United States Patent 9,320,714: A Detailed Analysis
Overview of the Patent
United States Patent 9,320,714, titled "Tablet," is owned by Takeda Pharmaceuticals Usa Inc. and is associated with the drug Actoplus Met. This patent is one of the several that protect the intellectual property of Actoplus Met, a medication used to treat type 2 diabetes.
Patent Details
- Patent Number: US9320714
- Issue Date: August 11, 2015
- Expiration Date: February 2029[2].
Inventors and Assignees
The patent is assigned to Takeda Pharmaceuticals Usa Inc. The inventors and specific details about their contributions are not explicitly mentioned in the available sources, but the patent is part of Takeda's broader intellectual property portfolio.
Claims and Scope
Primary Claims
The patent primarily covers the formulation and composition of Actoplus Met tablets. Here are some key aspects of the claims:
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Tablet Composition: The patent describes the specific formulation of the tablet, including the active ingredients, excipients, and the method of preparation. This includes details on the film-coating layer, which may contain substances like hydroxypropylmethyl cellulose or hydroxypropyl cellulose[5].
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Dosage and Administration: The claims also cover the dosage form, which is typically an oral tablet. This includes specifications on the size, shape, and other physical characteristics of the tablet.
Scope Concepts
The scope of this patent can be analyzed using the concept of scope concepts, which categorize patents by their claims and overarching themes. For US9320714, the scope concepts would include:
- Drug Formulation: This patent is heavily focused on the formulation of Actoplus Met, including the specific combination of active ingredients and excipients.
- Dosage Forms: The patent covers the tablet form of the drug, including its physical and chemical properties.
- Manufacturing Process: The claims may also include methods for manufacturing the tablets, ensuring consistency and quality in the final product.
Patent Landscape
Family Patents
Actoplus Met is protected by a family of patents, each covering different aspects of the drug. Here is a brief overview of some of the other patents in this family:
- US9101660: This patent covers a solid preparation of Actoplus Met and is set to expire in January 2027[2].
- Expired Patents: Several other patents related to Actoplus Met have already expired, including those covering pharmaceutical compositions filed between 1996 and 2001[2].
Global Protection
While US9320714 provides protection within the United States, Actoplus Met is also protected by patents in multiple other countries. Understanding the global patent landscape is crucial for strategizing market entry and identifying potential generic entry points[2].
Exclusivity and Generic Launch
The patent exclusivity for Actoplus Met is set to expire in February 2029, which is when generic versions of the drug can be launched. The current active patents, including US9320714, play a critical role in delaying generic competition until their expiration dates[2].
Patent Analytics and Claim Coverage
To fully understand the protection offered by US9320714, patent analytics tools can be used. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent coverage. For example, using a Claim Coverage Matrix, one can determine which claims are actively protecting the intellectual property and where there might be gaps in coverage[3].
Impact on Market Strategy
Understanding the scope and claims of US9320714 is vital for market strategy. Here are a few key points:
- Competitive Advantage: The patent provides Takeda Pharmaceuticals with a competitive advantage by preventing generic competition until its expiration.
- Market Entry Points: Analyzing the broader patent landscape can help identify markets with weaker patent protection, which could be ideal for generic entry points.
- Product Development: The patent details can guide the development of new products or formulations that do not infringe on the existing claims.
Legal and Regulatory Considerations
The patent is subject to various legal and regulatory requirements. For instance, the FDA's Orange Book provides detailed information on drug patents and exclusivities, which is crucial for understanding the regulatory environment[4].
Key Takeaways
- Patent Expiration: US9320714 expires in February 2029, marking the potential launch date for generic versions of Actoplus Met.
- Scope and Claims: The patent covers the formulation, composition, and dosage form of Actoplus Met tablets.
- Global Protection: Actoplus Met is protected by a family of patents across multiple countries.
- Market Strategy: Understanding the patent landscape is crucial for market strategy, including identifying competitive advantages and potential generic entry points.
FAQs
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What is the primary focus of US9320714?
- The primary focus of US9320714 is the formulation and composition of Actoplus Met tablets.
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When does the patent expire?
- The patent expires in February 2029.
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Who owns the patent?
- The patent is owned by Takeda Pharmaceuticals Usa Inc.
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What other patents protect Actoplus Met?
- Actoplus Met is protected by a family of patents, including US9101660 and several expired patents.
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How does the patent impact market strategy?
- The patent provides a competitive advantage by delaying generic competition and guides the development of new products to avoid infringement.
Cited Sources:
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Actoplus Met patent expiration - Pharsight
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United States Patent 9,320,714
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Patent Analytics | Intellectual Property Law
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Approved Drug Products with Therapeutic Equivalence Evaluations
