United States Patent 7,767,851: A Comprehensive Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,767,851, titled "Ferric organic compounds, uses thereof and methods of making same," is a significant patent in the field of pharmaceuticals, particularly for the treatment of hyperphosphatemia and other conditions. This patent, held by Keryx Biopharmaceuticals, Inc., is part of a broader intellectual property portfolio that protects their drug Auryxia (ferric citrate).
Patent Overview
Publication and Status
The patent was published on August 3, 2010, and has since been a cornerstone in Keryx's intellectual property strategy. It is classified under various categories, including C07F15/02 for iron compounds and A61P39/04 for chelating agents[1].
Inventors and Assignees
The patent was assigned to Keryx Biopharmaceuticals, Inc., reflecting the company's research and development efforts in creating novel ferric organic compounds.
Claims and Scope
Composition Claims
The patent claims a novel form of ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH. This solubility is a critical factor in the drug's efficacy and stability[1].
Method of Use Claims
The patent includes method of use claims, particularly for treating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The method involves administering a therapeutically effective amount of an orally administrable form of ferric citrate[2][4].
Manufacturing Specifications
A key aspect of the patent is the specification of the active pharmaceutical ingredient (API) having a BET active surface area greater than about 16 sq. m/g. This high surface area is a manufacturing specification that enhances the drug's performance and distinguishes it from other formulations[2][4].
Patent Landscape
Related Patents
The patent is part of a robust patent family that includes several other U.S. patents, such as U.S. Patent Nos. 8,299,298, 8,338,642, 8,609,896, 8,754,257, 8,754,258, and 8,846,976. These patents collectively provide comprehensive protection for Auryxia, covering various aspects of its composition, method of use, and manufacturing process[2][4].
Patent Expiration and Extensions
The patents in this family are set to expire in 2024, although some may be extended beyond this date through patent term extensions. Keryx is also pursuing additional patent applications to extend the protection for Auryxia beyond 2030[2][4].
Clinical and Regulatory Approval
FDA Approval
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014, for the control of serum phosphorus levels in patients with CKD on dialysis. This approval underscores the clinical significance of the patent and its protected compounds[2][4].
Commercial and Market Impact
Market Protection
The patent provides substantial protection for Auryxia, preventing generic versions from entering the market until the patent expires. This protection is crucial for Keryx's market position and revenue generation from Auryxia sales[2][4].
Litigation and Enforcement
The patent has been involved in litigation, particularly in cases related to potential generic entrants. The centralization of these cases in the District of Delaware aims to ensure efficient resolution and prevent inconsistent rulings[5].
Technological and Scientific Significance
Novel Compounds
The patent introduces novel ferric organic compounds that are soluble over a wider pH range, enhancing their therapeutic efficacy. This innovation is significant in the treatment of hyperphosphatemia and other conditions where iron-based therapies are crucial[1].
Surface Area Specification
The specification of a high BET active surface area for the API is a technological advancement that distinguishes Auryxia from other ferric citrate formulations. This specification ensures better performance and stability of the drug[2][4].
Industry Expert Insights
CEO Commentary
Ron Bentsur, Chief Executive Officer of Keryx, highlighted the significance of the patent in fortifying the company's intellectual property position. He emphasized the importance of the high surface area specification as a manufacturing standard that provides substantial protection for Auryxia[2][4].
Future Developments and Challenges
Additional Patent Applications
Keryx continues to prosecute additional patent applications to extend the protection for Auryxia beyond the current expiration dates. These efforts aim to maintain market exclusivity and protect the company's investment in research and development[2][4].
Regulatory and Market Risks
The company faces risks related to regulatory approvals, market competition, and the potential entry of generic drugs. These risks are mitigated by the robust patent protection and ongoing efforts to secure additional intellectual property rights[4].
Key Takeaways
- Novel Compounds: The patent introduces novel ferric organic compounds with enhanced solubility.
- Method of Use: The patent covers methods for treating hyperphosphatemia using orally administrable forms of ferric citrate.
- Manufacturing Specifications: The high BET active surface area specification is a critical manufacturing standard.
- Patent Family: The patent is part of a comprehensive patent family protecting Auryxia.
- Regulatory Approval: Auryxia was approved by the FDA for treating CKD patients.
- Market Protection: The patent provides substantial market protection against generic competition.
Frequently Asked Questions (FAQs)
What is the primary use of the compounds described in U.S. Patent 7,767,851?
The primary use is for treating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
What distinguishes the ferric citrate in U.S. Patent 7,767,851 from other formulations?
The ferric citrate in this patent has a BET active surface area greater than about 16 sq. m/g, which is a unique manufacturing specification.
When was Auryxia (ferric citrate) approved by the FDA?
Auryxia was approved by the FDA on September 5, 2014.
What is the significance of the high surface area specification in the patent?
The high surface area specification enhances the drug's performance and stability, and it serves as a manufacturing standard that distinguishes Auryxia from other formulations.
What are the risks associated with the patent protection for Auryxia?
The risks include regulatory uncertainties, potential generic competition, and the need for ongoing patent applications to maintain market exclusivity.
Cited Sources:
- US7767851B2 - Ferric organic compounds, uses thereof and methods of making same - Google Patents
- Keryx Biopharmaceuticals Announces Issuance of a New U.S. Patent for Auryxia(TM) (ferric citrate) Covering Orally Administrable Forms
- Patent Claims and Patent Scope - Hoover Institution
- Keryx Biopharmaceuticals Announces Issuance of a New U.S. Patent for Auryxia(TM) (ferric citrate) Covering Orally Administrable Forms
- AURYXIA (FERRIC CITRATE) PATENT LITIGATION MDL No. 2896
