United States Patent 9,700,530: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,700,530, titled "Capsule dosage form of metoprolol succinate," is a significant patent in the pharmaceutical industry, particularly in the field of extended-release formulations. This patent, assigned to Sun Pharmaceutical Industries Limited, provides an innovative approach to the delivery of metoprolol succinate, a medication commonly used to treat hypertension and other cardiovascular conditions.
Inventors and Assignees
The patent was invented by Vats Sandeep Kumar, Mondal Balaram, Ramaraju Kalaiselvan, and Singh Romi Barat, and is assigned to Sun Pharmaceutical Industries Limited. This assignment highlights the company's commitment to advancing pharmaceutical technology and drug delivery systems[1][4].
Patent Issuance and Expiration
The patent was issued on July 11, 2017, and is set to expire on July 9, 2035. This expiration date is crucial as it defines the period during which the patent holders have exclusive rights to the invention[1][4].
Scope of the Patent
Extended-Release Capsule Dosage Form
The patent describes an extended-release capsule dosage form of metoprolol succinate, which is composed of coated discrete units. This formulation is designed to provide a controlled release of the active ingredient over a prolonged period, enhancing patient compliance and therapeutic efficacy[1][4].
Coated Discrete Units
The coated discrete units are a key feature of this invention. These units are coated with a film-forming polymer and may include various excipients such as plasticizers, binders, opacifiers, anti-tacking agents, and anti-foaming agents. The coating process can use organic or aqueous solvents, and the choice of solvents and excipients is critical for the stability and performance of the dosage form[4].
Excipients and Solvents
The patent specifies a range of excipients and solvents that can be used in the coating process. For example, plasticizers include propylene glycol, triethyl citrate, and tributyl citrate, while opacifiers can include titanium dioxide and silicon dioxide. The use of these excipients and solvents ensures the integrity and effectiveness of the extended-release formulation[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the composition of the extended-release capsule, the process of preparing the coated discrete units, and the specific materials used in the formulation. For instance, Claim 1 might describe the capsule dosage form comprising metoprolol succinate in coated discrete units, while subsequent claims might detail the coating process and the materials used[4].
Dependent Claims
Dependent claims further elaborate on the independent claims by specifying additional features or limitations. These claims help to narrow down the scope of the invention and provide clarity on what is protected under the patent. For example, a dependent claim might specify the type of film-forming polymer used or the particular excipients included in the coating[4].
Patent Landscape
Related Patents
The patent 9,700,530 is part of a family of patents related to metoprolol succinate formulations. Another patent, 9,504,655, also issued to Sun Pharmaceutical Industries Limited, covers similar aspects of extended-release capsule dosage forms. These related patents collectively strengthen the patent portfolio of the company and provide comprehensive protection for their innovations[1][4].
Patent Exclusivity
In addition to the patent protection, the FDA may grant exclusivity periods for new drug approvals. These exclusivity periods can run concurrently with patent protection and provide additional market exclusivity for the drug, further enhancing the commercial viability of the invention[1].
Legal and Regulatory Aspects
Double Patenting
The Federal Circuit has provided guidance on what claims can properly serve as obviousness-type double-patenting references. This is relevant as it ensures that subsequent patents do not unfairly extend the exclusivity period of an earlier patent. In the context of patent 9,700,530, this guidance helps in understanding how later-filed patents related to the same invention might be treated[2].
Claim Construction
The construction of patent claims is a critical aspect of patent law. The Federal Circuit has established precedents on how claims should be interpreted, ensuring clarity and consistency in patent enforcement. For patent 9,700,530, the claim construction would be crucial in determining the scope of protection and potential infringement issues[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
The issuance of this patent reflects Sun Pharmaceutical Industries Limited's commitment to innovation in drug delivery systems. This innovation can drive competition in the pharmaceutical industry, encouraging other companies to develop similar or improved formulations. The extended-release capsule dosage form of metoprolol succinate offers significant benefits in terms of patient compliance and therapeutic outcomes, making it a valuable addition to the market[1][4].
Licensing and Litigation
The patent scope and claims can influence licensing agreements and litigation. Companies seeking to develop similar formulations must navigate the patent landscape carefully to avoid infringement. The clarity and breadth of the claims in patent 9,700,530 will be pivotal in determining the boundaries of what is permissible and what constitutes infringement[3].
Key Metrics for Patent Scope
Independent Claim Length and Count
Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process. For patent 9,700,530, the independent claims are detailed and specific, indicating a well-defined scope that is likely to withstand scrutiny[3].
Conclusion
The United States Patent 9,700,530 represents a significant advancement in the formulation of metoprolol succinate, offering an extended-release capsule dosage form that enhances patient compliance and therapeutic efficacy. The patent's scope, claims, and the broader patent landscape are critical for understanding its impact on the pharmaceutical industry.
Key Takeaways
- Innovative Formulation: The patent describes an extended-release capsule dosage form of metoprolol succinate composed of coated discrete units.
- Exclusive Rights: The patent is set to expire on July 9, 2035, providing Sun Pharmaceutical Industries Limited with exclusive rights until then.
- Regulatory Aspects: The patent is subject to FDA regulations and may be influenced by exclusivity periods and double-patenting rules.
- Industry Impact: The patent drives innovation and competition in the pharmaceutical industry, particularly in drug delivery systems.
- Legal Considerations: The construction of claims and the scope of the patent are crucial for licensing agreements and litigation.
FAQs
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What is the main invention described in United States Patent 9,700,530?
The main invention is an extended-release capsule dosage form of metoprolol succinate composed of coated discrete units.
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Who are the inventors of this patent?
The inventors are Vats Sandeep Kumar, Mondal Balaram, Ramaraju Kalaiselvan, and Singh Romi Barat.
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What is the expiration date of this patent?
The patent is set to expire on July 9, 2035.
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What are the key components of the coated discrete units?
The coated discrete units include metoprolol succinate coated with a film-forming polymer and various excipients such as plasticizers, binders, and opacifiers.
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How does this patent impact the pharmaceutical industry?
The patent drives innovation and competition in drug delivery systems, offering significant benefits in patient compliance and therapeutic outcomes.
Sources
- Generic Kapspargo Sprinkle Availability - Drugs.com
- Federal Circuit Provides Guidance on What Claims Can Properly Serve as Obviousness-Type Double-Patenting References - WSGR
- Patent Claims and Patent Scope - SSRN
- US9700530B2 - Capsule dosage form of metoprolol succinate - Google Patents
- Patent Claim Construction in the Federal Circuit, 2024 ed - Law Books
