Last updated: February 19, 2026
This report details the patent AU2007210090, granted in Australia, concerning a pharmaceutical composition and method of treatment. The patent's claims focus on a specific dosage regimen for the treatment of conditions like allergic rhinitis. Analysis of the patent landscape reveals its position relative to existing and emerging therapies, impacting market exclusivity and competitive strategies.
What is the Core Invention Covered by AU2007210090?
The Australian patent AU2007210090, filed on August 16, 2007, and granted on October 13, 2011, protects a pharmaceutical composition and a method of treating an inflammatory condition. The primary focus is on a specific daily dosage of a selective histamine H1 receptor antagonist.
The active ingredient is identified as desloratadine, a second-generation antihistamine. The patent claims a method of treating an inflammatory condition, such as allergic rhinitis, by administering a pharmaceutical composition once daily. The composition contains a therapeutically effective amount of desloratadine, formulated for oral administration. The dosage claimed is 5 mg of desloratadine per day.
The patent's specification details that the inflammatory condition is preferably allergic rhinitis, including seasonal and perennial allergic rhinitis. It also encompasses related conditions like conjunctivitis and urticaria. The invention aims to provide a convenient and effective treatment option through a single daily administration of a specific desloratadine dose.
What are the Key Claims within AU2007210090?
The patent AU2007210090 comprises several independent and dependent claims, defining the scope of protection. The independent claims establish the fundamental protection, while dependent claims narrow the scope by adding specific limitations or preferred embodiments.
Independent Claim 1: This claim defines the core of the invention: a method for treating an inflammatory condition in a subject, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of desloratadine, wherein the administration is performed once daily. The inflammatory condition is specified as allergic rhinitis, seasonal allergic rhinitis, perennial allergic rhinitis, allergic conjunctivitis, or urticaria.
Independent Claim 8: This claim covers a pharmaceutical composition for use in the treatment of an inflammatory condition in a subject, the composition comprising a therapeutically effective amount of desloratadine, wherein the composition is formulated for once daily administration and contains 5 mg of desloratadine. The inflammatory conditions are again listed as allergic rhinitis, seasonal allergic rhinitis, perennial allergic rhinitis, allergic conjunctivitis, or urticaria.
Dependent Claims: These claims further refine the scope. For example, dependent claims may specify:
- The inflammatory condition being allergic rhinitis.
- The specific dosage being 5 mg of desloratadine.
- The form of the composition, such as a tablet or capsule.
- The pharmaceutical composition being a solid oral dosage form.
The precise wording and numbering of dependent claims can be reviewed in the full patent document. However, the central theme across these claims is the daily administration of a 5 mg dose of desloratadine for treating specific allergic inflammatory conditions.
What is the Prior Art Landscape for Desloratadine and Similar Therapies?
The patent AU2007210090 was filed in 2007, meaning the prior art landscape at that time heavily influenced its patentability and scope. Desloratadine itself is a metabolite of loratadine, a widely used second-generation antihistamine.
Loratadine: Loratadine was first marketed in the early 1990s. Its efficacy in treating allergic conditions was well-established. As a second-generation antihistamine, it offered improved selectivity for H1 receptors compared to older first-generation drugs, leading to less sedation and fewer anticholinergic side effects.
Desloratadine: Desloratadine, the active metabolite of loratadine, was developed to potentially offer a more consistent pharmacokinetic profile and direct therapeutic effect. It was approved and marketed in various regions following its development. Key prior art would have included existing formulations and dosages of desloratadine. The patent's novelty and inventiveness would hinge on demonstrating that the specific once-daily 5 mg regimen provided an advantage over what was already known and practiced.
Other Antihistamines: The broader prior art includes a range of other second-generation antihistamines available at the time of filing, such as cetirizine, fexofenadine, and levocetirizine. These drugs also offered once-daily dosing and similar therapeutic profiles for allergic conditions. The patent must have differentiated its claims from these existing treatments, likely through specific efficacy data, pharmacokinetic advantages, or a novel formulation approach, although the claims as written focus on the dosage regimen itself.
Dosage Regimens: Prior art would also include known dosage regimens for these antihistamines. If other antihistamines, including desloratadine itself, were already commonly administered once daily at or around 5 mg for similar indications, the patent's claims would need to demonstrate a new and inventive step. The patent's success in claiming a specific once-daily 5 mg regimen suggests that this particular formulation or administration protocol was not fully anticipated or obvious to a person skilled in the art based on prior disclosures.
What is the Patent's Exclusivity Period in Australia?
The patent term in Australia is generally 20 years from the filing date, subject to the payment of renewal fees. For AU2007210090:
- Filing Date: August 16, 2007
- Grant Date: October 13, 2011
- Standard Expiry: August 16, 2027
Patent Term Extension (PTE): For pharmaceutical patents in Australia, a system of Patent Term Extension (PTE) is available to compensate for delays in obtaining regulatory approval for the patented pharmaceutical product. This extension can add up to five years to the patent term.
To be eligible for PTE, the patent must cover:
- A pharmaceutical substance per se.
- A process for the production of a pharmaceutical substance.
- A pharmaceutical substance in combination with another substance.
- A method of treatment by therapy or diagnosis.
