United States Patent 9,393,203: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,393,203, titled "Osmotic drug delivery system," is a significant innovation in the field of pharmaceuticals, particularly in drug delivery systems. This patent, issued on January 8, 2013, addresses the challenges associated with the release profiles of highly water-soluble drugs.
Background and Context
Osmotic drug delivery systems are designed to release drugs in a controlled manner, often using osmotic pressure to drive the release. These systems are crucial for maintaining therapeutic drug levels over an extended period, which is particularly important for drugs with erratic or incomplete release profiles[1].
Scope of the Patent
The patent 9,393,203 focuses on an oral osmotic pharmaceutical delivery system. Here are the key aspects of its scope:
Drug Characteristics
The system is specifically designed for highly water-soluble drugs that exhibit erratic or incomplete release profiles. This includes drugs like treprostinil, a prostacyclin analog used in the treatment of pulmonary arterial hypertension[1].
Delivery Mechanism
The osmotic delivery system uses osmotic pressure to release the drug. This mechanism ensures a consistent and controlled release of the drug, which is essential for maintaining therapeutic levels and minimizing side effects.
Components and Structure
The system typically includes a solid dosage form with a drug core, an osmotic layer, and sometimes additional components like granular materials, solvents, and sustained-release forms. The osmotic layer is critical as it controls the rate of drug release based on osmotic pressure[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Primary Claims
- Claim 1 describes the overall osmotic drug delivery system, including the drug core and the osmotic layer.
- Claims 3-5 specify the composition and structure of the system, including the use of specific materials like treprostinil and the configuration of the osmotic layer[2].
Detailed Composition
- The claims also detail the use of mixtures, granulation methods, and the role of solvents and sustained-release forms in the delivery system[1].
Patent Landscape
The patent landscape surrounding 9,393,203 is complex and involves several related patents and legal considerations:
Related Patents
- The patent is part of a series of patents related to the delivery of prostacyclin analogs, including patents like 8,252,839, 8,349,892, and 9,050,311. These patents collectively cover various aspects of drug delivery systems and methods[2].
Legal and Ownership Aspects
- The patent is owned by UTC (United Therapeutics Corporation), which has exclusive rights to develop, make, use, and sell products covered by this and related patents. This includes the right to sue for infringement[2].
Litigation and Infringement
- The patent has been involved in legal disputes, with UTC asserting its rights against potential infringers. For example, UTC has filed lawsuits to protect its intellectual property related to the delivery of prostacyclin analogs[2].
Technological and Pharmaceutical Impact
The osmotic drug delivery system described in this patent has significant implications for pharmaceutical technology and patient care:
Controlled Release
- The system ensures a controlled and sustained release of the drug, which can improve the efficacy and safety of highly water-soluble drugs[1].
Therapeutic Benefits
- For drugs like treprostinil, this system can provide consistent therapeutic levels, reducing the need for frequent dosing and minimizing side effects.
Future Developments
- The technology can be adapted for other drugs with similar release profile challenges, expanding its application in various therapeutic areas.
Economic and Market Impact
The economic and market impact of this patent is substantial:
Market Domination
- By providing a reliable and controlled drug delivery system, UTC can maintain a strong market position in the treatment of conditions like pulmonary arterial hypertension.
Competitive Advantage
- The exclusive rights granted by this patent give UTC a competitive advantage over other pharmaceutical companies, allowing it to develop and market products without direct competition.
Revenue Generation
- The controlled release mechanism can lead to higher patient compliance and better therapeutic outcomes, potentially increasing the revenue generated from these products.
Challenges and Limitations
While the patent offers several advantages, there are also challenges and limitations:
Complexity of the System
- The osmotic delivery system involves complex components and manufacturing processes, which can be challenging to replicate and scale up.
Regulatory Hurdles
- The system must comply with stringent regulatory requirements, including those related to drug safety, efficacy, and manufacturing standards.
Cost Considerations
- The development and production of such a system can be costly, which may affect its accessibility and affordability for patients.
Key Takeaways
- Controlled Drug Release: The patent 9,393,203 describes an osmotic drug delivery system that ensures controlled and sustained release of highly water-soluble drugs.
- Therapeutic Benefits: This system improves the efficacy and safety of drugs like treprostinil.
- Market Impact: The patent provides UTC with a competitive advantage and significant market potential.
- Challenges: The system's complexity, regulatory hurdles, and cost considerations are key challenges.
FAQs
What is the primary focus of the United States Patent 9,393,203?
The primary focus is on an oral osmotic pharmaceutical delivery system designed for highly water-soluble drugs with erratic or incomplete release profiles.
Which drug is specifically mentioned in the patent?
Treprostinil, a prostacyclin analog, is specifically mentioned as an example of a drug that can be delivered using this system.
Who owns the patent?
The patent is owned by United Therapeutics Corporation (UTC).
What are the key components of the osmotic delivery system?
The system includes a drug core, an osmotic layer, and sometimes additional components like granular materials and sustained-release forms.
What are the potential therapeutic benefits of this delivery system?
The system provides consistent therapeutic drug levels, reduces the need for frequent dosing, and minimizes side effects.
Cited Sources
- US9393203B2 - Osmotic drug delivery system - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp
- Patent Claims Research Dataset - USPTO
- THE U.S. PATENT APPLICATION PROCESS - SBIR
- CosmoKey Solutions GmbH & Co. KG v. Duo Security LLC - CAFC