Analyzing the Scope and Claims of United States Patent 8,178,518
Introduction
The United States Patent 8,178,518, part of a series of patents related to testosterone gel formulations, is a crucial component in the intellectual property portfolio of pharmaceutical companies. This patent, along with others in the same family, has been the subject of several legal disputes and analyses. Here, we will delve into the details of the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
U.S. Patent 8,178,518 is titled "Pharmaceutical composition" and is one of the patents in a series that includes U.S. Patent Nos. 7,320,968, 7,608,605, 7,608,606, 7,608,607, 7,608,608, 7,608,609, 7,608,610, 7,935,690, 8,063,029, and 8,178,518. These patents are associated with the drug product Testim®, a testosterone gel used for treating hypogonadism[5].
Claims and Scope
Primary Claims
The '518 patent, like its predecessors, claims methods and compositions for treating hypogonadism using a specific formulation of testosterone gel. Here are some key aspects of the claims:
- Composition: The patent describes a pharmaceutical composition that includes an androgen (testosterone), a cyclic enhancer (such as those described in U.S. Pat. No. 5,023,252 to Hsieh), and a thickening agent (e.g., carbomer)[1][5].
- Enhancer: The enhancer is a material capable of increasing the rate of passage of androgen through the skin or other body membrane. Specifically, it can be a cyclic ester or a cyclic ketone[1].
- Formulation: The composition is typically in the form of a gel, designed for transdermal application to supply testosterone to the blood of a male patient[4].
Specific Claim Language
Independent claim 1 of the '968 patent, which is similar in scope to the '518 patent, recites:
"A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type described in U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent. In preferred form, such a composition exists in the form of a gel and comprises an enhancer which is a cyclic ester or a cyclic ketone."[1]
Patent Landscape
Priority and Family
The '518 patent claims priority to the same application that issued as the '968 patent. This indicates that the inventions described in these patents are closely related and part of a continuous development process[5].
Related Patents
The patents in this family cover various aspects of the testosterone gel formulation, including different enhancers, thickening agents, and methods of application. For example:
- U.S. Patent Nos. 7,608,605-610: These patents cover similar compositions and methods, with slight variations in the formulation and application techniques.
- U.S. Patent Nos. 7,935,690 and 8,063,029: These patents may cover additional aspects such as different enhancers or manufacturing processes[5].
Legal Disputes and Infringement
Auxilium Pharmaceuticals, Inc. v. Upsher-Smith Laboratories, Inc.
In this case, Auxilium Pharmaceuticals and FCB I, LLC alleged that Upsher-Smith Laboratories infringed on their patents, including the '518 patent, by producing a testosterone gel formulation. The court analyzed whether the defendant's formulation infringed under the doctrine of equivalents, as it did not literally infringe the claims. The court ultimately ruled that the plaintiffs could not use the doctrine of equivalents to reach beyond what was claimed and described in the patents-in-suit[1].
Inequitable Conduct Claims
In another dispute, Watson alleged that the inventor, Robert J. Gyurik, misrepresented to the PTO that he was the sole inventor, despite Conrex Pharmaceuticals having developed and tested similar formulations before Gyurik filed the patent applications. This highlights the importance of accurate disclosure and inventorship in patent applications[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by these patents, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and overarching scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Interactive Claim Charts
Using tools like ClaimScape® software, companies can generate interactive claim charts that help technical experts determine whether a particular scope concept is applicable to a target product or method. This approach is quick and accurate, aiding in the identification of gaps in current coverage and highlighting future design opportunities[3].
Conclusion
The United States Patent 8,178,518 is a significant part of the intellectual property landscape for testosterone gel formulations. Understanding its claims, scope, and the broader patent landscape is crucial for pharmaceutical companies to protect their inventions and navigate potential legal disputes.
Key Takeaways
- The '518 patent covers a specific formulation of testosterone gel for treating hypogonadism.
- The composition includes an androgen, a cyclic enhancer, and a thickening agent.
- The patent is part of a family of patents claiming priority to the same application.
- Legal disputes have centered around infringement and inequitable conduct claims.
- Patent analytics tools are essential for managing and analyzing the claim coverage of such patents.
FAQs
Q1: What is the primary composition claimed in U.S. Patent 8,178,518?
A1: The primary composition claimed includes an androgen (testosterone), a cyclic enhancer, and a thickening agent, typically in the form of a gel.
Q2: How does the '518 patent relate to other patents in the same family?
A2: The '518 patent claims priority to the same application that issued as the '968 patent and is part of a series of patents covering similar compositions and methods.
Q3: What was the outcome of the Auxilium Pharmaceuticals, Inc. v. Upsher-Smith Laboratories, Inc. case?
A3: The court ruled that the plaintiffs could not use the doctrine of equivalents to reach beyond what was claimed and described in the patents-in-suit.
Q4: Why is accurate disclosure and inventorship important in patent applications?
A4: Accurate disclosure and inventorship are crucial to avoid inequitable conduct claims, as seen in the dispute involving Robert J. Gyurik and Conrex Pharmaceuticals.
Q5: How can companies effectively manage and analyze the claim coverage of their patents?
A5: Companies can use tools like Claim Coverage Matrix and interactive claim charts generated by software such as ClaimScape® to manage and analyze their patent claims effectively.
Sources
- Auxilium Pharms., Inc. v. Upsher-Smith Labs., Inc. - Casetext
- Auxilium Pharms., Inc. v. FCB I LLC - Robins Kaplan
- Patent Analytics - Schwegman
- US8178518B2 - Pharmaceutical composition - Google Patents
- Auxilium Pharms., Inc. v. Upsher-Smith Laboratories, Inc. - Robins Kaplan
