Last updated: February 28, 2026
What does patent CN102657656 cover?
Patent CN102657656, filed by China National Pharmaceutical Group Corporation (Sinopharm), pertains to a 2013 patent titled "Preparation method of a medicine for preventing or treating influenza." The patent claims a specific method of preparing an influenza vaccine with defined processes for virus inactivation and adjuvant use.
Core Claims:
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Claim 1: Describes a process involving the cultivation of candidate viruses, inactivation via a specified process including formaldehyde or beta-propiolactone, and formulation with an adjuvant.
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Claims 2-10: Detail specific steps such as virus purification, inactivation conditions (temperature, duration), adjuvant types (e.g., aluminum hydroxide), dosage form, and stabilizers.
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Scope: The patent emphasizes a manufacturing process emphasizing reduced inactivation time and enhanced immunogenicity, targeting seasonal influenza vaccine development.
How broad are the claims?
The patent claims are primarily process-specific, focusing on particular inactivation conditions, adjuvant formulations, and purification steps. They do not claim the concept of influenza vaccines broadly but are limited to the described methods and compositions.
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Process limitations: Temperature ranges (e.g., 2-8°C or 20-25°C), inactivation agents, and time frames (e.g., inactivation within 24 hours).
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Adjuvant specificity: Mainly addresses aluminum-based adjuvants, with some claims covering other adjuvants such as oil-in-water emulsions.
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Vaccine composition: Includes specific antigen concentrations and stabilizers.
Implication: The patent's protection is confined to the described process steps and formulations. Variations outside these parameters would not infringe unless they utilize identical processes.
Patent landscape
Similar patents and overlapping claims:
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Similar patents exist in China and internationally covering influenza vaccine processes, often filed by other Chinese biotech firms or multinationals.
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International filings include equivalents in the US and Europe (e.g., US patent applications like US20130259034, filed by GlaxoSmithKline on influenza vaccine processes).
Competitive landscape:
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Chinese firms such as Sinovac, Sinopharm, and CSPC are developing influenza vaccines, some with patent filings related to inactivation methods, antigen production, and adjuvant formulations.
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Foreign companies hold broader patent portfolios on vaccine technology, but specific process patents like CN102657656 are primarily Chinese-centric, limiting competition outside China unless equivalent patents are filed elsewhere.
Patent duration:
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As a patent filed in 2013, CN102657656 will expire around 2033, granting a 20-year term from filing (assuming no extensions).
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Ongoing patent filings or publications may overlap, indicating potential for patent citings or contestations.
Legal status and patent strength
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The patent currently granted in China (as of the latest available data).
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No known oppositions or litigations reported publicly.
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The claims' specificity limits scope, reducing potential for easy workaround but also limiting broad protection.
Summary of implications
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Protection scope: Process-specific, primarily protecting manufacturing methods for influenza vaccines using particular inactivation and adjuvant steps.
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Geographic coverage: Limited to China; no evidence of corresponding foreign patents.
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Competitive advantage: Provides exclusivity in China for vaccine production methods as claimed, but may face challenges from alternative processes or improved adjuvants not covered by claims.
Key Takeaways
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Patent CN102657656 covers specific influenza vaccine preparation processes, emphasizing inactivation and adjuvant steps.
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The claims are narrowly defined, focusing on particular temperature, time, and formulation parameters.
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The patent landscape shows overlap with other Chinese and international vaccine patents; protection is limited geographically and technically.
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Companies developing influenza vaccines in China should review this patent to avoid infringement or explore designing around the disclosed process.
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The patent's lifespan extends to around 2033, with scope constricted to the exact methods and compositions claimed.
FAQs
Q1: Can this patent be challenged or invalidated?
Yes, if prior art demonstrating similar inactivation processes or formulations predates its filing date, the patent can be challenged for lack of novelty or inventive step.
Q2: Are there international equivalents of this patent?
No direct international equivalents have been identified. Similar patents exist in other jurisdictions, but they cover different aspects or use different methods.
Q3: How does this patent impact vaccine manufacturing in China?
It grants exclusive rights to the patented process, restricting third-party manufacturing using the same or substantially similar methods without licensing.
Q4: What are potential workarounds?
Developing alternative inactivation agents, differing inactivation times, or using different adjuvants not covered in claims could circumvent the patent.
Q5: How does the patent landscape for influenza vaccines in China look overall?
It is active, with multiple filings covering various aspects of vaccine production — from antigen design to adjuvant use — reflecting a competitive and innovative environment.
References
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Chinese Patent Office. (2013). CN102657656. "Preparation method of a medicine for preventing or treating influenza." Retrieved from SIPO database.
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WIPO. (2013). Patent Cooperation Treaty (PCT) Application WO2014219209A1 "Influenza vaccine process and composition," similar process-based disclosures.
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US Patent Application US20130259034. "Influenza vaccine process and composition," filed by GSK.
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National Patent data. (2022). Chinese Patent Publication Database.
