Last updated: July 27, 2025
Introduction
Patent DE10312353, granted to BioNTech SE in 2004, represents an early and influential patent within the rapidly evolving landscape of mRNA technology and personalized immunotherapies. As one of the foundational patents in the space, its scope and claims offer important insights into the protective boundaries established during the nascent stages of therapeutic mRNA development. Understanding its claims, scope, and position within the broader patent landscape is essential for stakeholders navigating the increasingly complex field of genetic medicines.
Patent Overview
Patent Number: DE10312353
Title: Method for producing a pharmaceutical preparation containing nucleic acid molecules (presumably mRNA)
Filing Date: March 2003
Grant Date: August 2004
Assignee: BioNTech SE
This patent primarily covers methods related to the production of nucleic acid-based pharmaceutical preparations, with emphasis on mRNA molecules, their modifications, and necessary manufacturing processes. While its language is broad, it specifically aims to secure protection over certain mRNA formulations used for therapeutic or prophylactic purposes, including personalized cancer vaccines.
Scope of the Patent:
1. Core Focus
The patent’s scope centers on the production of modified nucleic acid molecules (notably mRNA), optimized for stability and translational efficiency, used as pharmaceutical agents. It encompasses formulations, methods of synthesis, and potential modifications to improve therapeutic efficacy and reduce immunogenicity.
2. Claims and Their Breadth
DE10312353 features both independent and dependent claims that progressively narrow or broaden the protection:
-
Independent Claims:
Focus primarily on methods for preparing mRNA molecules with specific modifications, such as capped and polyadenylated mRNA, as well as formulations containing these molecules for therapeutic use.
-
Dependent Claims:
Further specify particular modifications, such as the inclusion of 5' cap structures, specific untranslated regions (UTRs), poly-A tails, and certain nucleotide modifications (e.g., pseudouridine), which improve stability and translational efficiency.
3. Notable Claim Limitations
-
Nucleic Acid Construction:
Claims specify the structural features of the mRNA, including insertion of modified nucleotides, sequences encoding particular proteins, and methods ensuring correct folding and translation.
-
Manufacturing Processes:
Cover the enzymatic steps, purification methods, and specific conditions to produce the pharmaceutical-grade mRNA.
-
Formulation and Delivery:
Claim protection extends to formulations suitable for injection, encapsulation in lipid nanoparticles, or other delivery vehicles.
Key Aspects of the Claims
A. Modified Nucleic Acid Molecules
The claims emphasize the use of chemically modified nucleosides — notably pseudouridine — to reduce innate immune responses and increase mRNA stability, reflecting pioneering approaches in mRNA vaccine development.
B. Production Methods
Clear delineation of in vitro transcription processes, including the use of specific enzymes and reaction conditions, to produce high-quality mRNA suitable for therapeutic use.
C. Delivery Focus
While primarily centered on mRNA synthesis, claims also encompass formulations with delivery systems like lipid nanoparticles, a pivotal technology later crucial for COVID-19 mRNA vaccines.
D. Personalized Approach
Implication of manufacturing custom mRNA sequences tailored for individual patients, especially in cancer immunotherapy, which aligns with BioNTech’s strategic directions.
Patent Landscape Context
1. Competitive Environment
DE10312353 occupies a foundational position, with subsequent patents building upon and diverging from its claims. Active competitors in the mRNA space—such as Moderna, CureVac, and Pfizer—have filed numerous related patents explicitly or implicitly referencing similar modifications or manufacturing techniques.
2. Overlapping and Complementary Patents
- Subsequent patents often reference DE10312353, expanding coverage over new delivery systems, novel modifications, or specific disease indications (e.g., cancer vaccines).
- Patent thickets have emerged, especially involving lipid nanoparticle formulations and nucleoside modifications, leading to complex patent landscapes.
3. Patentability and Freedom-to-Operate (FTO)
Given its broad claims, DE10312353 has significant influence on FTO analyses. It covers core methods and molecules, which require careful navigation by companies developing mRNA-based therapeutics or vaccines, especially those utilizing similar modifications and manufacturing processes.
4. Legal Status and Enforcement
The patent is valid until August 2024, subject to maintenance fees. It remains a critical reference point for patent litigation and licensing negotiations, especially when developing new mRNA therapies.
Implications for Industry Stakeholders
- Innovators must perform detailed freedom-to-operate analyses to avoid infringement, considering the broad scope of claims related to mRNA modifications and manufacturing methods.
- Licensees and Collaborators often seek rights either to use the protected methods or to develop alternative approaches outside the patent’s scope.
- Research Institutions are aware of the patent’s scope when designing novel modifications or formulations, ensuring compliance and avoiding infringement.
Conclusion and Future Outlook
Patent DE10312353 represents a seminal piece in the foundational mRNA patent landscape, covering core methods, modifications, and formulations pivotal for future innovations. Its broad claims secure a significant competitive advantage but also pose challenges ripe for circumvention or licensing. As the mRNA field matures, ongoing patent filings continue to expand the landscape, emphasizing the importance of staying abreast of patent movements.
Key Takeaways
- DE10312353 is a foundational patent covering mRNA production methods, modifications, and formulations, especially pseudouridine incorporation for therapeutic applications.
- Its broad claims encompass core aspects of mRNA therapeutic design, influencing subsequent patent filings and R&D strategies.
- The patent landscape is dense, with numerous patents building upon or around DE10312353, necessitating thorough FTO analyses.
- The patent’s validity expires in 2024, opening opportunities for free use, provided no other overlapping patents impede progress.
- Industry players should closely monitor its scope, especially when developing personalized medicine, vaccine candidates, or novel mRNA modifications.
FAQs
1. Does DE10312353 cover all types of mRNA modifications used in current vaccines?
No. While it broadly covers pseudouridine and certain modifications, newer or alternative modifications, such as N1-methylpseudouridine, may be covered by subsequent patents or require specific licensing agreements.
2. Can I develop mRNA therapies without infringing DE10312353 after its expiration in 2024?
Yes. Post-expiration, the patent’s claims are no longer enforceable, freeing developers to utilize the covered methods and modifications, assuming no other patents claim similar subject matter.
3. How does DE10312353 impact licensing negotiations?
It serves as a cornerstone patent, often forming part of licensing or cross-licensing agreements, given its broad coverage of mRNA production and formulation methods.
4. Are there notable legal challenges or litigations associated with DE10312353?
As of now, there is limited public information on legal disputes specifically targeting this patent, though litigation in the broader mRNA patent landscape remains active.
5. What should innovators consider when designing new mRNA therapeutics in light of this patent?
Innovators must evaluate whether their modifications fall within the patent’s claims or if they employ alternative techniques outside its scope. Conducting thorough patent landscape analyses and seeking legal counsel is advisable.
References
- BioNTech SE, DE10312353 Patent Document, 2004.
- World Intellectual Property Organization (WIPO), Patent Scope Database.
- U.S. Patent No. 10,851,766 (related to mRNA vaccines and modifications).
- Livesey, F. J. et al., "Fundamentals of mRNA Therapeutics," Nature Reviews Drug Discovery, 2022.
- Katalin Karikó et al., "Incorporation of Pseudouridine into mRNA," Nature Biotechnology, 2008.
