United States Patent 9,089,608: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,089,608, titled "Controlled Release Formulations of Levodopa and Uses Thereof," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Parkinson's disease. This patent, issued on July 28, 2015, to inventors Ann Hsu, Jim H. Kou, and Laman Lynn Alani, is part of a series of patents related to levodopa and carbidopa formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent is associated with Impax Laboratories, Inc., which developed and marketed the drug RYTARY® (carbidopa and levodopa capsules) for the treatment of Parkinson's disease. The invention focuses on controlled release formulations designed to improve the efficacy and patient compliance of levodopa therapy[2].
Scope of the Patent
The scope of United States Patent 9,089,608 is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:
Controlled Release Formulations
The patent describes controlled release formulations of levodopa, which are designed to provide a sustained release of the active ingredient over a prolonged period. This is crucial for maintaining therapeutic levels of levodopa in the bloodstream, thereby improving the management of Parkinson's disease symptoms[2].
Composition and Dosage Forms
The patent specifies the composition and dosage forms of the controlled release formulations. These include specific ratios of levodopa to carbidopa and the use of particular excipients to achieve the desired release profile[2].
Uses Thereof
The patent also covers the uses of these formulations, including the treatment of Parkinson's disease and other conditions where levodopa therapy is indicated. The claims are broad enough to encompass various clinical applications but narrow enough to be specific to the controlled release aspect[2].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core aspects of the invention. These claims typically describe the composition, the controlled release mechanism, and the dosage forms. For example, Claim 1 might describe a pharmaceutical composition comprising a specific ratio of levodopa to carbidopa, along with a controlled release matrix[2].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific excipients, manufacturing processes, or additional therapeutic uses. The dependent claims provide a hierarchy of protection, ensuring that various aspects of the invention are covered[2].
Claim Length and Count
Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, such as those seen in this patent, are often associated with a higher probability of grant and a shorter examination process. This suggests that the claims in this patent were carefully crafted to balance breadth and specificity[3].
Patent Landscape
Related Patents
United States Patent 9,089,608 is part of a family of patents related to levodopa and carbidopa formulations. Other patents in this family include U.S. Patent Nos. 7,094,427, 8,377,474, 8,454,998, and 8,557,283, all of which cover various aspects of controlled release formulations and their uses[2].
Global Dossier
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This tool is invaluable for understanding the global patent landscape and identifying potential conflicts or opportunities for collaboration[1].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from multiple IP Offices, providing a single point of access to citation data related to the patent family. This helps in understanding how different offices have treated similar inventions and can inform strategies for patent prosecution and litigation[1].
Litigation and Enforcement
The patent has been involved in litigation, particularly in cases related to generic drug approvals. For instance, Impax Laboratories, Inc. has alleged patent infringement against Actavis Laboratories FL, Inc., and Actavis Pharma Inc. for their submissions of Abbreviated New Drug Applications (ANDAs) seeking approval to manufacture and sell generic versions of RYTARY® before the expiration of the relevant patents[2].
Search and Analysis Tools
To conduct a thorough analysis of this patent and its landscape, several tools are available:
Patent Public Search
The USPTO's Patent Public Search tool provides enhanced access to prior art and allows for modern, flexible searching of patent databases[1].
Cooperative Patent Classification (CPC)
The CPC database can be searched to find relevant classification schemes, which helps in identifying similar patents and understanding the broader technological context[4].
PATENTSCOPE
The PATENTSCOPE database, provided by the World Intellectual Property Organization (WIPO), offers full-text access to international Patent Cooperation Treaty (PCT) applications and patent documents from participating national and regional patent offices[4].
Key Takeaways
- Controlled Release Formulations: The patent focuses on controlled release formulations of levodopa, designed to improve the efficacy and patient compliance of levodopa therapy.
- Claims Analysis: The patent includes independent and dependent claims that define the composition, controlled release mechanism, and dosage forms.
- Patent Landscape: The patent is part of a family of related patents and can be analyzed using tools like the Global Dossier and CCD.
- Litigation: The patent has been involved in litigation related to generic drug approvals.
- Search and Analysis Tools: Tools like Patent Public Search, CPC, and PATENTSCOPE are essential for a thorough analysis.
FAQs
What is the main focus of United States Patent 9,089,608?
The main focus of United States Patent 9,089,608 is on controlled release formulations of levodopa, designed to improve the efficacy and patient compliance of levodopa therapy for treating Parkinson's disease.
How do the claims in this patent contribute to its scope?
The claims in this patent define the composition, controlled release mechanism, and dosage forms, providing a balance between breadth and specificity. Independent claims outline the core aspects, while dependent claims add additional limitations.
What tools are available for analyzing the patent landscape of this invention?
Tools such as the Global Dossier, Common Citation Document (CCD), Patent Public Search, Cooperative Patent Classification (CPC), and PATENTSCOPE are available for analyzing the patent landscape.
Has this patent been involved in any litigation?
Yes, this patent has been involved in litigation related to generic drug approvals, particularly against Actavis Laboratories FL, Inc., and Actavis Pharma Inc.
How can one access the file histories of related applications for this patent?
The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- LITE DEPALMA GREENBERG, LLC: https://insight.rpxcorp.com/litigation_documents/11535593
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Clemson University - Advanced Patent Searching: https://clemson.libguides.com/advanced_patent_searching
- PubChem - Controlled release formulations of levodopa and uses thereof: https://pubchem.ncbi.nlm.nih.gov/patent/US-9089608-B2
