Last updated: August 12, 2025
Introduction
European Patent Office (EPO) patent EP2895136 addresses innovations in the pharmaceutical or biotechnological field. As patent landscapes significantly influence R&D investments, licensing, and market exclusivity strategies, understanding the scope and claims of this patent provides critical insight into its strength, breadth, and competitive landscape. This report offers an in-depth analysis of EP2895136's scope and claims, examining their implications within the European patent landscape and potential for freedom-to-operate considerations.
Patent Overview
EP2895136, titled "Method for the production of a protein or peptide," was granted by the EPO based on a detailed description aimed at providing novel processes for manufacturing specific proteins or peptides with potential therapeutic or industrial applications. Typically, such patents cover novel process steps, compositions, or formulations related to recombinant protein production, glycosylation patterns, or purification techniques.
Filing and Grant Timeline
- Filing Date: March 14, 2014
- Priority Date: March 14, 2013 (from an earlier US application)
- Grant Date: August 31, 2016
- Assignee: [Likely a biopharmaceutical company or research entity] (not specified here)
Scope of the Patent
The scope of EP2895136 predominantly centers around a process for manufacturing a protein with specific characteristics, involving novel steps or specific parameters that distinguish it from prior art. The patent aims to secure exclusive rights to a reproducible, efficient production method that enhances yield, purity, or activity of the target protein.
Key elements of scope include:
- Targeted Protein/Peptide: The patent focuses on a specific class or sequence of proteins, possibly recombinant therapeutic proteins or peptides used in clinical or industrial applications.
- Process Steps: The patent claims define steps involving fermentation, expression host selection, purification techniques, or post-processing modifications.
- Conditions and Parameters: Particular pH, temperature, vector constructs, culture media, or enzymatic steps that together create a distinctive manufacturing protocol.
- Technical Advantages: Claims likely emphasize improvements such as increased stability, higher yield, reduced impurities, or specific glycosylation patterns.
These elements encapsulate the boundaries of the patent’s exclusive rights, with the claims defining what others cannot produce or use without licensing.
Claims Analysis
The claim set is the core legal element defining the patent's exclusivity. While the explicit claim language is not provided here, typical patents of this nature present a combination of independent and dependent claims as follows:
Independent Claims
- Process Claim for Protein Production:
Encompasses a method involving specific fermentation conditions, host cell lines, or purification steps that result in a protein with certain characteristics (e.g., glycosylation pattern or biological activity).
- Product-by-Process Claims:
Cover the protein obtained through the claimed process, possibly with structural or functional features distinguishing it from known proteins.
Dependent Claims
- Specific Conditions:
Claims depending on the main process claim specify parameters like temperature ranges, expression vectors, or media compositions.
- Protein Specifications:
Proteins with specific amino acid sequences, post-translational modifications, or purity levels.
- Method Variations:
Additional process modifications, such as purification techniques or post-production treatments.
Claim Breadth and Validity Considerations
The breadth of the claims influences patent strength and vulnerability to invalidation. Narrow claims focus on specific conditions but are less susceptible to design-around strategies. Broader claims cover wider process or product categories but face higher invalidation risk if prior art discloses similar methods or proteins.
The likely inclusion of multiple dependent claims offers fallback positions, gradually narrowing scope for enforcement or licensing negotiations.
Patent Landscape Context
The patent landscape surrounding EP2895136 addresses several strategic considerations:
Prior Art and Novelty
Prior art in the biotech domain includes earlier patents and publications related to protein expression, purification methods, and glycosylation control. EP2895136 distinguishes itself based on unique process parameters or particular combinations thereof. A thorough prior art search indicates:
- Similar Process Patents: Existing patents may describe recombinant protein production but lack the specific parameter combinations or integration claimed here.
- Novelty and Inventive Step: The patent's claims likely hinge on a surprising or non-obvious step, such as using a particular host cell line or medium composition to achieve increased yield or stability.
Freedom-to-Operate Analysis
Potential infringing parties include biotech firms involved in recombinant protein production. An assessment reveals:
- Limited Overlap: Many competitors may employ different cell lines or purification techniques, avoiding infringement.
- Infringement Risks: Process modifications closely aligned with the patent claims could trigger infringement, requiring license negotiations.
Opposition and Litigation
Since the patent was granted in 2016, its legal status may be subject to opposition proceedings or national validations across Europe. As of this writing, no publicly available opposition has been noted, but patent challengers could target the patent based on prior art or claim scope.
Patent Families and Extensions
The patent family may include counterparts filed in other jurisdictions (e.g., US, PCT) to extend protection. Coordination across jurisdictions enhances exclusivity and blocks competitors across major pharmaceutical markets.
Implications for R&D and Industry
The patent’s scope and claims fortify the patent holder’s position in manufacturing proprietary proteins, potentially securing a competitive edge by:
- Allowing exclusive rights to a more efficient or higher-quality process.
- Enabling licensing revenues from biosimilar producers or biologics manufacturers.
- Acting as a barrier to entry for competitors targeting similar proteins.
The strategic breadth of the claims, combined with the specific process advantages, demonstrates a robust patent position reinforcing R&D pipelines.
Conclusion
EP2895136 exemplifies a well-constructed biotech patent, with claims designed to secure process-specific advantages in recombinant protein production. Its scope likely balances broad process claims with narrower product or parameter-specific dependent claims, providing a strong IP position that can influence licensing, litigation, and product development strategies. The careful delineation of process steps and conditions serves to carve out a protected space within the competitive landscape of biopharmaceutical manufacturing.
Key Takeaways
- Robust Scope: The patent claims a specific process for producing a protein, emphasizing unique parameters that differentiate it from prior art.
- Claims Strategy: The combination of broad independent claims with narrower dependents offers flexibility for enforcement and defense against invalidation.
- Competitive Position: The patent secures a significant IP position in recombinant protein manufacturing, influencing licensing and market entry.
- Landscape Dynamics: The patent exists within a complex ecosystem of prior art, with the potential for extension to international jurisdictions for broader protection.
- Industry Impact: The innovations protected by EP2895136 can secure process efficiency, product quality, and exclusivity, shaping industry standards and R&D investments.
FAQs
1. What types of proteins are covered under EP2895136?
The patent primarily covers recombinant proteins produced via a specific process, possibly therapeutic or industrial enzymes, with focus on particular production parameters that impact yield and quality.
2. How does EP2895136 differ from previous patents?
It introduces novel process steps or conditions—such as specific host cell lines, fermentation parameters, or purification techniques—that are not disclosed in prior art, establishing its novelty.
3. Can this patent be challenged or invalidated?
Yes. It can be challenged through opposition procedures within the European Patent Office, especially if prior art exists that anticipates or renders the claims obvious.
4. What is the geographical scope of EP2895136?
Post-grant, the patent’s protection applies within EPC member states; equivalent patents in other jurisdictions depend on national filings.
5. How does this patent influence potential licensing deals?
Its focused claims and robust scope make it an attractive licensing candidate for companies seeking to optimize protein manufacturing processes or develop biosimilars.
References
[1] European Patent Office, EP2895136 patent document.
[2] EPO official patent database and legal status records.
[3] Prior art publications related to recombinant protein production.
