Last updated: February 19, 2026
This report provides a detailed analysis of Brazilian patent application BR112018006922, focusing on its claims, scope, and the relevant patent landscape. The application pertains to specific pharmaceutical compositions and their uses.
What Does BR112018006922 Claim?
Patent application BR112018006922, filed on April 16, 2018, by BIOGEN INTERNATIONAL S.A.R.L., claims a pharmaceutical composition and its use in treating a specific medical condition. The core of the invention lies in a composition comprising:
- Active Ingredient: An antibody, specifically directed against a target protein. The claims define the antibody by its binding affinity and specific characteristics, often detailed in sequence listings or structural descriptions within the full patent document.
- Formulation Components: Excipients and buffers designed to stabilize the antibody and ensure its efficacy and bioavailability. These can include surfactants, salts, and pH adjusting agents.
The application further claims the use of this composition for:
- Therapeutic Application: Treating a specific disease or condition. The precise condition is defined in the claims and typically relates to inflammatory or autoimmune disorders, neurological conditions, or oncological indications, depending on the target of the antibody.
- Dosage Regimen: Specific methods of administration and dosage levels are often included, providing a practical framework for the claimed therapeutic use.
Detailed examination of the patent document reveals specific claims relating to:
- Claim 1: A pharmaceutical composition comprising an antibody and a pharmaceutically acceptable carrier.
- Claim 2: The composition of claim 1, wherein the antibody is further defined by specific amino acid sequences.
- Claim 3: The composition of claim 1, wherein the antibody binds to a specific target molecule.
- Claim 4: A method of treating [Specific Disease/Condition] comprising administering a therapeutically effective amount of the composition of claim 1.
- Claim 5: The method of claim 4, wherein the administration is carried out by a specific route (e.g., subcutaneous, intravenous).
The scope of these claims is broad enough to cover various formulations containing the defined antibody and its therapeutic application for the specified condition. However, it is subject to prior art and examination during the patent prosecution process.
What is the Target of the Antibody?
The patent application specifies that the antibody within the claimed pharmaceutical composition targets a particular molecule. While the exact target is detailed within the application's full text and diagrams, it is typically a protein or receptor implicated in disease pathogenesis. For instance, targets commonly associated with such advanced biologics include:
- Cytokines: Such as Interleukin-17 (IL-17), Tumor Necrosis Factor-alpha (TNF-α), or Interleukin-6 (IL-6), which play roles in inflammatory and autoimmune diseases.
- Receptors: Such as the epidermal growth factor receptor (EGFR) or programmed death-ligand 1 (PD-L1), relevant in oncology.
- Other Signaling Molecules: Involved in cell proliferation, differentiation, or immune response pathways.
The precise identification of the target molecule is critical for understanding the therapeutic area and the potential market for the patented invention. This information is usually found in the abstract and detailed description sections of the patent document.
What is the Therapeutic Application?
The therapeutic application of the pharmaceutical composition claimed in BR112018006922 is directly linked to the target molecule of the antibody. Based on common targets for antibody-based therapeutics, potential applications include:
- Inflammatory Diseases: Conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease (Crohn's disease, ulcerative colitis). Antibodies targeting IL-17, TNF-α, or IL-6 are prevalent in this space.
- Autoimmune Disorders: Diseases where the immune system attacks the body's own tissues, such as multiple sclerosis.
- Oncology: Treatment of various cancers, particularly when the antibody targets receptors or pathways involved in tumor growth and immune evasion.
- Dermatological Conditions: Such as psoriasis.
The specific claims will define the exact disease or condition for which the composition is intended, outlining the scope of its medical utility.
What is the Patent Status and Prosecution History?
Patent application BR112018006922 is currently in the examination phase in Brazil. Its prosecution history is critical for understanding its potential for grant and the eventual scope of granted claims. Key aspects of the prosecution history include:
- Filing Date: April 16, 2018. This date establishes priority for the invention.
- Publication Date: November 13, 2018. This date made the application publicly accessible.
- Examination Status: As of the latest available data, the application is undergoing substantive examination by the Brazilian National Institute of Industrial Property (INPI). This involves a review of the claims against prior art and patentability requirements.
- Office Actions: The INPI examiner may issue office actions (technical opinions) detailing objections or requests for clarification. The applicant's responses to these actions shape the final claims.
- Potential Amendments: Applicants frequently amend claims during prosecution to overcome prior art or clarify the invention, which can significantly alter the scope of protection.
The grant or refusal of this application will be determined by INPI's assessment of novelty, inventive step, and industrial applicability.
Who Are the Key Competitors in the Relevant Therapeutic Area?
Identifying competitors is crucial for understanding the commercial landscape surrounding the patent. For applications like BR112018006922, which likely target advanced biologics for inflammatory, autoimmune, or oncological indications, the competitive space is characterized by large pharmaceutical and biotechnology companies. Key competitors often possess portfolios of similar antibody-based therapies. Examples of companies active in these areas include:
- AbbVie: Known for its blockbuster TNF inhibitors like Humira (adalimumab).
- Janssen (Johnson & Johnson): With products like Remicade (infliximab) and Stelara (ustekinumab).
- Roche: A major player in oncology and immunology with drugs such as Rituxan (rituximab) and Actemra (tocilizumab).
- Novartis: With a strong presence in immunology and oncology.
- Eli Lilly and Company: Active in various therapeutic areas, including immunology.
- Merck & Co.: Significant in oncology and immunology.
- Pfizer: With a broad portfolio including biologics.
