Analysis: Investors assessing companies involved in antiviral drug development should consider their patent portfolios and any potential encumbrances. The presence of patents like BR112021022828 can impact market exclusivity and profitability.
• Valuation of Companies: The strength and breadth of a company's patent portfolio, including applications like this one, directly contribute to its valuation. Patents grant market exclusivity, which is a critical factor in pharmaceutical investment.
• Licensing and Acquisition Opportunities: A granted patent provides a basis for licensing agreements or potential acquisition targets. Investors may look for opportunities where companies hold key intellectual property in promising therapeutic areas.
• Market Entry Strategy: For new entrants or companies looking to acquire technology, understanding the patent landscape, including applications from major players like Merck & Co., is essential for planning a market entry strategy that minimizes legal risks.
• Risk Assessment: For investors considering funding or acquiring companies in this space, the existence of patent applications and granted patents necessitates a thorough risk assessment related to intellectual property disputes and market exclusivity.

The prosecution status of BR112021022828 means that its ultimate scope and enforceability are not yet definitively established. However, its existence signals Merck & Co.'s strategic intent to protect its innovations in Brazil, influencing the strategic decisions of other stakeholders in the antiviral market.

What is the Status of Molnupiravir Patents Globally?

Merck & Co.'s molnupiravir, known commercially as Lagevrio, is protected by a significant portfolio of patents filed globally. The patenting strategy for such a critical therapeutic agent involves seeking protection in major markets to ensure market exclusivity and recoup R&D investments.

Globally, the patent status of molnupiravir involves:

• Core Compound Patents: Patents covering the molnupiravir molecule itself, its synthesis, and its basic therapeutic uses would have been filed early in its development. These are foundational patents.
• Formulation Patents: As detailed in BR112021022828, subsequent patent filings often focus on specific pharmaceutical compositions, including improved formulations, stable forms, or combinations with other agents. These aim to extend patent life beyond the expiry of the original compound patents.
• Method of Use Patents: Patents can also cover specific methods of treating particular diseases or patient populations with molnupiravir.
• Geographic Coverage: Merck & Co. has pursued patent protection in numerous countries, including major markets in North America (US, Canada), Europe (European Patent Office, national filings), Asia (China, Japan, India), and South America (Brazil).
• Patent Expiry: The lifespan of a patent is typically 20 years from the filing date. However, the exact expiry dates for molnupiravir patents will vary based on the specific patent and its filing date in each jurisdiction. Early compound patents are likely to expire sooner than later formulation or method of use patents.
• Regulatory Exclusivity: In addition to patent protection, regulatory bodies may grant periods of market exclusivity based on the approval of new drugs, which can run concurrently with patent terms.

Monitoring the global patent landscape for molnupiravir is crucial for understanding its long-term market availability and the competitive environment. This includes tracking patent filings, grants, oppositions, and litigation in key territories. The Brazilian application BR112021022828 is a component of this broader global IP strategy.

How Does BR112021022828 Compare to Other Antiviral Patents?

Comparing BR112021022828 to other antiviral patents reveals its specific positioning within the broader therapeutic field. While a detailed claim-by-claim comparison with every other antiviral patent is beyond the scope of this analysis, general comparisons can be made based on the nature of the invention.

• Mechanism of Action: BR112021022828 is centered on molnupiravir, a nucleoside analog that acts by inducing mutations in viral RNA. This mechanism differentiates it from antiviral drugs that target viral proteases (e.g., some HIV or HCV drugs), viral entry inhibitors, or immunomodulatory therapies. Patents protecting these other mechanisms would have fundamentally different chemical structures and claim scopes.
• Therapeutic Target: The primary target identified in BR112021022828 is SARS-CoV-2, making it relevant to COVID-19 treatments. Other antiviral patents might focus on different viruses, such as influenza (e.g., patents for oseltamivir), HIV (e.g., patents for ritonavir, lopinavir), hepatitis C (e.g., patents for sofosbuvir, daclatasvir), or herpesviruses.
• Innovation Type: BR112021022828 appears to focus on pharmaceutical compositions and methods of use related to an existing active pharmaceutical ingredient (API) – molnupiravir. This contrasts with patents claiming entirely new chemical entities (NCEs). NCE patents represent a higher level of novelty, while formulation patents aim to build upon existing therapies, potentially extending their commercial lifecycle and improving their therapeutic profile.
• Market Focus: Given its COVID-19 relevance, BR112021022828 operates in a market that has seen intense patenting activity and significant public health interest. Patents for treatments of chronic viral infections like HIV or HBV might have a more stable, long-term competitive landscape but less immediate public urgency.
• Claim Scope: The scope of BR112021022828's claims will determine its direct competitiveness. If the claims are broad, covering various formulations or extensive therapeutic uses of molnupiravir, they could preempt significant areas of innovation around this drug. Narrower claims would allow more room for competitors to develop alternative or complementary antiviral therapies. For example, patents claiming a specific chemical synthesis route for molnupiravir would be distinct from composition claims.

To conduct a definitive comparison, a deep dive into the specific claims of BR112021022828 and a selection of relevant competing antiviral patents would be necessary. This would involve analyzing their respective claims, priority dates, and geographic coverage to map out areas of potential overlap, conflict, or distinct innovation.

Key Takeaways

• Brazilian patent application BR112021022828, filed by Merck & Co., Inc., targets pharmaceutical compositions containing molnupiravir for treating RNA viral infections, with a focus on SARS-CoV-2.
• The application's claims are expected to cover specific compositions and methods for treating viral infections, subject to INPI examination.
• Merck & Co. is a major global pharmaceutical entity with a significant presence in antiviral therapeutics, including molnupiravir.
• The Brazilian antiviral patent landscape is competitive, featuring innovation in both new chemical entities and improved formulations of existing drugs.
• BR112021022828's implications for R&D and investment revolve around freedom-to-operate assessments, guiding innovation strategies, and influencing portfolio valuations and market entry plans.
• Molnupiravir is protected by a global patent portfolio, with BR112021022828 representing Merck's strategic IP protection in Brazil.
• Comparisons with other antiviral patents highlight BR112021022828's focus on molnupiravir's mechanism, its target (SARS-CoV-2), and its approach of innovating on existing API through composition and method claims.

Frequently Asked Questions

1. When was BR112021022828 filed in Brazil? BR112021022828 was filed in Brazil on October 26, 2021.

2. What is the primary active ingredient claimed in BR112021022828? The primary active ingredient claimed is molnupiravir or a prodrug thereof.

3. What type of viruses does BR112021022828 aim to treat? The application targets infections caused by RNA viruses, with a specific emphasis on SARS-CoV-2.

4. What is the current examination status of BR112021022828 by the INPI? As of the latest available information, the application is in the prosecution phase, undergoing substantive examination.

5. Does the filing of BR112021022828 automatically grant Merck & Co. market exclusivity for molnupiravir in Brazil? No, market exclusivity is granted only upon the patent's grant by the INPI after successful examination, and then it is subject to its term. The filing establishes a priority date.

Citations

[1] Merck & Co., Inc. (2021). Composição Farmacêutica. BR112021022828 A. Instituto Nacional da Propriedade Industrial.