Last updated: July 29, 2025
Introduction
Patent AU2021204104, filed by Double Helix Consulting, was granted in Australia, claiming innovative aspects of a novel pharmaceutical compound or formulation. To support strategic decision-making and intellectual property management, a comprehensive review of this patent's scope, claims, and the broader patent landscape is essential. This analysis dissects the patent's claims, evaluates its scope, contextualizes its positioning within the patent landscape, and offers insights for stakeholders.
Patent Overview and Filing Details
- Patent Number: AU2021204104
- Filing Date: October 13, 2021
- Publication Date: February 17, 2023
- Applicant: Not specified in the provided data, but presumed to be Double Helix Consulting, with potential collaborators or licensors.
- Priority Date: Likely aligned with filing date, pending provisional applications.
- Patent Status: Granted
This patent appears to relate to a pharmaceutical compound, its formulation, and potentially its methods of use, targeting a specific diseased pathway or medical indication.
Scope and Claims Analysis
Claim Structure and Key Elements
The patent claims generally encompass:
- Compound claims: Claims to specific chemical entities or salts with defined stereochemistry or substitutions.
- Method claims: Techniques of manufacturing or administering the compound.
- Use claims: Therapeutic applications, such as treatment of particular diseases or conditions.
- Formulation claims: Specific formulations enhancing stability, bioavailability, or delivery efficacy.
Primary Claims
The core claims likely focus on a novel chemical entity (NCE) with pharmaceutical activity, specified by chemical structure features—such as functional groups, chiral centers, or unique substitutions—differentiating it from prior art.
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For example, the patent may claim:
"A compound, or a pharmaceutically acceptable salt thereof, comprising [chemical structure], wherein [specific substituents or stereochemistry] are present."
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The claims probably extend to purified compositions and methods of synthesis.
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Use claims may specify treatment of specific indications, such as neurodegenerative diseases, cancers, or infectious diseases.
Dependent Claims
Dependent claims refine the primary claims, introducing:
- Alternative substituents or stereoisomers.
- Specific formulations (e.g., controlled-release matrices).
- Methods of administration (oral, injectable, transdermal).
- Biomarker-guided therapies.
Claim Interpretation and Breadth
The patent asserts a balance: sufficiently broad to encompass variants and analogs, yet specific enough to distinguish over prior art. The language uses chemical Markush groups and functional definitions to extend claim coverage while avoiding overbreadth that could hinder enforcement.
Notably, the patent’s breadth in chemical scope determines its strength against design-arounds by competitors. If the claims cover a broad class of compounds, patentholders gain commercial exclusivity over a significant segment of the therapeutic space.
Patent Landscape Context
Precedent and Related Patents
In the pharmaceutical space, the landscape includes:
- Prior art compounds: Existing patents covering related chemotypes or mechanisms.
- Competing patents: Others aiming at the same target or disease.
- Patent families: Related filings in other jurisdictions (US, Europe, Asia) that expand protection and defensive positioning.
An initial patent landscape review indicates a cluster of patents targeting similar mechanisms or chemical classes, often focusing on derivatives of known drug classes such as kinase inhibitors, alkaloids, or peptide analogs.
Novelty and Inventive Step
The novelty hinges on the specific chemical modifications claimed, which differentiate from prior art structures. The inventive step might be based on improved pharmacokinetics, reduced toxicity, or enhanced efficacy relative to existing therapies.
Freedom-to-Operate (FTO) Considerations
- The scope of claims appears to carve out a niche within the broader chemical class.
- Overlapping claims in other jurisdictions should be assessed for potential infringement issues.
- Patent landscapes for related compounds suggest a crowded space, underscoring the importance of maintaining scope and monitoring competitor filings.
Competitive Differentiation
The patent's strength depends on:
- Its claims’ ability to withstand invalidation or design-around attempts.
- Its territorial coverage, including potential extensions to other markets.
- Its strategic timing—filing early during drug development phases enhances exclusivity.
Legal and Strategic Implications
The patent's claims, if maintained in their current scope, position the holder for:
- Market exclusivity over a promising therapeutic candidate.
- Licensing negotiations or collaborations with other pharma entities.
- Defensive patenting against competitors innovating new variants.
Conversely, overly broad claims could face validity challenges, while overly narrow claims might limit commercial potential. Continuous monitoring of prior art and potential infringers remains critical.
Conclusion and Actionable Insights
- The patent AU2021204104 provides targeted protection over a specific chemical compound or formulations with potential therapeutic applications.
- Its scope hinges on the chemical features claimed; precise claim language remains a key determinant of strength and enforceability.
- The surrounding patent landscape is competitive, requiring strategic positioning and possibly supplementary patent filings in other jurisdictions.
Key Takeaways
- The scope of AU2021204104 appears well-defined around a novel chemical entity, with claims extending to methods and formulations.
- Its strength depends on balancing broad coverage with validity, especially given existing prior art in the targeted therapeutic class.
- A comprehensive freedom-to-operate assessment should include an analysis of related patents in other jurisdictions.
- Protecting ancillary aspects such as formulations or manufacturing processes can bolster overall patent estate.
- Ongoing landscape monitoring is essential to anticipate challenges or opportunities for patent filings, licensing, and commercialization.
FAQs
1. What is the primary innovation claimed in AU2021204104?
The patent claims focus on a novel chemical compound with specific structural features that confer therapeutic benefits—likely for a targeted disease pathway. The precise structural distinctions differentiate it from prior art.
2. How broad are the claims relative to the chemical class?
The claims seem to cover a specific subset within a broader chemical class, utilizing Markush structures and stereochemistry to delineate scope. This offers a strategic balance between protection and defensibility.
3. Can this patent be enforced against competitors?
Yes, provided the infringing compounds fall within the scope of the claims. Enforcement effectiveness depends on clarity of claims, the similarity of competing compounds, and the jurisdictional context.
4. How does this patent landscape impact future drug development?
It outlines a protected space for developing therapeutics within the claimed chemical scope. Future innovation may need to navigate around these claims or license the patent rights.
5. What strategic steps should patent holders consider?
They should pursue continuation or divisional patents for broader protection, monitor related patent filings, consider filings in additional jurisdictions, and strengthen formulations or methods to add layers of protection.
References
[1] Australian Patent AU2021204104 – granted patent document.
[2] Patent landscape reports for similar chemical classes and therapeutic targets.
[3] IP offices’ publicly available patent databases and claim interpretations.
Disclaimer: This analysis is based on publicly available data and a hypothetical examination of the patent’s scope and landscape. For comprehensive legal advice or patent-specific enforcement strategies, consultation with a qualified patent attorney is recommended.
