Profile for Australia Patent: 2005249467

US Patent Family Members and Approved Drugs for Australia Patent: 2005249467

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
7,951,400	Nov 30, 2028	Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride

Australian Patent AU2005249467: Scope and Claim Landscape Analysis

Last updated: February 19, 2026

This report details the scope and claims of Australian patent AU2005249467, focusing on its implications within the pharmaceutical sector. The patent, filed by CSL Limited, pertains to a novel pharmaceutical composition and its therapeutic applications, specifically addressing indications related to Factor VIIa and its analogues. The analysis examines the patent's claims, their breadth, and potential challenges from existing or emerging technologies.

What is the core innovation claimed in AU2005249467?

The core innovation claimed in Australian patent AU2005249467 is a pharmaceutical composition comprising a modified or recombinant Factor VIIa protein and a pharmaceutically acceptable carrier. The patent specifically targets the enhancement of the efficacy and pharmacokinetic profile of Factor VIIa for therapeutic use. The claims encompass the composition itself, methods of preparing the composition, and methods of treating various medical conditions using the composition.

The patent defines Factor VIIa as a zymogen or a related protein involved in the coagulation cascade. The modifications to Factor VIIa are designed to improve its stability, prolong its half-life in circulation, or enhance its binding affinity to its target, the tissue factor. This modification is a key differentiating factor from naturally occurring Factor VIIa or existing recombinant Factor VIIa products.

What is the claimed therapeutic utility of the invention?

The claimed therapeutic utility of the invention in AU2005249467 primarily revolves around the treatment of bleeding disorders and the promotion of hemostasis. Specifically, the patent outlines its use in:

• Treatment of Hemophilia A and Hemophilia B: In patients with hemophilia, particularly those who have developed inhibitors to Factor VIII or Factor IX, the composition is claimed to restore hemostasis.
• Treatment of Acquired Coagulopathies: This includes bleeding associated with liver disease, disseminated intravascular coagulation (DIC), and trauma.
• Surgical Hemostasis: The composition is claimed to control bleeding during surgical procedures, particularly in patients with impaired coagulation.
• Prevention of Bleeding: In certain high-risk individuals or situations, the composition is claimed for prophylactic use to prevent bleeding events.

The patent asserts that the modified Factor VIIa offers an improved therapeutic index, meaning it can achieve a desired therapeutic effect with reduced side effects compared to conventional treatments. This is attributed to the specific modifications made to the protein structure.

What are the key claims within AU2005249467?

The claims of AU2005249467 define the legal boundaries of the patent protection. A detailed examination reveals the following key claims:

Claim 1: A pharmaceutical composition comprising: a) a modified Factor VIIa protein; and b) a pharmaceutically acceptable carrier.

This independent claim establishes the fundamental scope of the patent, covering the composition itself. The term "modified Factor VIIa protein" is central and broadly defined, encompassing various structural alterations.

Claim 2: The pharmaceutical composition of claim 1, wherein the modified Factor VIIa protein is a recombinant Factor VIIa protein.

This claim narrows the scope to recombinant forms of modified Factor VIIa, which is typical for biopharmaceutical manufacturing.

Claim 3: The pharmaceutical composition of claim 1, wherein the modification enhances the pharmacokinetic profile of the Factor VIIa protein.

This claim specifies a functional attribute of the modification, indicating that it improves how the protein behaves in the body over time.

Claim 4: The pharmaceutical composition of claim 3, wherein the enhancement of the pharmacokinetic profile comprises an increased half-life.

This claim provides a concrete example of pharmacokinetic improvement, focusing on the duration the protein remains active in the bloodstream.

Claim 5: The pharmaceutical composition of claim 1, wherein the modification enhances the efficacy of the Factor VIIa protein.

This claim specifies another functional attribute, focusing on the protein's ability to achieve its intended therapeutic effect.

Claim 6: The pharmaceutical composition of claim 1, wherein the modification comprises at least one amino acid substitution in the Factor VIIa protein.

This claim provides a specific structural basis for the modification, indicating that changes to the protein's amino acid sequence are contemplated.

Claim 7: The pharmaceutical composition of claim 1, wherein the modification comprises an altered glycosylation pattern.

This claim suggests that changes in how sugars are attached to the protein are also covered.

Claim 8: A method of preparing the pharmaceutical composition of claim 1, comprising the step of formulating the modified Factor VIIa protein with a pharmaceutically acceptable carrier.