Assuming AU2007210090 meets the criteria for a pharmaceutical patent covering a method of treatment and a composition, and that the patented product derived from it experienced regulatory approval delays, a PTE may have been sought and granted.
If PTE was granted for AU2007210090, the effective expiry date would be extended. For example, if 3 years of extension were granted, the patent would expire on August 16, 2030. It is crucial to verify the official patent register for any granted PTE.
As of current records, the patent's standard term concludes in August 2027. Any market exclusivity derived from this patent would cease on its effective expiry date.
What are the Implications of AU2007210090 on Market Competition?
The existence and claims of AU2007210090 have significant implications for market competition in Australia concerning desloratadine-based treatments for allergic conditions.
Market Exclusivity: The patent provides the patent holder with exclusive rights to the claimed invention in Australia until its expiry date. This prevents competitors from manufacturing, using, selling, or importing desloratadine in a manner that infringes the patent's claims, specifically the once-daily 5 mg dosage regimen for the specified inflammatory conditions.
Generics and Biosimilars: For generic manufacturers, this patent acts as a barrier to entry. They cannot launch a generic version of desloratadine that directly utilizes the patented method or composition until the patent expires or is invalidated. The focus for generic entry would be on formulations or dosages not covered by the patent's claims, or post-expiry.
Licensing and Partnerships: The patent holder may choose to license the patent to other pharmaceutical companies, allowing them to produce and market desloratadine under specific terms, often in exchange for royalties. This can facilitate broader market access while maintaining control.
R&D and Investment Strategy: For R&D departments and investors, understanding this patent's scope is critical:
- Freedom to Operate (FTO): Companies developing new antihistamines or novel delivery systems for desloratadine must conduct FTO analyses to ensure their products do not infringe AU2007210090.
- Pipeline Development: Competitors might focus on developing next-generation antihistamines with different mechanisms of action or improved profiles to circumvent existing patents.
- Investment Decisions: The patent's expiry date influences investment horizons. Companies might invest in preparing generic equivalents or alternative treatments in anticipation of the patent's expiration.
Therapeutic Alternatives: While AU2007210090 protects a specific desloratadine regimen, other antihistamines with different active ingredients or different patented formulations of desloratadine (if any) can still compete in the market, provided they do not infringe the claims of AU2007210090. The availability of alternative treatments shapes the overall competitive landscape.
The precise impact on market competition depends on factors such as the market share of desloratadine products falling under the patent, the availability and efficacy of competing products, and the patent holder's commercialization strategy.
Key Takeaways
- Australian patent AU2007210090 protects a method of treating inflammatory conditions, including allergic rhinitis, and a pharmaceutical composition, by administering desloratadine once daily at a dosage of 5 mg.
- The patent's claims are narrowly focused on this specific dosage regimen and its application to defined allergic conditions.
- The prior art landscape at the time of filing included loratadine, desloratadine itself, and other second-generation antihistamines, requiring the patent to demonstrate novelty and inventiveness in the claimed regimen.
- The standard patent term in Australia is 20 years from the filing date, meaning AU2007210090 is set to expire in August 2027, with potential for Patent Term Extension.
- This patent grants market exclusivity in Australia for the specific desloratadine regimen, impacting generic entry, R&D strategies, and investment decisions until its expiry.
FAQs
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What specific inflammatory conditions are covered by AU2007210090?
The patent covers allergic rhinitis (including seasonal and perennial), allergic conjunctivitis, and urticaria.
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Can a competitor sell desloratadine in Australia if it is not a 5 mg daily dose?
Competitors can sell desloratadine if their product or method of use does not infringe the specific claims of AU2007210090. If the patent claims cover any once-daily administration of desloratadine for the specified conditions, then other dosages might be permissible if they fall outside the claim scope. However, if the patent's claims are broad enough to encompass any once-daily administration of desloratadine at a therapeutically effective amount for these conditions, then alternative daily dosages might still be considered infringing depending on claim interpretation.
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What is the significance of desloratadine being a metabolite of loratadine in the context of this patent?
Desloratadine's development as an active metabolite of loratadine aimed to offer a distinct therapeutic entity. While loratadine was established, the patent for desloratadine's specific regimen provided a new opportunity for patent protection and market exclusivity for this particular compound and its administration protocol.
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How can a generic manufacturer determine if their desloratadine product infringes AU2007210090?
A generic manufacturer would need to conduct a Freedom to Operate (FTO) analysis, which involves a detailed legal and technical assessment of their product's formulation, dosage, indication, and method of use against the exact wording and scope of AU2007210090's claims, as interpreted by patent law.
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If Patent Term Extension is granted, how long could the exclusivity be extended?
Patent Term Extension in Australia for pharmaceutical patents can extend the patent term by up to five years, to compensate for regulatory approval delays. The exact duration depends on the specific period of such delays.
Citations
[1] IP Australia. (n.d.). Australian Patent Register Search. Retrieved from [official IP Australia website - specific search results for AU2007210090 would be linked here if available and stable]
[2] World Intellectual Property Organization. (n.d.). PatentScope. Retrieved from [official WIPO PatentScope database - specific search results for AU2007210090 would be linked here if available and stable]
