United States Patent 11,446,266: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,446,266, titled "Combination composition," is a significant patent that combines two widely used analgesics and anti-inflammatory drugs: paracetamol (acetaminophen) and ibuprofen. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on November 4, 2010, and granted on October 1, 2018, pertains to a combination composition designed to relieve pain and/or inflammation. This invention is particularly noteworthy for its formulation and administration method, which includes an intravenous solution[1].
Scope of the Patent
Active Ingredients
The patent focuses on a combination of paracetamol and ibuprofen, two drugs that are commonly used separately for pain relief and anti-inflammatory purposes. The combination is intended to enhance therapeutic efficacy while potentially reducing the side effects associated with higher doses of individual drugs[1].
Formulation
The composition is formulated as an intravenous solution, which is a novel aspect compared to traditional oral or topical formulations. This intravenous form is designed for use in a hospital environment, facilitating precise dosing and rapid onset of action[1].
Dosage and Administration
The patent specifies that the composition is administered on a 6-hourly basis. The solution includes suitable excipients such as antioxidants, pH modulators, buffering agents, isotonicity agents, and purified water to ensure stability and compatibility for intravenous administration[1].
Claims of the Patent
Primary Claims
The primary claims of the patent revolve around the combination of paracetamol and ibuprofen in a specific ratio for intravenous use. These claims include:
- A combination composition comprising paracetamol and ibuprofen for relieving pain and/or inflammation.
- A method of treating pain and/or inflammation by administering this composition intravenously[1].
Dependent Claims
Dependent claims further specify the details of the composition, such as:
- The exact dosages of paracetamol and ibuprofen.
- The inclusion of specific excipients.
- The method of administration, including the 6-hourly dosing schedule[1].
Patent Landscape
Related Patents
The patent landscape for combination analgesics is complex, with numerous patents covering various formulations and administration methods. For example, other patents may cover different ratios of paracetamol and ibuprofen or alternative delivery methods such as oral tablets or topical creams[1].
Prior Art
Prior art in this field includes existing combination products that are administered orally, such as tablets containing 150 mg ibuprofen and 500 mg paracetamol. However, the intravenous formulation and specific dosing regimen described in this patent are distinct and innovative[1].
Litigation and Enforcement
Patent litigation in the pharmaceutical sector is common, and the validity of patents can be challenged on various grounds, including obviousness-type double patenting or lack of written description. However, the specific claims of US11446266B2 have not been reported to be under litigation as of the current date[2].
Impact on the Pharmaceutical Industry
Therapeutic Benefits
The combination of paracetamol and ibuprofen in an intravenous solution offers significant therapeutic benefits, particularly in hospital settings where rapid and controlled pain relief is critical. This formulation can be especially beneficial for patients who cannot take oral medications due to their condition[1].
Market Competition
The introduction of this patented composition can influence market competition by offering a unique and potentially more effective treatment option. This could lead to increased market share for the patent holder and may prompt other pharmaceutical companies to develop similar or alternative products[1].
Metrics for Measuring Patent Scope
Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth and clarity of patent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent likely involved a detailed review of the claims to ensure they were specific, clear, and not overly broad. This process would have helped in narrowing the scope of the patent to ensure its validity and enforceability[3].
Global Patent System Integration
Global Dossier
The Global Dossier service provided by the USPTO allows for the integration of patent data from various IP offices, facilitating a more streamlined and harmonized global patent system. This service can be useful for tracking the patent family and related applications of US11446266B2 across different jurisdictions[4].
Common Citation Document
The Common Citation Document (CCD) application consolidates prior art citations from multiple IP offices, which can be crucial for assessing the novelty and non-obviousness of the claims in this patent[4].
Key Takeaways
- Combination Composition: The patent combines paracetamol and ibuprofen for intravenous use, targeting pain and inflammation relief.
- Intravenous Formulation: This is a novel aspect, designed for hospital use with precise dosing and rapid onset.
- Specific Claims: The patent includes claims for the composition, method of treatment, and specific dosing regimen.
- Patent Landscape: The patent fits into a broader landscape of combination analgesics but stands out due to its intravenous formulation.
- Therapeutic Impact: Offers significant benefits in hospital settings, particularly for patients unable to take oral medications.
- Market and Legal Implications: Could influence market competition and is subject to the usual scrutiny and potential litigation in the pharmaceutical sector.
FAQs
What is the primary focus of United States Patent 11,446,266?
The primary focus is on a combination composition of paracetamol and ibuprofen for intravenous use to relieve pain and/or inflammation.
What is unique about the formulation described in this patent?
The formulation is unique because it is designed as an intravenous solution, which is distinct from traditional oral or topical formulations.
How is the composition administered?
The composition is administered intravenously on a 6-hourly basis.
What are the key excipients included in the composition?
The composition includes antioxidants, pH modulators, buffering agents, isotonicity agents, and purified water.
How does this patent impact the pharmaceutical industry?
It offers a new treatment option with potential therapeutic benefits, especially in hospital settings, and could influence market competition among pharmaceutical companies.
Sources
- US11446266B2 - Combination composition - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - USPTO
