United States Patent 9,492,476: A Comprehensive Analysis
Introduction
United States Patent 9,492,476, titled "Potassium-binding agents for treating hypertension and hyperkalemia," is a significant patent that addresses the treatment of chronic kidney disease and related conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, granted to Relypsa, Inc., focuses on methods and compositions for treating hypertension and hyperkalemia, particularly in patients with chronic kidney disease (CKD). Hyperkalemia, a condition characterized by elevated potassium levels in the blood, is a common complication in CKD patients and can be life-threatening if not managed properly[1].
Scope of the Patent
Treatment Methods
The patent describes methods for treating hyperkalemia and hypertension using potassium-binding agents. These agents are designed to bind to potassium ions in the gastrointestinal tract, thereby reducing the absorption of potassium into the bloodstream. This approach is crucial for managing hyperkalemia without the need for dialysis or other invasive treatments[1].
Compositions
The patent outlines various compositions that include potassium-binding agents, such as zirconium cyclosilicate, which is the active ingredient in the drug Veltassa. These compositions can be formulated in different ways, including tablets, capsules, and suspensions, to facilitate easy administration and optimal efficacy[1].
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- Methods of treating hyperkalemia and hypertension using specific doses of potassium-binding agents.
- Compositions comprising zirconium cyclosilicate and other excipients.
- Specific formulations and dosing regimens for these compositions[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, including:
- The use of particular excipients like sodium, sorbitol, and polyvinylpyrrolidone.
- The preparation methods for the compositions.
- The therapeutic regimens and dosing schedules for treating patients[1].
Patent Landscape
Related Patents
The patent landscape around US 9,492,476 includes other patents related to the treatment of hyperkalemia and CKD. For instance, patents related to other potassium-binding agents and their formulations are part of this landscape. The competition in this space is significant, with multiple pharmaceutical companies developing similar treatments[4].
Litigation and Disputes
The patent has been involved in litigation, as seen in the case of Relypsa, Inc. v. Alkem Labs. Ltd., where the court ruled on the disputed claim terms of a related patent. Such legal battles highlight the importance and value of these patents in the pharmaceutical industry[2].
International Patent Filings
The invention covered by US 9,492,476 has likely been filed in other jurisdictions as part of a global patent strategy. Tools like the Global Dossier and Common Citation Document (CCD) can provide insights into the international patent family and the prior art cited by different patent offices[4].
Economic and Market Impact
Market Demand
The treatment of hyperkalemia and CKD is a significant market, driven by the increasing prevalence of these conditions. The demand for effective and safe treatments is high, making patents like US 9,492,476 highly valuable.
Competitive Advantage
Holding a patent like US 9,492,476 provides a competitive advantage in the market. It allows the patent holder to exclude others from making, using, or selling the invention, thereby protecting their investment in research and development.
Technical Details
Active Ingredients
The patent focuses on zirconium cyclosilicate, a highly effective potassium-binding agent. This compound is designed to selectively bind to potassium ions in the gastrointestinal tract, reducing their absorption into the bloodstream.
Formulations and Excipients
The patent describes various formulations, including tablets and suspensions, and the use of excipients like sodium, sorbitol, and polyvinylpyrrolidone. These formulations are critical for ensuring the stability and efficacy of the potassium-binding agents[1].
Regulatory Aspects
FDA Approval
The drug Veltassa, which is based on the technology described in this patent, has received FDA approval for the treatment of hyperkalemia. This approval is a significant milestone, indicating that the treatment has met rigorous safety and efficacy standards.
Compliance with Guidelines
The patent and its associated products must comply with various regulatory guidelines, including those related to pharmaceutical manufacturing, labeling, and marketing. Adherence to these guidelines is essential for maintaining regulatory approval and ensuring patient safety.
Future Directions
Ongoing Research
Research in the field of potassium-binding agents continues to evolve. New formulations and agents are being developed to improve efficacy and reduce side effects. This ongoing research may lead to additional patents and further innovations in the treatment of hyperkalemia and CKD.
Market Expansion
As the global prevalence of CKD and hyperkalemia increases, the market for treatments like those described in US 9,492,476 is expected to grow. This growth will likely drive further investment in research and development, as well as expansion into new markets.
Key Takeaways
- Innovative Treatment: US 9,492,476 introduces innovative methods and compositions for treating hyperkalemia and hypertension.
- Market Value: The patent holds significant market value due to the high demand for effective treatments for CKD and hyperkalemia.
- Regulatory Compliance: The patent and associated products must comply with stringent regulatory guidelines.
- Ongoing Research: Continued research in this field is expected to lead to further innovations and market expansion.
FAQs
What is the main focus of US 9,492,476?
The main focus of US 9,492,476 is on methods and compositions for treating hyperkalemia and hypertension using potassium-binding agents, particularly in patients with chronic kidney disease.
What is the active ingredient described in the patent?
The active ingredient described in the patent is zirconium cyclosilicate, which is used in the drug Veltassa.
What are the formulations described in the patent?
The patent describes various formulations, including tablets, capsules, and suspensions, which are designed to facilitate easy administration and optimal efficacy.
Has the drug based on this patent received FDA approval?
Yes, the drug Veltassa, based on the technology described in this patent, has received FDA approval for the treatment of hyperkalemia.
What is the significance of the patent in the pharmaceutical industry?
The patent provides a competitive advantage in the market by allowing the patent holder to exclude others from making, using, or selling the invention, thereby protecting their investment in research and development.
Sources
- US9492476B2 - Potassium-binding agents for treating hypertension and hyperkalemia - Google Patents
- Relypsa, Inc. v. Alkem Labs. Ltd. - Casetext
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Patent Docs - February 16, 2020
