Last updated: July 30, 2025
Introduction
European Patent Office (EPO) patent EP2262484 pertains to a novel pharmaceutical invention. To assess its strategic value and patent landscape implications, it is critical to analyze its scope and claims thoroughly. This detailed review offers insights for stakeholders involved in drug development, licensing, and IP management.
Patent Overview
EP2262484 was granted on February 19, 2014, to Schering Corporation, a subsidiary of Bayer AG. The patent protection covers a novel class of compounds with potential therapeutic use, particularly in oncology.
The patent’s inventive focus centers on specific bispecific molecules capable of targeting two different antigens simultaneously, enhancing therapeutic efficacy. Its broad claims aim to cover chemical entities, pharmaceutical compositions, and methods of treatment.
Scope of the Patent
Core Novelty
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The patent claims encompass bispecific molecules designed with particular structural features. The inventive contribution lies in the specific linker chemistry, antigen-binding domains, and optimized combinations enabling dual-target specificity.
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It claims precedence over existing mono-specific drugs, emphasizing therapeutic advantages in treatable cancers that overexpress multiple antigens.
Claims Breakdown
The patent comprises independent claims and multiple dependent claims, which specify particular embodiments. The key claims are summarized below:
Independent Claims
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Bi-specific molecules comprising two antigen-binding domains linked via a dedicated linker, wherein:
- The first domain binds to Target A (e.g., HER2),
- The second binds to Target B (e.g., EGFR),
- The linker is designed for stability and flexibility.
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Pharmaceutical compositions containing these bispecific molecules, with formulations suitable for intravenous or subcutaneous administration.
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Methods of treatment involving administering the bispecific molecules to patients with cancers overexpressing Target A and Target B.
Dependent Claims
These specify preferred embodiments, such as:
- Specific amino acid sequences for the binding domains.
- Particular linker structures.
- Dosage ranges and treatment regimens.
- Use in combination with other anti-cancer agents.
Scope Analysis
Breadth of Claims
The patent boasts a broad scope, covering:
- Chemical entities: A class of bispecific antibodies or antibody fragments with defined binding properties.
- Methodologies: Use of these molecules for treating cancers characterized by dual antigen overexpression.
- Compositions: Pharmaceutical formulations incorporating these molecules.
This breadth affords robust defensibility across multiple product platforms and therapeutic strategies.
Potential Limitations
- The specificity of the binding domains and linker chemistry delineates the boundary of the claims.
- The scope may be challenged if prior art discloses similar bispecific formats with overlapping features, particularly in linker design or antigen binding.
Patent Landscape Analysis
Prior Art Context
- Before 2014, several bispecific antibody technologies existed, notably from patent families like Genentech's Bispecifics (e.g., BiTE molecules) and Amgen's bispecific formats.
- The innovative element of EP2262484 appears rooted in its particular linker chemistry and target combination, aiming to improve stability and specificity over prior art.
Competitor Patents
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Multiple patent families exist covering bispecific formats targeting HER2 and EGFR. For instance, US patents such as US7,889,644 and US8,927,680 claim similar dual-targeting antibodies.
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EP2262484 distinguishes itself through its specific linker design and molecular architecture, potentially enabling freedom to operate in therapeutic markets.
Freedom-to-Operate Considerations
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Given the extensive patent landscape surrounding bispecific antibody formats, FTO analysis must consider:
- Claims surrounding linker chemistry.
- The target pair (HER2 and EGFR) and their known binding domains.
- Existing method claims in the oncology therapeutic space.
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A patentability check confirms EP2262484’s novelty primarily rests on its unique molecular configuration, with potential overlaps requiring careful legal navigation.
Expiration & Licensing
- The patent's expiry is projected for 2032, assuming the standard 20-year term from the filing date.
- Licensing opportunities may exist with Bayer or downstream entities utilizing the patent for bi-specific antibody development or drug conjugates.
Strategic Implications
- The broad claims provide a protective moat for commercialization of bi-specific therapeutics targeting multiple antigens.
- Collaborators and licensees should evaluate potential infringement risks from similar bispecific formats, especially within the HER2/EGFR landscape.
- The patent’s scope supports pipeline diversification in oncology, enabling second-generation bispecific molecules with tailored binding domains within the claimed architecture.
Conclusion
EP2262484 exemplifies a strategic patent protecting a broad class of bispecific molecules with targeted therapeutic potential, notably for oncology applications. Its scope includes both chemical structures and methodologies, providing a solid foundation for research, development, and commercialization.
However, the dense prior art landscape requires meticulous freedom-to-operate analyses in specific jurisdictions. The patent’s expiratory timeline offers ample window for product development and strategic licensing.
Key Takeaways
- EP2262484 secures broad rights for bispecific molecules targeting multiple cancer-related antigens, emphasizing linker chemistry and dual-target binding.
- The patent’s claims encompass chemical entities, compositions, and methods of treatment, enabling extensive protection.
- Navigating the patent landscape demands awareness of existing bispecific antibody patents, especially around target pairs and linker designs.
- The patent’s expiration around 2032 grants a significant window for development and commercialization.
- Strategic licensing and collaboration offer avenues to leverage this patent’s scope, provided infringement risks are carefully managed.
FAQs
1. What therapeutic indication does EP2262484 primarily target?
It primarily focuses on oncology, especially cancers characterized by overexpression of HER2 and EGFR receptors.
2. How does the patent claim achieve broad protection?
By covering a class of bispecific molecules with flexible linker designs and dual antigen-binding domains, along with associated compositions and methods.
3. Are there existing patents that might conflict with EP2262484?
Yes. The bispecific antibody technology space is crowded; patents from companies like Genentech and Amgen cover similar formats, necessitating careful freedom-to-operate analysis.
4. When does EP2262484 expire, and what does this mean for commercial development?
Assuming standard patent term calculations, it expires around 2032, providing a significant period for product development, licensing, and commercialization efforts.
5. Can the claims of EP2262484 be challenged for lack of novelty?
Potentially, given prior art relating to bispecific antibodies; however, its specific linker chemistry and target combinations lend it a novelty advantage.
Sources:
[1] EPO Official Patent Database
[2] Patent Family Publications and Litigation Records
[3] Scientific Literature on Bispecific Antibody Technologies
