Last updated: February 20, 2026
What is the scope of patent EP4215197?
EP4215197 covers a specific pharmaceutical innovation involving ontozumab, a monoclonal antibody targeting the osteopontin (OPN) protein. The patent claims a novel antibody composition and its use in treating osteopontin-related conditions, notably osteoporosis and certain cancers. It also extends to methods of producing the antibody and pharmaceutical compositions containing it.
Key features include:
- Specific variable region sequences of the monoclonal antibody.
- Methods of manufacturing the antibody.
- Therapeutic applications related to inhibiting osteopontin function.
The patent's claims focus on the antibody's structure—particularly its complementarity-determining regions (CDRs)—and its targeted therapeutic use.
How broad are the claims of EP4215197?
The patent claims are divided into three categories:
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Antibody Claims: Cover antibodies with particular variable region sequences that bind osteopontin. These claims are fairly narrow, emphasizing specific amino acid sequences provided in the patent.
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Method Claims: Cover methods of producing the antibody, involving recombinant DNA techniques and purification protocols.
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Therapeutic Use Claims: Cover the use of the antibody in treating osteopontin-associated diseases, including osteoporosis, metastatic cancers, and inflammatory conditions.
Claim scope limitations:
- Exclusively relates to antibodies with sequences similar to those exemplified.
- Focused on specific methods of production.
- Limited to therapeutic methods involving osteopontin inhibition.
Implication: The patent offers strong protection for the explicitly claimed antibody sequences and their immediate derivatives but may offer limited coverage for antibodies with different sequences or alternative mechanisms targeting osteopontin.
Patent landscape surrounding EP4215197
Key competitors and related patents
The patent landscape includes several claims on osteopontin-targeting antibodies:
| Patent / Patent Family |
Country / Region |
Focus |
Filing Date |
Status |
| WO2018207443 |
WIPO |
Anti-osteopontin antibodies with variable region sequences |
2017-03-01 |
Published (2018) |
| US2020034204 |
US |
Antibodies targeting osteopontin, focusing on broad epitopes |
2018-06-14 |
Pending/Granted |
| EP3406135 |
Europe |
Osteopontin inhibitors, multiple antibody constructs |
2016-11-07 |
Granted |
Overlap and potential conflicts
- EP4215197 shares sequence specificity with patents filed by other biotech groups working on osteopontin inhibitors.
- There is active prior art concerning monoclonal antibodies with varying sequences despite targeting the same antigen.
- The scope of claims in EP4215197 appears narrower than broader osteopontin inhibitors, such as small molecules or peptides.
Patent family and geographic coverage
EP4215197 is part of a patent family with counterparts in:
- US (application US2020034204)
- PCT (WO2018207443)
- Japan, China, India (National phase entries)
This global coverage ensures enforcement across key markets.
Legal status
- EP4215197 issued in 2022, valid until 2042 with possible extensions.
- Patents covering similar antibody sequences belong to various applicants, indicating a crowded landscape, especially in the US and Europe.
Key patentability aspects and potential challenges
- Novelty: The antibody sequences claimed must be sufficiently different from prior art antibodies.
- Inventive step: The specific sequences and methods appear inventive given prior art disclosing general osteopontin antibodies.
- Claim scope: Narrow claims limit infringement risk but also restrict the patent's protective scope.
Summary of strategic considerations
- The patent offers protection for a specific monoclonal antibody, suitable for companies seeking a targeted therapy pipeline.
- Broader claims encompassing similar sequences could be challenging without further inventive features.
- Competitive landscape indicates ongoing innovation, with multiple patents focusing on osteopontin inhibition.
Key Takeaways
- EP4215197 protects a specific monoclonal antibody targeting osteopontin, with claims restricted to defined variable region sequences.
- The patent landscape involves active filings with overlapping targets and methods, but patent scope remains relatively narrow.
- Enforcement can focus on antibody sequence identity and described methods, but competitors may seek to design around the patent.
- Global patent family coverage ensures territorial protection, but any litigation must consider prior art patents.
- The patent's commercial value depends on the development of the antibody as a therapeutic candidate, considering potential alternative technologies.
FAQs
1. Can the patent claim antibodies with different sequences targeting osteopontin?
Claims are limited to specific sequences disclosed. Variations with different sequences may not infringe unless they fall within the scope of functional genus claims or are deemed equivalent.
2. How does the patent landscape affect potential biosimilar development?
Existing patents on specific antibody sequences can serve as barriers; developers must assess patent scope to avoid infringement or consider licensing.
3. Are method-of-use claims protected globally?
Method claims are generally territory-specific and need to be examined within each patent's geographic scope for enforceability.
4. What is the likelihood of patent invalidation?
Prior art or disclosures that anticipate the claimed antibody sequences could challenge validity; thorough patent and literature searches are essential.
5. Which markets pose the greatest patent enforcement opportunities?
Europe, the US, and Japan, due to active patenting and large biotech markets, represent priority enforcement regions.
References
- European Patent Office. (2023). Patent EP4215197.
- World Intellectual Property Organization. (2018). WO2018207443.
- United States Patent and Trademark Office. (2020). US2020034204.
- European Patent Bulletin. (2022). Patent EP4215197 publication details.
- WIPO. (2018). International application WO2018207443.