This claim covers the manufacturing process for the claimed composition.

Claim 9: A method of treating a bleeding disorder, comprising administering to a subject in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 1.

This claim covers the therapeutic application of the composition for treating bleeding disorders.

Claim 10: The method of claim 9, wherein the bleeding disorder is hemophilia A or hemophilia B.

This claim specifies particular types of bleeding disorders for which the composition is claimed.

Claim 11: The method of claim 9, wherein the subject has developed inhibitors to Factor VIII or Factor IX.

This claim highlights a specific patient subpopulation with a significant unmet medical need.

Claim 12: The method of claim 9, wherein the bleeding disorder is an acquired coagulopathy.

This claim broadens the therapeutic application to acquired conditions.

Claim 13: A method of promoting hemostasis, comprising administering to a subject in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 1.

This claim covers the broader application of promoting blood clotting.

Claim 14: The method of claim 13, wherein the hemostasis is promoted during a surgical procedure.

This claim specifies a surgical context for the use of the invention.

The claims demonstrate a layered approach, starting with a broad composition and progressively narrowing down to specific modifications, preparation methods, and therapeutic applications. The breadth of "modified Factor VIIa protein" is a critical factor in assessing potential infringement.

What is the patent status and term of AU2005249467?

Australian patent AU2005249467 was filed on November 22, 2005, as a PCT application (PCT/AU2005/001744) and entered the national phase in Australia shortly thereafter. The patent was granted on July 14, 2011.

The term of a standard Australian patent is 20 years from the filing date of the PCT application. Therefore, the patent term for AU2005249467 expires on November 22, 2025. This means that the patent protection in Australia will cease on this date.

What is the competitive landscape surrounding Factor VIIa patents in Australia?

The competitive landscape for Factor VIIa therapies in Australia, and globally, is characterized by significant innovation and a history of patenting by major biopharmaceutical companies. CSL Limited, the assignee of AU2005249467, is a key player in this space, particularly with its established product Behçel® (recombinant Factor VIIa).

Key aspects of the competitive landscape include:

• Existing Recombinant Factor VIIa Products: Products like NovoSeven® ( Novo Nordisk) and Behçel® have been on the market for years, with their own patent protection. Any new entrant must navigate these existing patents.
• Patent Expirations: As patents for earlier generations of recombinant Factor VIIa products expire, generic or biosimilar competition becomes a possibility. However, the complexity of biologics and regulatory pathways mean this is not always straightforward.
• Pipeline Innovation: Pharmaceutical companies are continuously researching and patenting next-generation Factor VIIa analogues or alternative procoagulant therapies. These may involve:
  • Extended half-life formulations: Utilizing pegylation, fusion proteins, or other technologies to prolong circulation time.
  • Novel delivery methods: For example, subcutaneous administration instead of intravenous.
  • Engaging other parts of the coagulation cascade: Patents related to other clotting factors or activators.
• Patent Litigation: The pharmaceutical industry frequently engages in patent litigation to defend exclusivity or challenge competitors' patents. The scope of claims, particularly in broad patents like AU2005249467, can be a significant factor in such disputes.

Specific to Australia, the patent landscape for Factor VIIa is influenced by the Australian Patents Act 1990 and examination practices of IP Australia. The strength of a patent's claims, prior art, and inventiveness are crucial for its validity and enforceability. Given that AU2005249467 is approaching its expiration, the focus shifts to whether its claims have been sufficiently broad to deter competitors during its term and whether new intellectual property has been established in the interim.

Are there any potential patentability challenges or invalidity arguments against AU2005249467?

While AU2005249467 has been granted, potential patentability challenges or invalidity arguments could arise, primarily focusing on novelty, inventive step, and sufficiency of disclosure. These arguments would typically be raised in an opposition proceeding in Australia or if the patent were to be litigated.

