United States Patent 10,675,287: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,675,287, hereafter referred to as the '287 patent, is a significant intellectual property asset in the pharmaceutical sector, particularly in the treatment of partial-onset seizures. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '287 patent is associated with the pharmaceutical product APTIOM® (eslicarbazepine acetate), which is used as an adjunctive therapy and monotherapy for treating partial-onset seizures. The patent is held by Sunovion Pharmaceuticals Inc., a Delaware corporation, and is listed in the FDA's Orange Book along with other related patents[4].
Scope of the Patent
The '287 patent covers specific methods and formulations related to the use of eslicarbazepine acetate. Here are the key aspects of its scope:
Methods of Administration
The patent includes claims that cover various methods of administering eslicarbazepine acetate. These methods are crucial for the effective treatment of partial-onset seizures and are designed to optimize the therapeutic benefits of the drug[4].
Formulation Claims
In addition to the methods of administration, the patent also includes claims related to the formulation of the drug. This includes specific tablet formulations that contain eslicarbazepine acetate as the active pharmaceutical ingredient (API)[4].
Claims of the Patent
The '287 patent asserts several claims, each of which is critical for defining the intellectual property protection:
Claim 3
This claim is specifically mentioned in litigation documents and pertains to a method of administering eslicarbazepine acetate. It is one of the key claims that have been asserted in patent infringement cases[4].
Other Claims
The patent includes multiple claims that cover different aspects of the drug's use and formulation. For example, claims may cover the dosage forms (200, 400, 600, and 800 mg), the frequency of administration, and other specific details that distinguish the patented methods and formulations from generic or unauthorized versions[4].
Patent Landscape
The '287 patent is part of a larger patent landscape that includes several other patents related to APTIOM® and its use.
Related Patents
Other patents listed in the Orange Book for APTIOM® include U.S. Patents 10,675,354, 10,675,536, 10,675,781, and 10,675,954. These patents collectively protect various aspects of the drug, including its composition, methods of use, and specific formulations[4].
International Patent Protection
While the '287 patent is specific to the United States, similar patents may exist in other jurisdictions, providing global protection for the intellectual property. This is often achieved through the Patent Cooperation Treaty (PCT) or direct filings in other countries[1].
Litigation and Enforcement
The '287 patent has been involved in several litigation cases, particularly against generic drug manufacturers seeking FDA approval for their versions of eslicarbazepine acetate.
Infringement Claims
Companies like Alkem Laboratories Limited have been accused of patent infringement due to their submission of Abbreviated New Drug Applications (ANDAs) to the FDA. These cases often involve disputes over the validity and infringement of the patent claims[4].
Declaratory Judgments
In some cases, defendants have sought declaratory judgments of noninfringement and invalidity of the asserted patents. These counterclaims are part of the broader legal strategy to challenge the patent's validity and scope[4].
Search and Analysis Tools
To understand the full scope and impact of the '287 patent, various search and analysis tools can be utilized:
USPTO Patent Public Search
This tool allows for a comprehensive search of prior art and related patents, helping to identify the unique aspects of the '287 patent and its position within the broader patent landscape[1].
Global Dossier
This service provides access to the file histories of related applications from participating IP Offices, which can be useful in understanding the international patent family and any office actions related to the patent[1].
Common Citation Document (CCD)
The CCD application consolidates citation data from multiple IP offices, enabling a more integrated view of the prior art cited by different offices for the same invention[1].
Economic and Strategic Impact
The '287 patent has significant economic and strategic implications for Sunovion Pharmaceuticals Inc. and the pharmaceutical industry as a whole.
Market Exclusivity
The patent provides market exclusivity for APTIOM® until its expiration, protecting Sunovion's investment in research and development and allowing the company to recoup its costs[2].
Competitive Advantage
The unique claims and scope of the '287 patent give Sunovion a competitive advantage in the market for treatments of partial-onset seizures. This advantage is critical in maintaining market share and revenue[4].
Key Takeaways
- Scope and Claims: The '287 patent covers specific methods of administering eslicarbazepine acetate and its formulation, providing broad protection for APTIOM®.
- Patent Landscape: The patent is part of a larger portfolio of patents related to APTIOM®, including other U.S. patents listed in the Orange Book.
- Litigation: The patent has been involved in several infringement cases against generic drug manufacturers.
- Search and Analysis Tools: Tools like the USPTO Patent Public Search, Global Dossier, and CCD are essential for understanding the patent's scope and impact.
- Economic and Strategic Impact: The patent provides market exclusivity and a competitive advantage for Sunovion Pharmaceuticals Inc.
FAQs
Q: What is the primary focus of the '287 patent?
The primary focus of the '287 patent is on the methods of administering eslicarbazepine acetate and its specific formulations for treating partial-onset seizures.
Q: Which company holds the '287 patent?
The '287 patent is held by Sunovion Pharmaceuticals Inc.
Q: What is the significance of the Orange Book listing for the '287 patent?
The Orange Book listing indicates that the '287 patent is one of the patents that protect APTIOM® and is recognized by the FDA as a valid patent covering the drug.
Q: How does the '287 patent impact generic drug manufacturers?
The '287 patent prevents generic drug manufacturers from marketing their versions of eslicarbazepine acetate until the patent expires, unless they can successfully challenge the patent's validity or obtain a license.
Q: What tools can be used to analyze the scope and impact of the '287 patent?
Tools such as the USPTO Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to analyze the scope and impact of the '287 patent.
Sources
- USPTO: Search for patents - USPTO
- Insight.RPXCorp: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...
- USPTO: Patent Claims Research Dataset - USPTO
- VLEX: Bial-Portela & CA. v. Alkem Labs. - Case Law - VLEX 910617312
- Unified Patents: US-10675287-B2 - Methods of Treatment of Partial Onset Seizures ...
