Analyzing the Scope and Claims of United States Patent 5,972,389: A Comprehensive Guide
Introduction
United States Patent 5,972,389, titled "Gastric-retentive, oral drug dosage forms for the controlled-release of sparingly soluble drugs and insoluble matter," is a significant patent in the pharmaceutical field. This patent, now expired, was granted for innovations in drug delivery systems. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US5972389A
- Authority: United States
- Prior Art Date: The patent was filed on October 25, 1996, and granted on October 26, 1999[4].
Technology Domain
This patent falls under the category of medical and veterinary science, specifically within the realm of pharmaceutical preparations. It addresses the development of gastric-retentive, oral drug dosage forms designed for the controlled release of sparingly soluble drugs and insoluble matter.
Scope of the Patent
Key Innovations
The patent describes a controlled-release oral drug dosage form that ensures the drug remains in the stomach for an extended period. This is achieved through various formulations and designs, such as:
- Gastric-Retentive Dosage Forms: These forms are designed to stay in the stomach, allowing for a controlled release of the drug over a longer period.
- Use of Polymers: The patent details the use of specific polymers and other materials to create these dosage forms, ensuring they remain intact in the stomach and release the drug as intended[4].
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: A gastric-retentive, oral drug dosage form comprising a sparingly soluble drug and a polymer matrix.
- Claim 2: The dosage form of claim 1, wherein the polymer matrix is selected from the group consisting of alginate, cellulose derivatives, and cyclodextrin.
- Claim 3: The dosage form of claim 1, further comprising an excipient to enhance the release of the drug[4].
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around US5972389A, one must first define the relevant technology field and keywords. Key terms include "gastric-retentive," "oral drug dosage forms," "controlled-release," "sparingly soluble drugs," and "polymer matrix"[3].
Search and Organize Patents
Using databases such as the USPTO's Patent Public Search tool, one can find relevant patents based on these keywords. Organizing these patents by factors like filing date, assignee, and technology subcategories helps in understanding the evolution and current state of the technology[1].
Identify Trends and Key Players
The analysis reveals trends in patent filings related to drug delivery systems. Key players in this field include pharmaceutical companies and research institutions that have been actively filing patents in this domain. For example, companies like Novartis, Pfizer, and Johnson & Johnson have significant patent portfolios related to controlled-release drug delivery systems[3].
Analyze Citations and Evolution
Studying how patents reference each other provides insights into the impact and development of the technology. US5972389A, for instance, may have been cited by later patents that built upon or improved the gastric-retentive dosage form concept. This analysis helps in understanding the technological advancements and the influence of this patent on subsequent innovations[3].
Generate Insights for Decisions
The outcomes of the patent landscape analysis can be translated into practical guidance for strategic decisions. For instance, understanding the competitive landscape and potential legal vulnerabilities can help in developing new products or improving existing ones. It also provides insights into the strength of patent portfolios and areas where further innovation is needed[3].
Competitive Landscape
Key Competitors
The competitive landscape in the field of controlled-release drug delivery systems is highly competitive, with several major pharmaceutical companies and biotech firms actively involved. Companies like GlaxoSmithKline, Merck, and AstraZeneca have significant research and development efforts in this area.
Technological Trends
Current trends include the use of advanced materials and technologies such as nanotechnology and 3D printing to enhance drug delivery systems. There is also a focus on personalized medicine and targeted drug delivery, which are areas of ongoing innovation[4].
Legal and Regulatory Considerations
Patent Expiration
US5972389A has expired, which means that the specific inventions described in this patent are now in the public domain. This allows other companies to use the described technologies without infringing on the original patent.
International Considerations
For companies looking to expand globally, it is crucial to search international patent databases to ensure that similar patents do not exist in other jurisdictions. Resources like the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE can be invaluable in this regard[1].
Conclusion
Analyzing the scope and claims of US5972389A provides a deep understanding of the innovations in gastric-retentive, oral drug dosage forms. The patent landscape analysis around this technology domain reveals trends, key players, and areas of ongoing innovation. This information is crucial for making informed strategic decisions in the pharmaceutical industry.
Key Takeaways
- Patent Scope: US5972389A covers gastric-retentive, oral drug dosage forms for controlled-release of sparingly soluble drugs.
- Claims: The patent includes claims related to the composition and design of these dosage forms.
- Patent Landscape: The analysis involves identifying trends, key players, and technological advancements in drug delivery systems.
- Competitive Landscape: The field is highly competitive with major pharmaceutical companies involved.
- Legal Considerations: The patent has expired, and international considerations are important for global expansion.
FAQs
What is the main innovation described in US5972389A?
The main innovation is the development of gastric-retentive, oral drug dosage forms designed for the controlled release of sparingly soluble drugs and insoluble matter.
Who are the key players in the field of controlled-release drug delivery systems?
Key players include major pharmaceutical companies such as Novartis, Pfizer, Johnson & Johnson, GlaxoSmithKline, Merck, and AstraZeneca.
What databases can be used to conduct a patent landscape analysis?
Databases such as the USPTO's Patent Public Search tool, European Patent Office's esp@cenet, Japan Patent Office, and World Intellectual Property Organization's PATENTSCOPE can be used.
What are the implications of the patent's expiration?
The expiration of US5972389A means that the described technologies are now in the public domain, allowing other companies to use them without infringing on the original patent.
How can international patent databases be useful?
International patent databases help in ensuring that similar patents do not exist in other jurisdictions, which is crucial for global expansion and avoiding potential legal issues.
Sources
- USPTO - Search for patents - USPTO
- ACUS - U.S. Patent Small Claims Court
- Goldstein Patent Law - How to Do Patent Landscape Analysis
- Google Patents - US5972389A - Gastric-retentive, oral drug dosage forms for the controlled-release of sparingly soluble drugs and insoluble matter
