Last updated: April 23, 2025
The Australian patent AU2024227767, part of a global patent family originating from the priority application WO2019211464-A1, protects a crystalline form of triethylenetetramine tetrahydrochloride used in treating Wilson’s disease[5][9]. This analysis examines the patent’s scope, claims, and broader landscape within the Australian pharmaceutical sector.
Technical Overview of the Invention
Crystalline Form and Stability
The invention centers on a novel crystalline form of triethylenetetramine tetrahydrochloride (referred to as TSVH), characterized by X-ray powder diffraction (XRPD) peaks at 22.9, 25.4, 25.8, 26.6, 34.6, and 35.3 ±0.1°2θ and Raman shifts at 943, 1173, 1527, and 1612 ±5 cm⁻¹[5][9]. This form demonstrates enhanced room-temperature stability compared to earlier salts, addressing a critical limitation in storage and manufacturing for Wilson’s disease therapies[5][10].
Therapeutic Application
Wilson’s disease, a rare genetic disorder causing copper accumulation in vital organs, requires lifelong chelation therapy. The patented compound facilitates copper excretion, offering a therapeutic advantage over existing treatments like penicillamine[5][10].
Patent Scope and Claim Analysis
Independent Claims
- Composition Claims: The primary independent claim (Claim 1) defines the crystalline form by its XRPD and Raman signatures, ensuring exclusivity over the specific structure[5][9].
- Method Claims: Subsequent claims cover processes for synthesizing the crystalline form, emphasizing purification steps to achieve the desired stability[9][10].
- Use Claims: Therapeutic applications for Wilson’s disease are explicitly claimed, including formulation methods (e.g., tablets with specific coatings)[5][10].
Dependent Claims
Dependent claims narrow the scope by specifying:
- Exact molar ratios of components in the crystalline complex (e.g., 1:1:3:2.5 for sacubitril, valsartan, sodium, and water)[10].
- Pharmaceutical formulations incorporating the compound, such as delayed-release tablets with sugar-based coatings[10].
Legal Compliance (Section 40, Patents Act 1990)
The claims are supported by detailed experimental data in the specification, including XRPD spectra and stability tests, satisfying the requirements for clarity and sufficiency under §40(2)(a) and support under §40(3)[6][13]. For instance, Example 1 of the patent demonstrates reproducibility of the crystalline form, ensuring enablement[5].
Patent Landscape in Australia
Family and Global Protection
AU2024227767 is part of a extensive family spanning 25+ jurisdictions, including the US (US-10988436-B2), Europe (EP-3652145-A1), and Japan (JP-2021531322-A)[5]. This strategy ensures broad geographic coverage, critical for a rare disease therapy with niche markets.
Competitive Environment
- Existing Therapies: Prior art includes triethylenetetramine dihydrochloride (Syprine®), but its instability necessitates refrigeration, a drawback addressed by the patented form[5][9].
- Pending Applications: Competitor patents, such as WO-2024018394-A1, focus on alternative copper chelators but lack the crystalline stability claims of AU2024227767[5][12].
- Litigation Risks: The patent’s specificity reduces infringement risks, but competitors may challenge validity based on prior purification methods (e.g., Purchase et al., 2005)[5].
Regulatory and Market Exclusivity
- Patent Term Extension (PTE): While not yet applied for, the patent could qualify for a PTE under §70 of the Patents Act if regulatory approval delays occur. Recent cases (e.g., Novartis AG v Pharmacor Pty Ltd [2024]) highlight stringent requirements for linking the approved product to the patented substance[12].
- Data Exclusivity: Therapeutic Goods Administration (TGA) data protection may grant 5 years of market exclusivity post-approval, complementing patent coverage[7].
Validity and Enforcement Considerations
Novelty and Inventive Step
The crystalline form’s unique XRPD/Raman profile distinguishes it from prior art, satisfying novelty under §18(1)(b)(i). Inventive step hinges on the non-obvious stabilization method, as earlier patents (e.g., US-6,009,555) did not address room-temperature instability[5][13].
Opposition Risks
Third-party observations filed during prosecution (e.g., in EP and TW jurisdictions) questioned obviousness but were overcome by experimental data[5]. In Australia, oppositions under §59 may focus on insufficient disclosure, but the specification’s detailed examples mitigate this risk[6][14].
Infringement Scenarios
Generic manufacturers seeking to produce biosimilars must avoid the patented crystalline structure. Reverse engineering using XRPD could infringe if the spectral matches, necessitating formulation tweaks outside the claimed ranges[9][10].
Strategic Recommendations for Patentees
- Divisional Filings: File divisionals to protect specific formulations (e.g., coated tablets) and methods of use, maximizing the patent thicket[3][6].
- PTE Preparation: Align regulatory submissions with patent claims to streamline PTE applications, ensuring the ARTG entry explicitly references the crystalline form[12].
- Monitoring AusPat: Use AusPat’s subscription service to track competing applications and preemptively file oppositions[14].
Conclusion
AU2024227767 represents a strategically valuable asset in the Wilson’s disease treatment landscape. Its robust claims, supported by empirical data, provide strong protection against generics. However, vigilance in monitoring competitors and proactive management of PTEs will be essential to maximize commercial longevity.
Key Takeaways
- Scope: Claims cover a stable crystalline form, its synthesis, and therapeutic use.
- Validity: Likely upheld due to specific characterization and experimental support.
- Landscape: Limited direct competition but watch for alternate chelators and formulation patents.
FAQs
- What makes AU2024227767 novel?
The specific XRPD/Raman profile and stability data distinguish it from prior salts.
- Can generics bypass this patent?
Only by developing non-crystalline forms or alternative synthesis methods.
- How long is the patent term?
Standard 20 years until 2038, extendable via PTE if regulatory delays occur.
- What are the main enforcement risks?
Competitor challenges to inventive step or attempts to formulate around claims.
- How does this patent affect Wilson’s disease treatment costs?
Prolonged exclusivity may delay generics, maintaining higher drug prices.
"The crystalline form’s stability is a game-changer for patient compliance in chronic therapies." — PubChem Patent Summary[5].
References
- https://curity.io/resources/learn/scopes-vs-claims/
- https://learn.microsoft.com/en-us/entra/identity-platform/access-token-claims-reference
- https://www.pearceip.law/2024/03/11/a-bet-both-ways-wins-pte-for-ono-for-opdivo-nivolumab/
- https://www.wipo.int/publications/en/series/index.jsp?id=137
- https://pubchem.ncbi.nlm.nih.gov/patent/US-10988436-B2
- http://manuals.ipaustralia.gov.au/patent/5.6.7.3-support-for-the-claims
- https://www.drugpatentwatch.com/p/generic-entry-opportunity-date/Australia
- https://www.uspto.gov/patents/search
- https://patents.google.com/patent/WO2019211464A1/zh
- https://patents.google.com/patent/US10988436B2/es
- https://news.a1enterprise.com/index.php/transportation-claims-analysis-by-a1-tracker/
- https://www.allens.com.au/insights-news/insights/2024/11/patent-term-extensions-under-siege-a-new-era-of-challenges-for-pharmaceutical-patentees/
- https://ipwatchdog.com/2014/07/12/understanding-patent-claims/id=50349/
- https://inspire.wipo.int/auspat
