United States Patent 11,291,645: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,291,645, titled "Aqueous iron carbohydrate complexes, their production and medicaments containing them," was granted to Vifor (International) AG on April 5, 2022. This patent is a continuation of several earlier applications and represents a significant development in the field of iron carbohydrate complexes.
Background and Prior Art
The patent builds upon a series of earlier applications, starting from German Application No. 10249552.1 filed on October 23, 2002, and includes multiple continuations and divisions, such as U.S. application Ser. No. 10/531,895 and PCT/EP2003/011596[4].
Inventors and Assignee
The inventors listed are Peter Geisser, Erik Philipp, and Walter Richle, all from Switzerland. The assignee is Vifor (International) AG, based in St. Gallen, Switzerland[1].
Scope of the Invention
The patent describes aqueous iron carbohydrate complexes, their production, and their use in medicaments. These complexes are water-soluble and are obtained from aqueous solutions of iron(III) salts and carbohydrates. The invention is particularly relevant in the treatment of iron deficiency and related conditions[4].
Claims
The patent includes multiple claims that define the scope of the invention. Key claims include:
- The process of producing the aqueous iron carbohydrate complexes.
- The composition of the complexes themselves.
- The use of these complexes in medicaments, particularly for treating iron deficiency.
The specification must enable a person skilled in the art to practice the full scope of the claimed invention, as emphasized by the Amgen v. Sanofi decision under 35 U.S.C. § 112(a)[3].
Enablement Requirement
The patent application must meet the enablement requirement, which means the specification must provide sufficient detail to allow a person skilled in the art to make and use the entire class of claimed inventions. This is crucial, as the Court has held that "the more one claims, the more one must enable"[3].
Production Process
The production process involves combining an aqueous solution of an iron(III) salt with an aqueous solution of a carbohydrate, followed by oxidation. This process results in a stable, water-soluble iron carbohydrate complex[4].
Medicinal Applications
The iron carbohydrate complexes are designed for use in medicaments, particularly for treating iron deficiency and related conditions. These complexes offer improved bioavailability and stability compared to other iron formulations[4].
Patent Landscape
The patent landscape in this area is complex, with multiple prior patents and applications cited. The patent office reviews the application to ensure that the invention is novel, nonobvious, and enabled. The presence of numerous prior art references indicates a highly developed field with ongoing innovation[1][2].
Prosecution History
The patent application went through several stages, including provisional and non-provisional filings. The process involved amendments and arguments to address patentability issues raised by the patent examiner. The final grant of the patent indicates that the inventors successfully navigated these challenges[2].
Commercial and Practical Implications
The commercial value of this patent is significant, given the widespread need for effective iron deficiency treatments. The costs associated with patenting, including drafting and filing the application, as well as prosecution costs, are substantial but can be recovered through commercial partnerships or licensing agreements[2].
Legal and Regulatory Considerations
The patent is subject to U.S. and international patent laws. The inventors must ensure that the invention was not publicly disclosed before filing the patent application, especially in countries without a grace period for public disclosure. The patent's validity is presumed under 35 U.S.C. § 282, but it can be challenged through various legal avenues[2][5].
Key Takeaways
- Invention Scope: The patent covers aqueous iron carbohydrate complexes, their production, and their use in medicaments.
- Enablement: The specification must enable a person skilled in the art to practice the full scope of the claimed invention.
- Production Process: Involves combining iron(III) salt and carbohydrate solutions followed by oxidation.
- Medicinal Applications: Designed for treating iron deficiency with improved bioavailability and stability.
- Patent Landscape: Highly developed field with numerous prior art references.
- Commercial Implications: Significant commercial value with potential for recovery of patenting costs through partnerships or licensing.
FAQs
What is the main subject of United States Patent 11,291,645?
The main subject is aqueous iron carbohydrate complexes, their production, and their use in medicaments.
Who are the inventors of this patent?
The inventors are Peter Geisser, Erik Philipp, and Walter Richle.
What is the significance of the enablement requirement in this patent?
The enablement requirement ensures that the specification provides sufficient detail to allow a person skilled in the art to make and use the entire class of claimed inventions.
How are the aqueous iron carbohydrate complexes produced?
The production involves combining an aqueous solution of an iron(III) salt with an aqueous solution of a carbohydrate, followed by oxidation.
What are the potential commercial implications of this patent?
The patent has significant commercial value, particularly in the treatment of iron deficiency, and the costs associated with patenting can be recovered through commercial partnerships or licensing agreements.
Cited Sources
- United States Patent and Trademark Office. Aqueous iron carbohydrate complexes, their production and medicaments containing them. US Patent 11,291,645 B2, April 5, 2022.
- KU Office of Research. Intellectual Property Protection. [Online]. Available: https://research.ku.edu/intellectual-property-protection
- IPWatchdog. Amgen v. Sanofi: Seven Months In, Has Anything About Patent Enablement Changed? January 9, 2024.
- Justia Patents. Aqueous iron carbohydrate complexes, their production and medicaments containing them. US Patent 11,291,645 B2, April 5, 2022.
- United States Court of Appeals for the Federal Circuit. VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC. September 16, 2024.
