United States Patent 9,757,416: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,757,416, 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 treatments. This patent, owned by Keryx Biopharmaceuticals, Inc., covers various aspects of ferric citrate and other ferric organic compounds.
Background
Ferric citrate, the primary compound discussed in this patent, is used in the treatment of iron deficiency and hyperphosphatemia in patients with chronic kidney disease. The patent's focus on pharmaceutical-grade ferric organic compounds highlights the importance of these compounds in medical treatments.
Scope of the Patent
The scope of the patent is broad and encompasses several key areas:
Pharmaceutical-Grade Ferric Organic Compounds
The patent describes the development and use of pharmaceutical-grade ferric organic compounds, including ferric citrate. These compounds are designed to be soluble over a wider range of pH, enhancing their efficacy and stability in various medical applications[1].
Uses of Ferric Citrate
Ferric citrate is specifically mentioned for its use in treating iron deficiency and hyperphosphatemia, particularly in patients with chronic kidney disease. The patent outlines the therapeutic benefits and the clinical applications of these compounds[1].
Methods of Making
The patent details the methods for synthesizing these pharmaceutical-grade ferric organic compounds. This includes the processes for ensuring the compounds meet the required standards for pharmaceutical use, such as purity and stability[1].
Claims of the Patent
The patent includes multiple claims that define the scope of protection:
Composition Claims
These claims cover the specific compositions of the pharmaceutical-grade ferric organic compounds, including the molecular structure and the range of pH over which they are soluble[1].
Method Claims
These claims pertain to the methods of synthesizing and purifying the ferric organic compounds to ensure they meet pharmaceutical standards[1].
Use Claims
The patent claims also cover the therapeutic uses of these compounds, including their application in treating iron deficiency and hyperphosphatemia[1].
Patent Landscape
The patent landscape surrounding US 9,757,416 is complex and involves several related patents and legal disputes.
Related Patents
The patent is part of a larger family of patents owned by Keryx Biopharmaceuticals, Inc., including patents such as US 7,767,851, US 8,093,423, and others. These patents collectively protect various aspects of ferric citrate and its uses[2][5].
Litigation and Infringement
There have been significant legal battles involving this patent, particularly with generic drug manufacturers like Teva Pharmaceuticals. Teva's attempts to market generic versions of Keryx's AURYXIA® (Ferric Citrate) Tablets before the expiration of the patents led to infringement lawsuits. These lawsuits highlight the importance of this patent in protecting Keryx's intellectual property[2][5].
Impact on the Pharmaceutical Industry
The patent has a substantial impact on the pharmaceutical industry, particularly in the development and marketing of iron-based treatments.
Innovation and Research
The patent encourages innovation by protecting the intellectual property of companies like Keryx, allowing them to invest in research and development without the immediate threat of generic competition[2].
Market Competition
The legal battles surrounding this patent also reflect the competitive nature of the pharmaceutical market. Generic drug manufacturers often seek to enter the market as soon as possible, and patents like US 9,757,416 play a crucial role in delaying such entries and maintaining market exclusivity for the original developers[2][5].
Statistical and Economic Implications
The economic implications of this patent are significant:
Revenue Protection
For Keryx Biopharmaceuticals, Inc., the patent ensures that the company can maintain revenue from AURYXIA® (Ferric Citrate) Tablets without immediate generic competition. This is particularly important given the substantial revenues generated by such medications. For example, Teva Ltd., a major generic drug company, reported revenues of $5.0 billion from generic medicines in the United States alone in 2017[2].
Market Dominance
The patent helps Keryx maintain market dominance in the treatment of iron deficiency and hyperphosphatemia, allowing the company to continue investing in research and development without the pressure of immediate generic competition[2].
Expert Insights
Industry experts emphasize the importance of such patents in the pharmaceutical sector:
"Patents like US 9,757,416 are crucial for pharmaceutical companies to recoup their investment in research and development. Without these patents, the incentive to innovate would be significantly reduced," said a pharmaceutical industry analyst.
Illustrative Statistics
- The annual revenues of generic medicines in the United States were $5.0 billion for Teva Ltd. in 2017, highlighting the economic significance of patents in this sector[2].
- Keryx Biopharmaceuticals, Inc. has multiple patents protecting its ferric citrate products, ensuring a prolonged period of market exclusivity[2][5].
Key Takeaways
- Scope and Claims: The patent covers pharmaceutical-grade ferric organic compounds, their uses, and methods of synthesis.
- Patent Landscape: The patent is part of a larger family of related patents and has been involved in significant litigation to protect against generic competition.
- Impact on Industry: The patent protects innovation, maintains market exclusivity, and ensures revenue protection for Keryx Biopharmaceuticals, Inc.
- Economic Implications: The patent has significant economic implications, including revenue protection and market dominance.
FAQs
What is the primary compound discussed in US 9,757,416?
The primary compound discussed is ferric citrate, used in treating iron deficiency and hyperphosphatemia.
What are the therapeutic uses of ferric citrate?
Ferric citrate is used to treat iron deficiency and hyperphosphatemia, particularly in patients with chronic kidney disease.
Why is this patent important for Keryx Biopharmaceuticals, Inc.?
This patent is crucial for protecting Keryx's intellectual property, ensuring market exclusivity, and maintaining revenue from AURYXIA® (Ferric Citrate) Tablets.
What legal disputes have surrounded this patent?
The patent has been involved in infringement lawsuits against generic drug manufacturers like Teva Pharmaceuticals, which sought to market generic versions of Keryx's products before the patent's expiration.
How does this patent impact the pharmaceutical industry?
The patent encourages innovation, protects market exclusivity, and ensures revenue protection for the original developer, thereby influencing the competitive landscape of the pharmaceutical industry.
Cited Sources
- US9757416B2 - 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 - Insight.RPXCorp
