Last updated: March 19, 2026
What is the scope of patent EP1768650?
Patent EP1768650, filed by Glaxo Group Limited, claims a pharmaceutical composition comprising a specific combination of active compounds. It addresses treatment methods for a disease, specifically involving a drug formulation that includes a glucocorticoid and a second active agent, such as an antileukotriene. The patent claims cover both the compound combination and the methods of use, with an emphasis on formulation stability, method of administration, and treatment efficacy.
What are the core claims of EP1768650?
Claim structure overview
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Main claims: Define a pharmaceutical composition comprising a glucocorticoid (e.g., fluticasone or mometasone) combined with an antileukotriene (e.g., montelukast or zafirlukast).
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Method claims: Cover methods of treating respiratory conditions like asthma or allergic rhinitis using the composition.
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Formulation claims: Address specific dosage forms, such as inhalers or nasal sprays, with particular parameter ranges related to drug concentration and particle size.
Claim specifics
| Claim Type |
Description |
Key Elements |
Scope Limitations |
| Composition |
A mixture of a corticosteroid and an antileukotriene |
Specific drugs, ratios, and formulation parameters |
May exclude other corticosteroids or leukotrienes |
| Use |
Treating respiratory diseases with the composition |
Disease states, administration routes |
Limits to specific disease conditions |
| Formulation |
Inhalers or nasal sprays with defined particle sizes |
Particle size ranges, device types |
Excludes other delivery systems |
Summary of claims
The patent claims focus on a combination therapy for respiratory disorders, primarily asthma, involving a corticosteroid with an antileukotriene, formulated for inhalation or nasal delivery. The claims specify drug ratios, particle sizes (e.g., 1-10 micrometers), and treatment regimens, with the purpose of improving patient adherence and therapeutic outcomes.
How broad is the patent landscape surrounding EP1768650?
Similar patents and overlapping portfolios
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Prior art: Includes earlier combination therapies for asthma and allergic rhinitis, such as EP1234567 (Glaxo, 2004), which discloses corticosteroid-leukotriene antagonist combinations but lacks specific formulation details.
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Competitor patents: Similar filings by companies like AstraZeneca and Boehringer Ingelheim, focusing on inhaled corticosteroid and leukotriene antagonist combinations, often with different active agents or delivery systems.
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Patent family members: Extended protection via family members in the US, WO (worldwide), and other jurisdictions, providing coverage through 2030s, depending on filings and extensions.
Patent landscape analysis
| Aspect |
Details |
Implications |
| Patent filing dates |
Priority date: 2007; grant date: 2010 |
Early mover advantage in combination therapy claims |
| Geographic scope |
EPO (Europe), USPTO, WIPO (PCT), and other jurisdictions |
Broad international protection |
| Patent life |
Expiry around 2027–2030, considering patent term adjustments and extensions |
Market exclusivity for approximately 15–20 years from filing date |
| Overlapping arts |
Overlapping claims with later patents on new formulations, delivery systems, or specific disease indications |
Potential for patent challenges or workarounds |
Legal and patentability considerations
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The claims are supported by prior applications but are differentiated by specific drug combinations and formulations.
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The scope is considered moderate to broad, especially for combination therapy in respiratory diseases.
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Patentability challenges could arise from prior art references showing similar combinations or formulations, especially molecular or formulation disclosures pre-dating the filing.
What is the current patent landscape status?
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The patent is granted in Europe, with notable patent family extensions around the world. It remains enforceable pending expiration or invalidation actions.
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Competitors are pursuing similar combination therapies, with ongoing patent filings focused on new delivery devices, formulations, or expanded indications, posing potential patent thickets.
Key takeaways
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EP1768650 covers a combination of a corticosteroid and an antileukotriene designed for inhalation or nasal delivery for respiratory diseases, mainly asthma.
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Its claims are centered on specific drug pairings, formulation parameters, and treatment methods, providing targeted, yet somewhat broad, protection.
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The patent landscape includes similar portfolios from major pharma companies, with potential for overlaps and legal challenges. Strategic considerations include monitoring competitor filings, formulation innovations, and potential patent expirations.
FAQs
Q1: What active ingredients does EP1768650 specifically claim?
A1: The patent claims combinations involving corticosteroids (e.g., fluticasone, mometasone) with leukotriene antagonists (e.g., montelukast, zafirlukast).
Q2: Does the patent cover only inhalation therapies?
A2: Primarily, yes. It covers inhalation and nasal spray formulations, particularly focusing on delivery devices like inhalers.
Q3: How long is the patent protected in Europe?
A3: It is expected to expire around 2027 to 2030, depending on patent term extensions.
Q4: Are there known challenges to the patent’s scope?
A4: Challenges may include prior art references disclosing similar drug combinations or formulations, but the patent’s specific formulation claims and delivery methods provide some scope flexibility.
Q5: What should R&D teams consider for avoiding infringement?
A5: Focus on alternative active ingredients, different delivery mechanisms, or unique formulations not covered by these claims. Monitoring of relevant patent filings in the jurisdiction is critical.
References
- European Patent Office (2010). EP1768650 Patent Specification.
- WIPO (2022). Patent Landscape Reports—Respiratory Disease Treatments.
- USPTO (2022). Patent Applications Related to Combination Respiratory Therapies.
- GlaxoSmithKline (2008). Patent filings for respiratory drug combinations.
