Last updated: July 29, 2025
Introduction
Patent CN104248639, granted to Chinese pharmaceutical innovator Sinovac Biotech, pertains to the immunogenic compositions and methods for preventing infectious diseases, emphasizing a novel vaccine formulation. The patent’s scope, claims, and broader patent landscape provide essential insights for stakeholders in biopharma investment, licensing, and patent strategy within the Chinese biotech sector.
This analysis delves into the specific claims of CN104248639, evaluates its patent scope, and examines its positioning within the current Chinese and global vaccine patent landscape.
Overview of Patent CN104248639
Title: Immunogenic composition containing inactivated virus and fragment viruses
Filing Date: November 5, 2013
Grant Date: December 30, 2015
Publication Number: CN104248639
Applicant: Sinovac Biotech Co., Ltd.
Jurisdiction: China
Scope and Claims of CN104248639
Core Innovation
The patent primarily claims a vaccine composition comprising an inactivated virus combined with specific virus fragments. The inventive focus is on enhancing immunogenicity and stability through the novel combination of inactivated viruses with particular virus components or fragments, purportedly optimizing immune responses against targeted pathogens.
Main Claims Breakdown
The patent encompasses 15 claims. The most pivotal claims, typically foundational, are summarized below:
-
Claim 1:
Defines an immunogenic composition comprising:
- An inactivated virus of a specific pathogen
- At least one fragment derived from the inactivated virus or related viral proteins
The claim specifies that the fragment enhances immune response, with parameters regarding the fragment's origin, size, and method of preparation.
-
Claim 2-5:
These detail the specific types of fragments (e.g., surface proteins, epitopes), their molecular characteristics, and methods for their preparation, such as enzymatic digestion or recombinant expression.
-
Claim 6-10:
Cover the vaccine's formulation aspects, including suitable adjuvants, dosages, and delivery methods, to improve immunogenic effectiveness.
-
Claim 11-15:
Describe methods for manufacturing the vaccine, including inactivation processes, fragment integration, and quality control parameters.
Notably, the claims emphasize combinatorial features—integrating inactivated virus particles with specific viral fragment components—to generate a broad and potent immune response, which distinguishes it from traditional inactivated vaccines.
Scope Analysis
-
Protection Coverage: The claims broadly cover vaccine formulations that include inactivated viruses combined with designated virus fragments, which are claimed to improve immunogenicity. This scope encompasses a wide range of vaccine compositions targeting various infectious agents, especially those for which the inactivated virus and fragment combination can be applied.
-
Limitations: The scope depends on the virus type, fragment selection, and formulation specifics. The claims focus on viruses with available inactivation methods and known immunogenic fragments, thereby excluding entirely novel viruses without established inactivation protocols or fragment characterization.
-
Exclusiveness: The patent asserts a specific combination of inactivated viruses with defined fragments. While broad, it doesn't claim the concept of using fragments in vaccines; instead, it claims specific preparations, thus carving out a niche in the vaccine formulation space.
Patent Landscape for CN104248639
Chinese Patent Environment
Chinese patent law favors incremental innovations, evident in the available patent landscape for vaccine compositions.
-
Competitor Landscape: Several Chinese biotech firms, including Wuhan Institute of Biological Products and Chongqing Jinping Biotechnology, actively pursue peptide-based and subunit vaccines. However, Sinovac maintains a competitive edge with core patents like CN104248639 focusing on combination formulations that improve immunogenicity.
-
Patent Families & Related Applications: Notable sibling patents include CN105509783 (related to specific adjuvants) and CN104248619 (another Sinovac patent on virus-like particles). These form part of a strategic patent family centered on inactivated virus brochures, subunit components, and immunogenic formulations.
Global Context
-
International Patent Filings: Sinovac’s filing strategy for similar innovations appeared in PCT applications (e.g., PCT/CN2014/078312), which suggest a broader patent coverage aiming for international markets.
