Detailed Analysis of the Scope and Claims of United States Patent 6,562,873
Overview of the Patent
United States Patent 6,562,873, titled "Compositions containing therapeutically active components having enhanced solubility," was granted on May 13, 2003, to inventors Orest Olejnik and Edward D. S. Kerslake, and assigned to Allergan, Inc.[4][5].
Patent Scope
The patent focuses on compositions that include therapeutically active components (TACs) with enhanced solubility. Here are the key aspects of the patent scope:
Therapeutically Active Components (TACs)
The patent describes compositions that contain TACs, which are often insoluble in liquid carriers. The invention aims to enhance the solubility of these TACs to ensure uniform and accurate administration, as well as effective in vivo diffusion through cell membranes or lipid bilayers[4].
Solubilizing Agents
The compositions include solubilizing agents to enhance the solubility of TACs. However, these agents must be compatible with the preservatives in the compositions to avoid reducing their effectiveness[4].
Oxy-Chloro Components
A significant aspect of the patent is the use of oxy-chloro components, such as stabilized chlorine dioxides and alkali metal chlorites, as preservatives. These components maintain their preservative effectiveness even in the presence of solubilizing agents, ensuring the stability and safety of the compositions[4].
Specific Composition Examples
The patent details specific compositions, such as those containing Brimonidine tartrate, a solubilizing agent like carboxymethylcellulose, and an oxy-chloro component. These compositions are designed to be ophthalmically acceptable and free of cyclodextrins[4][5].
Patent Claims
The patent includes several claims that define the scope of the invention:
Claim Structure
The claims are structured to cover various aspects of the compositions, including:
- The presence of TACs and solubilizing agents.
- The use of oxy-chloro components as preservatives.
- The specific concentrations and combinations of these components.
- The absence of cyclodextrins in the compositions[5].
Key Claims
- Claim 1: A composition comprising a therapeutically active component, a solubilizing agent, and an oxy-chloro component.
- Claim 32: A composition that is ophthalmically acceptable, containing a TAC, a solubilizing agent, and an oxy-chloro component.
- Claim 35: A specific composition example including Brimonidine tartrate, carboxymethylcellulose, and an oxy-chloro component[5].
Examination and Scope Metrics
The examination process for this patent, like many others, would have involved a thorough review of the claims to ensure they are clear, specific, and not overly broad. Research on patent scope metrics suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Prior Art
The patent cites several prior art patents related to compositions with enhanced solubility and preservative components. These include patents by Portoghese, Gluchowski, Morella et al., and others, which indicate the evolutionary nature of the invention[5].
Global Dossier and International Context
While the patent is specific to the United States, the Global Dossier service provided by the USPTO allows users to see related applications filed at participating IP Offices. This can provide insights into how similar inventions are treated globally[1].
Litigation and Licensing
The scope and claims of this patent could impact licensing and litigation costs. Broader or less clear claims might lead to increased costs due to potential disputes over patent validity and infringement. However, the specific and well-defined claims in this patent help mitigate such risks[3].
Practical Applications
The compositions described in this patent are particularly useful in ophthalmic applications, where the solubility and stability of therapeutically active components are crucial. The use of oxy-chloro components as preservatives ensures that the compositions remain effective and safe for use.
Key Takeaways
- Enhanced Solubility: The patent focuses on enhancing the solubility of therapeutically active components.
- Oxy-Chloro Components: These components are used as preservatives to maintain the stability and safety of the compositions.
- Specific Compositions: Detailed examples of compositions, including those containing Brimonidine tartrate, are provided.
- Patent Claims: The claims are structured to cover various aspects of the compositions, ensuring clarity and specificity.
- Practical Applications: The compositions are particularly useful in ophthalmic applications.
FAQs
Q1: What is the main focus of United States Patent 6,562,873?
A1: The main focus is on compositions containing therapeutically active components with enhanced solubility.
Q2: What role do oxy-chloro components play in the patent?
A2: Oxy-chloro components serve as preservatives, maintaining the stability and safety of the compositions.
Q3: Are cyclodextrins included in the compositions described in the patent?
A3: No, the compositions are specifically designed to be free of cyclodextrins.
Q4: How do the claims in this patent impact licensing and litigation costs?
A4: The specific and well-defined claims help reduce licensing and litigation costs by minimizing disputes over patent validity and infringement.
Q5: What is the significance of the Global Dossier in relation to this patent?
A5: The Global Dossier allows users to see related applications filed at participating IP Offices, providing insights into the global treatment of similar inventions.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USPTO - Disclaimers: https://www.uspto.gov/news/og/2004/week44/patdisc.htm
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - US6562873B2: https://patents.google.com/patent/US6562873B2/en
- US Patent - US 6,562,873 B2: https://patentimages.storage.googleapis.com/pdfs/bf9f659a059f085cb6ac/US6562873.pdf
