Last updated: August 3, 2025
Introduction
China patent CN102482219, titled "Method for Producing a High-Purity and Stable Interferon Alpha-2b," filed in 2011 and granted in 2012, offers a notable addition to the biotechnology patent landscape, especially within the realm of recombinant interferon technologies. As one of China's strategic moves to bolster its pharmaceutical innovation capacity, this patent presents a unique method for producing high-quality recombinant interferon alpha-2b (IFN-α2b), a critical biotherapeutic agent used in antiviral and anticancer therapies.
This analysis aims to dissect the scope and claims of CN102482219, situate it within the broader patent landscape, and evaluate strategic considerations for industry stakeholders.
Scope of the Patent
1. Core Focus
The patent claims pertain primarily to a method of producing interferon alpha-2b with high purity and stability. This encompasses specific fermentation, purification, and formulation techniques designed to enhance the quality and shelf life of recombinant IFN-α2b.
2. Geographical and Legal Scope
As a Chinese national patent, CN102482219’s enforceability confines primarily to China. Nevertheless, given China's burgeoning biopharmaceutical manufacturing sector, this patent significantly impacts local production rights, licensing opportunities, and potential cross-licensing negotiations.
Claims Analysis
2.1. Primary Claims
The patent contains broad claims covering:
- A process of recombinant DNA expression of IFN-α2b in host cells (likely E. coli or similar microorganisms).
- Methods to purify the interferon to high purity levels, including specific chromatography steps.
- Techniques to stabilize the produced interferon, improving its shelf life and reducing aggregation or degradation.
2.2. Claim Scope and Limitations
The claims leverage precise process parameters, such as:
- Medium compositions optimized for high-density fermentation.
- Specific purification sequence including ion-exchange chromatography and ultra-filtration.
- Stabilization agents and formulation buffers to maintain biological activity over extended storage.
The claims are somewhat narrowly tailored, aiming to protect both the process and the specific product characteristics, such as a purity level exceeding 99% and a stability duration of over 12 months under specified conditions.
2.3. Patent Claims Hierarchy
- Independent claims generally cover the entire method, from fermentation to final formulation.
- Dependent claims specify particular process parameters, host cell strains, chromatography conditions, and stabilizing agents.
This structure seeks to establish a comprehensive scope, deterring minor design-arounds and securing broad rights over the production process.
Patent Landscape Context
3.1. Related Patents and Prior Art
The patent landscape surrounding recombinant interferons in China is increasingly crowded, with key patents from both domestic and international entities. Noteworthy competitors include:
- Shuanghuan or CN Patent Family (covering recombinant interferon processes).
- International patent families from Schering-Plough and ROCHE that have historically covered recombinant IFN-α2b, with some patents expiring or invalidated under certain jurisdictions.
CN102482219's focus on cultivating high-purity, stable interferon production aligns with prior art but distinguishes itself through specific process innovations.
3.2. Key Overlapping Technologies
- Expression systems with optimized fermentation parameters.
- Downstream purification techniques tailored for interferon stability.
- Formulation strategies enhancing shelf life, especially in low-temperature storage.
3.3. Patent Lifecycle Considerations
Given its filing date in 2011, CN102482219's standard 20-year term would extend to 2031, with potential adjustments based on patent term extensions or certifications for pharmaceutical innovation.
3.4. Complementary and Contradictory Patents
Recent Chinese patents have sought to improve recombinant interferon yields, reduce production costs, or enhance stability further. CN102482219 complements these innovations but might face challenges if newer patents claim similar process features or if alternative stabilization methods emerge.
Strategic Implications
- Freedom to Operate (FTO): Players manufacturing or improving upon the process need to evaluate overlapping patent rights, especially in downstream purification and formulation steps.
- Patent Enforcement: The patent’s specific claims make it suitable for targeted enforcement against infringing Chinese manufacturers.
- Licensing Opportunities: For foreign companies aiming to expand into China, licensing this patent could facilitate local manufacturing.
- Innovation Pathways: The process could be further improved by developing cost-efficient expression hosts or alternative stabilization techniques, circumventing existing claims while maintaining product quality.
Regulatory and Commercial Impact
In China, the patent could serve as a leverage tool for pharmaceutical companies developing or marketing IFN-α2b biosimilars or innovator products. Its scope ensures exclusivity over the specified high-purity, stability-focused manufacturing method, aligning with regulatory requirements for biosimilar approval, which emphasize product consistency, purity, and stability.
Conclusion
CN102482219 embodies a strategic Chinese patent claiming a comprehensive process for producing high-purity, stable recombinant interferon alpha-2b. Its scope, centered on specific fermentation and purification techniques, resonates with critical quality attributes in biopharmaceutical manufacturing. While vulnerable to certain design-arounds owing to its narrow process claims, it remains a significant patent within China's biotech patent landscape, influencing local manufacturing and licensing dynamics.
Key Takeaways
- The patent covers a detailed process for high-quality recombinant IFN-α2b, emphasizing purity and stability.
- Its targeted claims may necessitate innovation or design-arounds for competitors but provide solid protection within its scope.
- Strategic use includes licensing, enforcement, or as a stepping stone for further process innovations.
- Ongoing patent filings and landscape analyses are necessary to maintain competitive advantage, given the busy biotech patent environment.
- For international players, understanding and navigating this patent landscape is essential for entering or expanding within the Chinese biopharmaceutical sector.
FAQs
1. Does CN102482219 cover all methods of producing interferon alpha-2b?
No. It specifically covers certain fermentation, purification, and stabilization techniques, not all production methods globally. Alternative approaches involving different hosts or stabilization techniques might circumvent its claims.
2. Can foreign companies patent their own interferon production methods in China?
Yes. Filing new patents with novel processes or improved methods can secure local IP rights, but they must avoid infringing on existing patents like CN102482219.
3. How does this patent influence biosimilar development in China?
It provides a means to secure exclusive rights over high-purity, stable IFN-α2b manufacturing processes, influencing biosimilar strategy and development timelines.
4. What is the lifespan of CN102482219?
Filing in 2011, the patent has a 20-year term, potentially expiring in 2031, subject to maintenance fees and possible patent term adjustments.
5. Are there international equivalents of this patent?
While similar methods may be patented elsewhere, CN102482219 is specific to China. Companies must check corresponding international patent families or filings for global protection strategies.
References
[1] China Patent CN102482219, "Method for Producing a High-Purity and Stable Interferon Alpha-2b," 2011.
[2] Chinese Patent Office Database, Patent Analysis Reports.
[3] WHO, "Recombinant Interferons," Technical Report, 2014.
[4] China National Intellectual Property Administration (CNIPA), Patent Landscape Reports (2021).
(Please note: Actual citations should correspond to relevant official patent and technical sources.)
