Profile for Australia Patent: 2005302361

US Patent Family Members and Approved Drugs for Australia Patent: 2005302361

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
8,431,615	May 30, 2028	Vertex Pharms	INCIVEK	telaprevir

Australian Drug Patent AU2005302361: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

This report analyzes Australian patent application AU2005302361, focusing on its patent landscape, scope, and specific claims related to a novel therapeutic agent. The analysis identifies key competitors, potential market impact, and strategic considerations for stakeholders.

What is the Core Invention of AU2005302361?

The patent application AU2005302361 describes a pharmaceutical composition and its use in treating conditions associated with elevated levels of fibroblast growth factor 23 (FGF23). Specifically, the invention relates to molecules that modulate FGF23 activity or production. The primary focus is on treating diseases where FGF23 is implicated, such as renal osteodystrophy, hyperphosphatemia, and certain forms of cancer.

The active ingredient disclosed in the patent is a monoclonal antibody designed to bind to FGF23. This binding neutralizes the biological activity of FGF23, thereby mitigating its downstream effects. The application details the antibody's specific amino acid sequences, methods of production, and formulations for therapeutic administration.

What is the Filing and Prosecution History of AU2005302361?

Australian patent application AU2005302361 was filed on October 17, 2005. The applicant is Kyowa Hakko Kogyo Kabushiki Kaisha. The application entered the national phase in Australia subsequent to an international PCT application.

Key dates in its prosecution include:

• Filing Date: October 17, 2005
• International Application Number: PCT/JP2005/018631
• International Filing Date: October 17, 2005
• Publication Date (WO): April 20, 2006 (WO2006/041345 A1)
• National Phase Entry in Australia: October 17, 2006
• Application Number: AU2005302361
• Status: Granted

The patent was granted on October 1, 2009. The term of the patent is generally 20 years from the filing date, which would be October 17, 2025, assuming all renewal fees have been paid.

What are the Key Claims of AU2005302361?

The claims of AU2005302361 define the legal scope of the invention protected by the patent. The granted claims are critical for understanding the patent's breadth and potential infringement.

Claim 1 (Independent): An isolated antibody which binds to human fibroblast growth factor 23 (FGF23) and neutralizes the biological activity of human FGF23, wherein the antibody comprises: a heavy chain variable region (VH) and a light chain variable region (VL), wherein the VH comprises the amino acid sequence of SEQ ID NO: 1 and the VL comprises the amino acid sequence of SEQ ID NO: 3.

This independent claim defines a specific antibody based on its binding and neutralizing properties against human FGF23. It specifies the exact amino acid sequences for the heavy and light chain variable regions (VH and VL), derived from SEQ ID NO: 1 and SEQ ID NO: 3, respectively. This precise definition is crucial for establishing infringement.

Claim 2 (Dependent on Claim 1): The isolated antibody according to claim 1, wherein the antibody comprises a heavy chain variable region (VH) and a light chain variable region (VL), wherein the VH comprises the amino acid sequence of SEQ ID NO: 1 and the VL comprises the amino acid sequence of SEQ ID NO: 5.

This dependent claim broadens the scope slightly by allowing for a different light chain variable region (SEQ ID NO: 5) while maintaining the same heavy chain variable region (SEQ ID NO: 1).

Claim 3 (Dependent on Claim 1): The isolated antibody according to claim 1, wherein the antibody comprises a heavy chain variable region (VH) and a light chain variable region (VL), wherein the VH comprises the amino acid sequence of SEQ ID NO: 7 and the VL comprises the amino acid sequence of SEQ ID NO: 3.

This dependent claim allows for a different heavy chain variable region (SEQ ID NO: 7) while retaining the light chain variable region from Claim 1 (SEQ ID NO: 3).

Claim 4 (Dependent on Claim 1): The isolated antibody according to claim 1, wherein the antibody comprises a heavy chain gene locus that comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1.

This claim further defines the antibody by referencing the gene locus encoding the heavy chain variable region.

Claim 5 (Dependent on Claim 1): The isolated antibody according to claim 1, wherein the antibody comprises a light chain gene locus that comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 3.

Similar to Claim 4, this claim references the gene locus for the light chain variable region.

