United States Patent 9,504,647: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 9,504,647, titled "Pharmaceutical formulations of desmopressin," pertains to the development and use of specific pharmaceutical formulations of desmopressin. Desmopressin is a synthetic analog of vasopressin, commonly used to treat conditions such as central diabetes insipidus, nocturia, and primary nocturnal enuresis (bedwetting)[4].
Scope of the Patent
Indicated Conditions
The patent covers formulations of desmopressin intended for various medical conditions, including:
- Central diabetes insipidus
- Nocturia
- Primary nocturnal enuresis (PNE)
- Neurogenic diabetes insipidus
- Temporary polyuria and polydipsia following head trauma or surgery in the pituitary region[1][4].
Pharmaceutical Formulations
The patent describes several pharmaceutical formulations of desmopressin, including:
- Dosage Forms: The patent outlines various dosage forms such as tablets, capsules, and sub-lingual tablets. These formulations are designed to enhance the bioavailability and stability of desmopressin[1].
- Matrix Materials: The use of gelatin, agar, and other matrix materials to create sustained-release formulations is detailed. These materials help in controlling the release of desmopressin, ensuring a prolonged therapeutic effect[1].
- Manufacturing Processes: Methods such as direct compression, freeze-drying, and sublimation are discussed to produce these formulations. These processes are crucial for maintaining the integrity and efficacy of the drug[1].
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: A pharmaceutical formulation comprising desmopressin, a matrix material, and optionally a solvent, designed for the treatment of conditions like central diabetes insipidus and nocturia[1].
- Claim 2: A method of preparing the pharmaceutical formulation involving the use of gelatin or agar as the matrix material[1].
- Claim 3: A dosage form of the pharmaceutical formulation, specifically a sub-lingual tablet, for rapid absorption and onset of action[1].
Dependent Claims
The patent also includes several dependent claims that further specify the composition and method of preparation:
- Claim 4: The pharmaceutical formulation may include additional ingredients such as fillers, surface-active agents, and sweeteners to enhance palatability and stability[1].
- Claim 5: The method of preparing the formulation may involve freeze-drying or sublimation to remove solvents and improve the shelf life of the product[1].
Patent Landscape
Related Patents
The patent landscape for desmopressin formulations is extensive, with multiple patents covering various aspects of its use and formulation:
- Other Desmopressin Patents: There are over 20 patents related to desmopressin, covering different indications, formulations, and manufacturing processes. These patents highlight the ongoing research and development in this area[4].
- Competing Formulations: Other patents may cover competing formulations or methods of delivery, such as intranasal sprays or oral solutions, which could impact the market share of the patented formulations[4].
Intellectual Property Protection
The patent analytics approach can help in understanding the coverage and gaps in intellectual property protection for desmopressin formulations:
- Claim Coverage Matrix: This tool helps in categorizing patents by claims and scope concepts, enabling a comprehensive analysis of the patent landscape. It identifies which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
- Claim Charts: Interactive claim charts generated by software like ClaimScape® can be used to review patent coverage with technical experts, determining the applicability of scope concepts to target products or methods[3].
Market and Clinical Implications
Clinical Trials and Approval
Desmopressin formulations have undergone extensive clinical trials across various phases, leading to their approval for multiple indications. The patent's focus on specific formulations can influence the development and approval of new products:
- Clinical Trials: Desmopressin has been through numerous clinical trials, including Phase 0 to Phase 4, ensuring its safety and efficacy in different patient populations[4].
- Regulatory Approval: The drug has received approval in the US and other countries for its indicated conditions, which validates the clinical significance of the patented formulations[4].
Market Impact
The patented formulations can have a significant market impact by offering improved efficacy, convenience, and patient compliance:
- Competitive Advantage: Unique formulations and delivery methods can provide a competitive edge in the market, attracting patients and healthcare providers seeking more effective and convenient treatments[1].
- Patient Compliance: Sustained-release formulations and sub-lingual tablets can enhance patient compliance by reducing the frequency of dosing and improving the ease of administration[1].
Key Takeaways
- Specific Formulations: The patent covers specific pharmaceutical formulations of desmopressin, including sustained-release and sub-lingual forms.
- Broad Indications: The formulations are indicated for various conditions such as central diabetes insipidus, nocturia, and primary nocturnal enuresis.
- Manufacturing Processes: The patent details several manufacturing processes, including freeze-drying and sublimation.
- Intellectual Property: The patent landscape is complex, with multiple patents covering different aspects of desmopressin formulations.
- Market and Clinical Implications: The patented formulations have significant clinical and market implications, offering improved efficacy and patient compliance.
FAQs
Q: What is the primary use of desmopressin?
A: Desmopressin is primarily used to reduce renal excretion of water in conditions such as central diabetes insipidus and nocturia, and to treat bedwetting and excessive urination[4].
Q: What are the different dosage forms covered by the patent?
A: The patent covers various dosage forms including tablets, capsules, and sub-lingual tablets[1].
Q: How does the patent protect the intellectual property of desmopressin formulations?
A: The patent protects the intellectual property through specific claims that define the composition, method of preparation, and use of the formulations. Tools like claim coverage matrices and claim charts help in analyzing and maintaining this protection[3].
Q: What is the significance of using gelatin or agar in the formulations?
A: Gelatin or agar serves as matrix materials to create sustained-release formulations, ensuring a prolonged therapeutic effect and improving the stability of the drug[1].
Q: Are there any ongoing clinical trials for desmopressin formulations?
A: Yes, desmopressin has been and continues to be involved in various clinical trials across different phases to further establish its safety and efficacy in different patient populations[4].
Cited Sources
- US9504647B2 - Pharmaceutical formulations of desmopressin - Google Patents
- Pharmaceutical formulations of desmopressin - Patent US-9504647-B2 - PubChem
- Patent Analytics | Intellectual Property Law - SLWIP
- Desmopressin: Uses, Interactions, Mechanism of Action - DrugBank - DrugBank
