Last updated: February 19, 2026
Australian patent application AU2021230371, filed by CUREVAC AG, claims a pharmaceutical composition and its use in treating or preventing viral infections, particularly those caused by RNA viruses such as flaviviruses. The application seeks to protect specific formulations designed for enhanced delivery and efficacy of nucleic acid-based therapeutics, notably messenger RNA (mRNA) vaccines.
What Are the Core Inventions Claimed in AU2021230371?
The patent application centers on two primary areas: a novel pharmaceutical composition and a method of using this composition for therapeutic purposes. The composition is characterized by its specific components and their synergistic effects.
What is the Pharmaceutical Composition?
The core of the claimed invention lies in a pharmaceutical composition comprising:
- Nucleic Acid Molecule: This is the active ingredient. It is specifically defined as a nucleic acid molecule encoding an antigen or an immunomodulatory protein. In the context of the application, this frequently refers to mRNA encoding viral antigens for vaccine development. The nucleic acid molecule may be single-stranded or double-stranded.
- Lipid Component: The composition includes a specific combination of lipids crucial for forming lipid nanoparticles (LNPs) that encapsulate and protect the nucleic acid. This lipid component includes:
- Ionizable Lipid: An ionizable lipid is essential for facilitating cellular uptake. The application lists specific structural classes of ionizable lipids and provides examples. For instance, it may be a lipid of formula (I) or (II) as defined in the patent specification, which broadly covers lipids with a tertiary amine head group and specific alkyl or alkenyl chain lengths. Examples such as 2-[(poly(ethylene glycol))-2-aminoethyl]-N,N-dimethyldodecan-1-amine (PEG2-DMG) are referenced as related but the claims focus on specific structural variations that confer improved properties. The patent details specific pKa ranges for these ionizable lipids, typically between 5.0 and 7.4, which is critical for endosomal escape.
- Neutral Lipid: This lipid contributes to the structural integrity of the LNP. Examples provided include cholesterol.
- Phospholipid: This lipid component aids in LNP formation and stability. Phosphatidylcholine is a representative example cited.
- PEGylated Lipid: A lipid covalently linked to polyethylene glycol (PEG) is included to increase the circulation half-life of the LNPs and reduce immune recognition. Specific PEGylated lipids with varying PEG chain lengths and linker structures are described. The chain length of the PEG moiety is a key parameter, often specified to be between 1000 and 5000 Daltons.
- Excipient(s): The composition may optionally include one or more excipients. These can include buffering agents to maintain pH, salts to adjust osmolality, or stabilizing agents. The patent explicitly mentions substances like Tris buffer or sodium chloride.
The relative molar ratios of these components within the LNP are also critical, with the application often specifying ranges for the ionizable lipid, neutral lipid, phospholipid, and PEGylated lipid to optimize LNP formation and payload delivery. For instance, the ionizable lipid often constitutes the largest molar fraction of the lipids.
What is the Method of Use Claimed?
The patent application also claims methods of using the described pharmaceutical composition. These methods are directed towards:
- Treating or Preventing Viral Infections: The primary therapeutic indication is the treatment or prevention of viral infections. The application specifically targets infections caused by RNA viruses, including but not limited to:
- Flaviviruses: This category includes Dengue virus, Zika virus, West Nile virus, and Yellow Fever virus.
- Coronaviruses: Such as SARS-CoV-2.
- Orthomyxoviruses: Including influenza viruses.
- Paramixoviruses: Such as respiratory syncytial virus (RSV).
- Administering the Composition: The claimed method involves administering a therapeutically or prophylactically effective amount of the pharmaceutical composition to a subject in need thereof. The route of administration is typically specified as parenteral, such as intramuscular or subcutaneous injection.
- Inducing an Immune Response: By delivering the nucleic acid encoding an antigen, the composition is intended to stimulate an immune response against the target virus. This immune response can involve the production of antibodies and T-cells.
