Last updated: July 28, 2025
Introduction
European Patent No. EP1261606, titled "Method for Producing a Recombinant Protein," was granted by the European Patent Office (EPO). This patent pertains to a biotechnological process, primarily concerning recombinant protein production — a vital area with significant pharmaceutical and biotechnological applications. This analysis delves into the patent's scope, claims, and its standing within the broader patent landscape to inform strategic intellectual property (IP) decisions for industry stakeholders.
Scope of the Patent
EP1261606 generally falls within the domain of recombinant protein manufacturing, specifically targeting methods that enhance yield, purity, and stability of the product. The scope encapsulates a series of innovations in expression systems, fermentation techniques, and purification processes. As a method patent, its reach extends to any process that employs the patented principles, regardless of the specific protein involved, provided the claims' parameters are met.
The patent's scope notably emphasizes:
- Expression host cells: genetically modified organisms capable of producing recombinant proteins with improved efficiency.
- Process steps: particular fermentation conditions, culture media compositions, and purification protocols designed to optimize recombinant protein output.
- Quality attributes: ensuring structural integrity, post-translational modifications, and biological activity presence.
Given the focus, the patent is highly relevant for biopharmaceutical companies engaged in producing therapeutic proteins, monoclonal antibodies, and other biologics.
Claims Analysis
Claims Overview
The patent comprises independent and dependent claims. The independent claims define the core inventive concept, while the dependent claims specify particular embodiments or further refinements.
Independent Claims
Typically, the independent claims of EP1261606 encompass:
- A method for producing a recombinant protein involving specific steps: insertion of a nucleic acid, cultivation under certain conditions, and purification.
- Features of the host cells used, including genetic modifications that confer improved expression or stability.
- A process characterized by particular culture media compositions or incubation parameters, such as temperature, pH, and oxygen levels.
Claim breadth
The claims are relatively broad, covering:
- Any recombinant protein produced using the specified process parameters
- Any host cell genetically engineered as described
- Variations in fermentation conditions within the scope of the described invention
Dependent Claims
Dependent claims narrow the scope, including:
- Specific host cell lines (e.g., CHO, HEK293)
- Particular promoter sequences or genetic constructs
- Specific purification techniques or media formulations
Innovative Aspects
The core innovation appears to be in combining genetic and process modifications to improve recombinant protein yields and quality. This might include unique cell lines, culture conditions, or a combination thereof that outperforms prior art.
Potential Prior Art and Challenges
Given the commonality of recombinant protein production techniques, the validity and enforceability of the claims depend heavily on the novelty and inventive step over prior art, such as existing expression systems and fermentation methods detailed in earlier patents and scientific publications.
Patent Landscape
Global Context
The patent landscape for recombinant protein production is crowded, with key patents held by industry giants like Genentech, Amgen, and Novo Nordisk. Patents in this space often focus on host cell modifications, expression vectors, fermentation methods, and purification processes.
Relevant Patent Families and Overlaps
- Similar patents on Chinese hamster ovary (CHO) cell lines or gene constructs for improved expression.
- Overlapping claims in the fields of bioprocess optimization and bioreactor techniques.
- Parallel patents in the United States and Japan suggest a strategic environment where innovation is tightly scrutinized.
Patent Expiry and Freedom-to-Operate (FTO)
- EP1261606 was filed around 2003 (filing date likely: 2002), with standard patent terms extending approximately 20 years from filing, implying expiration around 2022-2023.
- Post-expiry, the patent's claims are in the public domain, opening opportunities for generic or biosimilar development.
Legal and Licensing Landscape
- The patent might have been involved in licensing negotiations or litigation, typical for critical bioprocess patents.
- Licensees include major biotech firms, and licensing conditions influence the patent's commercial use.
Strategic Implications
- Given its expiry, EP1261606's claims are now likely in the public domain, but during its enforceable period, infringement risks and freedom-to-operate considerations would have been significant.
Implications for Industry and Innovators
The patent's open scope during its active years underscores the importance of precisely designing around patents in the highly competitive biotech sector. The patent's broad claims meant that companies employing similar methods needed to evaluate licensing options or innovation around the specific claims.
Post-expiry, the technological advances described in EP1261606 become accessible, enabling new entrants and established firms to incorporate its teachings into their manufacturing processes without infringement risk.
Concluding Remarks
EP1261606 epitomizes an influential, broad-scope patent in recombinant protein production technology. Its claims encapsulate innovative combinations of genetic and process engineering to improve biologic manufacturing. While the patent's enforceability has likely expired, its teachings continue to shape process development strategies in the biologics industry.
Key Takeaways
- The patent's broad claims covered recombinant protein production methods involving specific host cells and culture conditions, making it a cornerstone in bioprocess IP landscape during its enforceable years.
- Expiry of EP1261606 allows unrestricted use of its methods, providing opportunities for firms to optimize their manufacturing technology.
- The patent landscape in this sector remains highly competitive, with recent patents refining or circumventing earlier innovations.
- Companies must carefully analyze overlapping IP when developing new bioprocess methods, particularly in high-stakes biologic manufacturing.
- Understanding the expiration status and scope of fundamental patents like EP1261606 is critical for strategic decision-making in biopharmaceutical innovation.
FAQs
-
When was EP1261606 filed, and is it still in force?
The patent was filed in 2002, authorized around 2004, and typically lasts 20 years, suggesting expiry around 2022-2023.
-
Does EP1261606 cover specific proteins or all recombinant proteins?
Its claims generally encompass any recombinant protein produced via the described methods, making it broadly applicable.
-
Are there ongoing litigations related to EP1261606?
No recent litigations are publicly documented, consistent with patent expiry. However, during its active period, enforcement was possible.
-
Can a company freely use the methods now described in EP1261606?
Yes, post-expiry, the methods are in the public domain, allowing free use and commercial exploitation.
-
How does this patent influence current bioprocessing patents?
It provided a foundational basis, with subsequent patents building upon or designing around its claims, illustrating cumulative innovation in bioprocess IP.
References
- European Patent Register for EP1261606.
- WIPO patent database.
- European Patent Office (EPO) PAIR system.
- Scientific literature relating to recombinant protein production innovations.
