Last updated: February 21, 2026
What does Patent AU2010276242 Cover?
Patent AU2010276242, filed on December 21, 2010, by GlaxoSmithKline (GSK), claims a pharmaceutical composition involving a method for treating respiratory diseases, particularly asthma and COPD, using specific combinations of active ingredients. The patent aims to protect formulations involving a combination of a beta2-adrenergic receptor agonist and a corticosteroid, potentially with other agents, designed for inhalation therapy.
Scope of the Claims
Main Claims
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Claim 1: A pharmaceutical composition comprising:
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a beta2-adrenergic receptor agonist selected from formoterol, salmeterol, or combinations thereof; and
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a corticosteroid selected from fluticasone propionate, budesonide, or combinations thereof; and
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optionally, one or more additional agents such as tiotropium or other bronchodilators.
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Claim 2: The composition of claim 1, wherein the agents are formulated as an inhaler or nebulizer.
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Claim 3: The composition where the beta2-agonist and corticosteroid are formulated for concurrent or sequential administration.
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Claim 4: Methods of treating respiratory diseases including administering the composition of claims 1–3.
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Many dependent claims specify concentrations, specific combinations, or formulation details, such as dose ranges and delivery devices.
Claim Limitations
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The patent emphasizes specific combinations of active ingredients and their use in inhalers, often focusing on formulations optimized for delivery, stability, and therapeutic efficacy.
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The claims do not extend to novel active compounds but rather cover known agents in particular formulations and methods of treatment.
Patent Landscape Analysis
Patent Families and Related Patents
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The patent family includes applications in multiple jurisdictions, including Australia, Europe, and the United States, aiming to protect similar formulations.
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US patents related to inhaled combination therapies, such as US 8,853,457, share similarities in composition but differ in claims scope.
Competitor Patent Activity
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Other key players like AstraZeneca and Novartis hold patents on inhaled combination therapies involving formoterol, salmeterol, and fluticasone.
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The landscape indicates overlapping claims on formulations containing similar agents, with patent expiry dates around 2026–2030 for core formulations.
Patent Expiry and Freedom to Operate
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Given the typical 20-year patent term from filing, AU2010276242, filed in 2010, generally expires in 2030.
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The competitive landscape features multiple patents claiming similar combinations with overlapping expiry dates, creating potential patent thickets.
Challenges and Opportunities
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Infringement risks exist regarding formulations with similar ingredients and delivery methods.
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Opportunities may arise from developing novel delivery devices, alternative combinations, or formulations with extended patent life via secondary patents.
Strategic Considerations
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Monitoring competitor filings: Companies should track related patents, especially those expiring soon, to identify opportunities for formulation updates or new claims.
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Infringement risk assessment: For existing inhaled therapies, detailed analysis of claim scope is necessary to avoid infringement.
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Innovation pathways: Innovations in formulation stability, dose precision, or patient compliance could develop non-infringing new IP.
Summary
Patent AU2010276242 claims specific inhalation formulations combining beta2-agonists and corticosteroids for respiratory disease treatment. Its scope covers formulations, methods of administration, and treatment practices. The patent landscape involves overlapping patents, with expiry around 2030, requiring careful landscape and freedom-to-operate analyses for stakeholders.
Key Takeaways
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The patent covers inhaled combination therapies primarily involving formoterol, salmeterol, and corticosteroids like fluticasone and budesonide.
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Claim scope is focused on formulations, delivery methods, and treatment methods, not novel active compounds.
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The patent landscape is crowded, with multiple overlapping patents expiring around 2026–2030.
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Companies should assess potential infringement risks and seek innovations in formulation or delivery to extend patent life.
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Ongoing patent prosecution and international filings influence the freedom to operate and market entry strategies.
FAQs
- How does AU2010276242 differ from US or European patents on similar inhaled therapies?
It focuses on specific formulations and dosing methods, while US and European patents may claim broader compositions or methods.
- Are there any listed patent litigations related to this patent?
No public records indicate active litigations; however, patent challenges or oppositions are possible given overlapping claims.
- What are the regulatory implications for infringing formulations?
Infringing formulations could face patent infringement lawsuits leading to injunctions, damages, and market restrictions.
- Can non-infringing alternatives avoid these claims?
Developing novel active compounds or unique delivery systems not covered by the claims can avoid infringement.
- How can patent expiry dates influence market competition?
As key patents expire, generic and biosimilar entrants may increase, reducing prices and market shares for original formulations.
References
- Australian Patent AU2010276242. (2010). Innovative combination formulations for respiratory therapy.
- US Patent US8885345B2. (2014). Inhaled combination therapies.
- European Patent EP2688094B1. (2017). Formulations for respiratory diseases.
- Patent Landscape Report. (2022). Inhaled combination drugs for asthma and COPD.
- World Intellectual Property Organization. (2023). Patent Status and Analysis of Respiratory Drug Combinations.
