United States Patent 8,802,717: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,802,717, titled "Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione," is a significant patent in the pharmaceutical industry, particularly in the treatment of arthritic conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication and Legal Status
The patent, numbered US8802717B2, was published on August 5, 2014, and its legal status indicates that it has expired as of March 19, 2023[4].
Inventors and Assignees
The patent was assigned to Celgene Corporation, a major pharmaceutical company known for its innovative treatments, including Otezla (apremilast), which is the compound described in this patent.
Scope of the Patent
Subject Matter
The patent describes methods for treating arthritic conditions using the compound (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione, commonly known as apremilast. This compound is used in the treatment of psoriatic arthritis and other inflammatory conditions[4].
Claims
The patent includes multiple claims that define the scope of the invention. These claims typically cover:
- The specific compound and its derivatives.
- Methods of treating arthritic conditions using the compound.
- Dosage forms and administration methods.
- Specific indications such as psoriatic arthritis.
For example, Claim 1 might describe the compound itself, while subsequent claims might detail the methods of use, dosage regimens, and specific arthritic conditions treated[4].
Claims Analysis
Independent and Dependent Claims
Independent claims define the broadest scope of the invention and are typically more general. Dependent claims narrow down the scope by adding additional limitations or specifics. In the case of US8802717B2, the independent claims would likely cover the compound and its use in treating arthritic conditions, while dependent claims might specify particular dosages, administration routes, or specific types of arthritis[4].
Claim Charts and Coverage
To analyze the coverage of this patent, claim charts can be used, as described in patent analytics practices. These charts help in visualizing which claims cover specific aspects of the technology and identify any gaps in coverage. For instance, a claim chart for US8802717B2 would show which claims protect the use of apremilast for psoriatic arthritis and other conditions, helping to determine the overall value and scope of the patent[3].
Patent Landscape
Related Patents
The patent landscape surrounding US8802717B2 includes several other patents related to apremilast and its use. These patents, such as US6962940, US7208516, US7427638, US7659302, US7893101, US8455536, and US9872854, collectively form a robust portfolio protecting various aspects of apremilast, including different formulations, methods of use, and solid forms[5].
Global Dossier and IP5 Offices
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service is crucial for understanding the global patent landscape for US8802717B2 and its related patents, providing insights into office actions, citations, and classifications across different jurisdictions[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art citations from participating IP Offices, enabling a comprehensive view of the prior art landscape for the patent family. This tool is essential for understanding how different offices have treated the same invention, which can be particularly relevant in litigation and opposition proceedings[1].
Litigation and Regulatory Context
ANDA Filings and FDA Approval
The patent has been involved in several legal disputes related to Abbreviated New Drug Applications (ANDAs) filed with the FDA. For example, Aurobindo’s ANDA for generic versions of Otezla (apremilast) triggered litigation over the validity and infringement of the patents, including US8802717B2. These disputes highlight the importance of this patent in protecting Celgene’s intellectual property rights[5].
Paragraph IV Certifications
In the context of ANDA filings, paragraph IV certifications are crucial. These certifications state whether the applicant believes the patent is invalid or not infringed. For US8802717B2, such certifications would have been part of the ANDA process, reflecting the applicant’s stance on the patent’s validity and scope[2].
Practical Implications
Patent Analytics and Claim Coverage
Understanding the scope and claims of US8802717B2 is vital for companies involved in the development or manufacture of similar compounds. Patent analytics tools, such as Claim Coverage Matrices and Claim Charts, help in identifying gaps in coverage and potential design opportunities. This analysis can guide strategic decisions on patent maintenance, licensing, and litigation[3].
Expiration and Post-Expiration Strategies
With the patent having expired, generic versions of apremilast can now be marketed without infringing on this specific patent. However, other related patents may still be in force, and companies must navigate this complex landscape carefully. Post-expiration strategies might include evaluating the remaining patent portfolio, assessing market competition, and planning for future innovations.
Key Takeaways
- Patent Scope: US8802717B2 covers methods for treating arthritic conditions using the compound apremilast.
- Claims Analysis: The patent includes independent and dependent claims defining the compound, methods of use, and specific indications.
- Patent Landscape: The patent is part of a broader portfolio protecting apremilast, with related patents covering various aspects.
- Litigation and Regulatory Context: The patent has been involved in ANDA-related litigation and FDA approval processes.
- Practical Implications: Understanding the patent’s scope and claims is crucial for strategic decisions in the pharmaceutical industry.
FAQs
What is the compound described in US8802717B2?
The compound described is (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione, commonly known as apremilast.
What is the legal status of US8802717B2?
The patent has expired as of March 19, 2023.
How does the Common Citation Document (CCD) relate to this patent?
The CCD consolidates prior art citations from participating IP Offices, providing a comprehensive view of the prior art landscape for the patent family.
What is the significance of paragraph IV certifications in ANDA filings?
Paragraph IV certifications state whether the applicant believes the patent is invalid or not infringed, which is crucial in the ANDA process.
How can patent analytics tools help in understanding US8802717B2?
Patent analytics tools like Claim Coverage Matrices and Claim Charts help in identifying gaps in coverage, potential design opportunities, and the overall value of the patent claims.
Sources
- USPTO - Search for patents - USPTO
- FDA - Apremilast Tablets - accessdata.fda.gov
- SLWIP - Patent Analytics | Intellectual Property Law
- Google Patents - US8802717B2 - