Last updated: February 19, 2026
This report details the scope and claims of Australian patent AU2017281296, focusing on its relevance to the pharmaceutical industry. The patent, granted to CSL Limited, covers specific pharmaceutical compositions and their use in treating iron deficiency. An analysis of its claims, geographic scope, and the broader patent landscape provides insights for R&D and investment.
What is the Core Innovation Protected by AU2017281296?
Patent AU2017281296 protects pharmaceutical compositions containing ferric derisomaltose. This active pharmaceutical ingredient is a complex of iron (III) hydroxide with a partially hydrolyzed dextrin (derisomaltose). The patent claims cover specific formulations of this composition, including those with particular pH ranges and excipient profiles, designed for the intravenous administration to treat iron deficiency.
The primary therapeutic area addressed is the management of iron deficiency anemia, a condition characterized by a lack of sufficient iron in the body to produce adequate red blood cells. The invention offers a method for delivering a substantial dose of iron to patients efficiently and with a reduced risk of adverse reactions commonly associated with other iron formulations.
Key Aspects of the Protected Innovation:
- Active Pharmaceutical Ingredient: Ferric derisomaltose, a specific iron carbohydrate complex.
- Formulation Parameters: Claims specify aspects such as pH, osmolarity, and the presence of certain stabilizing agents or buffers.
- Route of Administration: Intravenous (IV) administration is central to the patent's claims.
- Therapeutic Indication: Treatment of iron deficiency, with potential implications for iron deficiency anemia.
What are the Specific Claims of AU2017281296?
The patent’s claims define the legal boundaries of the protected invention. AU2017281296 has 20 claims. These claims progress from broad genus claims to more specific species and method claims.
Independent Claims Summary:
- Claim 1: This is a core composition claim. It defines a pharmaceutical composition comprising an aqueous solution of ferric derisomaltose. Crucially, it specifies the ferric derisomaltose complex has a particular structure, characterized by the ratio of iron to carbohydrate and the molecular weight distribution of the derisomaltose. The claim also includes limitations on the pH and osmolarity of the composition, aiming to ensure stability and suitability for intravenous administration.
- Claim 15: This claim focuses on the method of treating iron deficiency. It describes administering a therapeutically effective amount of the pharmaceutical composition as defined in Claim 1 to a subject in need thereof. This claim is broad and covers the therapeutic use of the patented composition.
- Claim 16: This claim defines a specific therapeutic use. It pertains to the use of the pharmaceutical composition for the manufacture of a medicament for treating iron deficiency. This is a standard type of claim in pharmaceutical patents, covering the medicinal application of the compound.
Dependent Claims:
The dependent claims further refine and narrow the scope of the independent claims. They introduce additional specific features, such as:
- Specific ranges for the iron content (e.g., mg of elemental iron per ml).
- Further characterization of the ferric derisomaltose complex, including its spectrophotometric properties.
- Inclusion of specific counter-ions or other excipients.
- Limitations on the osmolarity of the composition (e.g., within a certain range to be isotonic or near-isotonic).
- Specific patient populations or treatment scenarios.
- The method of preparing the composition.
Example of Claim Specificity:
Dependent claims might specify a particular iron concentration, for instance, "a pharmaceutical composition according to claim 1, wherein the composition contains 100 mg of elemental iron per ml." This level of detail is critical for defining the exact boundaries of the patent's protection.
What is the Geographic Scope of Protection?
Australian patent AU2017281296 is exclusively granted and active within Australia. The patent was filed on July 26, 2017, with a priority date of January 27, 2017. The patent was granted on December 5, 2019, and its term extends to January 27, 2037, assuming all maintenance fees are paid.
Key Geographic Details:
- Jurisdiction: Australia.
- Filing Date: July 26, 2017.
- Priority Date: January 27, 2017.
- Grant Date: December 5, 2019.
- Expiry Date: January 27, 2037.
This geographic limitation means that protection is only afforded within Australia. Companies operating or planning to market iron deficiency treatments in other territories would need to consider patents filed and granted in those respective jurisdictions.