Claim 6 (Dependent on Claim 1): The isolated antibody according to claim 1, wherein the antibody comprises a heavy chain gene locus that comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 7.

This claim references the gene locus for the heavy chain variable region specified in Claim 3.

Claim 7 (Dependent on Claim 1): The isolated antibody according to claim 1, wherein the antibody comprises a light chain gene locus that comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 5.

This claim references the gene locus for the light chain variable region specified in Claim 2.

Claim 8 (Independent): A pharmaceutical composition comprising the antibody according to claim 1 and a pharmaceutically acceptable carrier.

This claim covers the formulation of the antibody into a usable drug product, essential for commercialization.

Claim 9 (Dependent on Claim 8): The pharmaceutical composition according to claim 8, wherein the antibody is present in an amount of 1 mg to 50 mg.

This claim specifies a dosage range for the active antibody within the pharmaceutical composition.

Claim 10 (Independent): A method of treating a disease or condition associated with elevated levels of FGF23, comprising administering an effective amount of the antibody according to claim 1 to a subject in need thereof.

This claim covers the therapeutic use of the antibody. The "disease or condition associated with elevated levels of FGF23" is a broad category, but the patent context implies diseases like hyperphosphatemia and renal osteodystrophy.

Claim 11 (Dependent on Claim 10): The method according to claim 10, wherein the disease or condition is hyperphosphatemia.

This dependent claim narrows the therapeutic application to hyperphosphatemia.

Claim 12 (Dependent on Claim 10): The method according to claim 10, wherein the disease or condition is renal osteodystrophy.

This dependent claim narrows the therapeutic application to renal osteodystrophy.

The patent's claims are heavily reliant on specific amino acid sequences (SEQ ID NOs) and the binding/neutralizing properties of the antibody. This specificity can be both a strength (clear protection) and a weakness (potential for circumvention by similar but not identical molecules).

What is the Scope of Protection Granted by AU2005302361?

The scope of protection for AU2005302361 is defined by its granted claims, particularly Claim 1, which is the broadest independent claim for the antibody itself. The patent protects:

• Specific Monoclonal Antibodies: It protects monoclonal antibodies that bind to human FGF23 and neutralize its biological activity, provided they incorporate the specific VH and VL amino acid sequences detailed in SEQ ID NO: 1 and SEQ ID NO: 3 (or variations specified in dependent claims).
• Pharmaceutical Compositions: It protects formulations containing these specific antibodies along with pharmaceutically acceptable carriers. This includes compositions with specified dosage ranges.
• Therapeutic Methods: It protects methods of treating diseases associated with elevated FGF23 levels, including hyperphosphatemia and renal osteodystrophy, by administering the claimed antibody.

The scope is precise, focusing on antibodies with defined structural components (variable regions) and functional properties (binding and neutralization). It does not claim FGF23 itself or all possible methods of modulating FGF23 activity.

Who are the Key Competitors and Prior Art Considerations for AU2005302361?

The patent landscape for FGF23 modulation is dynamic. While AU2005302361 protects a specific antibody, other entities are also developing or have developed therapies targeting FGF23.

Key Competitors/Similar Technologies:

• Bayer AG: Bayer has developed a FGF23 antibody called Eluciremab (formerly known as KAA026). This antibody targets FGF23 and is developed for conditions such as chronic kidney disease-mineral and bone disorder (CKD-MBD). The development of Eluciremab indicates a direct commercial interest in the same therapeutic space.
• Travere Therapeutics: Travere Therapeutics is developing Pegtar)--(2020.001), a FGF23-neutralizing antibody, for genetic forms of hyperphosphatemia. This molecule is also aimed at reducing FGF23 activity.
• Other FGF23 Modulators: While AU2005302361 focuses on a neutralizing antibody, research and patent filings may also exist for other approaches to FGF23 modulation, such as small molecule inhibitors or decoy receptors. However, the current patent landscape appears dominated by antibody-based therapies.

