United States Patent 8,093,423: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,093,423 is a significant patent within the intellectual property portfolio of Keryx Biopharmaceuticals, Inc., particularly in relation to their product Auryxia (ferric citrate). This patent is crucial for understanding the company's strategic positioning and the protection of their innovative pharmaceutical product.
Background of Auryxia (Ferric Citrate)
Auryxia, approved by the FDA on September 5, 2014, is an oral, iron-based phosphate binder used to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The patent landscape surrounding Auryxia is complex and multifaceted, with several patents providing comprehensive protection[1][2].
Patent Details: U.S. Patent 8,093,423
- Issuance and Expiration: U.S. Patent 8,093,423 was issued and is set to expire in 2026, before any potential patent term extension[1][2].
- Claims and Coverage: This patent contains composition and method of use claims that cover Auryxia. It is part of a broader patent family that includes several other U.S. patents, such as 7,767,851, 8,299,298, 8,338,642, 8,609,896, 8,754,257, 8,754,258, and 8,846,976, which expire in 2024[1][2].
Scope of the Patent
The scope of U.S. Patent 8,093,423 is defined by its claims, which are designed to protect the unique aspects of Auryxia:
- Composition Claims: These claims cover the specific formulation of ferric citrate used in Auryxia, including its active pharmaceutical ingredient (API) and the manufacturing specifications that distinguish it from other formulations[1].
- Method of Use Claims: The patent includes claims for the method of treating hyperphosphatemia by administering a therapeutically effective amount of an orally administrable form of ferric citrate. This ensures that any use of a similar formulation for the same therapeutic purpose would infringe on this patent[1].
Significance in the Patent Family
U.S. Patent 8,093,423 is one of several patents that collectively form a robust intellectual property shield for Auryxia. This patent family provides comprehensive protection by covering various aspects of the drug, including its composition, method of use, and specific manufacturing specifications.
Manufacturing Specifications
A key aspect of this patent is the specification of the API's surface area. The patent claims cover orally administrable forms prepared from a ferric citrate having a BET (Brunauer-Emmett-Teller) active surface area greater than about 16 sq. m/g. This high surface area is a critical manufacturing specification that distinguishes Auryxia from other potential formulations[1].
Patent Term Extension
Keryx Biopharmaceuticals has filed applications under the patent term extension provisions of 35 U.S.C. § 156 for several of its patents, including U.S. Patent 8,093,423. If granted, this could extend the patent protection for Auryxia by up to an additional 5 years[4].
Litigation and Generic Challenges
The patents covering Auryxia, including U.S. Patent 8,093,423, have been involved in litigation related to generic challenges. Under the Hatch-Waxman Act, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with a paragraph IV certification, which can lead to patent infringement disputes. Centralization of these cases in the District of Delaware has been ordered to ensure efficient resolution and prevent inconsistent rulings[5].
Impact on Innovation and Competition
The robust patent protection provided by U.S. Patent 8,093,423 and its associated patents can influence innovation and competition in the pharmaceutical industry. While strong patent protection can incentivize innovation by securing returns on investment, overly broad patents can also increase licensing and litigation costs, potentially diminishing incentives for further innovation[3].
Key Takeaways
- Comprehensive Protection: U.S. Patent 8,093,423 is part of a broad patent family that provides extensive protection for Auryxia.
- Specific Claims: The patent includes composition and method of use claims that are critical for distinguishing Auryxia from other formulations.
- Manufacturing Specifications: The high surface area of the API is a key manufacturing specification protected by this patent.
- Litigation and Generic Challenges: The patent has been involved in litigation related to generic challenges, highlighting its importance in protecting Auryxia’s market position.
- Impact on Innovation: Strong patent protection can both incentivize innovation and potentially increase costs associated with licensing and litigation.
Frequently Asked Questions (FAQs)
Q: What is the primary use of Auryxia (ferric citrate) covered by U.S. Patent 8,093,423?
A: Auryxia is used to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Q: What is the significance of the surface area specification in U.S. Patent 8,093,423?
A: The patent specifies that the API must have a BET active surface area greater than about 16 sq. m/g, which is a critical manufacturing specification distinguishing Auryxia from other formulations.
Q: How does the patent term extension provision affect U.S. Patent 8,093,423?
A: If granted, the patent term extension could add up to an additional 5 years to the patent protection for Auryxia.
Q: What is the role of the Hatch-Waxman Act in relation to generic challenges to Auryxia?
A: The Hatch-Waxman Act allows generic manufacturers to file ANDAs with a paragraph IV certification, which can lead to patent infringement disputes and is a key aspect of the litigation landscape surrounding Auryxia.
Q: How does strong patent protection like that provided by U.S. Patent 8,093,423 impact innovation in the pharmaceutical industry?
A: Strong patent protection can incentivize innovation by securing returns on investment but may also increase licensing and litigation costs, potentially affecting the overall innovation landscape.
Cited Sources:
- Keryx Biopharmaceuticals Announces Issuance of a New U.S. Patent for Auryxia(TM) (ferric citrate) Covering Orally Administrable Forms - Marketscreener.
- Keryx Biopharmaceuticals Announces Issuance of a New U.S. Patent for Auryxia(TM) (ferric citrate) Covering Orally Administrable Forms - GlobeNewswire.
- Patent Claims and Patent Scope - SSRN.
- Akebia Therapeutics, Inc. - Akebia Therapeutics.
- AURYXIA (FERRIC CITRATE) PATENT LITIGATION MDL No. 2896 - JPML.
