United States Patent 5,075,114: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,075,114, titled "Taste masking and sustained release coatings for pharmaceuticals," is a significant patent in the pharmaceutical industry, particularly in the field of drug delivery systems. This patent, granted to various inventors, outlines innovative methods and compositions for coating pharmaceuticals to mask their taste and achieve sustained release. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent was filed on November 9, 1990, and granted on December 17, 1991. It addresses a critical issue in pharmaceutical formulation: the unpleasant taste of many medications, which can affect patient compliance. The invention provides a solution by using specific coatings to mask the taste and ensure a sustained release of the active ingredients.
Scope of the Patent
Invention Overview
The patent describes a method for coating pharmaceutical granules or particles with a polymer blend to achieve taste masking and sustained release. The coating composition typically includes cellulose acetate, polyvinyl acetate, or other polymers that can effectively mask the taste of the medicament and control its release over time[5].
Key Components
- Polymer Blend: The patent specifies the use of a polymer blend that includes cellulose acetate, polyvinyl acetate, and other compatible polymers. This blend is crucial for both taste masking and sustained release.
- Coated Granules: The granules or particles of the medicament are coated with the polymer blend. The coating process ensures that the taste of the medicament is masked, and the release of the active ingredient is controlled.
- Weight Percent: The patent details that the coated granules should contain from about 8 to about 15 weight percent of the polymer blend[5].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. For example:
- Claim 1 describes a chewable tablet with coated granules intended for taste masking and containing a specified weight percent of the polymer blend[5].
Dependent Claims
Dependent claims further specify the details of the independent claims. These may include variations in the composition of the polymer blend, the method of coating, or the type of medicament used.
Claim Construction
In patent law, claim construction is crucial for determining the scope of the invention. The language of the claims themselves, along with the specification and prosecution history, are key in this analysis. For instance, if the specification clearly defines terms or limits the scope of the claims, these definitions are binding[1].
Patent Landscape
Prior Art
The patent landscape includes prior art that may have influenced or been considered during the granting of this patent. Prior art keywords such as "medicament," "cellulose acetate," "coated," and "coating" indicate the existing knowledge in the field at the time of filing[5].
Related Patents
Other patents in the same field may have similar or overlapping claims. For example, patents related to sustained release formulations or taste masking technologies could be relevant. The USPTO's Patent Public Search tool and the Global Dossier service can be used to identify related patents and their status[4].
International Context
The global patent system, facilitated by tools like the Common Citation Document (CCD), allows for the consolidation of prior art cited by multiple patent offices. This helps in understanding the international patent landscape and potential overlaps or conflicts[4].
Economic and Market Impact
Market Demand
The demand for taste-masked and sustained-release pharmaceuticals is significant, particularly for pediatric and geriatric populations. This patent addresses a critical need in the market, potentially influencing the development of new pharmaceutical products.
Competitive Advantage
Companies holding such patents can gain a competitive advantage by offering unique formulations that improve patient compliance. This can lead to higher market share and revenue.
Legal Considerations
Patent Validity and Infringement
The validity and infringement of the patent are determined through legal proceedings. Courts consider intrinsic evidence such as the claims, specification, and prosecution history to construe the scope of the patent. Extrinsic evidence, such as prior art, can also be relevant but must not contradict the intrinsic evidence[1].
Litigation and Disputes
Patent disputes often arise over claim construction, infringement, and validity. For instance, in cases like McNeil-PPC, Inc. v. Perrigo Co., courts must carefully analyze the claims and specification to determine the scope of the invention and whether it has been infringed[1].
Industry Expert Insights
Industry experts emphasize the importance of robust patent protection in the pharmaceutical sector. According to Dr. Alan Marco, Chief Economist at the USPTO, "Patent claims and patent scope are critical in defining the boundaries of an invention and ensuring that innovators can protect their intellectual property"[3].
Statistics and Trends
The USPTO's Patent Claims Research Dataset provides insights into patent scope and claims trends. For example, the dataset shows that patents with broader claims tend to have a greater impact on the market and are more likely to be cited by subsequent patents[3].
Key Takeaways
- Innovation in Drug Delivery: The patent introduces innovative methods for taste masking and sustained release, enhancing patient compliance.
- Scope and Claims: The patent's scope is defined by its claims, which specify the composition and process of the coating.
- Market Impact: The patent has significant market implications, offering a competitive advantage to companies that hold it.
- Legal Considerations: The validity and infringement of the patent are subject to legal interpretation based on intrinsic and extrinsic evidence.
FAQs
What is the main purpose of the coating in US Patent 5,075,114?
The main purpose of the coating is to mask the taste of the medicament and achieve a sustained release of the active ingredients.
How does the polymer blend contribute to the invention?
The polymer blend, which includes cellulose acetate and polyvinyl acetate, is crucial for both taste masking and controlling the release of the medicament.
What are the key components of the coated granules?
The coated granules contain from about 8 to about 15 weight percent of the polymer blend.
How is the scope of the patent determined?
The scope of the patent is determined by the language of the claims, the specification, and the prosecution history.
What tools can be used to search for related patents?
Tools such as the USPTO's Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) can be used to search for related patents.
Sources
- McNeil-PPC, Inc. v. Perrigo Co., 443 F. Supp. 2d 492.
- U.S. Patent and Trademark Office (USPTO), USA.gov.
- Patent Claims Research Dataset, USPTO.
- Search for patents, USPTO.
- Taste masking and sustained release coatings for pharmaceuticals, US5075114A, Google Patents.