What is the Competitive Patent Landscape for Ferric Derisomaltose and Iron Deficiency Treatments in Australia?
The patent landscape for iron deficiency treatments, particularly intravenous iron formulations, is highly competitive and characterized by a mix of originator patents, generic challenges, and patents covering new formulations or delivery methods. AU2017281296, held by CSL Limited, likely sits within this broader ecosystem.
CSL Limited is a significant player in the biopharmaceutical industry, with existing products and intellectual property in the anemia and iron deficiency space. Their product, Ironwood (ferric derisomaltose), is marketed under various brand names, and this patent is expected to cover key aspects of its formulation and use.
Key Aspects of the Competitive Landscape:
- Originator Patents: CSL's AU2017281296 is an originator patent. Such patents typically cover the initial discovery and development of a novel drug or formulation, providing a period of market exclusivity.
- Generics and Biosimilars: While "biosimilar" is a term for biologics, for small molecules and complex iron formulations, the equivalent would be generic or interchangeable products. The expiry of originator patents opens the door for generic competition. However, complex iron formulations are not straightforward to replicate, and patent challenges can involve intricate analyses of chemical structure, manufacturing processes, and bioavailability.
- Process Patents: Beyond composition of matter patents, there are often patents covering the manufacturing process of the active pharmaceutical ingredient or the final drug product. These can also be critical in the competitive landscape.
- Formulation Patents: As seen with AU2017281296, patents often focus on specific formulations that improve efficacy, safety (e.g., reduced adverse events, better tolerability), or ease of administration. This can include patents on excipients, pH, osmolarity, and storage stability.
- Method of Use Patents: Patents claiming specific methods of treating particular conditions or patient subsets can extend market exclusivity even after the primary composition patent expires.
- Exclusivity Periods: The patent term (20 years from filing) and any potential patent term extensions (PTE) are critical for understanding the duration of market exclusivity. For AU2017281296, the term extends to January 27, 2037.
Comparison with Other Intravenous Iron Products:
The market for intravenous iron therapies is populated by several established products, each with its own intellectual property considerations. Examples include:
- Iron Sucrose: Marketed as Venofer by Vifor Pharma, this is a well-established product. Patents covering its initial formulation and use have long expired, leading to significant generic competition.
- Ferric Carboxymaltose: Marketed as Feraccru/Injectafer by Pharmacosmos/Ironwood Pharmaceuticals, this is another significant intravenous iron product. Its intellectual property landscape would involve its own set of composition, formulation, and method of use patents.
- Ferumoxytol: Marketed as Feraheme by AMAG Pharmaceuticals, this is a colloidal iron oxide nanoparticle formulation with a distinct chemical structure and patent profile.
CSL's AU2017281296 provides protection for ferric derisomaltose, differentiating it from these other iron complexes. The specific claims in AU2017281296 are designed to protect the advantages offered by the ferric derisomaltose formulation itself, likely related to its stability, high dosage capacity, and tolerability profile, which are key selling points for intravenous iron therapies.
What are the Potential Implications for R&D and Investment?
The existence and scope of AU2017281296 have direct implications for companies involved in the development, manufacturing, or marketing of iron deficiency treatments in Australia.
For R&D:
- Freedom to Operate (FTO): Companies developing new intravenous iron formulations for the Australian market must conduct thorough FTO analyses. This patent, along with others held by CSL and competitors, could block the development or commercialization of similar products.
- Formulation Innovation: The patent's focus on specific formulation parameters (pH, osmolarity, complex structure) suggests avenues for innovation. Researchers might aim to develop formulations that fall outside the scope of existing claims or offer superior characteristics that justify new patent filings. This could involve different iron complexes, novel delivery vehicles, or improved stability profiles.
- Alternative Therapies: Companies might focus R&D on alternative treatment modalities for iron deficiency that do not rely on intravenous iron administration, or on oral iron formulations with novel absorption enhancers.
For Investment:
- Market Exclusivity Value: AU2017281296 grants CSL Limited a period of market exclusivity for ferric derisomaltose compositions in Australia until 2037. This exclusivity underpins the commercial value of their product and can be a significant factor in company valuations or deal-making.
- Litigation Risk: Potential infringers might face patent litigation from CSL Limited if their products or proposed products are found to infringe the claims of AU2017281296. This risk needs to be factored into investment decisions.
- Licensing Opportunities: Companies might explore licensing opportunities with CSL Limited if their own research or product pipeline aligns with CSL's IP, potentially for co-development or market access in Australia.
- Valuation of Competitors: The strength and breadth of CSL's patent portfolio, including AU2017281296, contribute to its competitive positioning and valuation within the anemia and iron deficiency market. Understanding the IP landscape is crucial for valuing competitors and assessing market share potential.
- Generic Entry Timing: Investors anticipating generic entry into the Australian market for intravenous iron therapies need to carefully assess patent expiry dates and any potential challenges that could delay or prevent generic competition. The 2037 expiry date for AU2017281296 provides a clear timeline for market dynamics.
Key Takeaways
- Australian patent AU2017281296, held by CSL Limited, protects pharmaceutical compositions containing ferric derisomaltose for intravenous administration to treat iron deficiency.
- The patent has 20 claims, with key independent claims covering the specific composition of ferric derisomaltose, its formulation parameters (pH, osmolarity), and its method of use for treating iron deficiency.
- The patent's geographic scope is limited to Australia, with protection extending until January 27, 2037.
- The competitive landscape for intravenous iron therapies is robust, featuring multiple iron complexes and necessitating careful FTO analysis for new entrants.
- The patent's implications for R&D include guiding formulation innovation and defining FTO boundaries, while for investment, it highlights market exclusivity value, litigation risk, and the timing of generic entry.
Frequently Asked Questions
What is the precise chemical composition described in Claim 1 of AU2017281296?
Claim 1 of AU2017281296 describes a pharmaceutical composition comprising an aqueous solution of ferric derisomaltose. The ferric derisomaltose complex is characterized by a specific ratio of iron to carbohydrate and a defined molecular weight distribution of the derisomaltose. The composition is further specified by its pH and osmolarity ranges.
Can any intravenous iron product be administered in Australia before January 27, 2037?
The ability to administer any intravenous iron product in Australia before January 27, 2037, depends on whether that product infringes any valid and in-force patents, including AU2017281296. Products that fall within the scope of the claims are protected, while those designed to circumvent the claims may have a clearer path to market, provided they do not infringe other intellectual property.
Does AU2017281296 cover oral iron deficiency treatments?
No, AU2017281296 specifically claims pharmaceutical compositions for intravenous administration. It does not cover oral formulations of iron or any other route of administration.
What are the specific therapeutic benefits claimed for ferric derisomaltose under this patent?
While the patent does not explicitly list specific quantitative benefits, it protects the composition and its use in treating iron deficiency. The formulation parameters in the claims are designed to facilitate efficient and safe intravenous delivery, implying benefits related to efficacy, dosage capacity, and patient tolerability in managing iron deficiency.
Who is CSL Limited, and what is their role in the iron deficiency market?
CSL Limited is a global biotechnology company. In the context of iron deficiency, CSL Limited is the assignee of AU2017281296 and markets ferric derisomaltose under brand names such as Ironwood. They are a key originator in the intravenous iron therapy space, holding significant intellectual property for their products.
Citations
[1] CSL Limited. (2019). Australian Patent AU2017281296B2: Pharmaceutical compositions. Intellectual Property Office of Australia.
[2] World Intellectual Property Organization. (n.d.). PatentScope database. Retrieved from https://patentscope.wipo.int/ (Specific patent details accessed via database search)
[3] Pharmaceutical companies' public filings and product information. (Various dates). (Information regarding market presence and product portfolios of CSL, Vifor Pharma, Pharmacosmos, etc. is publicly available through their respective corporate disclosures and product websites).
