United States Patent 11,197,830: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 11,197,830, titled "Pharmaceutical composition containing acetaminophen and ibuprofen," is a significant patent in the pharmaceutical industry, particularly in the realm of pain management. This patent, issued on December 14, 2021, outlines a specific formulation and method of manufacturing a solid oral dosage form containing a combination of acetaminophen and ibuprofen.
Background
The combination of acetaminophen and ibuprofen is well-known for its efficacy in treating mild to moderate acute pain. However, the specific formulation and manufacturing process described in this patent offer unique advantages over existing products.
Patent Scope
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
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Claim 1: This claim describes a solid oral dosage form containing 325 mg of acetaminophen and 97.5 mg of ibuprofen, or 500 mg of acetaminophen and 150 mg of ibuprofen. The dosage form is characterized by specific particle size distributions for ibuprofen[4][5].
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Claim 17: This claim specifies the method of treating mild to moderate acute pain using the described pharmaceutical composition[5].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims (such as Claim 1) stand alone and define the invention, while dependent claims (such as Claim 17) build upon the independent claims and provide additional details or limitations.
Claim Language and Patent Scope Metrics
Research on patent scope often involves metrics such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. For US Patent 11,197,830, the claims are relatively specific, focusing on the exact composition and particle size distributions, which suggests a narrower scope but higher clarity and validity[3].
Manufacturing Process
The patent describes a detailed manufacturing process involving the combination of acetaminophen and ibuprofen with various excipients, diluents, and lubricants. Key steps include:
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Jet Milling: The process involves jet milling the active ingredients to achieve specific particle sizes. This method is crucial for ensuring the uniform distribution and stability of the active materials[4].
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Blending and Coating: The milled ingredients are blended with other components and then coated with a suitable coating agent if necessary[4].
Particle Size Distribution
The patent emphasizes the importance of particle size distribution for both acetaminophen and ibuprofen. For example, the [D90] of the ibuprofen is specified to be within a particular range (greater than 2 μm but less than 18 μm), and the [D50] is also defined within specific limits (greater than 1 μm but less than 12 μm)[4].
Pharmaceutical Acceptability
The composition must be pharmaceutically acceptable, meaning it includes solvents, dispersion media, coatings, and other agents that are physiologically compatible. The patent lists various examples of such agents and their roles in the formulation[4].
Prior Art and Cited Patents
The patent cites several prior patents, such as U.S. Patent 5,260,337, which also relate to pharmaceutical compositions containing acetaminophen and ibuprofen. These citations indicate the evolution of the technology and the specific innovations introduced by the current patent[5].
International Patent Landscape
While this patent is specific to the United States, similar formulations and manufacturing processes may be patented in other countries. For instance, the European Patent Office (EPO) and the Japan Patent Office (JPO) have databases that can be searched to see if similar patents exist internationally[1].
Legal and Regulatory Considerations
The patent's legal status is active, indicating that it is currently enforceable. However, the legal status can change due to various factors such as litigation, re-examination, or expiration. It is important to monitor the patent's status through official gazettes and patent databases[4].
Impact on Innovation and Litigation
The specificity and clarity of the claims in this patent can reduce the likelihood of litigation and licensing disputes, which are common issues with broader or less clear patents. This can incentivize further innovation in the pharmaceutical sector by providing clear boundaries and expectations for similar inventions[3].
Conclusion
United States Patent 11,197,830 represents a significant advancement in the formulation and manufacturing of pharmaceutical compositions containing acetaminophen and ibuprofen. The patent's specific claims, detailed manufacturing process, and emphasis on particle size distribution contribute to its clarity and validity. This patent serves as a model for how clear and specific patent claims can facilitate innovation and reduce legal complexities.
Key Takeaways
- Specific Composition: The patent describes a specific solid oral dosage form containing 325 mg of acetaminophen and 97.5 mg of ibuprofen, or 500 mg of acetaminophen and 150 mg of ibuprofen.
- Manufacturing Process: The process involves jet milling and blending with specific excipients.
- Particle Size Distribution: The patent specifies precise particle size ranges for ibuprofen.
- Pharmaceutical Acceptability: The composition must include physiologically compatible agents.
- Legal and Regulatory Considerations: The patent is currently active, but its status can change.
FAQs
What is the main innovation of US Patent 11,197,830?
The main innovation is the specific formulation and manufacturing process for a solid oral dosage form containing a combination of acetaminophen and ibuprofen, particularly the use of jet milling to achieve precise particle size distributions.
How does the patent specify particle size distribution?
The patent specifies that the [D90] of the ibuprofen should be greater than 2 μm but less than 18 μm, and the [D50] should be greater than 1 μm but less than 12 μm.
What is the significance of jet milling in the manufacturing process?
Jet milling ensures the uniform distribution and stability of the active materials by reducing them to specific particle sizes, which is crucial for the efficacy and stability of the pharmaceutical composition.
Are there similar patents internationally?
Similar patents may exist in other countries, and databases such as those provided by the European Patent Office (EPO) and the Japan Patent Office (JPO) can be searched to find them.
How does the clarity of the patent claims impact innovation and litigation?
The clarity and specificity of the claims reduce the likelihood of litigation and licensing disputes, thereby incentivizing further innovation by providing clear boundaries and expectations for similar inventions.
Cited Sources:
- USPTO: "Search for patents - USPTO" - https://www.uspto.gov/patents/search
- ACUS: "U.S. Patent Small Claims Court" - https://www.acus.gov/research-projects/us-patent-small-claims-court
- SSRN: "Patent Claims and Patent Scope" - https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents: "Pharmaceutical composition containing acetaminophen and ibuprofen" - https://patents.google.com/patent/US11197830B2/en
- Justia Patents: "Pharmaceutical composition containing acetaminophen and ibuprofen" - https://patents.justia.com/patent/11197830
