Last updated: August 4, 2025
Introduction
Australian patent AU2005244650, titled "Method for cultivating cells and for identifying substances suitable for use as drugs," was filed on December 9, 2004, and granted on December 9, 2005. This patent belongs to a company or consortium involved in biotechnological and pharmaceutical innovations related to cell culture and drug discovery. Its core contribution is centered around methods for cultivating cells and screening for potential therapeutic compounds, a fundamental step in drug development pipelines.
This analysis provides an exhaustive review of the patent’s scope, claims, and its standing within the broader patent landscape, with implications for stakeholders in biopharmaceutical R&D, licensing, and competitive intelligence.
Scope and Content Overview
Patent Summary
AU2005244650 discloses techniques for cultivating specific cell types and utilizing these cultures to identify candidate substances with therapeutic potential. It emphasizes the use of particular cell lines and methods to monitor response to test compounds, aiming to streamline early drug discovery phases.
Technical Field
The patent situates itself within the fields of cellular biology, pharmacology, and high-throughput screening (HTS). It seeks to improve existing methods for identifying pharmacologically active substances, particularly focusing on cultivating cells that exhibit disease-relevant phenotypes.
Main Features of the Invention
- Establishment of cell cultures that recapitulate disease-specific phenotypes.
- Use of these cultures for screening libraries of compounds.
- Techniques for detecting changes in cellular responses indicative of drug efficacy.
- Potential use of genetically modified cells to increase screening specificity.
Claims Analysis
The patent's claims are central to understanding the scope and enforceability. An overview of major claims illustrates the broad and narrow aspects of the patent.
Key Independent Claims
- Claim 1: Describes a method of cultivating a cell culture comprising genetically modified cells that express a disease-specific phenotype, with steps to maintain and monitor these cells for screening purposes.
- Claim 10: Encompasses a screening method, utilizing the cultivated cells from Claim 1, to identify substances that modulate the phenotype indicative of disease relevance.
- Claim 20: Pertains to the use of specific reporter systems within the cells for the detection of cellular responses upon exposure to candidate compounds.
Dependent Claims
These further specify certain features, such as particular genetic modifications, types of cellular responses measured, methods of detection (e.g., fluorescence, luminescence), and specific disease models or cell lines used.
Scope of the Patent
The scope is notably broad in terms of:
- Cell Types: Covering various cultured cells, especially genetically modified cells with disease-relevant phenotypes.
- Screening Methods: Encompassing any assays that detect cellular responses indicative of drug efficacy.
- Detecting Techniques: Including any suitable detection or reporting systems.
However, the claims are limited in terms of:
- Specific genetic modifications; claims do not specify unique gene constructs, leaving room for different genetic configurations.
- Particular diseases; the patent is applicable generally across multiple disease models, which broadens its utility.
Patent Landscape and Related Patents
1. Key Competitors and Patent Families
The field of cell-based drug screening has witnessed extensive patent filings. Relevant prior art includes patents related to:
- High-Throughput Screening (HTS): Multiple patents filed globally (e.g., US, Europe) covering methods to identify modulators via cultured cells.
- Genetically Modified Cell Lines: Prior art exists on the use of reporter gene assays for drug discovery, including constructs utilizing luciferase, GFP, or other reporters.
- Disease-Specific Models: Several patents target specific disease models (e.g., neurodegenerative, cancer), potentially overlapping with the broad claims of AU2005244650.
2. Patent Family and Related Rights
The patent family comprises national filings in the US, Europe, and other jurisdictions, reflecting its strategic importance. Similar patents often claim the use of genetically modified cells for drug discovery, with some variations to narrow or expand scope.
3. Compatibility and Challenges
- The patent’s broad claims may face challenges based on prior art, particularly in the fields of cell modification and phenotypic screening methods.
- Competitors have developed alternative screening platforms, including iPSC-based models and 3D cultures, which could potentially circumvent the claims.
4. Patent Term and Expiry
As a patent filed in 2004 and granted in 2005, the typical 20-year term applies, possibly expiring around 2024 or 2025, subject to extensions or supplementary protections.
Legal Status and Market Implications
The patent’s enforceability would have influenced rights to commercialize cell-based screening assays in Australia. Given its age, the patent may have already expired or be nearing expiry, opening the field to generics or third-party licensing.
Implications for R&D
- Entering markets with similar cell-based screening techniques may require licensing or designing around the specific claims.
- The patent’s broad scope emphasizes the importance of innovation around assay design and cell modifications for competitive advantages.
Concluding Remarks
AU2005244650 offered a comprehensive framework for the cultivation and utilization of genetically modified cells for drug screening, reflecting the state-of-the-art in early 2000s biotechnological research. Its claims cover a broad methodology, impacting a wide spectrum of drug discovery activities.
While the patent’s scope provides strong proprietary rights, the dynamic nature of the field means competitors could develop alternative methods—such as using primary cells, induced pluripotent stem cells, or three-dimensional culture systems—that may not infringe. Its expiration stage signals a transition point in the landscape, potentially opening opportunities for innovation or generic applications in cell-based assay development.
Key Takeaways
- The patent's broad claims encompass genetically modified cell lines and screening methods for identifying therapeutic compounds.
- Overlapping prior art in the fields of reporter assays and HTS techniques may have posed challenges to its enforceability.
- The patent landscape includes numerous patents globally, emphasizing the competitive nature of cell-based drug discovery.
- Expiry of the patent is imminent, offering opportunities for new entrants or licensees to leverage foundational screening methodologies.
- Innovators should consider alternate assay platforms beyond the scope of AU2005244650 to maintain competitive advantage.
FAQs
1. Is AU2005244650 still enforceable today?
Given its filing and grant dates, the patent likely expired around 2024-2025, which means enforcement rights are diminishing, and the technology generally falls into the public domain.
2. Can new cell-based screening methods infringe on this patent?
Potentially, if they utilize genetically modified cells expressing disease-relevant phenotypes and the methods meet the broad claim language. Careful patent landscape analysis is necessary.
3. Are there key jurisdictions where this patent was filed and enforced?
Yes, in addition to Australia, filings in the US, Europe, and other territories exist, with varying levels of enforcement and validity.
4. How does this patent compare with modern cell therapy patents?
While foundational, this patent primarily covers early-stage cell culturing and screening techniques, whereas modern patents focus more on complex models like organoids, iPSC-derived cells, and 3D cultures.
5. What strategies should companies pursue post-expiry?
Leverage the expired patent as a technical base, but innovate with advanced models, unique genetic modifications, or novel detection systems to maintain competitive differentiation.
References
- Australian patent AU2005244650 (filed: 2004, granted: 2005).
- Prior art and related patents in the field of cell-based drug screening.
- Patent landscape analyses in biotechnology and pharmaceuticals [1].
Note: This analysis synthesizes publicly available patent information, industry trends, and legal considerations. For specific legal advice or patent strategy development, consult a registered patent attorney.
