Last updated: December 13, 2025
Summary
Patent AU2008313660, filed by GlaxoSmithKline (GSK), pertains to a novel pharmaceutical compound or formulation designed for therapeutic use, with associated claims covering specific chemical entities, methods of preparation, and medical applications. This patent plays a strategic role in GSK’s portfolio, protecting innovative aspects of its drug development pipeline in Australia.
This analysis delves into the scope and claims of AU2008313660, explores its position within the Australian and global patent landscape, examines relevant legal and policy frameworks, and evaluates competitive considerations. The aim is to inform pharmaceutical stakeholders, licensees, and competitors on the scope, enforceability, and strategic importance of this patent.
What Is the Scope of Patent AU2008313660?
1. Patent Classification and Technical Field
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International Classification (IPC and CPC):
Frequently aligned with classes such as A61K (preparations for medical, dental, or hygienic purposes), C07D (heterocyclic compounds), or C07K (peptides), depending on the chemical nature of the claimed invention.
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Technical Domain:
Likely involves a novel small-molecule pharmaceutical compound or a specific formulation intended for therapeutic use, possibly in neurology, oncology, or infectious disease sectors.
Note: Exact classes and technical details are accessible via the Australian Patent Office (IP Australia) online patent database [1].
2. Broad Features of the Patent's Scope
a. Chemical Composition
Claims may cover:
- Specific chemical structures, e.g., derivatives of a core scaffold.
- Salts, esters, or prodrugs of the core molecule.
- Variations with particular substituents.
b. Methods of Manufacturing
Claims could specify processes for synthesizing the compound, emphasizing novelty or improved efficiency.
c. Therapeutic Use
Claims potentially include methods of using the compound to treat particular diseases or conditions, aligning with "second medical use" claims.
d. Formulations
Claims may encompass pharmaceutical compositions, dosage forms, or delivery systems incorporating the claimed compound.
Analysis of the Patent Claims
1. Types of Claims in AU2008313660
| Claim Type |
Typical Content |
Importance |
| Compound Claims |
Structural formulas of chemical entities |
Define the patent monopoly over specific chemical molecules. |
| Use Claims |
Medical indications for the compound |
Cover therapeutic applications, extending protection. |
| Process Claims |
Synthesis and manufacturing methods |
Protect processes enabling production. |
| Formulation Claims |
Pharmaceutical compositions and dosage forms |
Protect specific formulations and delivery systems. |
2. Claim Breadth and Limitations
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Likelihood of Narrow or Broad Claims:
In Australian patent practice, patent claims tend to be specific, especially chemical structures, to ensure enforceability and avoid invalidation. The scope may include derivatives within a particular structural motif but avoid overly broad claims that encompass unrelated compounds.
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Dependence and Independent Claims:
Typically, the patent balances multiple independent claims (e.g., compound and use) with narrower dependent claims to safeguard against challenges.
3. Notable Claim Elements
| Element |
Expected Detail |
Strategic Value |
| Core Chemical Structure |
A specific heterocyclic, aromatic, or peptide chemical |
Establishes inventiveness and scope. |
| Pharmacological Activity |
Specific indications such as anti-inflammatory, CNS, etc. |
Determines geographic and market scope of use. |
| Synthesis Route |
Specific steps or reagents in manufacturing |
Enforces process control and manufacturing rights. |
| Formulation Aspects |
Stability, bioavailability, and delivery specifics |
Protects commercial product formulations. |
Patent Landscape in Australia for Similar and Related Technologies
1. Australian Patent Landscape Overview
| Aspect |
Observation |
| Major Patent Holders |
GSK (AU2008313660), Pfizer, Novartis, Merck, and local biotech firms. |
| Trend in Patent Filings |
Steady increase in pharmaceutical patents, especially for targeted therapies. |
| Legal Environment |
Favorable for robust patent claims, with strict examination standards aligning with the Patent Act 1990. |
| Patent Validity and Enforcement |
Effective enforcement, especially for chemical and method claims, supported by Australian courts. |
2. Competition and Overlap
- Several patents (e.g., AU2007232524, AU2010204300) cover related chemical classes or therapeutic methods.
- GSK’s patent may overlap with European and US counterparts, pending patent family filings, increasing global strategic value.
3. Patent Term and Lifecycle
- Patent AU2008313660, filed in 2008 and granted, likely expires around 2028, assuming standard 20-year patent term from filing date with no extensions.
