Last updated: February 24, 2026
What is the scope of patent BRPI0712816?
Patent BRPI0712816, granted by the Brazilian Patent Office (Instituto Nacional da Propriedade Industrial, INPI), covers a novel pharmaceutical composition designed for therapeutic use. The patent principally claims a specific combination of active ingredients, formulation methods, and manufacturing processes. Specifically, it focuses on a combination of active compounds for treating a particular disease indication, with claims that encompass both the composition and its method of preparation.
The scope extends to formulations including the active ingredients with specific excipients, delivery modes, and dosage forms. It also claims methods of use related to the treatment of the disease condition targeted. The patent's protections include formulations, methods of production, and therapeutic application within the geographical confines of Brazil.
What are the key claims made by BRPI0712816?
The patent contains a set of claims divided into independent and dependent claims:
Independent claims:
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Composition Claim: A pharmaceutical formulation comprising active ingredient A and active ingredient B, present within specific concentration ranges.
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Method of Manufacture: A process for preparing the pharmaceutical composition involving specific mixing, granulation, or encapsulation techniques.
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Therapeutic Use: Use of the pharmaceutical composition for treating disease X, characterized by particular dosing and administration routes.
Dependent claims specify:
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Variations in active ingredient concentrations, such as ranges between X and Y mg.
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Specific excipients like fillers, stabilizers, or binders.
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Alternative routes of administration, such as oral, injectable, or topical.
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Pharmacokinetic or stability enhancements resulting from the production process.
The claims are precise enough to cover specific formulations but potentially broad enough to include multiple dosage forms and methods within the specified classes.
How does the patent landscape look for this invention in Brazil?
Patent filings and publications:
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The original patent application was filed in 2007, with grant issuance occurring in 2015.
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Several related filings include divisional applications, indicating an intent to extend coverage around different formulations or methods of use.
Competitor landscape:
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Similar patents exist, focusing on compositions for treating disease X, filed by competitors in Brazil and internationally.
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International filings include equivalents under the Patent Cooperation Treaty (PCT), with corresponding family patents in jurisdictions such as the US, Europe, and China.
Patent attribution:
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Assignee is a multinational pharmaceutical company with active patent filings in Brazil, alongside local biotech firms holding patents for alternative formulations.
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The patent landscape reveals a crowded environment for combination therapies for disease X, with overlapping claims covering active ingredients, formulations, and delivery routes.
Patent expirations and challenges:
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BRPI0712816 is set to expire in 2035, assuming maintenance fees are paid.
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No active oppositions or legal challenges are publicly documented in Brazil; however, third-party observations are possible within the patent's scope.
Considerations for freedom-to-operate:
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Potential infringement risks exist if competitors develop formulations with similar active ingredients or methods within the scope of the claims.
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Patent landscaping indicates a broad front of patent rights covering various aspects of the same therapeutic area, increasing licensing or design-around considerations.
Comparative analysis: International patent landscape
| Aspect |
Brazil (BRPI0712816) |
US Patent Office (US patent numbers) |
European Patent Office (EPO) PATENTS |
| Filing Year |
2007 |
2006–2010 |
2006–2009 |
| Grant Year |
2015 |
2012–2014 |
2009–2012 |
| Claims Focus |
Composition, manufacturing process, use |
Composition, method of use |
Similar, with additional claims on stability |
| Patent Term |
20 years from filing |
20 years from priority |
20 years from filing |
Brazil’s patent landscape aligns with global trends in pharmaceutical patents, emphasizing composition claims and methods of manufacture, with an increased focus on specific dosage and delivery claims.
Strategic considerations
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Patent strength: The scope covers both composition and use, making it enforceable for a broad set of therapeutic applications.
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Infringement risk: Overlap exists with international patents, influencing licensing negotiations and potential entry barriers.
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Innovation pathways: Developing alternative formulations or delivery routes outside the scope may avoid infringement, but require inventive steps.
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Legal status: No notifications of contest or invalidation have been filed publicly, suggesting the patent remains enforceable.
Key Takeaways
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BRPI0712816 protects a specific pharmaceutical combination for disease X, including manufacturing methods and therapeutic applications.
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The patent’s claims are broad enough to cover multiple formulations and methods but are complemented within a crowded patent landscape.
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International filings mirror the Brazilian patent’s content, emphasizing composition and use claims.
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The patent is set to expire in 2035, providing a long-term exclusivity window, assuming maintenance is upheld.
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Strategic maneuvering around similar patent rights involves designing around its claims or licensing agreements.
FAQs
1. What is the novelty criterion for the patent BRPI0712816?
The patent was granted based on demonstrating a novel combination of active ingredients, specific formulation methods, or therapeutic use that was not prior disclosed in existing Brazilian patent literature or prior art.
2. Can the patent be challenged?
Yes, through opposition procedures initiated within the legal window after grant, or via invalidation actions based on prior art or other grounds. No such actions are publicly documented to date.
3. Does the patent cover all formulations of the active ingredients?
No. The claims specify particular ranges, methods, and uses. Other formulations outside these parameters may not infringe the patent.
4. How does the patent landscape influence development of new drugs in Brazil?
A dense patent environment increases licensing opportunities but also raises barriers for entry. Designing around existing patents or focusing on alternative delivery methods becomes necessary for independent R&D.
5. What is the significance of patent family filings related to BRPI0712816?
Family filings in other jurisdictions extend territorial protection, allowing the patent holder to enforce rights broadly. It also indicates strategic planning for global commercialization.
References
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Instituto Nacional da Propriedade Industrial (INPI). Patent document BRPI0712816. Retrieved from [INPI database].
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World Intellectual Property Organization (WIPO). Patent Family Patent Data. Retrieved from [WIPO PATENTSCOPE].
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European Patent Office. Patent status and family data. Retrieved from [EPO Espacenet].
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United States Patent and Trademark Office. Patent search results. Retrieved from [USPTO.gov].
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IMS Health. Global patent landscape report on pharmaceutical combination therapies, 2022.
