United States Patent 9,974,826: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,974,826, titled "Methods comprising desmopressin," is a patent that focuses on the use of desmopressin, a synthetic analogue of the natural hormone vasopressin, for specific medical treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Desmopressin
Desmopressin is widely used to treat conditions such as nocturnal enuresis (bedwetting), central diabetes insipidus, and certain types of bleeding disorders. It works by mimicking the natural hormone vasopressin to regulate water balance in the body[1].
Patent Overview
Publication and Legal Status
The patent was granted on May 22, 2018, and is currently active, with an expiration date determined by the patent term. The legal status indicates that it is still in force, but this status is subject to change based on various factors such as maintenance payments and potential legal challenges[1].
Study Design and Efficacy
The patent describes a clinical study designed to evaluate the efficacy of desmopressin in reducing nocturnal voids. The study consisted of two parts: Part I, which was a randomized, double-blind, placebo-controlled phase, and Part II, which continued the treatment from Part I or reassigned placebo subjects to active treatments. The primary endpoints included the change in mean number of nocturnal voids from baseline to the final visit and the proportion of subjects with a >33% reduction in nocturnal voids[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims cover:
- Dosage Forms: The patent specifies the use of desmopressin in orally disintegrating tablets, administered once per night, approximately 1 hour before bedtime.
- Dosage Strengths: The claims include specific dosage strengths of 10 μg, 25 μg, 50 μg, and 100 μg.
- Efficacy Endpoints: The claims are tied to the efficacy endpoints, such as the reduction in nocturnal voids, which were the primary focus of the clinical study[1].
Method of Administration
The method of administration is a critical aspect of the patent. Subjects were instructed to place the orally disintegrating tablet under their tongue without water, ensuring a specific mode of delivery that is distinct from other forms of desmopressin administration[1].
Clinical Study Details
Study Phases
- Part I: This phase was a randomized, double-blind, placebo-controlled study where subjects received either desmopressin or a placebo.
- Part II: Subjects who received active treatment in Part I continued on the same treatment, while those on placebo were randomly reassigned to one of the four active treatments[1].
Subject Participation and Withdrawal
Subjects had the right to withdraw from the study at any time, and the investigator could discontinue subjects due to safety concerns or noncompliance. The study ensured that any withdrawal was done safely and with agreement between the investigator and the sponsor[1].
Efficacy and Safety
Primary Endpoints
The primary endpoints were the change in mean number of nocturnal voids from baseline to the final visit and the proportion of subjects with a >33% reduction in nocturnal voids. The study demonstrated that the 100 μg dose of desmopressin was superior to placebo in achieving these endpoints[1].
Safety Considerations
The study monitored safety parameters, including serum sodium levels, to ensure that the treatment did not lead to significant adverse effects. The administration method and dosage were designed to minimize risks while maximizing efficacy[1].
Patent Landscape
Patent Scope Metrics
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. In the case of US9974826B2, the claims are specific and focused on the method of administration and efficacy endpoints, indicating a well-defined scope[3].
Recent Developments in Patent Law
The Supreme Court's ruling in Amgen Inc. v. Sanofi emphasizes the importance of the enablement requirement under 35 U.S.C. § 112. This ruling suggests that patent claims must be supported by a specification that enables a person skilled in the art to make and use the entire scope of the invention. This principle is relevant to patents like US9974826B2, where the specification must clearly describe the method of administration and the expected outcomes[5].
Global Patent System Integration
The Global Dossier service provided by the USPTO allows for the integration of patent family data from participating IP offices. This service can help in understanding the global patent landscape for desmopressin-related inventions and ensuring that any new patents align with international standards and requirements[4].
Key Takeaways
- Specific Dosage Forms: The patent is specific to orally disintegrating tablets of desmopressin.
- Efficacy Endpoints: The primary endpoints focus on the reduction in nocturnal voids.
- Clinical Study Design: The study included a randomized, double-blind, placebo-controlled phase followed by a continuation phase.
- Safety Monitoring: The study monitored safety parameters, including serum sodium levels.
- Patent Scope: The claims are well-defined and focused on the method of administration and efficacy.
FAQs
What is the primary use of desmopressin in the context of US9974826B2?
The primary use of desmopressin in this patent is to reduce nocturnal voids, particularly in the treatment of nocturnal enuresis.
What are the dosage strengths covered by the patent?
The patent covers dosage strengths of 10 μg, 25 μg, 50 μg, and 100 μg of desmopressin.
How is the desmopressin administered according to the patent?
The desmopressin is administered as an orally disintegrating tablet placed under the tongue without water, approximately 1 hour before bedtime.
What were the primary endpoints of the clinical study described in the patent?
The primary endpoints were the change in mean number of nocturnal voids from baseline to the final visit and the proportion of subjects with a >33% reduction in nocturnal voids.
How does the recent Supreme Court ruling on patent claims affect patents like US9974826B2?
The ruling emphasizes the need for patent specifications to enable a person skilled in the art to make and use the entire scope of the invention. This ensures that patents like US9974826B2 have clear and complete descriptions of the method of administration and expected outcomes.
Sources
- US9974826B2 - Methods comprising desmopressin - Google Patents
- Patent Claims Research Dataset - USPTO
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- Supreme Court Issues Patent Ruling Curbing Broad Functional Claims in Patents - Vorys
