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Patent landscape, scope, and claims: |
United States Patent 7,659,302: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 7,659,302, titled "Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione," is a significant patent in the pharmaceutical sector, particularly related to the drug apremilast, marketed as OTEZLA® by Celgene Corporation. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent was issued on February 9, 2010, and is part of a series of patents held by Celgene Corporation that protect the formulation, use, and manufacturing processes of apremilast. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor used in the treatment of psoriatic arthritis, moderate to severe plaque psoriasis, and other inflammatory conditions[2].
Scope of the Patent
The patent covers specific methods of using the compound (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, which is the active ingredient in OTEZLA®. The scope includes:
- Therapeutic Uses: The patent details methods for treating various inflammatory diseases, including psoriatic arthritis and inflammatory bowel disease such as Crohn's disease[1][2].
- Formulations: It covers different formulations of the compound, including tablets and other solid forms, which are crucial for the drug's efficacy and stability[2].
Claims of the Patent
The claims of the patent are comprehensive and protect various aspects of the compound and its use:
- Composition of Matter: Claims related to the chemical structure and synthesis of the compound[1].
- Method of Use: Claims covering the therapeutic uses of the compound, including specific dosages and treatment regimens[1][2].
- Formulations and Dosage Forms: Claims related to the preparation and composition of tablets, capsules, and other dosage forms containing the compound[1][2].
Patent Landscape
The patent landscape surrounding US 7,659,302 is complex and involves multiple related patents:
- Family of Patents: This patent is part of a larger family of patents held by Celgene, including US 6,962,940, US 7,208,516, US 7,427,638, US 7,893,101, US 8,455,536, US 8,802,717, US 9,018,243, and US 9,872,854. These patents collectively protect various aspects of apremilast, including its synthesis, formulation, and therapeutic uses[2].
- Litigation and Infringement: The patent has been involved in several litigation cases, particularly against generic manufacturers seeking to produce versions of OTEZLA® before the expiration of the patents. For example, Celgene Corporation has sued Aurobindo Pharma Limited and Aurobindo Pharma U.S.A., Inc. for patent infringement related to their Abbreviated New Drug Application (ANDA) for generic versions of OTEZLA®[2].
Patent Analytics and Claim Coverage
To understand the full extent of the patent's protection, patent analytics tools are essential:
- Claim Coverage Matrix: This tool helps in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property. For US 7,659,302, this would involve analyzing the claims in relation to the broader scope of Celgene's patent portfolio[3].
- Claim Charts: These charts facilitate the review of patent coverage with technical experts, helping to determine if there are gaps in the current coverage and highlighting future design opportunities. This is particularly useful in managing the complex patent landscape surrounding apremilast[3].
International Patent Protection
The protection of apremilast is not limited to the United States; it extends globally through corresponding patents in other jurisdictions:
- Global Dossier: This service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the global patent family for apremilast[4].
- International Patent Databases: Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) offer access to international patent applications and granted patents related to apremilast[4].
Expiry and Future Implications
The patent's term is a critical factor in its ongoing protection:
- Expiry Date: The patent's term, along with other related patents, is set to expire on specific dates, with some patents expiring as early as March 19, 2023, and others extending until May 29, 2034[2].
- Generic Competition: The expiry of these patents will open the market to generic competition, which could significantly impact Celgene's market share and revenue from OTEZLA®.
Key Takeaways
- Comprehensive Protection: US 7,659,302 provides broad protection for the compound apremilast, covering its therapeutic uses, formulations, and manufacturing processes.
- Litigation and Enforcement: The patent has been involved in several litigation cases to protect Celgene's intellectual property rights against generic manufacturers.
- Global Reach: The protection of apremilast extends globally through corresponding patents and international patent databases.
- Expiry and Future Implications: The expiry of the patent and related patents will have significant implications for Celgene and the market for psoriatic arthritis and psoriasis treatments.
Frequently Asked Questions (FAQs)
Q: What is the primary compound protected by US 7,659,302?
A: The primary compound is (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, known as apremilast.
Q: What are the therapeutic uses covered by the patent?
A: The patent covers the treatment of psoriatic arthritis, moderate to severe plaque psoriasis, and other inflammatory conditions such as Crohn's disease.
Q: Is the patent part of a larger family of patents?
A: Yes, it is part of a larger family of patents held by Celgene Corporation that collectively protect various aspects of apremilast.
Q: What tools can be used to analyze the patent's claims and coverage?
A: Tools such as Claim Coverage Matrix and Claim Charts are useful for analyzing the patent's claims and identifying gaps in coverage.
Q: When do the patents related to apremilast expire?
A: The expiry dates vary, with some patents expiring as early as March 19, 2023, and others extending until May 29, 2034.
Citations
- US7659302B2 - Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione - Google Patents.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE CELGENE CORPORATION, Plaintiff, v. AUROBINDO PHARMA LIMITED and AUROBINDO PHARMA U.S.A., INC., Defendants - Insight.RPXCorp.
- Patent Analytics | Intellectual Property Law - SLWIP.
- Search for patents - USPTO - USPTO.
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