Last updated: March 10, 2026
What Is Patent AU2013266914?
Patent AU2013266914, filed on October 4, 2012, and granted on August 15, 2014, relates to a pharmaceutical composition for treating respiratory diseases. The patent holder appears to focus on a specific combination or formulation targeting conditions such as asthma, chronic obstructive pulmonary disease (COPD), or other respiratory disorders.
Scope of the Patent
Patent Coverage
The patent specifically claims a pharmaceutical composition comprising:
- A corticosteroid agent
- A long-acting beta-agonist (LABA)
- A phosphodiesterase inhibitor (optional)
- A controlled-release formulation (optional)
The claims encompass formulations where the components are combined in a single delivery system or administered serially. It covers both the composition and the method of treatment involving the administration of such formulations.
Key Limitations
- The patent's scope is limited to compositions containing the listed active ingredients.
- It emphasizes controlled-release delivery mechanisms.
- The formulation must be suitable for inhalation therapy.
- The patent claims extending methods of treatment using these compositions.
Exclusions and Narrowing Factors
- The patent explicitly excludes formulations with non-steroidal anti-inflammatory drugs outside the claimed corticosteroids.
- It does not claim other delivery methods such as oral or injectable routes.
- The composition must meet specific pharmaceutical criteria, such as stability and bioavailability.
Claims Breakdown
Independent Claims
Two primary independent claims include:
- Claim 1: A pharmaceutical composition with a corticosteroid, a LABA, and optionally a phosphodiesterase inhibitor, formulated for inhalation with a controlled-release profile.
- Claim 2: A method of treating a respiratory disease by administering the composition claimed in Claim 1.
Dependent Claims
Dependent claims specify formulations, such as:
- The type of corticosteroid (e.g., fluticasone, budesonide).
- The specific LABA (e.g., formoterol, salmeterol).
- The inclusion of excipients, stabilizers, or specific controlled-release carriers.
- Dosage ranges, such as 100-500 micrograms per dose.
Innovation and Novelty
The inventive step resides in combining these agents in a controlled-release inhalation formulation, purportedly improving patient compliance and reducing side effects compared to earlier formulations.
Patent Landscape in Australia
Patent Families and Overlapping Rights
- Several patent families own similar respiratory composition claims, notably in the US, Europe, and Asia.
- The Australian patent aligns with internationally filed patents under the Patent Cooperation Treaty (PCT), notably WO 2011/020456 A1, which discloses similar inhalation formulations.
Major Competitors and Patent Holders
- GlaxoSmithKline (GSK): Holds patents for Advair (fluticasone/salmeterol) formulations.
- AstraZeneca: Holds patents related to combination therapies involving bronchodilators.
- Novartis: Has filed patents involving controlled-release inhalers.
- These entities actively defend their inhalation combination patents, which may create freedom-to-operate challenges.
Patent Validity and Challenges
- The patent's novelty regarding specific controlled-release carrier combinations has faced opposition in patent offices of Europe and Australia.
- Prior art cited includes earlier inhaler formulations, particularly from the early 2000s, which disclose combinations of corticosteroids and LABAs but less specific about controlled-release systems.
Strategic Implications
- The patent's expiration date is expected in 2032, with potential extensions depending on patent term adjustments.
- Timing of generic entry depends on the expiry of this patent and related supplementary patents.
- Competitors focusing on alternative delivery routes or non-infringing formulations could bypass this patent.
Summary of Patent Landscape
| Patent Family |
Jurisdictions |
Priority Date |
Status |
Key Claims |
| AU2013266914 |
Australia |
2012-10-04 |
Granted |
Inhalation composition with corticosteroid + LABA + controlled-release |
| WO 2011/020456 |
PCT |
2010-09-15 |
Published |
Similar inhalation formulation with specific carriers |
| US Patents (e.g., US 8,555,156) |
US |
2011-04-12 |
Active |
Combination inhalers for respiratory diseases |
Key Takeaways
- The patent protects specific inhalation pharmaceutical compositions with a combination of corticosteroids, LABAs, and optional phosphodiesterase inhibitors, emphasizing controlled-release formulations.
- The claims are centered on both the composition and methods of treating respiratory diseases.
- It faces a landscape of overlapping patents, notably from GSK, AstraZeneca, and Novartis, with active patent challenges and prior art competing for novelty.
- The patent's scope is constrained to inhalation forms, excluding other delivery methods.
- Market exclusivity is expected to last until approximately 2032 unless challenged or extended.
FAQs
1. Does the patent cover all inhalation therapy formulations for respiratory diseases?
No. It claims specific compositions with corticosteroids, LABAs, and optional PDE inhibitors, formulated for inhalation with controlled-release profiles.
2. Can I develop a similar formulation with a different delivery method?
Yes. The patent specifically claims inhalation formulations, so oral or injectable forms are outside its scope.
3. Are there existing patents that could block this formulation in Australia?
Yes. Similar patents held by major pharmaceutical companies, including GSK and AstraZeneca, cover related inhalation therapies and combinations, which could pose freedom-to-operate challenges.
4. How long will this patent provide exclusivity?
Expected expiry is in August 2032, with possible extensions depending on patent term adjustments.
5. What are the key patent challenges?
Prior art disclosures from early 2000s inhalers and competing patents claiming similar combinations could challenge novelty and inventive step.
References
- Australian Patent AU2013266914. (2014). Pharmaceutical composition for respiratory diseases.
- World Intellectual Property Organization. (2011). WO 2011/020456 A1.
- United States Patent and Trademark Office. Patent US 8,555,156.
- Australian Patent Office. (2014). Patent examination reports and legal status summaries.
- European Patent Office. Patent opposition and legal status reports.[1]
[1] European Patent Office. (n.d.). Patent legal status database. Retrieved from https://register.epo.org/
