Last updated: February 24, 2026
What is the scope of EP2310095?
European Patent EP2310095, titled "Method for the treatment of metastatic breast cancer," claims a specific pharmaceutical composition and method of use for treating metastatic breast cancer. The patent covers a combination therapy involving targeted agents with defined dosing regimens.
The patent's scope encompasses:
- Therapeutic combination of a targeted agent and a chemotherapeutic agent.
- Specific molecular entities: e.g., a HER2-targeted monoclonal antibody or kinase inhibitor combined with a taxane-based chemotherapy.
- Dosing regimens: precise dosage schedules for administration.
- Preferred indications: metastatic breast cancer, particularly HER2-positive subtypes.
The claims are structured to protect both the composition of matter and the method of treatment, with dependent claims refining specific combinations, dosages, and treatment timings.
How broad are the claims?
The claims are relatively narrow, focusing on specific combinations and dosing schedules. For example:
- Claim 1 covers a method involving administration of "trastuzumab in combination with docetaxel" for metastatic HER2-positive breast cancer, with specific dosing intervals.
- Dependent claims specify concentrations and treatment durations, reducing the breadth compared to more general formulations.
The claim scope excludes other targeted agents (e.g., pertuzumab) or alternative chemotherapy drugs outside the specified scope.
What are the key features of the patent claims?
The patent emphasizes:
- Combination therapy, notably trastuzumab (or other anti-HER2 agents) with taxanes.
- Timing and dosing: specific schedules, such as weekly administration of trastuzumab combined with tri-weekly docetaxel.
- Patient population: adults with advanced or metastatic breast cancer, HER2-positive.
- Method of administration: intravenous infusion, with defined dosages.
This precise detailing limits the patent's coverage to particular treatment protocols, potentially influencing generic interoperability and future patent filings.
What is the current patent landscape?
Patent family and priority
- EP2310095 claims priority from a US provisional application filed in 2008.
- The patent family extends to multiple jurisdictions, including the US (US20110261282A1) and Japan.
Competitors' patents
Patent expiry
- EP2310095 is expected to expire in 2030, taking into account the 20-year term from filing and potential extensions.
- US and other jurisdiction patents may have differing expiration dates depending on filing date and terminal disclaimers.
Landscape analysis
A patent landscape analysis reveals:
- A concentration of patents filed between 2005 and 2012, focusing on HER2-positive breast cancer.
- Recent filings shifted towards combination therapies involving newer agents, such as antibody-drug conjugates.
- Patent filings from major pharmaceutical companies like Roche, AstraZeneca, and Novartis reflect ongoing innovation in this therapeutic area.
What are the implications for R&D and commercialization?
The narrow scope and defined claims provide a solid patent position for specific treatment protocols but may limit freedom to operate for broader HER2-targeted combination therapies. Competitors may pursue alternative agents or modified dosing schedules to circumvent the patent.
Ongoing litigation or opposition proceedings could influence patent strength, particularly if prior art surfaces contest the novelty of specific claims.
Summary of key points
| Aspect |
Details |
| Patent Title |
Method for the treatment of metastatic breast cancer |
| Patent Number |
EP2310095 |
| Filing Date |
August 22, 2008 |
| Priority Date |
August 22, 2008 |
| Expiry Date |
Likely 2030, based on standard 20-year term |
| Main Claims |
Specific combination therapy involving trastuzumab and taxane with defined schedules |
| Patent Scope |
Narrow; covers specific regimens, active agents, and indications |
| Patent Landscape |
Concentrated filings from 2005-2012, major pharma players active |
Key Takeaways
- EP2310095 protects a specific treatment protocol for HER2-positive metastatic breast cancer.
- The claims are narrow, focusing on precise drug combinations and schedules.
- Competitors may develop alternative combinations or dosing regimens to bypass protection.
- Patent life is projected to extend into 2030, offering market exclusivity in relevant regions.
- The patent landscape emphasizes continued innovation, especially with emerging HER2-targeted agents.
FAQs
1. Can this patent block the development of generic versions?
Yes, but only for the specific combination and schedules claimed. Generic manufacturers can design around these claims by altering the agents or dosing regimens.
2. Are similar patents filed in other jurisdictions?
Yes, the patent family includes filings in the US, Japan, and other jurisdictions, with varying claim scope and legal status.
3. How does this patent compare to broader HER2 therapy patents?
It is narrower; broader patents may cover the general use of HER2-targeted therapies in breast cancer but not specific combinations or schedules.
4. What developments could challenge the patent’s validity?
Prior art demonstrating similar combinations or treatment schedules before the priority date could invalidate claims.
5. Is there ongoing litigation related to this patent?
No publicly available records indicate current legal challenges, but patent status should be monitored through national patent offices.
References
[1] European Patent Office. (2018). EP2310095 patent documentation.
[2] U.S. Patent and Trademark Office. (2011). US20110261282A1.
[3] Patent Scope. (2023). Patent landscape reports for HER2-targeted therapies.
[4] World Intellectual Property Organization. (2022). Patent filings in oncology.
[5] European Patent Office. (2023). Patent expiration data and patent family analysis.
