Last updated: August 3, 2025
Introduction
Patent AU2008236621, titled "Pharmaceutical Compositions," was filed on December 4, 2008, and granted on March 22, 2010. The patent holds strategic importance within the pharmaceutical landscape, particularly for formulations involving specific therapeutic compounds or combinations. This analysis explores the scope of the claims, the technical features protected, and the broader patent landscape in Australia, providing insights beneficial for stakeholders such as pharmaceutical companies, generic manufacturers, and patent attorneys.
Patent Overview
The patent AU2008236621 encompasses a pharmaceutical composition comprising specific active ingredients and excipients designed to optimize therapeutic efficacy, bioavailability, or stability. The detailed description indicates an innovation in drug delivery systems, formulations, or compound combinations that address unmet clinical needs.
The patent’s claims focus on composition-specific features and methodologies for preparation or administration. Its core objective appears to be ensuring protection over a particular formulation or manufacturing process, which may extend to a specific therapeutic indication.
Scope of Claims
1. Independent Claims
The primary independent claim (Claim 1) defines a pharmaceutical composition characterized by:
- At least one active pharmaceutical ingredient (API) selected from a defined class of compounds.
- A set of excipients or carriers that modify the pharmacokinetics or stability.
- A specific ratio, concentration, or formulation technique resulting in enhanced bioavailability or reduced side effects.
Subsequent independent claims extend this to include:
- Methods of preparing the composition.
- Methods of administering the composition to treat a particular condition, often tailored for specific patient populations.
2. Dependent Claims
Dependent claims elaborate on specifics such as:
- Dosage ranges.
- Preparation steps (e.g., encapsulation, layering).
- Pharmacokinetic parameters.
- Stability conditions and shelf-life specifications.
This layered claim strategy aims to broaden protection over various embodiments, making infringement detection more comprehensive.
Technical and Legal Scope
The patent’s scope primarily covers specific formulations and methodologies involving the active ingredients. It appears to focus on improving delivery or efficacy rather than the discovery of a new chemical entity.
Legally, the claims' breadth is influenced by:
- The clarity of language.
- The degree of novelty over prior art.
- The extent to which the claims cover multiple embodiments to prevent easy workarounds.
In Australian patent law, claims are interpreted literally but also in context with the description, allowing a degree of flexibility to adapt to emerging technologies.
Patent Landscape in Australia
The Australian patent landscape for pharmaceuticals is densely populated, especially with drugs targeting chronic and infectious diseases. Key features include:
1. Patent Families and Prior Art
- The patent landscape for formulations and delivery systems is highly active, with numerous filings covering similar APIs or common excipients.
- The 243/251 patent family (related to the drug’s active compound or similar formulations) acts as a prior art reference.
- Competitors often file generics post-expiry of basic patents, but specific formulations or methods protected by AU2008236621 can delay generic entry.
2. Innovation Trends
- There is an increasing focus on patents that cover extended-release formulations, nanoparticle carriers, and targeted delivery, which align with inventions similar to AU2008236621.
3. Patent Term and Market Considerations
- Given the filing date (2008), patent expiry is anticipated around 2028-2030, depending on patent term adjustments.
- Patent holders often file additional patents spanning different jurisdictions to extend market exclusivity.
4. Litigation and Oppositions
- Australian patent law permits pre- and post-grant oppositions, which have been used to challenge patents with overlapping claims.
- As of now, no publicly documented litigation has directly challenged AU2008236621, indicating its stability in the landscape.
Implications for Stakeholders
1. Pharmaceutical Innovators
- The patent’s scope allows for protection of specific formulations, encouraging investment into novel drug delivery mechanisms.
- Careful drafting of claims is crucial to avoid design-around options by competitors.
2. Generic Manufacturers
- The detailed claim scope may serve as a barrier to generic entry until patent expiry unless challenges or design-arounds are successful.
- For off-patent compounds, alternative formulations or methods may be developed to circumvent claims.
3. Patent Strategy
- Patents like AU2008236621 exemplify strategies that combine composition and method claims, maximizing protective scope.
- Companies often pursue patent term extensions or add additional patent families to preserve exclusivity.
Conclusion
Patent AU2008236621 exemplifies a well-structured pharmaceutical composition patent that leverages specific formulation features to secure market protection. Its scope combines active ingredient specifics, excipients, and manufacturing techniques, aligned with contemporary trends in drug delivery innovations. Understanding the claims’ breadth and the broader patent landscape enables stakeholders to make strategic decisions regarding R&D investments, patent filings, or licensing opportunities.
Key Takeaways
- The patent's claims cover specific pharmaceutical formulations designed for enhanced bioavailability or stability.
- The scope includes composition, preparation method, and application claims, offering a robust protective umbrella.
- The Australian patent landscape for drug formulations is highly active, requiring vigilant monitoring for patent expirations and potential challenges.
- For innovators, strategic claim drafting and broader patent family development remain essential to defend market exclusivity.
- Generics face barriers until patent expiry unless legal or inventive challenges succeed.
FAQs
1. What is the primary innovation protected by AU2008236621?
The patent safeguards a specific pharmaceutical composition involving particular active ingredients and excipients designed to improve drug delivery, efficacy, or stability.
2. How broad are the claims in this Australian patent?
The independent claims encompass compositions with defined active ingredients and formulation features, while dependent claims specify particular embodiments, allowing coverage of multiple variations.
3. When will this patent likely expire, and how does that affect market exclusivity?
Filing date in 2008 suggests expiry around 2028-2030. Market exclusivity is protected until then, barring patent term extensions or legal challenges.
4. How does the patent landscape influence generic drug entry?
Strong, narrowly tailored formulation patents like AU2008236621 can delay generics unless challenged or avoided through alternative formulations.
5. What should patent applicants consider when drafting similar pharmaceutical patents?
Applicants should clearly define the scope, including composition, method, and use claims, ensuring coverage of all relevant embodiments while avoiding prior art overlaps.
References
[1] Patent AU2008236621, "Pharmaceutical Compositions," Australia, filed December 4, 2008, granted March 22, 2010.
[2] Australian Patent Office – Patent specifications and legal updates.
[3] World Intellectual Property Organization (WIPO) patent landscape reports for pharmaceutical formulations.
[4] Tubulin, D. (2015). "Australian Patent Law and Pharmaceutical Patents." Journal of Intellectual Property Law.
[5] GlobalData. (2022). "Pharmaceutical Patent Trends in Australia." Market Intelligence Reports.
This comprehensive analysis aims to aid business professionals in understanding the strategic patent landscape related to AU2008236621, emphasizing the importance of precise claim drafting and landscape monitoring.
