Detailed Analysis of the Scope and Claims of United States Patent 6,635,278
Introduction
United States Patent 6,635,278, titled "Pharmaceutical formulations," is a patent that describes specific compositions and methods related to pharmaceutical formulations, particularly those involving the nucleotide analog 9-[2-[[bis[(pivaloyloxy)methyl]phosphono]methoxy]ethyl]adenine. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, issued on October 21, 2003, pertains to pharmaceutical formulations that include the nucleotide analog mentioned above, along with various excipients to enhance stability, formulation, and delivery of the drug[4].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: This claim describes the pharmaceutical composition comprising the nucleotide analog and an alkaline excipient, such as magnesium carbonate or sodium bicarbonate, to stabilize the formulation.
- Claim 5: This claim specifies the formulation as a tablet, where the alkaline excipient is combined with the drug substance either as an intragranular or extragranular component.
Dependent Claims
- These claims further detail the composition by specifying the types and amounts of excipients, such as binders, disintegrants, diluents, lubricants, glidants, coloring agents, or flavoring agents, that can be included to enhance the formulation's stability and performance.
Scope of the Invention
The scope of the invention is focused on creating stable pharmaceutical formulations that resist degradation, particularly aqueous degradation. Here are some key aspects:
Stability Enhancement
The use of alkaline excipients like magnesium carbonate or sodium bicarbonate is crucial for maintaining the stability of the nucleotide analog. These excipients help in maximizing physical contact with the drug substance, thereby enhancing the formulation's overall stability[4].
Formulation Types
The patent covers various physical forms of the pharmaceutical formulation, including tablets, pills, discs, and rods. The composition can include a range of excipients to facilitate tablet compression, disintegration, and other manufacturing processes[4].
Patent Landscape Analysis
Technological Domain
The patent falls within the domain of pharmaceutical formulations, specifically in the area of antiviral drugs. This domain is highly competitive, with numerous patents and ongoing research aimed at improving drug stability, efficacy, and delivery.
Competitors and Market Players
Key players in this domain include pharmaceutical companies like Gilead Sciences, Pfizer, and Merck, among others. These companies are continuously innovating and patenting new formulations and delivery methods to stay competitive.
Patent Trends and Market Developments
- Mergers and Acquisitions: The pharmaceutical industry is known for its frequent mergers and acquisitions, which can significantly impact the patent landscape. Companies often acquire patents as part of these deals to expand their portfolio and market share.
- In/Licensing and Litigation: Patent landscape analysis reveals trends in in-licensing and out-licensing agreements, as well as litigation activities. For example, companies may license their patents to other firms or engage in legal battles over patent infringement[3].
Global Patent Family
The patent in question may be part of a larger global patent family, with corresponding patents filed in other countries. Tools like the Global Dossier and Common Citation Document (CCD) can help in identifying related applications and their legal status across different jurisdictions[1].
Tools and Resources for Analysis
USPTO Resources
- The USPTO's Patent Public Search tool and the Patent and Trademark Resource Centers (PTRCs) are invaluable resources for conducting thorough patent searches and analyzing the landscape.
- The Patent Examination Data System (PEDS) provides access to bibliographic data for all publicly available patent applications, which can be useful in tracking the status and trends of related patents[1].
International Databases
- Databases from the European Patent Office (EPO), Japan Patent Office (JPO), World Intellectual Property Organization (WIPO), and other international offices provide comprehensive access to global patent data. Tools like esp@cenet and PATENTSCOPE facilitate searches across multiple jurisdictions[1].
Generating a Comprehensive Report
Defining the Scope
Clearly defining the scope of the patent landscape search is crucial. This involves determining the regions to search, the time frame, and whether to include abandoned patents or patent families[3].
Search Strategy
Formulating a robust search strategy is essential. This includes identifying relevant patent and non-patent sources, collaborating with technical and market experts, and using specific keywords and patent class codes[3].
Statistical Analysis
The final report should include statistical figures and graphs to make the data more interpretable. This could involve charts showing patent trends, market developments, and the legal status of patents[3].
Key Takeaways
- Stability and Formulation: The patent emphasizes the importance of using alkaline excipients to enhance the stability of pharmaceutical formulations.
- Competitive Landscape: The pharmaceutical domain is highly competitive, with continuous innovation and patenting activities.
- Global Implications: The patent is part of a broader global patent family, and tools like Global Dossier and CCD are essential for analyzing its international implications.
- Market Insights: Patent landscape analysis provides valuable insights into market trends, mergers and acquisitions, and litigation activities.
Frequently Asked Questions (FAQs)
Q1: What is the main focus of United States Patent 6,635,278?
The main focus is on creating stable pharmaceutical formulations using the nucleotide analog 9-[2-[[bis[(pivaloyloxy)methyl]phosphono]methoxy]ethyl]adenine and alkaline excipients.
Q2: How does the patent enhance the stability of the drug?
The patent enhances stability by using alkaline excipients like magnesium carbonate or sodium bicarbonate, which maximize physical contact with the drug substance.
Q3: What types of formulations are covered by the patent?
The patent covers various physical forms, including tablets, pills, discs, and rods, with a range of excipients to facilitate manufacturing processes.
Q4: How can one analyze the patent landscape for this domain?
One can use tools like the USPTO's Patent Public Search, Global Dossier, and international databases like esp@cenet and PATENTSCOPE to analyze the patent landscape.
Q5: What are the implications of this patent for market players?
The patent provides valuable insights into market trends, competitors, and potential licensing opportunities, helping companies make informed decisions about their R&D investments and market strategies.
Cited Sources:
- USPTO - Search for patents[1]
- Google Patents - EP2648701A1[2]
- Sagacious Research - Navigating Technological Domains with Patent Landscape Analysis[3]
- Google Patents - US6635278B1[4]
- Google APIs - US7935817[5]