The method claims often link the administration of the composition to the generation of a protective immune response or the reduction of viral load and associated symptoms.
What is the Scope of the Patent Claims?
The scope of Australian patent AU2021230371 is defined by its claims, which outline the exclusive rights granted to the applicant. These claims are categorized into independent and dependent claims, with independent claims defining the broadest protection and dependent claims narrowing the scope to specific embodiments.
Independent Claims
Independent claims in AU2021230371 typically cover:
- Claim 1: A pharmaceutical composition comprising:
- A nucleic acid molecule encoding an antigen or an immunomodulatory protein.
- A lipid component comprising an ionizable lipid, a neutral lipid, a phospholipid, and a PEGylated lipid.
The specific structures and properties of these lipids, particularly the ionizable lipid (e.g., its pKa range and chemical structure) and the PEGylated lipid (e.g., PEG chain length), are detailed within this claim.
- Claim 10 (Example): A method of treating or preventing a viral infection in a subject, comprising administering a therapeutically or prophylactically effective amount of the pharmaceutical composition according to claim 1 to the subject.
The precise wording of these claims dictates what would constitute infringement. For example, if an independent claim requires the presence of a specific type of ionizable lipid with a particular pKa, any composition lacking this specific lipid would not fall under that claim's protection.
Dependent Claims
Dependent claims refine the scope of the independent claims by adding further limitations. These can include:
- Specific Lipid Structures: Further specifying the chemical structures of the ionizable lipid, neutral lipid, phospholipid, or PEGylated lipid. This might include specifying the length of alkyl chains, the type of head groups, or the position of double bonds.
- Lipid Ratios: Defining precise molar ratios or ranges for the different lipid components within the LNP.
- Nucleic Acid Properties: Specifying characteristics of the nucleic acid molecule, such as its size, modifications (e.g., N1-methylpseudouridine), or the specific antigen it encodes (e.g., a Dengue virus E protein antigen).
- Viral Targets: Narrowing the method claims to specific viral families or species, such as Dengue virus or SARS-CoV-2.
- Dosage and Administration: Specifying particular dosage ranges or routes of administration.
For instance, a dependent claim might specify that the ionizable lipid has a tertiary amine head group and two C12 alkyl chains, and that the molar ratio of ionizable lipid to phospholipid is between 2:1 and 5:1.
What is the Current Patent Landscape for AU2021230371?
The patent landscape surrounding AU2021230371 is dynamic and competitive, particularly concerning mRNA vaccine technology and lipid nanoparticle delivery systems. This patent is situated within a broader ecosystem of intellectual property protecting various aspects of nucleic acid therapeutics.
Key Competitors and Their Patents
Several major pharmaceutical and biotechnology companies hold significant patent portfolios in this space. These include:
- Moderna, Inc.: A leading developer of mRNA therapeutics and vaccines, Moderna has a substantial number of patents covering mRNA technology, LNP formulations, and specific vaccine candidates. Their early patents established foundational protection for mRNA delivery systems.
- BioNTech SE: Partnered with Pfizer for the development of a highly successful COVID-19 vaccine, BioNTech also possesses extensive intellectual property related to mRNA constructs, LNP formulations, and manufacturing processes.
- Arcturus Therapeutics: This company is known for its self-amplifying mRNA (saRNA) technology and its proprietary lipid-mediated delivery systems.
- Translate Bio (now Sanofi): Focused on mRNA therapeutics, Translate Bio has patents covering mRNA sequences and delivery platforms.
- University of Pennsylvania: Holds foundational patents related to LNP technology for nucleic acid delivery, which have been licensed to various companies, including Moderna.
The claims of AU2021230371 are likely to be assessed against existing patents from these entities, particularly concerning the novelty and inventiveness of its specific LNP composition and its application. Potential areas of overlap and potential patent disputes can arise from:
- Ionizable Lipid Structures: The specific chemical nature and pKa of the ionizable lipid are critical differentiating factors. Patents claiming similar ionizable lipid classes or specific compounds could pose challenges.
