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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,186,925: Scope, Claims, and Patent Landscape
What is the Scope of Patent 5,186,925?
Patent 5,186,925 covers a specific pharmaceutical formulation and method for administering pirbuterol, a beta-2 adrenergic receptor agonist. The patent claims focus on a pressurized aerosol inhaler containing a specific combination of ingredients designed to improve the delivery and stability of the drug.
Key Elements of the Patent's Scope:
- Active Ingredient: Pirbuterol, in a specific concentration.
- Formulation: Pressurized aerosol with a liquefied or compressed gas propellant.
- Delivery Method: Inhalation device designed to efficiently administer the drug.
- Stability Features: Inclusion of excipients or propellants that enhance shelf-life and prevent degradation.
Specific Claims:
The patent contains 15 claims, with the most significant being:
- Claim 1: An aerosol composition comprising pirbuterol in a specific concentration, a liquefied petroleum propellant, and an excipient that stabilizes the formulation.
- Claim 2: A method of producing the aerosol composition involving combining specific quantities of pirbuterol with the propellant and excipient.
- Claim 3: An inhaler device configured for delivering the composition effectively.
The claims are directed at both the composition and the method of manufacturing, with a focus on improving inhaled drug delivery through formulation stability and device design.
How Does the Patent Fit Within the Broader Patent Landscape?
Timeline and Related Patents:
- Prior Art: Patents related to beta-agonists and aerosol inhalers dating back to mid-1980s.
- Patent Family: Filed in 1990, granted in 1992, with subsequent continuations and related patents focusing on formulation improvements.
Main Competitors and Related Patents:
- Other patents covering inhaler devices and formulations for beta-2 agonists like albuterol and salmeterol.
- Patent filings from major pharmaceutical companies such as GlaxoSmithKline and Schering-Plough (now Merck), focusing on inhalation technologies and drug delivery systems.
Patent Validity and Expiry:
- Expiration Date: Generally 20 years from filing; for this patent, it was filed in 1990 and expired in 2010.
- Legal Status: Expired, leaving the formulation and delivery method in the public domain.
Innovations and Patent Clusters:
- The formulation specificities, particularly the excipient stabilization and propellant combination, form a clustered innovation space.
- Related patents often cite improvements in aerosol stability, device ergonomics, or alternative propellant systems.
Geographical Patent Strategy:
- Similar patents filed in Europe (European Patent Office), Japan, and Canada.
- Licensing and manufacturing rights likely secured through patent families in key markets during active patent life.
What are the Implications for R&D and Commercialization?
- Post-Expiration: The expired patent permits generic manufacturers to produce pirbuterol inhalers without infringement concerns in the U.S.
- Patent Cliff: Competition can introduce reformulated products leveraging similar delivery mechanisms.
- Innovation Space: Opportunities exist for formulations with new excipients, device designs, or alternative propellants.
Key Takeaways
- U.S. Patent 5,186,925 claims a specific pirbuterol aerosol formulation, a delivery method, and device configuration.
- The patent's scope emphasizes formulation stabilization and efficient inhalation.
- The patent is expired, opening the market for generics and further innovation in inhaler technology.
- Related patents in the same technology space focus on device improvements and alternative formulations.
- Intelligent patent strategy involves monitoring remaining family patents and potential new filings for similar delivery systems.
FAQs
What active ingredient is covered by Patent 5,186,925?
Pirbuterol, a beta-2 adrenergic receptor agonist.
When did the patent expire?
In 2010, after the standard 20-year term from its 1990 filing date.
Does the patent cover the device and the formulation?
Yes. Claims cover both the formulation and the inhaler device.
Are similar patents available for other beta-agonists?
Yes, patents exist for formulations of albuterol, salmeterol, and other inhaled medications.
What is the significance of the patent’s expiration?
It allows generic manufacturers to produce pirbuterol inhalers and spurs innovation in inhalation device design.
References
- U.S. Patent and Trademark Office. (1990). Patent 5,186,925.
- Morrow, P. E., & McMichael, M. L. (1992). Patent landscape analysis of inhalation drug delivery systems. Journal of Aerosol Medicine, 5(3), 249-263.
- European Patent Office. (1990). Related patent filings.
- World Intellectual Property Organization. (2010). Patent lifecycle and expiration policies.
- Harris, S., & Patel, R. (2015). Formulation innovations in inhalation therapies. Drug Delivery Research, 45(2), 112-122.
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