United States Patent 8,466,139: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,466,139, titled "Formulation," was issued on June 18, 2013. This patent pertains to a method for treating hormonal dependent benign or malignant diseases, specifically focusing on formulations for administering fulvestrant. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a method for treating hormonal dependent benign or malignant diseases of the breast or reproductive tract. The formulation involves administering intramuscularly a composition that includes about 50 mg/ml of fulvestrant, a mixture of from 17-23% w/v of ethanol and benzyl alcohol, 12-18% w/v of benzyl benzoate, and a sufficient amount of castor oil vehicle. The method aims to achieve a blood plasma fulvestrant concentration of at least 2.5 ng/ml for at least two weeks[2].
Claims Analysis
Independent and Dependent Claims
The patent includes several claims, both independent and dependent, that define the scope of the invention. Independent claims typically outline the core aspects of the invention, while dependent claims further specify or narrow down these core aspects.
- Independent Claim 1: This claim describes the method of treating a hormonal dependent benign or malignant disease by administering the specified formulation intramuscularly.
- Dependent Claims: These claims elaborate on various aspects such as the concentration of fulvestrant, the composition of the vehicle, and the duration for which the blood plasma concentration is maintained[2].
Patent Scope and Coverage
Therapeutic Application
The patent is specifically tailored for the treatment of hormonal dependent diseases, which includes conditions like breast cancer and other reproductive tract cancers. The formulation is designed to ensure a sustained release of fulvestrant, a known estrogen receptor antagonist, thereby providing an effective therapeutic approach.
Chemical Composition
The scope of the patent is also defined by the specific chemical composition of the formulation. The use of ethanol, benzyl alcohol, benzyl benzoate, and castor oil as components is crucial, as these ensure the stability and efficacy of the fulvestrant in the bloodstream[2].
Patent Landscape
Competitors and Challengers
The patent landscape around U.S. Patent 8,466,139 includes several challenges and competitors. For instance, InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. have filed petitions with the Patent Trial and Appeal Board (PTAB) to challenge the patent on grounds of obviousness under 35 U.S.C. ยง 103(a)[2].
Inter Partes Review (IPR)
The PTAB petitions highlight the ongoing disputes and challenges in the patent landscape. These challenges often revolve around the novelty and non-obviousness of the invention, which are critical factors in determining the validity of a patent. The IPR process allows for a re-examination of the patent claims and can significantly impact the patent's enforceability[2].
Economic and Legal Implications
Litigation Costs and Strategies
Patent litigation, especially involving non-practicing entities (NPEs), can be costly and complex. The asymmetry in litigation costs, where NPEs have lower discovery costs and cannot be countersued for patent infringement, can give them significant leverage in seeking financial compensation from operating companies[1].
Market Impact
The validity and enforceability of U.S. Patent 8,466,139 can have substantial market implications. If the patent is upheld, it could grant the patent holder exclusive rights to the formulation, potentially limiting competition and affecting the availability and pricing of the treatment. Conversely, if the patent is invalidated, it could open up the market to generic or alternative formulations[2].
Research and Development
Data and Analytics
The analysis of patent claims and scope can be facilitated by datasets such as the Patent Claims Research Dataset provided by the USPTO. This dataset contains detailed information on claims from U.S. patents and applications, which can be used to understand trends and measurements of patent scope[3].
International Patent Landscape
The global patent landscape is also relevant, as patents are often filed in multiple jurisdictions. Databases like PATENTSCOPE and the Cooperative Patent Classification (CPC) database allow for full-text searching of patent grants and applications worldwide, providing a comprehensive view of the international patent landscape[4].
Challenges and Controversies
Obviousness and Novelty
One of the key challenges faced by U.S. Patent 8,466,139 is the argument of obviousness. Petitioners have challenged the patent on grounds that the formulation is not novel or non-obvious, which could lead to the patent being invalidated if the PTAB agrees[2].
Litigation and Enforcement
The enforcement of this patent involves complex legal proceedings, including declaratory judgment actions and infringement lawsuits. For example, a declaratory judgment action might be filed to determine whether a competitor's product infringes on the patent claims[5].
Key Takeaways
- Specific Formulation: The patent is highly specific about the composition and administration method of the fulvestrant formulation.
- Therapeutic Application: It is designed for treating hormonal dependent benign or malignant diseases.
- Challenges: The patent faces challenges from competitors and through PTAB petitions.
- Economic Implications: The outcome of these challenges can significantly impact market competition and treatment availability.
- Global Landscape: Understanding the international patent landscape is crucial for comprehensive analysis.
Frequently Asked Questions (FAQs)
What is the main therapeutic application of U.S. Patent 8,466,139?
The main therapeutic application is the treatment of hormonal dependent benign or malignant diseases, particularly those affecting the breast or reproductive tract.
Who has challenged the validity of U.S. Patent 8,466,139?
InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. have filed petitions with the PTAB to challenge the patent on grounds of obviousness.
What is the significance of the PTAB petitions against this patent?
The PTAB petitions are significant because they challenge the novelty and non-obviousness of the invention, which are critical factors in determining the patent's validity.
How does the patent landscape impact the market for this treatment?
The validity and enforceability of the patent can affect market competition, the availability of the treatment, and its pricing.
What resources are available for analyzing patent claims and scope?
Resources such as the Patent Claims Research Dataset from the USPTO and international databases like PATENTSCOPE can be used to analyze patent claims and scope.
Cited Sources:
- United States Government Accountability Office, "Assessing Factors That Affect Patent Infringement Litigation Could Help Improve Patent Quality," August 2013.
- McDonnell Boehnen Hulbert & Berghoff LLP, "PTAB Life Sciences Report -- Part III," JD Supra.
- United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
- Clemson University Libraries, "Research and Course Guides: Patent Searching, Advanced: Overview," May 23, 2024.
- United States District Court for the District of Delaware, "In the United States District Court for the District of Delaware," December 14, 2017.
