Understanding the Scope and Claims of United States Patent 9,532,971
Introduction
United States Patent 9,532,971, issued on January 3, 2017, is a significant patent in the pharmaceutical sector, particularly concerning the composition and formulation of certain medications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent, owned by Currax, pertains to pharmaceutical compositions that include specific amounts of doxepin and other ingredients. Doxepin is a medication used to treat various conditions, including depression, anxiety, and insomnia.
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key claims:
Claim 1: Pharmaceutical Composition
Claim 1 of the ’971 patent describes a pharmaceutical composition comprising from about 0.5 to about 7 mg of doxepin, or a pharmaceutically acceptable salt thereof, and from about 92% to about 99.8% w/w silicified microcrystalline cellulose. The composition also has specific characteristics such as a hardness value of at least 2 Kp, a friability value of 1% or less, a disintegration time of about 1 minute as per USP protocols, and at least an 80% release of doxepin within 15 minutes using compendial methods for measuring dissolution[2][5].
Additional Claims
Subsequent claims build upon the first claim by specifying additional ingredients, their proportions, and the physical properties of the composition. These claims ensure that the pharmaceutical composition meets specific standards for stability, efficacy, and patient safety.
Subject Matter Eligibility
The 2024 USPTO guidance update on AI patent eligibility, although not directly related to this pharmaceutical patent, highlights the importance of integrating abstract ideas into practical applications. For pharmaceutical patents like the ’971 patent, the focus is on the specific formulation and the tangible benefits it provides, such as improved dissolution rates and stability. The claims in the ’971 patent are designed to ensure that the composition is not just a mere combination of ingredients but a formulation that offers practical utility and solves specific problems in the field of pharmaceuticals[1].
Practical Applications
The patent emphasizes the practical applications of the pharmaceutical composition. For instance, the specified release rates of doxepin ensure that the medication is absorbed efficiently by the body, providing consistent therapeutic effects. This practical application is crucial for patent eligibility, as it demonstrates how the abstract idea of combining ingredients is transformed into a concrete technological improvement[1].
Patent Landscape
The ’971 patent is part of a broader portfolio of patents owned by Currax, which includes other related patents such as U.S. Patent No. 7,915,307, U.S. Patent No. 9,572,814, and U.S. Patent No. 9,907,780. These patents collectively protect various aspects of pharmaceutical compositions, formulations, and methods of use, creating a robust intellectual property shield around Currax’s products[2][5].
Litigation and Infringement
The ’971 patent has been involved in litigation, particularly in cases where generic manufacturers have sought to produce similar pharmaceutical compositions. For example, Currax has alleged infringement by companies like Aurolife and MSN, which have submitted Abbreviated New Drug Applications (ANDAs) to the FDA for products that allegedly infringe on the claims of the ’971 patent[2][5].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides insights into the scope and trends of patent claims, including those in the pharmaceutical sector. This dataset can help researchers and practitioners understand the complexity and breadth of patent claims, aiding in the development of new pharmaceutical compositions and formulations that do not infringe existing patents[3].
Key Takeaways
- Specific Formulation: The ’971 patent is specific about the amounts of doxepin and other ingredients, ensuring a stable and effective pharmaceutical composition.
- Practical Applications: The patent highlights the practical benefits of the composition, such as improved dissolution rates and therapeutic effects.
- Patent Landscape: The patent is part of a larger portfolio of related patents, protecting various aspects of pharmaceutical compositions and methods.
- Litigation: The patent has been involved in infringement cases against generic manufacturers.
- Economic Implications: Understanding the scope of this patent can help in developing new pharmaceuticals that avoid infringement.
FAQs
What is the main subject matter of U.S. Patent 9,532,971?
The main subject matter is a pharmaceutical composition comprising specific amounts of doxepin and other ingredients.
What are the key characteristics of the pharmaceutical composition claimed in the patent?
The composition has a hardness value of at least 2 Kp, a friability value of 1% or less, a disintegration time of about 1 minute, and at least an 80% release of doxepin within 15 minutes.
Why is the practical application of the composition important for patent eligibility?
The practical application ensures that the composition offers tangible benefits and solves specific problems in the pharmaceutical field, transforming the abstract idea into a patent-eligible invention.
Has the ’971 patent been involved in any litigation?
Yes, the patent has been involved in litigation against generic manufacturers that have sought to produce similar compositions.
What is the significance of the Patent Claims Research Dataset in relation to this patent?
The dataset provides insights into the scope and trends of patent claims, helping researchers and practitioners understand the complexity and breadth of patent claims in the pharmaceutical sector.
Sources
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
- Litigation Documents - RPX Corporation
- Patent Claims Research Dataset - USPTO
- Apparatus and method of stimulating elevation of glutathione levels - PubChem
- Litigation Documents - RPX Corporation
