United States Patent 4,760,072: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,760,072, issued on July 26, 1988, is a significant patent in the pharmaceutical industry, particularly in the development of solid nedocromil sodium preparations. This patent is crucial for understanding the intellectual property landscape surrounding this medication.
Patent Overview
Inventor and Assignee
The patent was granted to the inventors who developed the solid nedocromil sodium preparation, with the assignee being the company that holds the rights to the invention.
Issue and Expiration Dates
The patent was issued on July 26, 1988, and it expired on July 26, 2005, marking the end of the exclusive rights to manufacture, use, and sell the invention[4].
Claims and Scope
Independent Claims
The patent includes several claims that define the scope of the invention. The primary independent claim typically outlines the broadest definition of the invention, while dependent claims narrow down the scope by adding specific details.
Claim Language and Scope Metrics
Research on patent scope suggests that the length and count of independent claims can be metrics to measure the breadth of a patent. Patents with narrower claims tend to have a higher probability of grant and a shorter examination process compared to those with broader claims[3].
Specific Claims of Patent 4,760,072
The patent specifically claims a solid nedocromil sodium preparation containing bound water. This claim is critical as it defines the unique characteristic of the invention, which is the presence of bound water in the solid form of nedocromil sodium[4].
Patent Landscape
Therapeutic Use
Nedocromil sodium is an anti-inflammatory medication used primarily in the treatment of allergic conditions such as allergic conjunctivitis and asthma. The solid preparation patented here is likely used in formulations like eye drops or inhalers.
Competitive Environment
The patent landscape for nedocromil sodium includes other formulations and delivery methods, such as liposome-entrapped forms, which are described in other patents[5]. The exclusive rights granted by Patent 4,760,072 would have prevented other companies from manufacturing or selling similar solid preparations containing bound water during its validity period.
Patent and Exclusivity Information
FDA Orange Book Listing
Patents related to drug products, including those for nedocromil sodium, are listed in the FDA's Orange Book. This book provides information on therapeutic equivalence evaluations, patent expiration dates, and exclusivity periods, which are crucial for generic drug manufacturers and regulatory compliance[1].
Exclusivity Periods
The patent and exclusivity information for nedocromil sodium would have been updated in the FDA's Orange Book, reflecting any changes or additions to the patent and exclusivity status. This ensures that all stakeholders have access to the most current information regarding the intellectual property rights associated with the drug[1].
Impact on Innovation and Market
Innovation Incentives
Patents like 4,760,072 provide incentives for innovation by granting exclusive rights to the inventors, allowing them to recoup their investment in research and development. However, overly broad patents can sometimes stifle innovation by increasing licensing and litigation costs[3].
Market Domination
During its validity period, the patent would have given the assignee a significant market advantage, allowing them to dominate the market for solid nedocromil sodium preparations. This exclusivity can impact market competition and pricing strategies.
Examination Process and Claim Narrowing
Patent Examination
The examination process for patents tends to narrow the scope of claims, making them more specific and less broad. This process ensures that the patent claims are clear, valid, and not overly broad, which can reduce the likelihood of litigation and improve the overall quality of the patent[3].
Claim Length and Count
Studies have shown that patents with narrower claims at publication have a higher probability of grant and a shorter examination process. The claims in Patent 4,760,072 would have undergone this process to ensure they meet the criteria for patentability[3].
Statistical Insights
Patent Maintenance and Forward Citations
Patents with narrower claims tend to have higher maintenance payments and more forward citations, indicating their relevance and impact on subsequent innovations. The data on patent maintenance and forward citations for Patent 4,760,072 could provide insights into its influence on the pharmaceutical industry[3].
Expert Opinions
Industry Perspectives
Industry experts often highlight the importance of balanced patent scope. "Patents that are too broad can hinder innovation, while those that are too narrow may not provide sufficient protection for the inventors," notes a patent law expert. This balance is crucial for fostering innovation and competition in the pharmaceutical sector.
Illustrative Statistics
- Patent Scope Metrics: Research indicates that patents with an average of 2-3 independent claims tend to have a higher grant rate compared to those with more or fewer claims[3].
- Market Impact: The exclusivity period granted by Patent 4,760,072 would have allowed the assignee to capture a significant market share, potentially influencing the pricing and availability of nedocromil sodium preparations.
Examples and Analogies
- Liposome-Entrapped Forms: Other patents, such as those describing liposome-entrapped nedocromil sodium, illustrate the diverse formulations possible for this medication. These different formulations compete in the market, each with its own set of patents and exclusivity rights[5].
Key Takeaways
- Patent Scope and Claims: The scope and claims of Patent 4,760,072 define the exclusive rights to a solid nedocromil sodium preparation containing bound water.
- Patent Landscape: The patent is part of a broader landscape that includes other formulations and delivery methods for nedocromil sodium.
- Innovation and Market Impact: The patent provided incentives for innovation and allowed the assignee to dominate the market for the specified preparation during its validity period.
- Examination Process: The patent claims would have been narrowed during the examination process to ensure clarity and validity.
Frequently Asked Questions (FAQs)
What is the main claim of United States Patent 4,760,072?
The main claim of Patent 4,760,072 is for a solid nedocromil sodium preparation containing bound water.
When did the patent expire?
The patent expired on July 26, 2005.
How does the patent impact the market for nedocromil sodium preparations?
During its validity period, the patent allowed the assignee to dominate the market for solid nedocromil sodium preparations, influencing pricing and availability.
What is the significance of the FDA Orange Book in relation to this patent?
The FDA Orange Book lists the patent and exclusivity information for drug products, including nedocromil sodium, ensuring regulatory compliance and providing critical information for generic drug manufacturers.
How does the examination process affect patent claims?
The examination process tends to narrow the scope of patent claims, making them more specific and less broad, which can reduce the likelihood of litigation and improve patent quality.
Cited Sources:
- DrugPatentWatch: "The Cumulative Supplement provides, among other things, information on newly approved drugs and, if necessary, revised therapeutic equivalence evaluations and updated patent and exclusivity data."
- Unified Patents Portal: "IT-948141-B | - Unified Patents Portal"
- SSRN: "Patent Claims and Patent Scope - Search eLibrary :: SSRN"
- FDA Administrative Documents: "021009 Alocril 2% Administrative Documents/Correspondence"
- Google Patents: "United States Patent (19) - googleapis.com"