- LNP Formulations: The precise combination and ratios of lipids in the LNP are key. Prior art claiming various LNP compositions with different lipid combinations or molar ratios would be relevant.
- mRNA Modifications and Designs: While AU2021230371 focuses on the delivery system, the underlying mRNA sequence and any modifications can also be subject to patent protection by other entities.
- Therapeutic Applications: The claimed method of treating specific viral infections may be subject to prior art related to other vaccines or therapeutic approaches for those diseases.
Examination Status and Prosecution History
The prosecution history of AU2021230371 with IP Australia is crucial for understanding its current status and potential validity. This includes:
- Examination: The patent application undergoes examination by IP Australia. This involves assessing novelty, inventive step, and industrial applicability against prior art.
- Office Actions: If the examiner identifies issues, they will issue "Office Actions" outlining objections. The applicant then has the opportunity to respond by amending the claims or providing arguments.
- Amendments: Amendments can narrow the scope of the claims to overcome prior art. The final granted claims are the result of this negotiation.
- Granted Status: If the application successfully navigates examination, it is granted, providing exclusive rights for a period, typically 20 years from the filing date.
- Opposition Period: Following grant, there is a period during which third parties can file oppositions against the patent.
As of the latest available information, AU2021230371 is likely in its examination phase or has recently been granted. Its specific claims and any amendments made during prosecution will significantly impact its enforceability and competitive standing. Understanding these details from the official prosecution documents is vital for a comprehensive analysis.
Key Takeaways
Australian patent application AU2021230371 protects a pharmaceutical composition featuring a specific lipid nanoparticle formulation designed for nucleic acid delivery and its use in treating viral infections. The core of the invention lies in a defined combination of an ionizable lipid with a specific pKa range, a neutral lipid, a phospholipid, and a PEGylated lipid, encapsulating a nucleic acid encoding an antigen or immunomodulatory protein. The claimed methods of use target a range of RNA viruses, including flaviviruses and coronaviruses. The patent landscape is characterized by intense competition from entities like Moderna and BioNTech, with potential patent disputes arising from overlapping claims in LNP composition and ionizable lipid structures. The ongoing examination and prosecution history before IP Australia are critical determinants of the patent's final scope and enforceability.
FAQs
-
What is the primary differentiator of the lipid nanoparticle (LNP) formulation claimed in AU2021230371 compared to other existing LNP technologies?
The primary differentiator is the specific chemical structure and defined pKa range of the ionizable lipid component, alongside particular molar ratios of the lipid components, which are claimed to enhance cellular uptake and endosomal escape for improved therapeutic efficacy.
-
Which specific viruses are explicitly mentioned or implied as targets for the claimed pharmaceutical composition and method?
The application explicitly targets RNA viruses, including flaviviruses (e.g., Dengue, Zika), coronaviruses (e.g., SARS-CoV-2), orthomyxoviruses (e.g., influenza), and paramyxoviruses (e.g., RSV).
-
What is the typical route of administration for the pharmaceutical composition described in AU2021230371?
The typical route of administration described is parenteral, such as intramuscular or subcutaneous injection.
-
How does the patent application address the potential for immune evasion or reduced circulation half-life of the LNPs?
The inclusion of a PEGylated lipid in the composition is designed to increase the circulation half-life of the LNPs and reduce their recognition by the immune system, thereby mitigating immune evasion and prolonging their presence in the body.
-
What are the implications of the patent's claims on potential generic drug development or competitor vaccine research in Australia?
If granted and maintained, the patent would grant exclusive rights to CureVac AG for the specific claimed compositions and methods in Australia. This would prevent other entities from manufacturing, using, or selling products that fall within the scope of these claims without a license, potentially impacting generic development and requiring competitors to design around the patented technology.
Citations
[1] CureVac AG. (2021). Pharmaceutical composition and method of treating or preventing viral infection. Australian Patent Application AU2021230371. IP Australia.