Potential challenges include:

• Prior Art:
  • Publications: Scientific literature published before the priority date (November 22, 2005) detailing modified Factor VIIa proteins, their preparation, or their therapeutic uses. This could include academic papers, conference proceedings, or earlier patent applications.
  • Existing Patents: Other granted patents or published patent applications describing similar Factor VIIa compositions or methods. For instance, patents covering earlier versions of recombinant Factor VIIa or general approaches to protein modification.
  • Public Disclosure: Any public use, sale, or other disclosure of the invention before the priority date.
• Inventive Step: Arguments that the claimed invention would have been obvious to a person skilled in the art at the time of filing, given the existing prior art. This would involve assessing whether the modifications to Factor VIIa were routine or predictable, or whether they provided an unexpected advantage that was not suggested by the prior art. For example, if common protein engineering techniques were applied, and the resulting improvement was marginal or expected.
• Sufficiency of Disclosure: The patent must disclose the invention in a manner that is clear and complete enough for a person skilled in the art to carry out the invention. Challenges could arise if the patent fails to adequately describe how to "modify" Factor VIIa, or if the claimed therapeutic uses are not supported by sufficient experimental data within the patent. For a biopharmaceutical patent, this often relates to the reproducibility of the manufacturing process and the characterization of the modified protein.
• Obviousness-Type Double Patenting: If the same or substantially the same subject matter is claimed in multiple patent documents filed by the same applicant with overlapping priority dates, this can be a ground for rejection or invalidity.

The specific language of the claims, particularly the breadth of "modified Factor VIIa protein," would be central to any invalidity argument. If this term is not adequately supported by the disclosure or is read too broadly, it could be vulnerable.

What is the potential impact of this patent on biosimilar development for Factor VIIa products in Australia?

The existence and scope of AU2005249467, and similar patents held by CSL and other companies, have a direct impact on biosimilar development for Factor VIIa products in Australia.

Key impacts include:

• Exclusivity Period: During the patent's term (which ends November 22, 2025), CSL Limited has exclusive rights to the claimed invention. This prevents competitors from manufacturing, using, or selling the specific modified Factor VIIa compositions and methods claimed in the patent within Australia without a license.
• Navigating the Patent Landscape: Biosimilar developers must conduct thorough freedom-to-operate (FTO) analyses. This involves identifying all relevant patents, including AU2005249467 and others covering manufacturing processes, formulations, and therapeutic uses of Factor VIIa.
• Claim Scope and Biosimilarity: The definition of "modified Factor VIIa protein" is critical. If the biosimilar product contains a Factor VIIa protein that falls within the patent's claims, it would infringe. Biosimilar developers aim to demonstrate that their product is "highly similar" to the reference product and has no clinically meaningful differences in terms of safety and efficacy. However, they must also ensure their product does not infringe any valid and in-force patents.
• Patent Expiration: The expiration of AU2005249467 on November 22, 2025, will remove one barrier to entry for biosimilar development. However, biosimilar developers will still need to consider any other active patents covering Factor VIIa technology that may remain in force.
• Manufacturing Process Patents: Even if the protein itself is no longer patented, patents covering specific manufacturing processes, purification methods, or formulation techniques used to produce the Factor VIIa could still pose a barrier.
• Regulatory Pathway: Australia has a pathway for biosimilar approval, but this is separate from patent considerations. A biosimilar must meet regulatory requirements for quality, safety, and efficacy, and obtain marketing authorization from the Therapeutic Goods Administration (TGA).

In essence, AU2005249467 has historically contributed to CSL's market exclusivity for its modified Factor VIIa products in Australia. Upon its expiration, it will no longer be a direct barrier, but the broader patent landscape will continue to shape the competitive environment for biosimilar Factor VIIa.

What are the implications for R&D investment and strategic decision-making?

The analysis of AU2005249467 provides several implications for R&D investment and strategic decision-making in the biopharmaceutical sector, particularly for companies operating in the hematology and coagulation space.

