United States Patent 9,962,336: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,962,336, titled "Extended release suspension compositions," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery systems. This patent, granted to innovators in the field, outlines a method for preparing stable extended release suspension compositions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
Extended release formulations are crucial in pharmaceuticals as they allow for the controlled release of active ingredients over a prolonged period, enhancing patient compliance and therapeutic efficacy. The patent in question addresses the challenges associated with maintaining the stability and effectiveness of these formulations[4].
Scope of the Patent
Invention Overview
The patent describes a method for preparing extended release suspension compositions that include multiple coated cores of an active ingredient. These compositions are designed to provide stable and controlled release of the active ingredient, ensuring consistent therapeutic effects over an extended period[4].
Key Components
- Active Ingredient: The core of the composition, which can be any pharmacologically active substance.
- Coating Layers: The patent specifies the use of pH-independent and pH-dependent polymers to create multiple coating layers. These layers are critical for controlling the release of the active ingredient and maintaining formulation stability[4][5].
Formulation Stability
The patent emphasizes the importance of avoiding leaching of the active ingredient during storage and reconstitution. This is achieved through the use of specific polymers and coating techniques that prevent the active ingredient from dissolving prematurely[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the method of preparation, the composition itself, and the specific components used in the formulation.
- Claim 1: This claim describes the method for preparing the extended release suspension composition, including the steps of coating the active ingredient cores with pH-independent and pH-dependent polymers[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of polymers used, the thickness of the coating layers, and the conditions under which the formulation is prepared.
- Claim 2: This claim specifies the use of microcrystalline cellulose as a pharmaceutical excipient and hydroxypropyl methyl cellulose as a film-forming polymer[4].
Claim Construction
The claims are constructed to ensure that the invention is clearly defined and distinguishable from prior art. The use of specific terms like "pH-independent polymer" and "pH-dependent polymer" helps in narrowing down the scope to the exact method and composition described[4].
Patent Landscape
Prior Art
The patent landscape in this area is rich with prior art that deals with various aspects of extended release formulations. For example, PCT Publication No. WO 2008/122993 and U.S. Pat. No. 7,906,145 describe similar formulations but with different coating layers and release mechanisms[4].
Competing Patents
Other patents in the field, such as those related to sustained release microcapsules, also play a significant role in defining the boundaries of this invention. These patents often overlap in terms of the materials and methods used but differ in specific details that are critical to the claims of US 9,962,336[4].
Subject Matter Eligibility
In the context of subject matter eligibility, particularly under the USPTO's guidelines, the claims of this patent must be analyzed to ensure they do not fall under the "product of nature" or "law of nature" exceptions. The use of specific coating layers and the method of preparation ensure that the claims amount to significantly more than just a natural product or a well-understood, routine, or conventional application[1].
Enablement and Written Description
The patent must also satisfy the enablement and written description requirements under 35 U.S.C. ยง 112(a). The specification must provide a written description in "such full, clear, concise, and exact terms as to enable any person skilled in the art" to make and use the invention. The detailed description of the coating layers, the active ingredient, and the method of preparation in the patent ensures compliance with these requirements[3].
Industry Impact
Pharmaceutical and Biotechnology Industries
This patent is particularly significant in the pharmaceutical and biotechnology industries, where extended release formulations are a cornerstone of drug delivery systems. The ability to maintain stability and control the release of active ingredients is crucial for therapeutic efficacy and patient compliance. The rigid position of the Federal Circuit on genus claims and enablement requirements makes it challenging for innovators to claim the full scope of their inventions, but patents like US 9,962,336 demonstrate how specific and detailed claims can provide meaningful patent protection[3].
Conclusion
The United States Patent 9,962,336 represents a significant advancement in the field of extended release suspension compositions. The detailed claims and the method of preparation outlined in the patent ensure that the invention is clearly defined and distinguishable from prior art. Understanding the scope and claims of this patent is essential for innovators and practitioners in the pharmaceutical and biotechnology industries.
Key Takeaways
- The patent describes a method for preparing extended release suspension compositions with multiple coated cores of an active ingredient.
- The use of pH-independent and pH-dependent polymers is critical for maintaining formulation stability.
- The claims are constructed to ensure clear definition and distinction from prior art.
- The patent satisfies subject matter eligibility, enablement, and written description requirements.
- The invention is significant in the pharmaceutical and biotechnology industries for its impact on drug delivery systems.
FAQs
What is the main focus of the United States Patent 9,962,336?
The main focus of the patent is on a method for preparing stable extended release suspension compositions that include multiple coated cores of an active ingredient.
What are the key components of the extended release suspension compositions described in the patent?
The key components include the active ingredient, pH-independent polymers, and pH-dependent polymers used in the coating layers.
How does the patent ensure formulation stability?
The patent ensures formulation stability by using specific polymers and coating techniques that prevent the active ingredient from leaching during storage and reconstitution.
What are the implications of this patent for the pharmaceutical and biotechnology industries?
This patent is significant for these industries as it provides a method for creating stable and effective extended release formulations, which are crucial for therapeutic efficacy and patient compliance.
How does the patent comply with subject matter eligibility requirements?
The patent complies by ensuring that the claims amount to significantly more than just a natural product or a well-understood, routine, or conventional application through the use of specific coating layers and methods of preparation.
Cited Sources:
- USPTO, "Subject Matter Eligibility Examples: Life Sciences," May 2016.
- Google Patents, "WO2015166473A1 - Extended release suspension compositions."
- DigitalCommons@NYLS, "Eviscerating Patent Scope."
- Google Patents, "US9962336B2 - Extended release suspension compositions."
- PubChem, "Extended release suspension compositions - Patent US-9962336-B2."
