United States Patent 7,022,340: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,022,340, titled "Pharmaceutical composition as solid dosage form and method for manufacturing thereof," is a significant patent in the pharmaceutical industry, particularly for the formulation and production of desmopressin, a therapeutically active ingredient. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Overview of the Patent
The patent, filed by Ferring Pharmaceuticals Inc., describes a novel pharmaceutical composition in the form of a solid dosage, specifically tablets, containing desmopressin or its pharmaceutically acceptable salt. The composition includes a compressed granulate with a lubricant in a specific percentage range (0.05 to less than 0.50 percent by weight)[1].
Scope of the Patent
Therapeutically Active Ingredient
The patent centers around desmopressin, a synthetic analogue of the natural hormone vasopressin, used primarily for treating conditions such as nocturnal enuresis, central diabetes insipidus, and certain cases of hemophilia and von Willebrand's disease[1].
Pharmaceutical Composition
The composition is characterized by its solid dosage form, typically tablets, which are manufactured using a compressed granulate. This granulate is composed of desmopressin and various excipients, diluents, or carriers, such as monosaccharides, disaccharides, oligosaccharides, and polysaccharides. The average particle size of these saccharides ranges from 60 to 1000 μm[1].
Additives and Excipients
The patent allows for the inclusion of various additives like disintegrating agents (e.g., Kollidon® 25), binders, flavoring agents, preservatives, and colorants. These additives enhance the stability, palatability, and efficacy of the final product[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. Key claims include:
- The pharmaceutical composition comprising desmopressin and a specific range of excipients.
- The method of manufacturing the solid dosage form using integrated machinery.
- The use of lubricants within a defined percentage range[1].
Dependent Claims
Dependent claims further specify the types of excipients, the particle size range, and the optional inclusion of additives. These claims provide a detailed description of the preferred embodiments of the invention[1].
Patent Landscape
Patent Expiration
The patent, filed in 2003, has expired, which means that the exclusive rights to manufacture and market the described pharmaceutical composition have lapsed. This expiration allows for generic entry into the market[2][4].
Litigation and Enforceability
There have been legal challenges to the patent's validity and enforceability. For instance, a civil action questioned the enforceability of the '340 patent, highlighting potential issues with patent quality and scope[5].
Metrics for Patent Scope
Independent Claim Length and Count
Studies on patent scope often use metrics such as independent claim length (ICL) and independent claim count (ICC) to assess the breadth and clarity of patent claims. Narrower claims, as measured by these metrics, are generally associated with a higher probability of grant and shorter examination processes[3].
Examination Process
The examination process for this patent would have involved narrowing the scope of the claims to ensure clarity and specificity. This process is crucial in maintaining patent quality and preventing overly broad claims that could impede innovation[3].
Manufacturing and Equipment
Integrated Machinery
The patent specifies the use of integrated machinery, such as the FT series provided by Forberg A/S, Norway, for the "one-pot" process of mixing and forming the granulate. This equipment is designed to streamline the manufacturing process, enhancing efficiency and consistency[1].
Tablet Compressing Equipment
Various tablet compressing equipment from manufacturers like Elizabeth-Hata International, Courtoy NV, Vector Corp., Fette GmbH, Manesty, and Kilian & Co. GmbH are mentioned as suitable for the production of these tablets[1].
Health and Medical Implications
Therapeutic Uses
Desmopressin, the active ingredient, is crucial for treating several medical conditions. The solid dosage form described in the patent ensures a stable and effective delivery of this medication, which is vital for patient health and compliance[1].
Public Health Impact
The expiration of this patent and the subsequent entry of generic versions can significantly impact public health by making the medication more accessible and affordable. This can lead to better treatment outcomes and improved quality of life for patients[2].
Key Takeaways
- Patent Scope and Claims: The patent defines a specific pharmaceutical composition and manufacturing method for desmopressin tablets, with detailed claims on excipients, additives, and equipment.
- Patent Expiration: The patent has expired, allowing for generic competition.
- Manufacturing: The use of integrated machinery and specific tablet compressing equipment is highlighted.
- Health Implications: The solid dosage form ensures effective delivery of desmopressin, with significant public health implications.
FAQs
What is the main therapeutic active ingredient in the patent?
The main therapeutic active ingredient is desmopressin, a synthetic analogue of vasopressin.
What is the significance of the particle size range of excipients?
The particle size range (60 to 1000 μm) of excipients like saccharides is crucial for the stability and efficacy of the final product.
Which equipment is recommended for manufacturing the tablets?
Integrated machinery like the FT series from Forberg A/S, Norway, and various tablet compressing equipment from manufacturers such as Elizabeth-Hata International and Fette GmbH are recommended.
Why is the expiration of the patent important?
The expiration allows for generic entry, making the medication more accessible and affordable, which can improve treatment outcomes and public health.
What are the potential legal challenges to the patent?
There have been challenges to the patent's validity and enforceability, highlighting concerns over patent quality and scope.
Sources
- US7022340B2 - Pharmaceutical composition as solid dosage form and method for manufacturing thereof - Google Patents
- Desmopressin Acetate patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Pharmaceutical drugs covered by patent 7,022,340 - Drug Patent Watch
- *Civil Action No. ,3:tjc\j^TJ- HBH** - Patent Docs
