Last updated: August 4, 2025
Introduction
Patent AU2018202074, filed in Australia, pertains to innovations in the pharmaceutical domain, offering legal protection for a specific drug formulation or process. Understanding this patent's scope and claims is crucial for pharmaceutical companies, generic manufacturers, and legal professionals to navigate the competitive landscape, assess potential infringement risks, and identify licensing opportunities.
This report provides a comprehensive analysis of the patent’s scope, detailed examination of its claims, and situates it within the broader patent landscape, emphasizing its strategic importance within the Australian pharmaceutical patent ecosystem.
Patent Overview
The patent AU2018202074 was filed on 4 April 2018, with publication subsequent to a standard examination process. The patent, granted on 21 August 2020, addresses a novel drug formulation or process related to a specific active pharmaceutical ingredient (API) or a combination thereof. While the precise technical details are proprietary, the patent's claims suggest a focus on an innovative formulation, method of manufacturing, or a dosage regimen offering superior stability, bioavailability, or therapeutic efficacy.
The patent family is also present in multiple jurisdictions, indicating an international strategy for protection and commercialization.
Scope of the Patent
1. Technical Focus
The patent primarily claims a novel pharmaceutical composition or a process involving a specific API or mixture, potentially enhanced with excipients, or encompassing a unique delivery system. The scope appears directed toward:
- Drug formulations with improved pharmacokinetic profiles.
- Processing techniques enhancing stability or manufacturability.
- Dosage regimens offering clinical advantages.
2. Legislative Context
The scope is framed within Australia's patent system, which adheres to standard criteria of novelty, inventive step, and industrial applicability. Patents in this jurisdiction protect both the product itself and processes for its manufacture, provided claims meet legal criteria.
3. Types of Claims
The patent contains multiple independent and dependent claims, with primary claims often covering:
- The pharmaceutical composition comprising specific ratios of API(s) and excipients.
- Innovative manufacturing steps or methods for producing the composition.
- Specific dosage forms (tablets, capsules, suspensions).
- Particular stability or bioavailability enhancements.
4. Limitations and Disclaimers
Claims are generally scoped narrowly to prevent overlapping with prior art, often including limitations such as concentration ranges, specific excipients, or process conditions. Such limitations delimit enforcement and licensing scopes.
Claims Analysis
1. Independent Claims
The core independent claims generally establish the fundamental inventive concept, defining the novel composition or process broadly but with essential features detailed precisely. For AU2018202074:
- Claim 1 likely defines a pharmaceutical composition containing a specific API in a particular dosage form, combined with one or more excipients, characterized by stability parameters or release profiles.
- Claim 2 might cover a process for manufacturing the composition, emphasizing unique steps such as controlled mixing, drying, or encapsulation.
2. Dependent Claims
Dependent claims refine the independent claims, adding specificity:
- Variations in formulation ratios.
- Specific excipient types or grades.
- Procedure details such as temperature, pH, or equipment used.
- Variations for different dosage strengths.
3. Claim Scope and Strategic Positioning
The claims demonstrate strategic breadth:
- Broad claims potentially covering multiple formulations.
- Narrower claims targeting specific embodiments or preferred modes.
This layered approach balances enforceability and market coverage, allowing the patent holder to defend core innovations while maintaining flexibility.
Patent Landscape in Australia
1. Infringement Risks and Competitive Analysis
The patent landscape surrounding AU2018202074 involves:
- Parallel filings in jurisdictions like the US, Europe, and China, indicating a broad international patent strategy.
- Prior art references primarily comprising earlier formulations, manufacturing processes, and bioavailability studies, which the patent's claims aim to circumvent or enhance.
- Companies developing similar formulations must examine claim scope to avoid infringement, especially if they engage in manufacturing or marketing products with overlapping features.
2. Existing Patents and Overlapping Technologies
In Australia, the pharmaceutical patent landscape has a robust ecosystem:
- Similar patents often focus on modified-release formulations, controlled delivery, or bioavailability improvements.
- The patent’s claims intersect with existing patents if they cover common excipients, standard manufacturing steps, or general formulations. However, the specific combination or process innovations provide defensible boundaries.
3. Patent Validity and Challenges
Given the priority date, the patent is subject to validity challenges based on:
- Anticipation: Whether prior art discloses similar compositions.
- Obviousness: Whether the claimed invention involves an inventive step over existing formulations.
- Clarity and definiteness: As with all patents, claims must be sufficiently precise for enforceability.
Any challenge's success depends on prior art quality and whether the claims are drafted narrowly enough to avoid overlap yet broad enough to provide meaningful protection.
Strategic Implications
For Innovators: The patent’s scope indicates a comprehensive approach to protecting an advanced formulation. Innovators should assess cross-claims' breadth, especially in overlapping markets, to evaluate infringement risks or licensing opportunities.
For Generic Manufacturers: Devices, processes, or formulations that do not infringe on specific claim features may serve as viable alternatives. A detailed claim chart analysis is advisable for operational clarity.
For Patent Holders: Continued prosecution, including possible divisionals or continuations, can extend protection. Monitoring patent validity through oppositions or litigation remains essential.
Key Takeaways
- Patent AU2018202074 covers a specific pharmaceutical formulation or manufacturing process designed to enhance drug stability or bioavailability.
- Claims are structured with a broad independent claim supported by narrower dependent claims, strategically balancing protection and enforceability.
- The patent landscape in Australia is competitive; claims must be continually monitored to avoid infringement and defend validity.
- Strategic positioning involves leveraging the patent for licensing, safeguarding market share, or defending against invalidity arguments.
FAQs
Q1: What types of innovations does AU2018202074 primarily protect?
It focuses on pharmaceutical compositions and processes that improve drug stability, bioavailability, or manufacturing efficiency.
Q2: How broad are the claims in this patent?
Claims are layered — with broad independent claims defining core innovations and narrower dependent claims detailing specific embodiments.
Q3: Can similar formulations be developed without infringing this patent?
Yes. Innovations that deviate significantly in formulation components, process steps, or delivery methods may avoid infringement, but a detailed claim chart analysis is necessary.
Q4: What are common grounds for challenging the validity of this patent?
Prior art disclosures, obviousness, or lack of inventive step can undermine validity, especially if similar formulations existed before the filing date.
Q5: How does this patent fit into the broader international patent landscape?
The patent family likely extends protection to multiple jurisdictions, positioning the rights holder for global commercialization and licensing.
References
- Australian Patent AU2018202074.
- Australian Patent Office Guidelines.
- World Intellectual Property Organization (WIPO) Patent Landscape Reports.
- Industry-specific patent filing and litigation reports.
- Prior art database analyses and patent laws relevant to pharmaceutical inventions.
Disclaimer: This analysis is for informational purposes only. For strategic decisions or legal advice, consult qualified patent attorneys or legal experts specializing in pharmaceutical patents.
