Understanding the Scope and Claims of United States Patent 11,058,648
Introduction
United States Patent 11,058,648, titled "Bupropion as a modulator of drug activity," is a patent that delves into the use of bupropion in various pharmaceutical applications. This analysis will explore the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, granted on August 17, 2021, describes dosage forms, drug delivery systems, and methods related to the sustained release of dextromethorphan or other drugs, with bupropion acting as a modulator of drug activity. This invention is significant in the pharmaceutical field, particularly in the areas of drug delivery and modulation.
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
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Claim 1: This claim describes a pharmaceutical composition comprising bupropion and dextromethorphan, where bupropion modulates the activity of dextromethorphan. The composition is designed for sustained release, which is a critical aspect of the invention[4].
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Claim 10: This claim outlines a method of treating a condition using the pharmaceutical composition described in Claim 1. The method involves administering the composition to a patient, where the bupropion enhances the therapeutic effect of dextromethorphan[4].
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. For example:
- Claim 2: This claim depends on Claim 1 and specifies that the pharmaceutical composition includes a controlled release formulation, which ensures that the drugs are released over a prolonged period[4].
Scope of the Invention
The scope of the invention is defined by the claims and the detailed description provided in the patent. Here are some key aspects:
Drug Modulation
The patent focuses on the use of bupropion as a modulator to enhance the therapeutic effects of dextromethorphan. This modulation is crucial for achieving the desired pharmacological outcomes without increasing the dosage of the primary drug[4].
Sustained Release
The invention involves sustained release formulations, which are designed to release the drugs over an extended period. This approach can improve patient compliance and reduce the frequency of dosing[4].
Therapeutic Applications
The patent suggests various therapeutic applications, including the treatment of conditions such as cough, pain, and other disorders where dextromethorphan is commonly used. The use of bupropion as a modulator can enhance the efficacy and safety profile of these treatments[4].
Patent Landscape
Patent Allowance Rates
The landscape for pharmaceutical patents, including those related to drug delivery and modulation, is complex. Studies have shown that the allowance rate for pharmaceutical patents has decreased over time, particularly in fields like "Drugs and Medical Instruments"[1].
Continuation Procedures
Many patent applications in the pharmaceutical field utilize continuation procedures to create related applications. This is evident from the data showing that 31% of progenitor applications in the USPTO use at least one continuation procedure, which can affect the overall allowance rate and the scope of protection[1].
Patent Eligibility
The eligibility of pharmaceutical patents, especially those involving drug formulations and delivery systems, is often scrutinized under the "Alice" test. This test determines whether the claims are directed to patent-eligible subject matter, ensuring that they do not preempt all possible ways of achieving a particular result[2].
Industry Impact
Innovation and Competition
Patents like US 11,058,648 drive innovation in the pharmaceutical industry by providing exclusive rights to inventors, which can encourage further research and development. However, they also create a competitive landscape where companies must navigate around existing patents to develop new products[5].
Regulatory Considerations
The regulatory environment, including the need for a potential small claims patent court, can influence how pharmaceutical patents are enforced and litigated. This could impact the cost and complexity of patent disputes, making it more accessible for smaller entities to protect their intellectual property[5].
Key Takeaways
- Bupropion as a Modulator: The patent highlights the use of bupropion to modulate the activity of dextromethorphan, enhancing its therapeutic effects.
- Sustained Release Formulations: The invention involves sustained release formulations, which are critical for improving patient compliance and reducing dosing frequency.
- Therapeutic Applications: The patent suggests various therapeutic applications, including the treatment of cough, pain, and other disorders.
- Patent Landscape: The allowance rate for pharmaceutical patents has decreased, and continuation procedures are commonly used. Patent eligibility is scrutinized under the "Alice" test.
- Industry Impact: The patent drives innovation and affects competition in the pharmaceutical industry, with implications for regulatory and litigation environments.
FAQs
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What is the primary focus of US Patent 11,058,648?
- The primary focus is on the use of bupropion as a modulator to enhance the therapeutic effects of dextromethorphan in sustained release formulations.
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How does the patent define the scope of the invention?
- The scope is defined by the independent and dependent claims, which specify the composition, method of treatment, and sustained release formulation.
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What are the therapeutic applications of this invention?
- The patent suggests applications in treating conditions such as cough, pain, and other disorders where dextromethorphan is commonly used.
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How does the patent landscape affect pharmaceutical patents?
- The landscape is influenced by decreasing allowance rates, common use of continuation procedures, and strict patent eligibility criteria under the "Alice" test.
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What is the potential impact of this patent on the pharmaceutical industry?
- It drives innovation, affects competition, and has implications for regulatory and litigation environments, particularly for smaller entities.
Sources
[4] - Bupropion as a modulator of drug activity - Patent US-11058648-B2
[1] - What Is the Probability of Receiving a US Patent? - Yale Journal of Law & Technology
[2] - CONTOUR IP HOLDING LLC v. GOPRO, INC. - United States Court of Appeals for the Federal Circuit
[5] - U.S. Patent Small Claims Court - Administrative Conference of the United States