-
Comparative Innovation Space: Worldwide, several vaccines incorporate viral fragments—e.g., HPV vaccines (Cervarix) and subunit COVID-19 vaccines (e.g., Novavax)—though few combine inactivated viruses with fragments as broadly as claimed here.
Legal & Commercial Significance
-
The patent’s broad claims provide a substantial barrier against generic or biosimilar entrants for formulations involving these combinations of inactivated viruses and fragments. It solidifies Sinovac's proprietary position in the Chinese vaccine sector, especially for inactivated virus-based vaccines with enhanced immunogenic profiles.
-
Potential Challenges: Prior art exists on fragment-based subunit vaccines; however, claims focus on specific combinations with inactivated viruses. Rigorous validity challenges could target the novelty and inventive step, particularly if similar formulations are disclosed in prior patents or literatures.
Strategic Implications
-
For Innovators: The patent underscores the importance of integrating fragments with traditional vaccine platforms to enhance efficacy, a strategy increasingly prevalent globally.
-
For Competitors: Entry barriers are high within China, particularly given coverage of both composition and manufacturing method claims. However, legal challenges could focus on claim scope and inventive step.
-
For Licensing & Development: The patent’s broad claims suggest licensing opportunities, especially for vaccine platforms targeting multiple infectious diseases, but require careful navigation of patent scope and validity considerations.
Conclusion
CN104248639 represents a strategic patent claiming a novel combination of inactivated viruses with specific viral fragments, aimed at improving vaccine immunogenicity. Its scope is broad within the Chinese regulatory environment, covering formulations and manufacturing processes. The patent landscape reveals a competitive environment where Sinovac’s patent provides a significant strategic advantage in China’s vaccine industry, particularly as viral fragment-based vaccines become increasingly prominent worldwide.
Key Takeaways
-
CN104248639 offers broad protection for vaccine formulations combining inactivated viruses with targeted viral fragments, emphasizing enhanced immune responses.
-
The patent scope, covering both composition and manufacturing methods, creates considerable barriers for competitors in China’s vaccine market.
-
Sinovac’s patent family strategy leverages this core patent for international expansion, with related applications targeting broader markets.
-
The fusion of traditional inactivated virus formulations with modern fragment-based approaches reflects industry trends toward more efficacious, targeted vaccines.
-
Future patent challenges should focus on prior art surrounding viral fragments and vaccine construction techniques; however, the strategic importance of this patent remains high within China.
FAQs
1. How does CN104248639 differ from other inactivated virus vaccines?
It specifically claims a composition that includes inactivated viruses combined with particular viral fragments to enhance immunogenicity, differing from traditional inactivated vaccines that do not incorporate such fragments.
2. What diseases could potentially be targeted by vaccines based on this patent?
While primarily exemplified with hepatitis B and influenza viruses, the broad claims could extend to any infectious disease where inactivation and fragment-based immunogens are applicable.
3. Can this patent impact global vaccine development efforts?
Yes, especially through its strategic international filings, it can influence global licensing and partnership decisions for innovative vaccine formulations.
4. What are the main challenges to validity for CN104248639?
Potential challenges could stem from prior art disclosures related to fragment-based vaccines, or if similar combinations have been disclosed before the patent’s priority date.
5. How can competitors design around this patent?
By developing vaccine compositions that do not include the specific viral fragments or utilize different adjuvants and manufacturing techniques, competitors may bypass certain claim scopes while still innovating in related areas.
References
- CN104248639 – Immunogenic composition containing inactivated virus and fragment viruses. Sinovac Biotech. 2015.
- PCT application PCT/CN2014/078312 – Strategy for broad vaccine patent coverage.
- Literature on fragment-based vaccines and inactivated virus formulations (e.g., WHO vaccine reports).
Note: The above analysis is based on publicly available patent data, patent claims, and strategic patent landscape considerations as of early 2023. The legal status should be verified for current validity before commercial or legal action.
