United States Patent 9,050,316: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,050,316, titled "Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same," is a significant patent in the pharmaceutical industry, particularly in the realm of iron-based therapies. This patent, owned by Keryx Biopharmaceuticals, Inc., covers various aspects of ferric citrate and other ferric organic compounds, their uses, and the methods for their production.
Background
Ferric citrate, the primary compound discussed in this patent, is used in the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) and as an iron replacement therapy. The patent highlights the importance of pharmaceutical-grade ferric organic compounds that are soluble over a wider range of pH, enhancing their efficacy and stability.
Scope of the Patent
Pharmaceutical-Grade Ferric Organic Compounds
The patent focuses on the development and use of pharmaceutical-grade ferric organic compounds, including ferric citrate. These compounds are designed to be soluble over a broader pH range, which is crucial for their stability and effectiveness in various therapeutic applications[1].
Uses of Ferric Citrate
Ferric citrate is approved for two main indications:
- Treatment of Hyperphosphatemia: In patients with CKD, ferric citrate helps to control phosphate levels in the blood.
- Iron Replacement Therapy: It is used to treat iron deficiency anemia in patients with CKD[2][5].
Methods of Production
The patent details methods for synthesizing these pharmaceutical-grade ferric organic compounds. These methods ensure the production of high-quality compounds with consistent properties, which is essential for pharmaceutical applications[1].
Claims of the Patent
The patent includes several claims that define the scope of protection for the inventions described. Here are some key claims:
Composition Claims
- Claims related to the composition of pharmaceutical-grade ferric organic compounds, including their solubility characteristics and purity standards.
- Specific claims on ferric citrate and its salts, emphasizing their pharmaceutical-grade quality[1].
Method Claims
- Claims covering the methods of synthesizing these compounds, including the steps involved in ensuring their solubility and stability.
- Claims on the processes for purifying and formulating these compounds for pharmaceutical use[1].
Use Claims
- Claims related to the therapeutic uses of ferric citrate, including its application in treating hyperphosphatemia and as an iron replacement therapy.
- Claims on the administration routes and dosages of these compounds[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 9,050,316 includes several related patents owned by Keryx Biopharmaceuticals, Inc. and other entities. These patents collectively cover various aspects of ferric citrate and other ferric organic compounds, including their production, formulation, and therapeutic uses.
Key Patents
- US 7,767,851: Covers the use of ferric citrate for treating hyperphosphatemia.
- US 8,093,423: Relates to the formulation of ferric citrate for oral administration.
- US 8,299,298: Details methods for the synthesis and purification of ferric citrate.
- US 8,609,896: Covers the use of ferric citrate as an iron replacement therapy[2][5].
Litigation and Infringement
The patent has been involved in several litigation cases, particularly against generic drug manufacturers seeking to market generic versions of AURYXIA® (Ferric Citrate) Tablets before the expiration of the patents. For example, Keryx Biopharmaceuticals, Inc. has sued Teva USA for patent infringement related to the submission of Abbreviated New Drug Applications (ANDAs) for generic versions of ferric citrate[2][5].
Expiration and Licensing
The patent's expiration date is crucial for understanding the future landscape of ferric citrate and related compounds. As the patent nears its expiration, generic manufacturers may seek to enter the market, potentially changing the competitive dynamics.
Impact on the Pharmaceutical Industry
Therapeutic Advancements
The patent has facilitated significant therapeutic advancements in the treatment of hyperphosphatemia and iron deficiency anemia, particularly in patients with CKD. The development of pharmaceutical-grade ferric citrate has improved patient outcomes by providing a more stable and effective treatment option.
Market Competition
The patent has also influenced market competition by protecting Keryx Biopharmaceuticals' exclusive rights to market AURYXIA® (Ferric Citrate) Tablets. This protection has allowed the company to maintain a significant market share in the treatment of hyperphosphatemia and iron deficiency anemia.
Conclusion
United States Patent 9,050,316 is a pivotal patent in the pharmaceutical industry, particularly in the field of iron-based therapies. It covers the development, production, and therapeutic uses of pharmaceutical-grade ferric organic compounds, including ferric citrate. The patent's claims and the broader patent landscape highlight its significance in protecting innovative therapeutic solutions and shaping the market for these treatments.
Key Takeaways
- Pharmaceutical-Grade Compounds: The patent focuses on the development of pharmaceutical-grade ferric organic compounds with enhanced solubility and stability.
- Therapeutic Uses: Ferric citrate is used for treating hyperphosphatemia and as an iron replacement therapy.
- Production Methods: Detailed methods for synthesizing and purifying these compounds are described.
- Patent Landscape: The patent is part of a larger portfolio of related patents covering various aspects of ferric citrate.
- Litigation: The patent has been involved in several litigation cases against generic drug manufacturers.
FAQs
What is the primary compound discussed in US Patent 9,050,316?
The primary compound discussed is ferric citrate, a pharmaceutical-grade iron-based compound.
What are the main therapeutic uses of ferric citrate?
Ferric citrate is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD) and as an iron replacement therapy.
Who owns US Patent 9,050,316?
The patent is owned by Keryx Biopharmaceuticals, Inc.
What is the significance of the patent's solubility claims?
The patent's claims on solubility ensure that the ferric citrate is stable and effective over a wider range of pH, which is crucial for its therapeutic applications.
Has the patent been involved in any litigation?
Yes, the patent has been involved in several litigation cases against generic drug manufacturers seeking to market generic versions of AURYXIA® (Ferric Citrate) Tablets.
Sources
- US9050316B2 - Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp