United States Patent 8,628,799: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,628,799, titled "Coated Tablet Formulation and Method," is a significant patent in the pharmaceutical industry, particularly in the realm of drug formulation and delivery. This patent, assigned to various pharmaceutical companies over its lifecycle, outlines a novel approach to coating tablets to enhance the stability and efficacy of medicaments.
Background and History
The patent was filed on April 26, 2011, as part of the U.S. Application No. 13/094,379, and it was granted on January 14, 2014[4][5].
Scope of the Patent
Invention Overview
The patent describes a coated tablet formulation designed to improve the chemical stability of medicaments, such as the DPP4-inhibitor saxagliptin, which is prone to intra-molecular cyclization. The formulation includes multiple coating layers applied to a tablet core, each serving specific functions[4].
Coating Layers
- Inner Seal Coating Layer: This layer includes a coating polymer, preferably a polyvinyl alcohol (PVA) based polymer, to protect the medicament from degradation.
- Second Coating Layer: This layer contains the medicament and a coating polymer.
- Outer Protective Coating Layer: This layer functions as a protective barrier and may include colorants but not the medicament.
- Optional Fourth Layer: This layer can be applied to differentiate tablets of various strengths and includes colorants and a coating polymer[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: Describes the coated tablet formulation with specific components and layers.
- Claim 2-10: Provide variations and additional details on the composition and application of the coating layers.
- Claim 11-15: Outline the method for preparing the coated tablet, including steps such as spray coating, fluid bed coating, and using perforated pan coaters[4].
Patent Landscape
Prior Art and Novelty
The patent distinguishes itself from prior art by introducing a multi-layer coating approach that enhances the chemical stability of the medicament. Unlike traditional tablets manufactured using dry or wet granulation techniques, this method ensures superior stability and facilitates the preparation of combination formulations[4].
Competitors and Litigation
This patent has been part of consolidated patent infringement actions, such as the case involving AstraZeneca and various generic pharmaceutical companies. However, the specific patent in question (US 8,628,799) was not the central focus of these litigations, which primarily revolved around other patents like the RE'186 patent[1].
Impact on the Pharmaceutical Industry
Innovation and Efficiency
The coated tablet formulation and method described in this patent have significant implications for the pharmaceutical industry. It allows for the development of more stable and effective drug formulations, particularly for medicaments that are prone to degradation. This innovation can lead to better patient outcomes and improved drug efficacy.
Cost and Manufacturing
The use of multi-layer coating techniques can also streamline the manufacturing process. By applying coatings using methods like spray coating or fluid bed coating, pharmaceutical companies can reduce production costs and improve the consistency of their products[4].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of patent scope and quality. For US 8,628,799, the claims are detailed and specific, indicating a well-defined scope. The examination process, which tends to narrow the scope of patent claims, likely ensured that the claims were clear and not overly broad[3].
Legal and Regulatory Considerations
Obviousness and Validity
The validity of a patent, including its obviousness, is a critical legal consideration. The legal standard for obviousness requires that the differences between the claimed invention and the prior art must not be such that the subject matter as a whole would have been obvious to a person of ordinary skill in the art. The patent in question, by introducing a novel multi-layer coating approach, would likely pass this test[1].
Conclusion
The United States Patent 8,628,799 represents a significant advancement in pharmaceutical formulation technology. Its detailed claims and specific coating layers provide a robust framework for improving the stability and efficacy of medicaments. Understanding the scope, claims, and patent landscape of this invention is crucial for pharmaceutical companies looking to innovate and protect their intellectual property.
Key Takeaways
- The patent introduces a novel multi-layer coating approach for tablets.
- The formulation enhances the chemical stability of medicaments like saxagliptin.
- The method includes specific coating layers and application techniques.
- The patent has implications for improving drug efficacy and manufacturing efficiency.
- The claims are detailed and specific, indicating a well-defined scope.
Frequently Asked Questions (FAQs)
What is the main innovation of US Patent 8,628,799?
The main innovation is the multi-layer coating approach for tablets, which enhances the chemical stability of medicaments.
How does the coating process improve drug stability?
The coating process involves applying multiple layers, including an inner seal coating, a medicament-containing layer, and an outer protective layer, which collectively protect the medicament from degradation.
What are the potential benefits of this patent for pharmaceutical companies?
The benefits include improved drug efficacy, streamlined manufacturing processes, and reduced production costs.
Has this patent been involved in any significant litigation?
While not the central focus, this patent has been part of consolidated patent infringement actions involving other related patents.
How does the patent scope of US 8,628,799 compare to other patents in the pharmaceutical industry?
The patent scope is well-defined with detailed and specific claims, indicating a clear and not overly broad scope, which is consistent with best practices in patent examination.
