Understanding the Scope and Claims of United States Patent 5,866,166
Introduction
United States Patent 5,866,166, titled "Storage Stable Thyroxine Active Drug Formulations and Methods for Their Production," is a significant patent in the pharmaceutical industry. This patent, granted on February 9, 1999, addresses the formulation and production of stable thyroxine (T4) active drug compositions. Here, we will delve into the details of the patent, its claims, and the broader patent landscape it operates within.
Background of the Patent
The patent was filed by Dwight D. Hanshew, Jr., and David John Wargo, and assigned to Mylan Pharmaceuticals Inc. It is a continuation of an earlier application filed on November 13, 2001, which was later abandoned[1].
Summary of the Invention
The patent describes methods and compositions for creating storage-stable thyroxine formulations. Thyroxine, a crucial hormone replacement therapy, is prone to degradation, which can affect its efficacy and shelf life. The invention focuses on stabilizing thyroxine in oral pharmaceutical compositions, ensuring that the drug remains effective over time.
Key Claims of the Patent
The patent includes several key claims that define the scope of the invention:
Claim 1: Composition
The patent claims a pharmaceutical composition comprising thyroxine, a stabilizing agent, and a filler. The stabilizing agent is crucial in preventing the degradation of thyroxine[1].
Claim 2: Method of Production
This claim outlines the method for producing the stable thyroxine formulation, including the steps of mixing, granulating, and compressing the ingredients[1].
Claim 3: Specific Formulation
The patent specifies a particular formulation that includes thyroxine, a stabilizing agent such as a chelating agent, and a filler like microcrystalline cellulose[1].
Detailed Description of the Invention
Stabilizing Agents
The patent emphasizes the use of stabilizing agents to prevent the degradation of thyroxine. These agents can include chelating agents, antioxidants, and other compounds that protect the hormone from environmental factors such as light, moisture, and oxygen[1].
Formulation Process
The process of formulating the stable thyroxine composition involves several steps:
- Mixing: Combining thyroxine with the stabilizing agent and filler.
- Granulating: Forming granules from the mixture to enhance stability and flow.
- Compressing: Compressing the granules into tablets or capsules[1].
Examples and Illustrations
The patent provides specific examples of formulations and their stability over time. For instance, Example 1 describes a formulation containing thyroxine, citric acid as a chelating agent, and microcrystalline cellulose as a filler. The stability of this formulation is tested under various conditions to demonstrate its efficacy[1].
Patent Landscape
Prior Art
The patent references several prior art patents that deal with pharmaceutical formulations and stability issues. These include patents related to the use of chelating agents, antioxidants, and other stabilizers in drug formulations[1].
Related Patents
Other patents in the same field, such as US6660303B2, focus on pharmaceutical superdisintegrants and their role in enhancing the stability and efficacy of drug formulations. These patents highlight the ongoing research and development in the pharmaceutical industry aimed at improving drug stability and delivery[4].
Economic and Legal Implications
Patent Scope and Claims
The scope of the patent is defined by its claims, which are critical in determining the boundaries of the invention. The Patent Claims Research Dataset by the USPTO provides insights into how patent claims are structured and analyzed, which can be relevant for understanding the scope of this patent[3].
Litigation and Enforcement
Patent litigation, as seen in cases like Mobile Acuity Ltd. v. Blippar Ltd., highlights the importance of carefully defining and enforcing patent claims. The validity and scope of patent claims can significantly impact legal outcomes in infringement cases[2].
Future Directions and Challenges
Small Claims Patent Court
The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could potentially simplify the process of resolving patent disputes related to smaller entities or less complex cases. This could impact how patents like 5,866,166 are enforced and litigated in the future[5].
Key Takeaways
- Stable Thyroxine Formulations: The patent focuses on creating stable thyroxine formulations using specific stabilizing agents and a detailed production process.
- Claims and Scope: The patent includes claims related to the composition, method of production, and specific formulations.
- Patent Landscape: The patent is part of a broader landscape of pharmaceutical patents dealing with drug stability and delivery.
- Economic and Legal Implications: The patent's scope and claims are crucial for its enforcement and litigation, and future legal frameworks like a small claims patent court could impact its application.
FAQs
What is the main focus of United States Patent 5,866,166?
The main focus is on creating storage-stable thyroxine active drug formulations and methods for their production.
What are the key components of the stable thyroxine formulation?
The key components include thyroxine, a stabilizing agent such as a chelating agent, and a filler like microcrystalline cellulose.
How does the patent describe the production process?
The process involves mixing, granulating, and compressing the ingredients to form stable tablets or capsules.
What is the significance of stabilizing agents in this patent?
Stabilizing agents prevent the degradation of thyroxine, ensuring the drug remains effective over time.
How does this patent fit into the broader patent landscape?
It is part of ongoing research and development in pharmaceutical formulations, particularly in enhancing drug stability and delivery.
What are the potential future directions for enforcing this patent?
Future directions could include the use of a small claims patent court for resolving disputes, simplifying the litigation process for smaller entities.
Sources
- Hanshew, Jr. et al., "Storage Stable Thyroxine Active Drug Formulations and Methods for Their Production," US007052717B2, May 30, 2006.
- Mobile Acuity Ltd. v. Blippar Ltd., CAFC, August 6, 2024.
- USPTO, "Patent Claims Research Dataset," August 28, 2017.
- US6660303B2, "Pharmaceutical superdisintegrant," Google Patents.
- ACUS, "U.S. Patent Small Claims Court," Administrative Conference of the United States.
