United States Patent 11,213,498: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,213,498, issued on January 4, 2022, pertains to an aqueous formulation comprising paracetamol and ibuprofen. This patent is significant in the pharmaceutical industry, particularly for the treatment of pain and inflammation. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventor and Assignee
The patent was invented by Thomas Jacobsen and assigned to Hyloris Pharmaceuticals S.A.[4].
Scope of the Invention
The patent describes an aqueous composition that includes paracetamol and ibuprofen, formulated for intravenous injection. This composition is specifically designed for the treatment of pain and/or inflammation.
Composition Details
- The aqueous formulation has a pH range of 6.3-7.3, which is crucial for stability and bioavailability.
- The composition can be tailored for various therapeutic needs, making it versatile for different clinical applications[4].
Claims of the Patent
The patent includes several key claims that define the scope of the invention:
Active Ingredients
- The composition includes paracetamol and ibuprofen as the active ingredients.
- Specific concentrations of these active ingredients are defined to ensure therapeutic efficacy[4].
pH Range
- The pH of the composition is maintained between 6.3 and 7.3, which is essential for the stability and effectiveness of the formulation[4].
Formulation for Intravenous Injection
- The composition is specifically formulated for intravenous administration, which is a critical aspect of its clinical application[4].
Patent Claims Analysis
The claims of the patent are designed to capture the essence of the invention while providing a clear boundary of what is protected.
Enablement Requirement
The patent claims must comply with the enablement requirement under 35 U.S.C. ยง 112(a), which means the specification must be written in "such full, clear, concise, and exact terms as to enable any person skilled in the art" to make and use the invention. This is particularly important in pharmaceutical patents where the scope of claims can significantly impact the protection and enforcement of the patent[3].
Written Description Requirement
The patent also needs to satisfy the written description requirement, ensuring that the specification describes the invention in sufficient detail to demonstrate possession of the invention. This is crucial to prevent overly broad claims that do not align with the disclosed invention[3].
Patent Landscape
The patent landscape surrounding this invention is complex and involves several related patents and exclusivities.
Related Patents
- Other patents, such as Patent 11,389,416 and Patent 11,446,266, also pertain to combinations of ibuprofen and paracetamol but with different formulations and claims. For example, Patent 11,446,266 describes an intravenous composition with different dosage ranges of ibuprofen and paracetamol[4].
Exclusivity and Patent Expiration Dates
- The patent has an expiration date of January 14, 2036. Additionally, exclusivity periods granted by the FDA can run concurrently with the patent term, affecting the market entry of generic versions[4].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry, particularly in the treatment of pain and inflammation.
Therapeutic Applications
- The intravenous formulation of paracetamol and ibuprofen offers a valuable treatment option for patients requiring rapid pain relief and anti-inflammatory effects, especially in clinical settings where oral administration is not feasible[4].
Competitive Landscape
- The existence of this patent and related patents creates a competitive landscape where other pharmaceutical companies must navigate around these claims to develop similar products. This can drive innovation but also presents challenges in terms of patent infringement and litigation[3].
Challenges and Opportunities
The patent landscape in the pharmaceutical industry is fraught with challenges and opportunities.
Genus Claims and Enablement
- The current jurisprudence on genus claims and enablement requirements can make it difficult for innovators to claim the full scope of their inventions without violating these requirements. This can lead to narrow claims that competitors can easily design around[3].
Innovation and Competition
- Despite these challenges, the patent system encourages innovation. Companies like Hyloris Pharmaceuticals S.A. continue to develop new formulations and compositions, driving advancements in therapeutic treatments[4].
Key Takeaways
- The United States Patent 11,213,498 protects an aqueous formulation of paracetamol and ibuprofen for intravenous injection.
- The patent claims are specific and must comply with enablement and written description requirements.
- The patent landscape includes related patents and exclusivities that impact the market and competition.
- The invention has significant therapeutic applications and drives innovation in the pharmaceutical industry.
Frequently Asked Questions (FAQs)
What is the primary use of the composition described in Patent 11,213,498?
The primary use of the composition is for the treatment of pain and/or inflammation through intravenous injection.
Who is the assignee of Patent 11,213,498?
The assignee of Patent 11,213,498 is Hyloris Pharmaceuticals S.A.
What is the pH range of the aqueous formulation described in the patent?
The pH range of the aqueous formulation is between 6.3 and 7.3.
When does the patent expire?
The patent expires on January 14, 2036.
How does this patent impact the development of similar products by other companies?
This patent creates a boundary that other companies must navigate around to avoid infringement. This can drive innovation but also presents challenges in terms of patent litigation and compliance.
Cited Sources:
- WO2009083759A1 - Oral pharmaceutical suspension comprising paracetamol and ibuprofen - Google Patents
- United States Patent - googleapis.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Generic Combogesic IV Availability - Drugs.com