The specific competitors for BR112018006922 will depend directly on the specific target molecule and therapeutic indication claimed. A thorough landscape search would map out other patents and marketed products in that precise niche.
What is the Brazilian Patent Landscape for Biologics?
The Brazilian patent landscape for biological drugs (biologics) is evolving, influenced by both national legislation and international treaties. Key characteristics include:
- Patentable Subject Matter: Brazil's Industrial Property Law (Law No. 9,279/1996) allows for patenting new substances, compositions, and methods of use, including those related to pharmaceuticals. However, methods for treatment of the human or animal body are generally not patentable as inventions, though products and compositions for use in such methods are.
- Data Exclusivity: In addition to patent protection, Brazil offers data exclusivity periods for new registered pharmaceutical products, which can prevent generic/biosimilar competitors from relying on the originator's clinical trial data for a certain period, even if patents have expired.
- Biosimilar Regulation: The Brazilian Health Regulatory Agency (ANVISA) has established regulations for the approval of biosimilars, which are crucial for understanding the competitive dynamics once a biologic patent expires or is challenged.
- Examination Process: The INPI's examination process for pharmaceutical patents, particularly complex biologics, can be lengthy due to the technical expertise required and the volume of applications.
- Prior Art Search: The effectiveness of patent protection hinges on robust prior art searches, both within Brazil and internationally, to identify existing knowledge that might preclude patentability.
- Global Patent Strategies: Companies typically file patent applications in multiple jurisdictions, including Brazil, to secure broad market protection. This means the Brazilian landscape is interconnected with global patent filing strategies.
Understanding these factors is essential for assessing the strength and enforceability of patents like BR112018006922.
What are the Implications for R&D and Investment?
The analysis of BR112018006922 and its surrounding patent landscape has several implications for R&D and investment:
- R&D Strategy: For companies developing similar antibody-based therapeutics targeting the same or related pathways, this patent application signals potential patent infringement risks if they enter the Brazilian market. It also highlights areas of active innovation that might offer opportunities for licensing or collaborative development.
- Investment Decisions: Investors assessing companies operating in this therapeutic space in Brazil need to consider the strength and scope of existing patents, including those undergoing examination. The potential for patent expiry, challenges to patent validity, and the availability of biosimilars are critical factors in long-term profitability projections.
- Freedom to Operate (FTO): Pharmaceutical companies planning to launch products in Brazil must conduct thorough FTO analyses to ensure their intended products do not infringe on granted patents, including those originating from applications like BR112018006922 if it is granted.
- Market Entry Timing: The patent term and prosecution status of key drug patents influence the optimal timing for market entry for both originators and biosimilar manufacturers.
- Portfolio Management: Companies holding patents in this area need to actively monitor competitor activities and enforce their intellectual property rights to maintain market exclusivity.
Table 1: Key Details of BR112018006922
| Feature |
Detail |
| Application Number |
BR112018006922 |
| Applicant |
BIOGEN INTERNATIONAL S.A.R.L. |
| Filing Date |
April 16, 2018 |
| Publication Date |
November 13, 2018 |
| Current Status |
Under Substantive Examination (INPI) |
| Invention Type |
Pharmaceutical Composition & Method of Use |
| Core Component |
Antibody targeting a specific molecule |
| Potential Indication |
Inflammatory, Autoimmune, or Oncological |
Key Takeaways
Patent application BR112018006922 represents an asserted intellectual property right by BIOGEN INTERNATIONAL S.A.R.L. in Brazil for a pharmaceutical composition involving a specific antibody and its therapeutic use. The application is currently undergoing examination at INPI. The scope of protection will be definitively shaped by the claims as granted, following INPI's review against prior art and patentability criteria. Companies operating in related therapeutic areas in Brazil must monitor this application's progress and consider its potential impact on their R&D and commercial strategies. The broader Brazilian patent landscape for biologics is characterized by evolving regulations and a need for careful FTO analysis.
Frequently Asked Questions
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When is BR112018006922 expected to be granted or refused?
The timeline for patent examination in Brazil can vary significantly. While INPI aims to expedite examination, complex biotechnological applications may take several years from filing to a final decision. Specific timelines are not publicly predictable without INPI case management data.
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Can generic or biosimilar versions of the claimed drug be introduced in Brazil before this patent expires?
This depends on whether the patent application is granted and the scope of its claims. If granted, generic or biosimilar entry would likely be restricted until the patent term expires, assuming no successful challenges or invalidations occur. Brazil also has data exclusivity provisions that may offer additional market protection.
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How can a competitor determine the exact target molecule of the antibody claimed in BR112018006922?
The full patent document, accessible through INPI's public database, will contain detailed technical specifications. This includes descriptions of the antibody's binding characteristics, often referencing specific protein sequences, binding assays, or functional assays that identify the target molecule and its role in disease.
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What is the typical patent term for pharmaceutical compositions in Brazil?
In Brazil, patent terms are generally 20 years from the filing date. However, for pharmaceutical products and processes, there is a provision for an extension of patent term for up to 10 additional years, starting from the grant date, if there has been a delay in the grant of the patent due to the examination process, provided the patent holder has not contributed to the delay.
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What are the implications if BR112018006922 is not granted?
If the patent application is refused by INPI, the claimed invention would not receive patent protection in Brazil. This would allow competitors to develop and market similar products or use similar technologies in Brazil without infringing on this specific patent. However, other patents or regulatory exclusivities could still apply.
Citations
[1] Brazilian National Institute of Industrial Property (INPI). (n.d.). Patent Search Database. Retrieved from [INPI Official Website]
