United States Patent 9,144,559: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,144,559, titled "Solid pharmaceutical compositions containing pregabalin," is a significant patent in the pharmaceutical industry, particularly for Pfizer, the assignee. This patent is part of a broader landscape of intellectual property protections surrounding pregabalin, a drug used to treat various conditions including epilepsy, neuropathic pain, and fibromyalgia.
Background on Pregabalin
Pregabalin, marketed under the brand name Lyrica, is a widely prescribed medication. The development and commercialization of pregabalin involve a complex web of patents and exclusivities that protect the drug's formulation, composition, and methods of use[2][4].
Patent Overview
Publication and Assignment
The patent 9,144,559 was assigned to Pfizer Products Inc. and was published on September 29, 2015. It describes solid pharmaceutical compositions containing pregabalin, which include a matrix forming agent and a swelling agent. These compositions are designed to enhance the drug's delivery and efficacy[4].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim describes a solid pharmaceutical composition comprising pregabalin, a matrix forming agent, and a swelling agent. The composition is designed to release pregabalin in a controlled manner[4].
- Dependent Claims: Subsequent claims further specify the types of matrix forming agents, swelling agents, and other components that can be used in the composition. These claims also detail the methods of preparing these compositions[4].
Scope of the Invention
The scope of the patent is defined by the claims, which cover specific formulations and methods related to pregabalin. The patent protects not only the exact composition but also variations that fall within the claimed scope. This includes different types of matrix and swelling agents, as well as various methods of formulation[4].
Patent Landscape
Orange Book Listing
The patent 9,144,559 is listed in the FDA's Orange Book, which compiles patent information for approved drugs. This listing is crucial because it informs potential generic manufacturers about the patents that could be asserted against them if they seek to market a generic version of the drug. The Orange Book listing also allows the brand-name manufacturer to update the patent information as new patents are issued or as existing patents expire[2][5].
Exclusivities and Patent Duration
The patent landscape for pregabalin includes various exclusivities and patent protections. The USPTO and FDA have analyzed the interplay between these patents and exclusivities, highlighting how they extend the market exclusivity period for branded drugs. For example, the study by the USPTO and FDA found that drugs like pregabalin are often covered by multiple patents and exclusivities, which can delay the entry of generic competitors[1].
Litigation and Declaratory Judgments
Patents like 9,144,559 are often at the center of litigation, particularly when generic manufacturers seek to enter the market. For instance, Sun Pharmaceutical Industries Limited filed a declaratory judgment action against Pfizer, challenging the validity and enforceability of several patents, including 9,144,559. This litigation is typical in the pharmaceutical industry, where the stakes are high and the protection of intellectual property is critical[2].
Metrics for Measuring Patent Scope
The scope of a patent like 9,144,559 can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. For example, longer independent claims may indicate broader patent scope, while higher claim counts can suggest more detailed and specific protections[3].
Impact on Innovation and Competition
The breadth and clarity of patent claims, as seen in 9,144,559, can significantly impact innovation and competition in the pharmaceutical industry. Broad and unclear claims can lead to increased litigation and licensing costs, potentially stifling innovation. Conversely, well-defined and clear claims can provide a clear roadmap for innovators and generic manufacturers, promoting healthy competition and innovation[3].
Key Takeaways
- Patent Scope: The patent 9,144,559 covers specific formulations and methods related to pregabalin, including the use of matrix forming agents and swelling agents.
- Orange Book Listing: The patent is listed in the FDA's Orange Book, informing generic manufacturers about potential patent barriers.
- Litigation: The patent has been involved in litigation, highlighting the importance of intellectual property protection in the pharmaceutical industry.
- Metrics for Patent Scope: Independent claim length and count can be used to measure the breadth and clarity of patent claims.
- Impact on Innovation: The clarity and breadth of patent claims can influence innovation and competition by affecting litigation and licensing costs.
FAQs
What is the main subject of United States Patent 9,144,559?
The main subject of United States Patent 9,144,559 is solid pharmaceutical compositions containing pregabalin, including specific formulations and methods of preparation.
Why is the Orange Book listing important for this patent?
The Orange Book listing is important because it informs potential generic manufacturers about the patents that could be asserted against them if they seek to market a generic version of the drug.
What metrics can be used to measure the scope of a patent like 9,144,559?
Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent like 9,144,559.
How does the patent landscape for pregabalin affect generic competition?
The patent landscape for pregabalin, including multiple patents and exclusivities, can delay the entry of generic competitors by extending the market exclusivity period for branded drugs.
What is the significance of litigation involving patents like 9,144,559?
Litigation involving patents like 9,144,559 is significant because it determines the validity and enforceability of the patents, which can impact the timing and feasibility of generic drug entry into the market.
Sources
- USPTO-FDA Report on Drug Patent and Exclusivity - USPTO
- Complaint for Declaratory Judgment - Sun Pharmaceutical Industries Limited vs. Pfizer, Inc.
- Patent Claims and Patent Scope - Hoover Institution
- Solid pharmaceutical compositions containing pregabalin - Google Patents
- Solid pharmaceutical compositions containing pregabalin - PubChem
