United States Patent 10,342,813: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 10,342,813, hereafter referred to as the '813 patent, is associated with calcium gluconate solutions in flexible containers, specifically for intravenous administration. This patent is held by HQ Specialty Pharma Corp. and is a crucial component in the medical field for treating acute symptomatic hypocalcemia.
Background and Context
The '813 patent was issued on October 29, 2018, following the FDA approval of HQ Specialty Pharma's New Drug Application (NDA 210906) for calcium gluconate in sodium chloride solution in bags for intravenous administration[2].
Scope of the Patent
Indications and Use
The patent covers the use of calcium gluconate in sodium chloride solution as an intravenous injection indicated for the treatment of acute symptomatic hypocalcemia. This solution is provided in a ready-to-use flexible plastic bag, designed to be administered intravenously without the need for dilution[2].
Technical Aspects
The patent involves the formulation and packaging of calcium gluconate in a way that ensures stability and ease of use. The solution is stored in flexible plastic bags, which is a significant innovation in the field of intravenous medications. This format enhances the convenience and safety of administration, as it eliminates the need for manual preparation and reduces the risk of contamination[2].
Claims of the Patent
Key Claims
The '813 patent includes several key claims that define the scope of the invention:
- Claim 1: This claim typically outlines the broadest definition of the invention, which in this case involves the composition of calcium gluconate in sodium chloride solution in a flexible container for intravenous administration.
- Subsequent Claims: These claims may include specific details about the concentration of calcium gluconate, the type of flexible container, and the method of administration. They also cover various aspects of the solution, such as its pH level, osmolarity, and sterility[2].
Infringement Claims
The patent holders have alleged infringement by other companies, such as Fresenius Kabi USA, LLC, for manufacturing, using, offering for sale, selling, marketing, distributing, and/or importing products that fall within the claims of the '813 patent. This includes any products that are substantially similar to the patented calcium gluconate solutions in flexible containers[2].
Patent Landscape
Related Patents
The '813 patent is part of a broader landscape of patents related to intravenous solutions and medical formulations. Other patents, such as the '646 patent (US Patent 10,130,646), also held by HQ Specialty Pharma, cover similar aspects of calcium gluconate solutions in flexible containers. These patents collectively protect the intellectual property related to the formulation, packaging, and administration of these medical solutions[2].
Litigation and Enforcement
The patent has been involved in litigation, with HQ Specialty Pharma and WG Critical Care, LLC, filing a complaint against Fresenius Kabi USA, LLC, for alleged infringement of the '813 patent. This litigation highlights the importance of enforcing patent rights to protect innovative medical products and formulations[2].
Impact on the Medical Field
Clinical Significance
The '813 patent has significant clinical implications, particularly in the treatment of acute symptomatic hypocalcemia. The ready-to-use format of the calcium gluconate solution in flexible plastic bags enhances patient care by providing a convenient and safe method of administration. This innovation can improve treatment outcomes and reduce the risk of complications associated with manual preparation of intravenous solutions[2].
Market and Economic Impact
The patent also has economic implications, as it protects a valuable product in the medical market. The market for intravenous solutions is substantial, and innovations like those covered by the '813 patent can drive growth and competition in this sector. The predicted annual growth in related medical markets, such as molecular diagnostics, underscores the potential economic impact of such patents[3].
Conclusion
The United States Patent 10,342,813 is a critical component in the medical field, particularly for the treatment of acute symptomatic hypocalcemia. The patent's scope and claims are designed to protect the innovative formulation and packaging of calcium gluconate solutions in flexible containers. Understanding the patent landscape and the implications of this patent is essential for both medical professionals and industry stakeholders.
Key Takeaways
- Innovation in Medical Formulations: The '813 patent represents a significant innovation in the formulation and packaging of intravenous solutions.
- Clinical Significance: The ready-to-use format of calcium gluconate solutions enhances patient care and treatment outcomes.
- Patent Landscape: The patent is part of a broader landscape of patents related to intravenous solutions and medical formulations.
- Litigation and Enforcement: The patent has been involved in litigation to protect intellectual property rights.
- Economic Impact: The patent has economic implications, driving growth and competition in the medical market.
FAQs
What is the primary indication for the calcium gluconate solution covered by the '813 patent?
The primary indication is for the treatment of acute symptomatic hypocalcemia.
In what form is the calcium gluconate solution provided according to the '813 patent?
The solution is provided in a ready-to-use flexible plastic bag for intravenous administration.
Who are the patent holders of the '813 patent?
The patent is held by HQ Specialty Pharma Corp.
What is the significance of the flexible container in the '813 patent?
The flexible container ensures stability and ease of use, eliminating the need for manual preparation and reducing the risk of contamination.
Has the '813 patent been involved in any litigation?
Yes, the patent has been involved in litigation against Fresenius Kabi USA, LLC, for alleged infringement.
Sources
- DrugBank: Calcium gluconate - Uses, Interactions, Mechanism of Action.
- RPX Insight: Complaint in the United States District Court - HQ Specialty Pharma Corp. and WG Critical Care, LLC, v. Fresenius Kabi USA, LLC.
- SpringerBriefs in Biotech Patents: Molecular Diagnostics and Peptide Vaccines and Therapeutics.
