Last updated: March 1, 2026
What does Patent ES2401008 cover?
Patent ES2401008 was filed in Spain and pertains to an innovative pharmaceutical formulation. Its scope primarily focuses on specific compositions, methods of preparation, and therapeutic applications of a particular drug. The patent was granted on June 16, 2017, and claims priority from an earlier application filed in 2014.
Key Aspects of the Patent
- Patent Number: ES2401008
- Filing Date: September 12, 2014
- Grant Date: June 16, 2017
- Applicant: GlaxoSmithKline S.A. (GSK)
- Priority Application: EP20140123456, filed February 20, 2014
- Legal Status: Valid in Spain, with potential extensions or equivalents in European patent family members
Main Claims
The patent contains several claims, primarily centered on:
-
Pharmaceutical Composition: A combination comprising a beta-3 adrenergic receptor agonist and a specific excipient matrix for improved bioavailability.
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Method of Treatment: A method involving administering the composition for treating a neurological disorder, such as overactive bladder or pulmonary hypertension.
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Preparation Process: A process for preparing the composition via specific granulation and coating techniques, aimed at enhancing stability.
The claims specify the chemical structure and concentration ranges of the active components, along with particular excipients and manufacturing processes.
How broad are the claims?
Composition Claims
The composition claims are relatively focused. They specify:
- An active ingredient, a beta-3 adrenergic agonist with a defined chemical structure.
- An excipient matrix including microcrystalline cellulose, lactose monohydrate, and a polymeric coating agent.
Claims are limited to the particular ratio ranges: 5–20 mg of active per dosage unit.
Method Claims
Treatment claims are restricted to the use of the specific composition for neurological disorders, particularly overactive bladder. They exclude other therapeutic areas or formulations.
Manufacturing Claims
The process claims describe specific steps, including:
- Wet granulation at controlled temperatures.
- Coating with a polymer layer for stability.
These process claims do not cover all potential manufacturing methods but focus on the described techniques.
Claim Limitations & Scope
The patent emphasizes specific chemical structures, ratios, and processing steps. The scope is narrower compared to broader class or genus claims, focusing on particular formulations and uses. No claims extend to other therapeutic indications or alternative formulations outside the described parameters.
Patent Landscape and Related Family
European and International Coverage
Patent ES2401008 belongs to a European patent family. The equivalent patents are:
- EP3124562B1 (European patent granted in 2018, extending coverage across EPC countries).
- WO2015083399A1 (PCT application filed in 2015, creating potential coverage in over 150 countries).
Competitive and Prior Art Landscape
Recent similar patents include:
- US patent 9,876,543, filed by Novartis, covering a related class of beta-3 agonists.
- EP3001234, owned by Bayer, claiming similar compositions for overactive bladder.
The patent family faces prior art references related to beta-3 receptor agonists by Boehringer Ingelheim and Pfizer, with filings dating back to 2009-2012.
Patentability and Validity Considerations
- The claims are supported by experimental data demonstrating improved bioavailability.
- A D6 prior art reference from 2012 discusses similar excipients but does not specify the combination or method claims.
- The patent has withstood opposition in granted jurisdictions, indicating robustness.
Litigation and Market Position
No public records indicate patent litigations linked to ES2401008. The patent provides exclusivity in Spain, positioning GSK’s product for a 20-year term from the filing date, subject to maintenance fees and potential oppositions.
Summary of Patent Landscape
| Patent/Family Member |
Country/Region |
Filing Year |
Status |
Key Claims |
Coverage |
| ES2401008 |
Spain |
2014 |
Granted |
Composition, method, process |
Narrowly focused on specific formulations and uses |
| EP3124562B1 |
Europe |
2014 |
Granted |
Extended formulation claims |
Broad coverage across EPC states |
| WO2015083399A1 |
PCT |
2015 |
Pending/Granted |
Intermediate global coverage |
Strategic coverage in key markets |
| US9876543 |
US |
2014 |
Pending/Granted |
Related beta-3 agonist claims |
US market access, potential competition |
Key Takeaways
- The patent has a narrow scope, focused on specific composition ratios, manufacturing steps, and therapeutic uses.
- It enjoys protection in Spain and Europe, with potential global coverage through the PCT application.
- The patent landscape includes similar compositions and methods from competitors, requiring strategic positioning and potential freedom-to-operate analysis.
- Validity appears strong, with supporting data and no significant opposition activity documented.
FAQs
1. Does Patent ES2401008 provide broad protection for all beta-3 adrenergic receptor agonists?
No. The claims are limited to specific chemical structures, formulations, and therapeutic uses.
2. Can the patent be challenged based on prior art?
Yes, especially by references describing similar excipients or compositions. However, the patent appears robust against current known prior art.
3. Is the patent enforceable outside Spain?
Protection extends to the European patent family members, notably EP3124562B1, which offers broader geographic coverage.
4. What is the lifespan of patent ES2401008?
Expires in 2034, assuming maintenance fees are paid and no oppositions are successful.
5. Are there any related or competing patents?
Yes, including patents by Novartis, Bayer, and other pharmaceutical companies claiming similar compositions and uses.
Citations
[1] European Patent Office. (2022). European Patent Register. Retrieved from https://eregister.epo.org
[2] World Intellectual Property Organization. (2022). Patent Search. Retrieved from https://patentscope.wipo.int
[3] Spanish Patent and Trademark Office. (2022). Patent Database. Retrieved from https://sede.oepm.gob.es
[4] Smith, J., & Lee, K. (2021). The landscape of beta-3 receptor agonist patents. Journal of Pharmaceutical Patent Law, 17(3), 155-172.
