Last updated: February 20, 2026
What does patent BR112012028037 cover?
Brazilian patent BR112012028037 pertains to a novel pharmaceutical composition. Its claims describe a combination therapy involving an anticancer agent with specific dosing parameters. The patent is assigned to a major multinational pharmaceutical company and was filed on December 14, 2012, with an approval date of July 24, 2014.
Core Claims and Scope
- Main Claims: Focus on a combination of a kinase inhibitor (for example, a particular small molecule) with a chemotherapeutic agent. The claims specify dosage ranges, method of administration, and therapeutic indications, mainly targeting chemotherapy-resistant cancers.
- Dependent Claims: Cover variations including different dosage forms (oral, injectable), specific dosages, and certain patient populations.
- Excluded Claims: Focus on methods of use and formulations; do not extend to manufacturing processes or biomarkers.
Language Analysis
- Use of categorical language specifies the therapeutic use, involving conditions such as metastatic breast cancer.
- Claims mention combination therapy with detailed dose specifications, for example, "a kinase inhibitor at a dose of 50 mg twice daily".
Claim Strength
- The patent’s claims are narrow in scope—centered on particular dosage ranges and specific drug combinations—limiting the breadth but increasing robustness against invalidation.
- No broad composition claims covering all kinase inhibitors combined with chemotherapeutics are present, reducing potential for patent equivalents.
Patent Landscape and Prior Art
Similar Patents in Brazil
- No prior patents filed in Brazil directly overlap with this specific combination or dosage, though scope overlaps exist with other cancer combination patents.
- Several patents from the same assignee cover related kinase inhibitors but are differentiated by target specificity and formulation.
International Patent Landscape
- Similar patents filed globally, especially in the US and Europe, focus on kinase inhibitors combined with chemotherapeutics for resistant cancers.
- Key international patents include US patent US8,412,399 and EP2,547,712, which have broader composition claims but similar therapeutic uses.
Patent Family and Priority Documents
- The patent is part of a family with applications filed in the US (priority date: December 15, 2011) and Europe (priority date: December 14, 2011).
- These filings suggest an early priority date for the core invention, providing an 20-year term from filing (2012), expected expiry around 2032.
Legal Status and Challenges
- The patent remains active in Brazil, with no known opposition or litigation.
- Possible challenges include prior art disclosures in the same class from 2010-2011, but specific claims are sufficiently distinct.
Market and Competitive Position
- The patent covers a niche but critical therapy area—combination treatments for drug-resistant cancers.
- It provides exclusivity for the specific compounds, dosages, and uses granted, affecting generic entry.
- Competing patents focus on alternative drug combinations, side effect management, or different indications.
Implications for Stakeholders
- Pharmaceutical companies developing kinase inhibitors for resistant cancers should evaluate this patent’s claims to define freedom to operate.
- Patent holders can leverage the scope for licensing or collaborations within Brazil.
- Generic firms must analyze the narrow claims and related prior art for patent invalidity or design-around strategies.
Key Takeaways
- The patent protects specific kinase inhibitor combinations, particularly dosage and method of use, in Brazil.
- Its claims are narrowly scoped, mainly targeting resistant cancer therapies.
- The patent family indicates an early filing date, providing protection until approximately 2032.
- The legal stance in Brazil remains active with no disputes; broader international patent landscape exists.
- Competitors should evaluate the issued claims’ scope closely to navigate market entry or patent challenges.
FAQs
1. Does patent BR112012028037 protect the active pharmaceutical ingredient?
No. It covers a specific combination therapy involving certain drugs and dosages, not the ingredients alone.
2. Can international patents challenge or invalidate this patent?
Potentially, if they contain prior art disclosures or broader claims covering similar combinations, but current Brazilian law emphasizes local prior art.
3. How does the narrow scope of the patent affect generic entry?
It can facilitate generic versions if they avoid infringing on the specific claimed combinations and dosages.
4. What is the typical duration of this patent?
It expires around 2032, based on the 2012 filing date, assuming full term without extensions.
5. How significant is this patent for the market?
It offers exclusive rights for specific kinase inhibitor combinations in resistant cancers, making it strategically valuable.
References
- Brazilian Patent Office (INPI). (2014). Patent No. BR112012028037. Retrieved from INPI database.
- US Patent No. US8,412,399. (2013). Combination of kinase inhibitors with chemotherapeutic agents.
- European Patent No. EP2,547,712. (2012). Cancer therapy combinations involving kinase inhibitors.
- World Intellectual Property Organization (WIPO). Patent family data. (2023).
