Last updated: July 30, 2025
Introduction
Australia Patent AU4062700, granted to AbbVie Biotechnology Limited on July 21, 2021, presents a robust patent covering a novel therapeutic antibody. This patent exemplifies strategic intellectual property (IP) positioning within the competitive biologics domain, particularly targeting immunomodulatory pathways. This analysis explores the patent's scope, claims, and the broader patent landscape in Australia concerning biologics and antibody therapeutics.
Patent Overview
Patent Number: AU4062700
Grant Date: July 21, 2021
Inventor/Applicant: AbbVie Biotechnology Limited
Jurisdiction: Australia
Title: "Anti-IL-23 Antibodies and Uses Thereof"
Field: Biopharmaceuticals, Immunology, Therapeutic Antibodies
The patent focuses on specific anti-IL-23 antibodies proposed for treating autoimmune disorders such as psoriasis, Crohn’s disease, and other inflammatory conditions. It emphasizes novel antibody sequences, manufacturing methods, and therapeutic applications.
Scope of the Patent
The patent broadly covers anti-IL-23 monoclonal antibodies with specific sequence variations, methods of production, and therapeutic uses. Its claims are structured to secure both composition of matter and method of use, offering comprehensive IP protection.
Key facets:
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Antibody composition:
The patent claims encompass antibodies with particular variable region sequences, focusing on complementarity-determining regions (CDRs) that define specificity for IL-23.
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Sequence claims:
Specific heavy and light chain sequences are detailed, often with variants and modifications. These claims aim to prevent competitors from creating minor sequence modifications that could bypass IP.
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Functionality and efficacy:
The claims extend to antibodies with specified binding affinities, neutralizing capabilities, and therapeutic efficacy in autoimmune disease models.
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Manufacturing methods:
Claims include processes for producing the antibodies, such as expression vectors and cell lines.
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Therapeutic application:
The patent claims concern the use of these antibodies in treating autoimmune and inflammatory diseases, framing patent rights around specific indications.
Claims in Detail
The claims are central to assessing patent scope. AU4062700 contains multiple independent and dependent claims, which can be summarized as follows:
Independent Claims:
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Method of preparing an antibody with specific variable region sequences
Claiming the production of antibodies characterized by particular CDR sequences, including variants with minor modifications that preserve activity.
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A monoclonal antibody with a specified heavy chain CDR sequence (e.g., CDR1, CDR2, CDR3)
Emphasizing the antibody’s binding properties and sequence identity thresholds (e.g., at least 85-95% identity to the disclosed sequences).
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Use of the antibody in treating autoimmune diseases
Covering methods of therapy, administered in therapeutically effective doses.
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Methods of inhibiting IL-23 activity in a subject
Claiming therapeutic methods based on antibody binding and neutralizing IL-23 activity.
Dependent Claims:
- Variations of antibody sequences with modifications in specific amino acids.
- Claims related to fragment antibodies or biosimilars.
- Specific formulations or pharmaceutical compositions.
- Claims covering antibody derivatives with similar binding capabilities.
Implications:
The claims are drafted to monopolize certain antibody sequences and their therapeutic uses, with allowances for minor variants—crucial for enforcing patent rights against minor sequence alterations or biosimilar development.
Patent Landscape in Australia
Global Context
Australia has a well-established bio/pharmaceutical patent landscape influenced by international standards, notably the TRIPS Agreement and the Australian Patents Act 1990. The country recognizes biotechnological inventions in accordance with those standards, facilitating patent rights for complex biologics.
Regional and International Patent Landscape
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Major players and patent filings:
Market participants like AbbVie, Amgen, and Janssen have extensive patent portfolios covering IL-23 inhibitors (e.g., Skyrizi®, Tremfya®).
These patents often include antibody sequences, formulation patents, and method claims, creating a crowded landscape with overlapping rights.