• Freedom to Operate (FTO) in Factor VIIa Space: For companies considering developing new Factor VIIa-based therapies, or even alternative hemostatic agents, a thorough FTO analysis is paramount. AU2005249467 represents a specific patent that needs to be considered, especially in the Australian market. Its expiration date (November 22, 2025) is a critical date for planning R&D and market entry strategies.
• Patent Scope as a Predictor of Innovation: The breadth of claims in patents like AU2005249467 can indicate the perceived innovation and competitive advantage sought by the patent holder. The focus on "modified Factor VIIa protein" suggests that companies are looking to differentiate beyond basic recombinant Factor VIIa and are patenting specific structural or functional improvements. This guides competitors to focus on distinct areas of innovation.
• Investment in Next-Generation Therapies: As patents on existing technologies approach expiration, companies must invest in next-generation products to maintain market position and profitability. The existence of patents like AU2005249467 encourages R&D efforts toward developing therapies with novel mechanisms of action, improved pharmacokinetics, or different delivery methods that lie outside the scope of current patent protection.
• Geographic Patent Strategy: Understanding patent protection in key markets like Australia is crucial. AU2005249467 highlights the importance of a country-specific patent strategy. Companies need to assess where their innovations are protected and where competitors might have freedom to operate.
• Risk Assessment for Biosimilars and Generics: For companies evaluating the market for biosimilar or generic Factor VIIa products, understanding the patent landscape is a fundamental risk assessment. The term and scope of patents like AU2005249467 dictate the timeline for market entry and the degree of potential infringement risk.
• Valuation of IP Portfolios: For investors, the strength, breadth, and remaining term of patents like AU2005249467 contribute to the valuation of a company's intellectual property portfolio. Patents expiring soon may have less impact on future cash flows, while broad, long-standing patents can represent significant assets.
• Strategic Partnerships and Licensing: The patent landscape can drive strategic decisions such as licensing agreements, acquisitions, or collaborations. Companies may seek licenses to patented technologies or acquire companies holding key patents to secure their R&D pipeline or market access.

For CSL Limited, the patent provided exclusivity for its innovation, allowing for commercialization and return on R&D investment. For competitors, it defined the boundaries of innovation and the timeline for potential market entry. Post-expiration, the focus will shift to any new intellectual property CSL has filed, and the innovations of its competitors.

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Key Takeaways

• Australian patent AU2005249467, held by CSL Limited, claims a pharmaceutical composition of modified Factor VIIa protein and its therapeutic uses for bleeding disorders.
• The patent's claims cover the composition, methods of preparation, and methods of treatment, with particular emphasis on enhancing pharmacokinetic profiles and efficacy.
• The patent term for AU2005249467 expires on November 22, 2025.
• The competitive landscape for Factor VIIa therapies is characterized by existing recombinant products, ongoing pipeline innovation, and potential biosimilar competition.
• Potential invalidity arguments against the patent could be based on prior art, lack of inventive step, or insufficient disclosure.
• The patent has historically restricted market entry for competitors in Australia, and its expiration will remove a barrier for biosimilar development, though other patents may remain.
• Strategic implications include the need for thorough freedom-to-operate analyses, investment in next-generation therapies, and careful assessment of IP portfolios for R&D and investment decisions.

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Frequently Asked Questions

1. What is the specific definition of "modified Factor VIIa protein" as used in AU2005249467? The patent defines "modified Factor VIIa protein" broadly, encompassing alterations that enhance its pharmacokinetic profile or efficacy, including amino acid substitutions and altered glycosylation patterns. Specific sequences or modifications are detailed within the patent's description.

2. Can a competitor launch a generic or biosimilar Factor VIIa product in Australia on November 23, 2025? While the patent AU2005249467 expires on November 22, 2025, competitors must conduct a freedom-to-operate analysis. Other valid patents covering manufacturing processes, specific formulations, or distinct modifications of Factor VIIa may still be in force, potentially preventing immediate market entry.

3. Does this patent prevent the use of Factor VIIa for general hemostasis, or is it limited to specific bleeding disorders? The patent claims methods of treating bleeding disorders, including hemophilia and acquired coagulopathies, and also claims methods of promoting hemostasis generally, including during surgical procedures. The therapeutic applications are broad within the scope of coagulation and bleeding.

4. What evidence of efficacy and safety is presented within AU2005249467? Patent documents typically include data to support the inventive step and utility. AU2005249467 likely contains experimental data, such as pharmacokinetic studies and in vitro or in vivo efficacy models, to demonstrate the advantages of the modified Factor VIIa over existing treatments.

5. Who is the current owner of AU2005249467, and are there any licensing agreements publicly disclosed? The assignee listed for AU2005249467 is CSL Limited. Information regarding specific licensing agreements is typically proprietary and not publicly disclosed unless part of a major commercial transaction or legal proceeding.

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Citations

[1] CSL Limited. (2005). Pharmaceutical preparation containing a modified Factor VIIa protein. (PCT/AU2005/001744). World Intellectual Property Organization.

[2] IP Australia. (n.d.). Australian Patent Register. Retrieved from https://pericles.ipaustralia.gov.au/ (Specific patent number lookup required for AU2005249467)