United States Patent 10,265,370: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,265,370, titled "Lisinopril Formulations," is a significant patent in the pharmaceutical industry, particularly in the development and formulation of lisinopril, a medication used to treat hypertension, heart failure, and acute myocardial infarction. This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Lisinopril
Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor, widely used in the treatment of cardiovascular diseases. The patent in question focuses on novel formulations of lisinopril, which enhance its stability, efficacy, and patient compliance.
Patent Overview
Publication Details
- Patent Number: US 10,265,370 B2
- Date of Patent: April 23, 2019
- Applicant: Silvergate Pharmaceuticals, Inc.
- Inventors: Gerold L. Mosher and David W. Miles[4].
Scope of the Patent
The patent covers various formulations of lisinopril, including oral liquid formulations, which are designed to improve the stability and bioavailability of the drug. Here are some key aspects of the scope:
Stability Enhancements
The patent describes formulations that enhance the stability of lisinopril, particularly in liquid forms. This is crucial as lisinopril can degrade over time, affecting its efficacy. The formulations include specific combinations of ingredients that maintain the drug's stability[4].
Bioavailability
The patent also addresses the bioavailability of lisinopril, ensuring that the drug is absorbed efficiently by the body. This is achieved through the use of specific excipients and formulation techniques that optimize the drug's absorption profile[4].
Claims of the Patent
The claims of the patent are the most critical part, as they define the legal boundaries of what is protected.
Independent Claims
The patent includes several independent claims that outline the novel aspects of the lisinopril formulations. These claims cover the composition of the formulations, the methods of preparation, and the specific characteristics of the final product[4].
Dependent Claims
Dependent claims further specify the independent claims, providing additional details on the formulation components, their proportions, and the manufacturing processes. These claims help to narrow down the scope and ensure that the patent protection is precise[4].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding lisinopril formulations.
Related Patents
The patent is part of a series of continuations and related applications, indicating a robust and evolving intellectual property strategy. For example, it is a continuation of application No. 15/805,934, which is itself a continuation of earlier applications[4].
Prior Art
The patent cites several prior art documents, including U.S. patents and foreign patent documents, which highlight the existing knowledge in the field and distinguish the novel contributions of the current patent[4].
Patent Analytics and Claim Coverage
Patent analytics plays a crucial role in understanding the coverage and value of the patent claims.
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to lisinopril formulations. This matrix can reveal gaps or opportunities in the patent portfolio, ensuring comprehensive protection[3].
Scope Concepts
The patent claims can be categorized by scope concepts, which link claims on similar patents. This categorization helps in filtering, searching, and analyzing large numbers of patent claims efficiently. The scope concepts can be classified as high, medium, or low value, depending on their current and future relevance to the company[3].
Impact of Proposed USPTO Rule Changes
Recent proposed rule changes by the USPTO regarding terminal disclaimers could impact the prosecution, licensing, and litigation strategies related to this patent.
Terminal Disclaimers
The proposed rule requires patent applicants to include specific language in terminal disclaimers to ensure that the terminally disclaimed patent is enforceable only if it is not tied to a patent with finally held unpatentable or invalid claims. This could affect how patents like US 10,265,370 are managed and challenged[5].
Prosecution Strategies
To avoid filing terminal disclaimers, patent applicants might combine conflicting claims into a single application, cancel or amend conflicting claims, argue for patentable distinctness, or file reissue applications. These strategies could influence the future of lisinopril formulation patents[5].
Industry Expert Insights
Industry experts emphasize the importance of thorough patent analytics and strategic management of patent claims.
"Understanding the scope and claims of your patents is crucial for maintaining a strong intellectual property position. It helps in identifying gaps and opportunities, which can be pivotal in market competition," says a patent analyst.
Statistics and Examples
- Stability Improvement: The novel formulations described in the patent have shown a significant improvement in the stability of lisinopril, with some formulations maintaining over 90% of the drug's potency over a year[4].
- Market Impact: The improved formulations have the potential to capture a substantial market share, given the widespread use of lisinopril. According to market research, ACE inhibitors like lisinopril account for a significant portion of the cardiovascular drug market.
Key Takeaways
- Novel Formulations: The patent introduces novel formulations of lisinopril that enhance its stability and bioavailability.
- Comprehensive Claims: The patent includes detailed independent and dependent claims that define the protected aspects of the formulations.
- Patent Landscape: The patent is part of a complex landscape with multiple related patents and prior art documents.
- Patent Analytics: Effective use of patent analytics tools is crucial for managing and leveraging the patent claims.
- Regulatory Changes: Proposed USPTO rule changes could impact the management and enforcement of this patent.
FAQs
What is the main focus of United States Patent 10,265,370?
The main focus of this patent is on novel formulations of lisinopril, an ACE inhibitor, which enhance its stability and bioavailability.
Who are the inventors of this patent?
The inventors of this patent are Gerold L. Mosher and David W. Miles.
What is the significance of the stability enhancements described in the patent?
The stability enhancements ensure that the lisinopril formulations maintain their potency over time, which is crucial for the drug's efficacy.
How do the proposed USPTO rule changes affect this patent?
The proposed rule changes regarding terminal disclaimers could impact how this patent is managed, licensed, and litigated, particularly in terms of ensuring that the patent is enforceable only if it is not tied to invalid or unpatentable claims.
What role does patent analytics play in managing this patent?
Patent analytics helps in identifying which patents and claims are actively protecting the intellectual property, revealing gaps or opportunities, and categorizing claims by their value to the company.
Sources
- US10265370B2 - Lisinopril formulations - Google Patents
- Patent Claims Research Dataset - USPTO
- Patent Analytics - Intellectual Property Law
- United States Patent - googleapis.com
- United States Patent and Trademark Office Proposes Changes to Terminal Disclaimer Practice - Sterne Kessler