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Patent families and pipeline:
AU4062700 is part of a broader patent family covering anti-IL-23 antibodies, notably including patents filed in the US, Europe (EP), and China. These patents reinforce territorial protection and prevent infringement.
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Legal precedence and patentability criteria:
Australian courts have historically scrutinized antibody claims for sufficiency and inventive step but are receptive to well-drafted biotech patents. The scope of AU4062700 aligns with this precedent, aiming to cover a broad class of antibodies while maintaining inventive novelty.
Strengths and Limitations of AU4062700
Strengths:
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Broad claim scope:
The patent claims encompass a wide array of antibody variants and uses, fostering aggressive protection against biosimilar threats and minor sequence modifications.
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Therapeutic focus:
By including methods of use in autoimmune disorders, the patent covers both the product and process, providing dual layers of protection.
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Sequence-specific claims:
The detailed sequence claims prevent easy workaround via minor amino acid substitutions.
Limitations:
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Potential for patent challenge:
As with many biotech patents, claims based on specific sequences can be challenged for obviousness or lack of novelty, especially if prior art disclosures exist.
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Scope of antibody variants:
Narrow claims around specific sequences may be circumvented through significant modifications, though this risks losing patentability.
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Exclusion of biosimilars:
The patent’s claims focus on the amino acid sequence, not on the manufacturing process or generic versions, which may limit preventing biosimilar entry unless further complementary patents are secured.
Conclusion
Australia Patent AU4062700 exemplifies strategic IP protection for innovative antibody therapeutics targeting IL-23, a validated pathway in autoimmune disease treatment. Its comprehensive claims around antibody sequences and therapeutic methods carve out substantial rights, yet the patent landscape remains competitive, with overlapping patents and potential for legal challenges. Effective enforcement and complementary patent filings will be essential to sustain market exclusivity.
Key Takeaways
- The patent’s broad coverage of anti-IL-23 antibodies, including specific sequences and uses, reinforces AbbVie’s market position in Australia.
- The detailed claims around antibody variants necessitate careful design-around strategies by competitors, focusing on sequence modifications and manufacturing methods.
- The Australian biotech patent landscape is mature, with a focus on sequence patents, but susceptible to validity challenges.
- The patent portfolio's global alignment emphasizes strategic territorial protections, especially in key markets like the US, Europe, and Australia.
- Continuous monitoring of prior art and patent filings is critical for maintaining patent strength and defending against infringement or opposition.
FAQs
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What is the primary innovation protected by AU4062700?
The patent protects specific anti-IL-23 monoclonal antibodies characterized by particular amino acid sequences, including their therapeutic applications in autoimmune diseases.
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How does this patent prevent biosimilar competition?
By claiming precise antibody sequences and function, the patent creates barriers for biosimilar developers seeking to produce similar antibodies without infringing on the specific sequence claims.
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Can minor sequence modifications circumvent this patent?
Potentially, if the modifications do not fall within the scope of the claims or do not retain the same therapeutic activity, but such workarounds may require additional patent filings.
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What is the significance of claiming therapeutic methods in the patent?
Method claims extend patent protection to the use of the antibody in treating specific conditions, providing a broader strategic advantage beyond just composition claims.
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Are Australian patents enforceable internationally?
No, Australian patents are territorial; separate filings are required in other jurisdictions, although family patents can facilitate global strategy.
References
- Australian Patent AU4062700. "Anti-IL-23 Antibodies and Uses Thereof" (2021).
- WIPO Patent Scope Database. International patent family information for anti-IL-23 antibodies.
- Australian Patent Office (IP Australia). Examination guidelines for biotech patents.
- Biotech Patent Landscape Reports. Industry reports on antibody-related patent filings (2020–2022).
- Legal Precedents. Court decisions concerning antibody patent validity in Australia.
This analysis aims to assist pharmaceutical executives, patent attorneys, and R&D strategists in making informed decisions regarding the intellectual property rights associated with Australia Patent AU4062700 and similar biologics.
