United States Patent 9,554,968: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,554,968, titled "Trilayer Coated Pharmaceutical Packaging," was granted to SiO2 Medical Products, Inc. in January 2017. This patent is significant in the field of pharmaceutical packaging, particularly for drugs that require precise and protective packaging. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent addresses the need for advanced pharmaceutical packaging that can protect sensitive drugs from environmental factors and ensure their stability and efficacy. Traditional packaging methods often fall short in providing the necessary barrier functions, especially for biologic and ophthalmic formulations[4][5].
Scope of the Invention
The patent covers a trilayer coated pharmaceutical packaging system designed to enhance the protection and stability of pharmaceutical formulations. Here are the key aspects of the scope:
Trilayer Coating System
The invention involves a trilayer coating system applied to the pharmaceutical packaging. This includes:
- A tie coating or layer, typically made of materials like SiOxCy or Si(NH)xCy.
- A barrier coating to prevent the penetration of gases and moisture.
- A protective coating to ensure the stability of the pharmaceutical formulation[4][5].
Application to Various Formulations
The trilayer coating system is applicable to a wide range of pharmaceutical formulations, including solutions, suspensions, and injectable drugs. This versatility makes the invention highly relevant in the pharmaceutical industry[4].
Claims of the Invention
The patent includes several claims that define the scope of the invention:
Independent Claims
The independent claims focus on the composition and structure of the trilayer coating system. Key claims include:
- The application of a tie coating to the article surface.
- The inclusion of a barrier coating to prevent gas and moisture penetration.
- The use of a protective coating to maintain the stability of the pharmaceutical formulation[4].
Dependent Claims
Dependent claims further specify the materials and methods used in the trilayer coating system. These include details on the materials for each layer, the coating process, and the types of pharmaceutical formulations that can be packaged using this system[4].
Patent Landscape
The patent landscape surrounding US 9,554,968 is complex and involves several related patents and technologies.
Related Patents
Other patents in the field of pharmaceutical packaging and sterilization include methods for gas sterilization and surface decontamination. For example, patents like those described in WO2014187779A1 and EP2453928 discuss hydrogen peroxide and ethylene oxide sterilization methods, which are relevant to the sterilization aspects of the trilayer coated packaging[1].
Competing Technologies
Competing technologies in pharmaceutical packaging often focus on different materials and coating systems. For instance, patents related to pre-filled syringes and intravitreal injections, such as those described in the patent application for sterilizable pharmaceutical packages, highlight the ongoing innovation in this field[1].
Impact on the Pharmaceutical Industry
The trilayer coated pharmaceutical packaging system has significant implications for the pharmaceutical industry:
Enhanced Protection and Stability
The trilayer coating system provides a robust barrier against environmental factors, ensuring the stability and efficacy of sensitive pharmaceutical formulations. This is particularly important for biologic drugs and ophthalmic solutions[4].
Compliance with Regulatory Standards
The patent ensures that the packaging system meets or exceeds regulatory standards for gas residuals and stability, as outlined in ISO 10993-7. This compliance is crucial for the approval and marketability of pharmaceutical products[1].
Future Developments and Challenges
As the pharmaceutical industry continues to evolve, there are several future developments and challenges to consider:
Advancements in Coating Technologies
Ongoing research and development in coating technologies are expected to further enhance the protective and barrier functions of pharmaceutical packaging. New materials and coating methods may offer even greater stability and protection for pharmaceutical formulations[4].
Regulatory Changes
Changes in regulatory standards and guidelines can impact the validity and scope of existing patents. Manufacturers must stay abreast of these changes to ensure their products remain compliant[3].
Key Takeaways
- The trilayer coated pharmaceutical packaging system offers enhanced protection and stability for pharmaceutical formulations.
- The patent covers a wide range of applications, including solutions, suspensions, and injectable drugs.
- The invention is part of a broader landscape of pharmaceutical packaging and sterilization technologies.
- Compliance with regulatory standards is a critical aspect of the patent.
- Future developments in coating technologies and regulatory changes will continue to shape the industry.
Frequently Asked Questions (FAQs)
What is the main innovation of US Patent 9,554,968?
The main innovation is the trilayer coating system applied to pharmaceutical packaging, which enhances the protection and stability of pharmaceutical formulations.
What types of pharmaceutical formulations can be packaged using this system?
The system is applicable to a wide range of formulations, including solutions, suspensions, and injectable drugs.
How does the trilayer coating system ensure stability and protection?
The system includes a tie coating, a barrier coating, and a protective coating, which together prevent gas and moisture penetration and maintain the stability of the pharmaceutical formulation.
What regulatory standards does the patent comply with?
The patent ensures compliance with ISO 10993-7 standards for gas residuals and stability.
How does this patent fit into the broader patent landscape?
The patent is part of a larger landscape of pharmaceutical packaging and sterilization technologies, including related patents on gas sterilization and surface decontamination methods.
Cited Sources:
- Justia Patents: Sterilizable pharmaceutical package for ophthalmic formulations.
- Drug Patent Watch: When do biologic drug patents expire and when will biosimilars be available?
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Trilayer coated pharmaceutical packaging.
- Golden Wiki: US Patent 9554968 Trilayer coated pharmaceutical packaging.