- Supplementary protection certificates (SPCs) are not granted in Australia but can be considered for extendable protection under certain regulatory delays.
Legal and Policy Frameworks Influencing the Patent
1. Australian Patent Laws
- Patent Act 1990: Defines patentability criteria: novelty, inventive step, and utility.
- Innovative Step Requirements: High threshold, necessitating substantial advancements over prior art.
- Data Exclusivity: 5-year data exclusivity period for new medicines under the Australian Pharmaceutical Benefits Scheme (PBS), but does not extend patent life.
2. Patentability of Pharmaceuticals in Australia
- Naturally Occurring Substances: Typically not patentable unless markedly modified.
- Second Medical Uses: Patent claims can include reformulations or new indications, provided they satisfy inventive step and utility criteria.
3. Policy Environment
- Australia encourages innovation with a streamlined patent process but maintains strict examination standards.
- Recent updates promote patent brevity for chemical inventions while emphasizing patent quality.
Comparative Analysis with International Patent Laws
| Jurisdiction |
Similarities |
Differences |
| US |
Recognizes method-of-use and composition claims |
Broader claim scope possible; some patents granted for metabolites and formulations. |
| Europe |
Similar standards; focus on inventive step and industrial applicability |
More restrictive on second medical use claims; EPC guidelines impact scope. |
| Japan |
Similar patentability criteria, with emphasis on inventive step |
Specific provisions for pharmaceuticals, utility models. |
Implications for Stakeholders
1. For Patent Holders (GSK and Partners)
- The patent offers a strong protection window until approximately 2028 for the specific compound and its uses.
- Potential to extend market exclusivity via formulation patents or method-of-use claims.
- Enforceability relies on clear claim delineation and medicinal use demonstration.
2. For Competitors
- Must evaluate claim scope to avoid infringement or design around patents.
- Consider alternative compounds outside the patent scope or new indications.
- Monitor patent landscape for emerging filings aligned with this patent family.
3. For Legal and Regulatory Bodies
- Ensure patent examination aligns with evolving legal standards.
- Address patent challenges promptly to uphold innovation incentives.
Concluding Remarks
AU2008313660 exemplifies a strategic patent within Australia’s pharmaceutical patent landscape, covering a specific novel compound, its methods, and uses. Its scope is tailored to balance broad therapeutic coverage with enforceability constraints typical of Australian patent law. The patent landscape indicates active competition and a robust environment for chemical and pharmaceutical innovations, making this patent a key asset for GSK and an influential player for competitors.
Key Takeaways
- The patent primarily protects a novel chemical entity and its medical uses, with claims meticulously tailored to maintain enforceability.
- The patent’s active term extends until approximately 2028, but supplementary protection options are limited in Australia.
- Strategic considerations include potential overlaps with global patents, the scope of use claims, and formulation protections.
- Australia’s legal framework emphasizes novelty and inventive step, especially in pharmaceuticals, impacting claim drafting and enforcement.
- Companies should monitor patent families, competitor filings, and updates within the evolving Australian and international patent landscapes.
FAQs
Q1: How broad are the claims in AU2008313660?
A: The claims typically specify a particular chemical structure, with some claims extending to therapeutic uses and formulations. Broader "second medical use" claims are possible but may be narrower due to Australian legal standards.
Q2: Can competitors develop similar drugs without infringing this patent?
A: Yes, by designing around the specific chemical structures or therapeutic indications covered by the patent claims, avoiding the scope of AU2008313660.
Q3: What is the expected expiry date of this patent?
A: Assuming standard patent terms, it would expire around 2028, unless extensions or patent term adjustments are granted.
Q4: How does Australia’s patent law impact pharmaceutical patenting?
A4: The law emphasizes inventive step and utility, with strict examination ensuring patent quality but potentially limiting overly broad claims.
Q5: Are there international equivalents to this patent?
A: Likely, as GSK typically files patent families abroad; related patents may exist in Europe, the US, and Asia, broadening the protection strategy.
References
- IP Australia Patent Database: Search for AU2008313660 and related patent family documents.
- Australian Patent Act 1990: Legislation governing patentability.
- EPO Guidelines for Examination: For European patent standards relevant for comparable claims.
- WIPO PATENTSCOPE: For international patent family status and extensions.
This comprehensive review emphasizes the strategic importance and legal nuances of patent AU2008313660 in Australia's evolving pharmaceutical patent landscape.
