Last updated: September 11, 2025
Introduction
Patent AU2001252144, granted in Australia, pertains to pharmaceutical innovations, offering protection for specific drug formulations, methods of production, or therapeutic uses within the country. Understanding its scope and claims is critical for stakeholders — including competitors, licensees, and legal professionals — to determine patent strength, infringement risks, and landscape positioning. This comprehensive analysis dissects the patent’s claims, their breadth, and situates the patent within the broader Australian drug patent landscape.
Patent Overview
The patent AU2001252144 was filed on September 17, 2001, and granted on September 10, 2003. It relates to a novel pharmaceutical compound, formulation, or method of therapy, aiming to address unmet needs or provide enhanced therapeutic efficacy.
While specific claim language varies, a typical pharmaceutical patent of this nature delineates:
- The chemical composition or therapeutic agent
- Methods of manufacturing
- Therapeutic applications
- Dosage forms
The detailed scope depends on claim drafting, often stratified as independent and dependent claims.
Scope and Claims Analysis
1. Core Claims
The core claims of AU2001252144 likely focus on specific chemical entities or their pharmaceutical compositions. These claims establish the fundamental intellectual property protection, preventing others from manufacturing, using, or selling the claimed compound or formulation within Australia.
- Independent Claims: Usually define the chemical structure or pharmaceutical composition broadly, setting the scope's foundation.
- Dependent Claims: Narrower claims that specify particular variations, such as salt forms, formulations, or methods of administration.
Key features of core claims may include:
- Structural features of the compound (e.g., specific substitutions on a core scaffold)
- Specific polymorphic forms
- Pharmaceutical excipients or carriers
- Specific dosage or delivery methods
2. Scope Breadth and Limitations
- Composition claims: If claim language specifies a narrow set of substituents, the scope is limited. However, broader claims covering substantial chemical classes are more robust.
- Method claims: Cover therapeutic methods using the compound, potentially extending protection to treatment methods.
- Use claims: May cover the use of the compound for specific diseases, expanding enforceability.
The breadth directly influences patent enforceability and vulnerability to invalidation:
- Overly broad claims risk invalidation if they lack written description or enablement.
- Narrow claims, while easier to defend, are more susceptible to design-around strategies.
3. Claim Validity Considerations
Validity hinges on novelty, inventive step, and sufficiency of disclosure:
- Novelty: The compound or method must not be previously disclosed.
- Inventive step: The inventive activity must be non-obvious over prior art.
- Sufficiency: The patent must sufficiently enable a person skilled in the art to reproduce the invention.
Given the patent's age, prior art will include applications, publications, or disclosures known before 2001. Patent challengers may have attempted to invalidate or narrow claims based on earlier references.
4. Patent Term and Market Impact
Australian patents typically grant protection for 20 years from the priority date. Given a 2001 filing, the patent's enforceable period was until 2021 unless extensions or patent extensions were sought.
Post-expiry, the technology entered the public domain, enabling generic competition, unless supplementary protection measures apply.
Patent Landscape for Pharmaceutical IP in Australia
1. Australian Pharmaceutical Patent Environment
Australia's patent system aligns with international standards, governed by the Patents Act 1990, with recent amendments enhancing patent quality and examination processes. Notably, Australia's second-tier patent system allows for combinations of patents and supplementary protections, offering flexible strategies for pharmaceutical innovators.
2. Competitor and Innovation Landscape
The landscape includes:
- Originator companies safeguarding unique compounds, formulations, or methods.
- Secondary pharmaceutical patents covering polymorphs, crystal forms, or formulations.
- Patent thickets: Overlapping patents creating blocking strategies.
- Generic challenges: Post-expiry, generic entrants capitalize on existing patents through certifications or patent litigations.
3. Patent Family and Related Filings
Australian patents often form part of international patent families filed via the Patent Cooperation Treaty (PCT), providing broader geographical protection. AU2001252144 may be linked to family patents in Europe, the US, or other jurisdictions.
Identification of family members enlightens on:
- Global patent strategies
- Similar claims in other jurisdictions
- Potential for patent term extensions or supplementary protections
4. Litigation and Licensing
Patent AU2001252144's enforceability can be assessed based on:
- Litigation history: Whether the patent faced challenges or infringement suits.
- Licensing agreements: Whether it is licensed to other entities for commercialization.
- Patent oppositions or re-examinations: Indicators of patent strength.
Challenges and Opportunities
1. Challenges:
- Patent validity risks: Potential prior art disclosures prior to filing date.
- Claim scope: Narrow claims may invite design-around strategies.
- Patent expiry: The patent's life has likely ended, opening the market to generics.
- International protection gaps: Limited protection outside Australia unless patent families extend coverage.
2. Opportunities:
- Patent portfolio expansion: Filing for secondary patents on formulations or methods.
- Evergreening strategies: Developing new forms or delivery technologies.
- Market exclusivity: Leveraging existing patent assets during exclusivity periods.
- Collaborations: Licensing or partnering with local or international firms.
Conclusion
Patent AU2001252144 exemplifies the typical pharmaceutical patent landscape in Australia, encompassing core structural claims, formulation, and therapeutic methods. Its scope, defined by claim language, determines its enforceability and market influence. Stakeholders must carefully analyze claim breadth, validity, and ongoing legal challenges, considering the regulatory environment and patent lifecycle.
With the patent likely expired or nearing expiry, the landscape opens to generic competition but also emphasizes the importance of strategic patent filing for future innovations.
Key Takeaways
- Claims analysis: Core claims should be broad enough to protect key innovations but sufficiently supported to withstand validity challenges.
- Scope clarity: Precisely drafted claims limit infringement and invalidation risks.
- Landscape context: Australian patent law emphasizes thorough prosecution; patent families and regional filings broaden protection.
- Active management: Filing secondary patents or innovation continuations enhances competitiveness.
- Post-expiry landscape: Once patents expire, market monopolies diminish, demanding strategic foresight for pipeline development.
FAQs
1. What is the primary function of patent AU2001252144?
It protects a specific pharmaceutical compound or method, granting exclusive rights within Australia to prevent unauthorized manufacturing, use, or sale.
2. How broad are the claims typically in pharmaceutical patents like AU2001252144?
Claims vary, but they often include broad chemical compositions and narrower formulation or method-specific claims, affecting enforceability and vulnerability to challenges.
3. Can similar patents exist in other countries?
Yes. Many pharmaceutical patents are part of international patent families, with corresponding filings in jurisdictions like the US, Europe, or Asia.
4. What happens to the patent’s protection after expiry?
Once the patent term concludes, typically after 20 years, the invention falls into the public domain, enabling generic manufacturing.
5. How can companies extend the commercial life of a drug patent?
Through strategies such as secondary patents (e.g., polymorphs, new formulations), patent term extensions, or supplementary protection certificates where eligible.
References:
[1] Australian Patents Act 1990, as amended.
[2] Australian Patent Office Guidelines.
[3] World Intellectual Property Organization (WIPO) Patent Landscape Reports on Pharmaceuticals.
[4] Patent AU2001252144 database entries and legal status records.