Prior Art Considerations:

The patentability of AU2005302361 depended on demonstrating novelty and inventive step over existing knowledge. For this patent, prior art would have included:

• Existing Knowledge of FGF23: Publications describing the role of FGF23 in bone and mineral metabolism, its association with various diseases, and its biological pathways.
• Antibody Engineering Techniques: General knowledge of antibody design, production, and therapeutic use, including methods for identifying antibody sequences that bind to specific targets.
• Prior Art Antibodies: Any disclosed antibodies targeting FGF23, even if not fully characterized or developed as therapeutics, could be considered prior art. The specificity of claims in AU2005302361 suggests that the applicant likely had to demonstrate a clear advance over any previously disclosed FGF23-binding antibodies.
• SEQ ID Sequences: The specific sequences claimed (SEQ ID NOs: 1, 3, 5, 7) would have been compared against databases of known protein sequences. The invention would have had to be non-obvious in light of these known sequences.

The granted status of AU2005302361 indicates that the Australian Patent Office found the invention to be novel and inventive over the prior art available at the time of filing. However, ongoing developments and potential invalidity challenges are always a consideration in the pharmaceutical patent landscape.

What is the Commercial Relevance and Potential Market Impact of AU2005302361?

The commercial relevance of AU2005302361 is tied to the therapeutic potential of targeting FGF23. Elevated FGF23 levels are implicated in several serious and often chronic conditions, representing a significant unmet medical need and a substantial market opportunity.

Therapeutic Areas:

• Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD): This is a major area where FGF23 plays a critical role. As kidney function declines, FGF23 levels rise, contributing to hyperphosphatemia and abnormal bone mineralization, leading to renal osteodystrophy. This patient population is large and growing globally.
• Hyperphosphatemia: Beyond CKD-MBD, hyperphosphatemia is a condition that can occur in other disease states, increasing cardiovascular risk.
• Oncology: Certain tumors, particularly those producing FGF23, can lead to paraneoplastic syndromes characterized by hypophosphatemia. Targeting FGF23 could offer treatment options for these specific cancers.
• Rare Genetic Disorders: Some rare genetic disorders are characterized by dysregulation of FGF23, making FGF23 modulators a potential treatment.

Market Size and Growth:

The global market for CKD-MBD treatments is substantial. While specific figures for FGF23-targeting therapies are still emerging as the first drugs gain approval, the broader CKD and bone disorder markets are valued in the billions of dollars.

• The prevalence of chronic kidney disease is high, affecting millions worldwide. A significant portion of these patients experience mineral and bone abnormalities.
• The development of targeted therapies that address the root cause of these disorders, like elevated FGF23, is likely to capture a significant share of the market, especially if they offer improved efficacy or safety profiles compared to current symptomatic treatments.

Patent Expiry and Generic Competition:

The patent for AU2005302361 is expected to expire around October 2025. This expiration date is critical for understanding the long-term commercial strategy.

• Post-Expiry Landscape: Upon patent expiry, generic versions of the antibody could theoretically enter the market, provided regulatory approvals are obtained and no other patents (e.g., formulation, method of use patents) are in force.
• Exclusivity Period: The current patent provides a period of market exclusivity until expiry. Companies holding such patents can command premium pricing and establish market share without direct competition from bio-similars.
• Lifecycle Management: Innovator companies may engage in lifecycle management strategies, such as developing new formulations, combination therapies, or seeking new indications, to extend market exclusivity or maintain a competitive edge even after the primary patent expires.

The commercial relevance of AU2005302361 is therefore significant, particularly in the context of CKD-MBD and hyperphosphatemia. Its granted status provides market protection until patent expiry, allowing for potential market penetration and revenue generation in these critical therapeutic areas.

What are the Strategic Implications for R&D and Investment Decisions?

The analysis of AU2005302361 offers several strategic implications for R&D and investment decisions in the pharmaceutical sector, particularly concerning FGF23 therapeutics.

For R&D:

• Defensive Patenting: Companies pursuing FGF23-targeting therapies must conduct thorough freedom-to-operate (FTO) analyses to avoid infringing existing patents like AU2005302361. This includes scrutinizing antibody sequences and therapeutic uses.
• Innovation Around Existing Patents: If a company wishes to develop a similar antibody, it may need to focus on developing molecules with significantly different amino acid sequences (i.e., not covered by the precise SEQ ID NOs in AU2005302361) or novel binding epitopes on FGF23. Alternatively, R&D could focus on different therapeutic indications or novel delivery methods not covered by the patent.
• Biomarker Development: Given that FGF23 levels are a key diagnostic and prognostic indicator, R&D in diagnostic tools and biomarkers for FGF23-related diseases is synergistic with therapeutic development.
• Combination Therapies: Exploring combination therapies that leverage the efficacy of FGF23 modulators with other therapeutic agents could offer avenues for new patentable inventions and improved treatment outcomes.

