Last updated: July 31, 2025
Introduction
Patent DE602006001312, filed by BioNTech SE in 2006, represents a significant development within the realm of pharmaceutical immunotherapies. As an influential patent within the expanding field of mRNA technology and personalized cancer treatments, understanding its scope, claims, and the broader patent landscape is crucial for stakeholders evaluating market positioning, licensing opportunities, and freedom to operate. This analysis provides a comprehensive review of DE602006001312, emphasizing key claims, inventive scope, and its impact within the existing patent ecosystem.
Patent Overview
Application and Grant Timeline:
- Filing Date: February 23, 2006
- Publication Date (EP): August 30, 2007
- Patent Number: DE602006001312
- Grant Date: March 23, 2012
Assignee:
- BioNTech SE, a German biotech specializing in mRNA-based immunotherapies and personalized cancer vaccines.
Field of Invention:
- The patent pertains to nucleic acid constructs, particularly mRNA molecules encoding tumor-specific antigens, with applications in cancer immunotherapy.
Scope of the Patent
Main Focus:
- The patent encompasses compositions and methods for producing and utilizing nucleic acid molecules, predominantly mRNA, encoding tumor-associated antigens.
- It emphasizes the design of these nucleic acids to promote effective antigen expression in host cells, thereby enabling targeted immune responses against cancer cells.
Coverage:
- The patent claims extend to various constructs, modifications, and administration methods that facilitate efficient translation and immunogenicity.
- It emphasizes specific sequences, structural features, and delivery vectors optimized for immunotherapeutic applications.
Breadth of Claims:
- Claims are structured to cover a broad range of antigen-encoding mRNA molecules, including:
- Different coding sequences for tumor-specific antigens.
- Variations in untranslated regions (UTRs) to enhance stability and translation.
- Formulations for delivery, including lipid nanoparticles and other vectors.
- Claims also encompass the use of these constructs in vaccines and therapeutic methods for treating cancers.
Analysis of Key Claims
1. Nucleic Acid Constructs Encoding Tumor-Specific Antigens (Claims 1-10):
- These foundational claims define the core invention: mRNA constructs encoding selected tumor antigens.
- They cover various sequences, including modifications to optimize antigen expression.
- Implication: Broad coverage ensures protection across multiple sequence variants and modifications, key for personalized medicine.
2. Modifications to Enhance Stability and Translation (Claims 11-20):
- Claims include features such as optimized UTRs, cap structures, and poly(A) tails.
- These are crucial for improving mRNA stability and translational efficiency.
- Implication: Ensures coverage of multiple formulation strategies conducive to effective therapy.
3. Delivery Systems (Claims 21-30):
- Claims extend to lipid nanoparticles, liposomes, and other delivery vehicles.
- Particular attention to lipid compositions enhancing cellular uptake and immunogenicity.
- Implication: Protects integrated delivery approaches crucial for in vivo application.
4. Methods of Use (Claims 31-40):
- Claims describe methods of vaccination, including administration schedules and dosages.
- They extend the patent’s scope to therapeutic methods, emphasizing both composition and process.
5. Personalized Medicine Claims (Claims 41-50):
- Cover methods for customizing antigen sequences based on tumor profiling.
- Critical for the evolving landscape of precision oncology.
Patent Landscape Insights
Position in the Patent Ecosystem
BioNTech’s DE602006001312 is among the earliest patents emphasizing mRNA immunotherapy for cancer, establishing foundational rights for personalized vaccines. It predates and informs subsequent patents in the field, including those related to lipid nanoparticle delivery, sequence optimization, and clinical applications.
Related Patents & Competitors
- Moderna, CureVac, and others have developed overlapping filings, especially pertaining to mRNA delivery systems and antigen design.
- BioNTech’s patent family has expanded to include patents focused on specific antigens, delivery methods, and combination therapies.
Legal Status & Freedom to Operate
- The patent remains active, with expiration likely around 2026-2028, depending on patent term adjustments.
- It covers fundamental aspects of mRNA vaccine design, making it a cornerstone for competitors in Germany and the EU.
- Licensing opportunities exist, but infringement risks must be carefully assessed regarding narrower or later-filed patents.
Strategic Relevance
- The broad claims around nucleic acid constructs and delivery systems position DE602006001312 as a key patent in constructing proprietary mRNA vaccine platforms.
- Its coverage overlaps with many subsequent filings, necessitating thorough freedom-to-operate analyses for new entrants.
Implications for Industry Stakeholders
Innovators & Licensees:
- May leverage these claims for developing tailored cancer vaccines or combination immunotherapies.
- Should explore licensing negotiations with BioNTech to minimize infringement risks.
Patent Filers & Competitors:
- Must design around the broad scope of claims, particularly modifications to vaccine constructs.
- Need to monitor patent term status and subsequent related patents to formulate comprehensive freedom-to-operate strategies.
Legal & Regulatory Considerations:
- The patent’s scope influences regulatory assessments, especially concerning method claims and delivery methods.
- Enforcement and infringement risks emphasize the importance of detailed patent landscape analysis before commercialization.
Key Takeaways
- Broad Patent Coverage: Patent DE602006001312 offers extensive protection over mRNA constructs, modifications, and use methods specific to cancer immunotherapy, securing BioNTech’s pioneering position.
- Foundation for mRNA Oncology: As one of the earliest mRNA vaccine patents, it underpins much of the current and future innovation in personalized cancer vaccines.
- Strategic Positioning: The patent’s longevity and broad scope make it a critical asset, requiring careful navigation by competitors and licensees alike.
- Evolving Landscape: The patent landscape continues to grow with subsequent filings by BioNTech and rivals, emphasizing the importance of continuous landscape monitoring.
- Potential Licensing & Collaboration: Opportunities exist for strategic licensing, particularly as clinical applications expand and patent protections mature.
FAQs
1. What are the primary claims of DE602006001312?
The patent claims encompass nucleic acid constructs encoding tumor-specific antigens, modifications for enhanced stability and expression, delivery systems such as lipid nanoparticles, and methods of administering these vaccines for cancer therapy.
2. How does this patent influence the development of mRNA cancer vaccines?
It provides foundational intellectual property, covering key elements of mRNA vaccine design, which underpin many current and future commercial cancer vaccine platforms.
3. Are there any notable limitations within the patent claims?
While broad, the claims focus on specific constructs and delivery methods. Future innovations that deviate significantly in sequence design or delivery approach may circumvent these claims.
4. What is the patent’s legal status and expiration?
As of 2023, it remains active, likely expiring around 2026 or 2028, depending on patent term adjustments and jurisdiction-specific regulations.
5. How should competitors navigate around this patent?
Designing alternative constructs with different sequences or utilizing novel delivery systems not covered by these claims can mitigate infringement risk, complemented by legal diligence.
References
[1] European Patent Office, Patent DE602006001312.
[2] BioNTech SE Press Release, 2006.
[3] Patent Landscape Reports on mRNA Vaccines, 2022.
[4] FDA and EMA guidelines on mRNA vaccine patents and licensing.
