United States Patent 10,751,325: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,751,325, titled "Stabilized oxymetazoline formulations and their uses," is a significant patent in the pharmaceutical industry, particularly in the treatment of rosacea and other skin conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes stabilized cream formulations of oxymetazoline, a vasoconstrictor commonly used to treat rosacea and other dermatological conditions. The invention includes methods for preparing these formulations and their therapeutic applications[4].
Key Components
- Active Ingredient: Oxymetazoline, known for its vasoconstrictive properties.
- Formulation: The patent details various cream formulations that stabilize oxymetazoline, enhancing its efficacy and shelf life.
- Therapeutic Uses: The formulations are designed to treat conditions such as rosacea, erythema, and other skin-related issues.
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. These claims can be broadly categorized into:
- Composition Claims: These claims describe the specific formulations of oxymetazoline, including the types and amounts of ingredients used.
- Method Claims: These claims outline the processes for preparing the stabilized formulations.
- Use Claims: These claims specify the therapeutic applications of the formulations, such as treating rosacea and other skin conditions[4].
Claim Examples
- Claim 1: A stabilized cream formulation comprising oxymetazoline, a polyethylene glycol, and an octadecan-1-ol.
- Claim 10: A method of treating rosacea comprising applying the stabilized cream formulation to the affected skin area.
Patent Landscape
Related Patents
The patent 10,751,325 is part of a larger family of patents related to oxymetazoline formulations and their therapeutic uses. Other patents in this family include:
- United States Patent Nos. 7,812,049; 8,420,688; 8,815,929; 8,883,838; 9,974,773; and 10,335,391, which are also associated with the treatment of rosacea and are owned by EPI Health and Allergan[5].
Global Dossier
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This service helps in understanding the global patent family and the dossier, classification, and citation data for these applications[1].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for visualizing the search results for the same invention produced by several offices on a single page[1].
Litigation and Enforcement
Infringement Claims
The patent 10,751,325 has been involved in litigation, particularly in a case where EPI Health and Allergan alleged that Perrigo UK FINCO Ltd. Partnership's generic version of oxymetazoline cream infringed on their patents. Perrigo had submitted an Abbreviated New Drug Application (ANDA) seeking FDA approval for their generic product, which the plaintiffs claimed would infringe on their patents[5].
Legal Implications
The litigation highlights the importance of patent protection in the pharmaceutical industry. The plaintiffs' assertion that Perrigo's ANDA product would infringe on their patents underscores the need for thorough patent searches and analysis to avoid potential legal disputes.
Economic and Market Impact
Market Dominance
Patents like 10,751,325 play a crucial role in maintaining market dominance for pharmaceutical companies. By protecting their formulations and therapeutic uses, companies like EPI Health and Allergan can ensure exclusivity in the market, which is vital for recouping investment in research and development.
Research and Development
The detailed information on claims from patents like 10,751,325, as provided in the Patent Claims Research Dataset by the USPTO, can be invaluable for researchers and developers. This dataset helps in understanding patent scope and trends, which can guide future research and innovation[3].
Conclusion
United States Patent 10,751,325 is a significant patent in the pharmaceutical sector, particularly for the treatment of rosacea. Understanding its scope, claims, and the broader patent landscape is crucial for both legal and business strategies.
Key Takeaways
- Stabilized Formulations: The patent describes stabilized cream formulations of oxymetazoline.
- Therapeutic Uses: The formulations are used to treat rosacea and other skin conditions.
- Litigation: The patent has been involved in infringement claims against generic manufacturers.
- Market Impact: The patent helps in maintaining market dominance and guides future research and development.
- Global Patent Family: The patent is part of a larger family of related patents.
FAQs
1. What is the main invention described in United States Patent 10,751,325?
The main invention is stabilized cream formulations of oxymetazoline and their therapeutic uses.
2. What are the key components of the stabilized formulations?
The key components include oxymetazoline, polyethylene glycol, and octadecan-1-ol.
3. What are the therapeutic applications of the formulations?
The formulations are used to treat conditions such as rosacea, erythema, and other skin-related issues.
4. Has this patent been involved in any litigation?
Yes, it has been involved in litigation where EPI Health and Allergan alleged infringement by Perrigo UK FINCO Ltd. Partnership.
5. How does this patent impact the market?
The patent helps in maintaining market dominance for the pharmaceutical companies and guides future research and development in the field.
Sources
- USPTO - Search for patents https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Stabilized oxymetazoline formulations and their uses https://patents.google.com/patent/US10751325B2/en
- Law Street Media - EPI Health, Allergan Claim Perrigo Infringing on Rosacea Treatment Patents https://lawstreetmedia.com/news/health/epi-health-allergan-claim-perrigo-infringing-on-rosacea-treatment-patents/