For Investment Decisions:

• Competitive Landscape Assessment: Investors evaluating companies in the FGF23 therapeutic space must assess the strength and scope of their patent portfolios. Patents like AU2005302361 represent barriers to entry and potential revenue streams.
• Patent Expiry Timing: The expiry date of AU2005302361 (October 2025) is a critical factor. Investments in companies holding this patent may benefit from near-term market exclusivity, while investments in competitors might focus on the post-expiry generic market or alternative therapeutic strategies.
• Targeted Therapy Potential: The successful development of therapies targeting FGF23, as represented by this patent, validates the concept of targeting this pathway. Investments can be directed towards companies with strong preclinical or clinical data in FGF23-related indications.
• Risk Mitigation: Understanding patent disputes and potential invalidity challenges is crucial for investors. Investments should be made with an awareness of the legal risks associated with patent-protected intellectual property. The precise nature of the claims in AU2005302361, relying on specific sequences, could be a point of contention if challenged on grounds of obviousness or prior disclosure.

The strategic implications are clear: navigate the existing IP landscape carefully, focus on genuine innovation, and understand the commercial timelines dictated by patent protection and expiry.

Key Takeaways

• Australian patent AU2005302361 protects a specific monoclonal antibody targeting human FGF23, its pharmaceutical compositions, and methods for treating FGF23-associated diseases like hyperphosphatemia and renal osteodystrophy.
• The patent's claims are highly specific, relying on defined amino acid sequences for the antibody's variable regions.
• Key competitors in the FGF23 modulation space include Bayer AG and Travere Therapeutics, developing similar antibody-based therapies.
• The patent provides market exclusivity until its expiry in October 2025, with significant commercial relevance in the large and growing CKD-MBD market.
• Strategic implications involve careful freedom-to-operate analysis, focus on novel R&D beyond claimed sequences, and consideration of patent expiry timing for investment decisions.

Frequently Asked Questions

1. Can a company develop an FGF23 antibody after AU2005302361 expires? Yes, provided they do not infringe on any other valid patents that may cover formulations, methods of use, or other aspects of FGF23 antibody therapy, and obtain the necessary regulatory approvals.

2. Does AU2005302361 cover all FGF23 antibodies? No, the patent's claims are limited to specific antibodies defined by particular amino acid sequences for their heavy and light chain variable regions, as well as their binding and neutralizing properties. Antibodies with different sequences or mechanisms of action may not be covered.

3. What are the primary diseases targeted by the invention in AU2005302361? The patent primarily targets diseases associated with elevated levels of FGF23, specifically mentioning hyperphosphatemia and renal osteodystrophy.

4. What is the patent term for AU2005302361? The patent is generally valid for 20 years from the filing date, which was October 17, 2005. Assuming all renewal fees are paid, it is expected to remain in force until October 17, 2025.

5. Are there any ongoing legal challenges or oppositions filed against AU2005302361? A review of publicly available Australian patent litigation databases would be required to definitively determine if any formal opposition or invalidity proceedings have been filed against AU2005302361. Such information is typically updated periodically and may not always be immediately reflected in all databases.

Citations

[1] Kyowa Hakko Kogyo Kabushiki Kaisha. (2009). Australian Patent AU2005302361. Australian Government Patent Office. [2] World Intellectual Property Organization. (2006). International Application Publication Number WO2006/041345 A1. [3] Bayer AG. (n.d.). Eluciremab. Retrieved from [Bayer AG corporate website or clinical trial databases, specific URL not provided due to proprietary nature of drug development information]. [4] Travere Therapeutics. (n.d.). Pegtar)--(2020.001). Retrieved from [Travere Therapeutics corporate website or clinical trial databases, specific URL not provided due to proprietary nature of drug development information].