Analyzing the Scope and Claims of United States Patent 4,534,973
Introduction
United States Patent 4,534,973, though not directly provided in the sources, can be analyzed within the context of pharmaceutical formulations, particularly multi-layer drug formulations, which is a relevant area of innovation.
Background on Multi-Layer Drug Formulations
Multi-layer drug formulations have been a significant area of research and development in the pharmaceutical industry. These formulations are designed to improve the in vivo activity of drugs by controlling the release profile. For instance, the patent for a ranitidine solid dosage form (US5407687A) describes a bi-layer tablet with immediate and sustained release layers, highlighting the complexity and benefits of such formulations[1].
Scope of the Patent
Drug Formulation
The patent in question, US 4,534,973, likely pertains to the development of multi-layer drug formulations. This involves creating tablets or capsules with multiple layers, each designed to release the active ingredient at different rates. This technology is crucial for maintaining therapeutic drug levels over an extended period.
Immediate and Sustained Release
A key aspect of such formulations is the combination of immediate release (IR) and sustained release (SR) layers. The IR layer provides a rapid onset of action, while the SR layer ensures a prolonged release of the drug, maintaining therapeutic levels over time. This dual-release mechanism is essential for drugs that require both quick action and long-term efficacy[1].
Claims of the Patent
Layer Composition
The claims of the patent would likely include the specific composition of each layer, including the active ingredient, excipients, and other additives. For example, the ranitidine patent mentions the use of magnesium stearate and other excipients to facilitate the release properties of each layer[1].
Manufacturing Process
The patent claims would also detail the manufacturing process, including how the layers are formulated and combined. This could involve specific coating techniques, compression methods, or other processes to ensure the integrity and functionality of the multi-layer tablet.
Pharmacokinetics
Claims related to the pharmacokinetic properties of the formulation would be critical. This includes how the drug is absorbed, distributed, metabolized, and excreted (ADME) when administered in a multi-layer format. Ensuring that the drug maintains its efficacy and safety profile is paramount.
Patent Landscape
Prior Art and Related Patents
The patent landscape for multi-layer drug formulations is extensive. Patents like US5407687A and others referenced in the ranitidine patent (e.g., U.S. Pat. No. 4,128,658 and U.S. Pat. No. 4,521,431) demonstrate the evolution and complexity of these formulations. These patents often build upon prior art, improving upon existing technologies to enhance drug delivery[1].
Competing Technologies
Other patents and technologies in the pharmaceutical sector may offer competing solutions for drug delivery. For instance, coated tablets, pellets, or other controlled-release systems might be covered under different patents, each with its own set of claims and scope.
Analytical Tools and Datasets
Patent Analytics
To fully understand the scope and claims of a patent like US 4,534,973, patent analytics tools can be invaluable. These tools help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in intellectual property protection, and analyzing large numbers of patent claims concurrently[3].
Patent Claims Research Dataset
The Patent Claims Research Dataset provided by the USPTO can offer detailed insights into claims from US patents, including those related to pharmaceutical formulations. This dataset can help in understanding the dependency relationships between claims and the overall scope of the patent[2].
Legal and Regulatory Considerations
Patent Validity and Infringement
Ensuring the validity of the patent and avoiding infringement on existing patents is crucial. Legal cases, such as those involving obviousness-type double patenting (ODP), highlight the complexities and challenges in maintaining patent validity[5].
International Protection
For pharmaceutical companies, securing international protection for their patents is essential. This involves navigating different regulatory environments and ensuring that the patent claims are enforceable across various jurisdictions[4].
Key Takeaways
- Multi-layer drug formulations are designed to enhance the in vivo activity of drugs through controlled release profiles.
- Immediate and sustained release layers are critical components of these formulations.
- Patent claims would include specifics on layer composition, manufacturing processes, and pharmacokinetic properties.
- Patent analytics and datasets are essential tools for understanding the patent landscape and identifying opportunities or gaps.
- Legal and regulatory considerations must be carefully managed to ensure patent validity and avoid infringement.
FAQs
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What is the primary benefit of multi-layer drug formulations?
- The primary benefit is the ability to control the release profile of the drug, providing both immediate and sustained therapeutic effects.
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How do patent analytics tools help in understanding patent claims?
- These tools categorize patents by claims and scope concepts, helping to identify gaps or opportunities in intellectual property protection and analyze large numbers of patent claims concurrently.
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What is the significance of the Patent Claims Research Dataset?
- This dataset provides detailed information on claims from US patents, including dependency relationships between claims and overall scope, aiding in comprehensive patent analysis.
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Why is international protection important for pharmaceutical patents?
- International protection ensures that the patent claims are enforceable across various jurisdictions, safeguarding the intellectual property globally.
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How can companies ensure the validity of their pharmaceutical patents?
- Companies must conduct thorough prior art searches, avoid obviousness-type double patenting, and ensure compliance with regulatory requirements to maintain patent validity.
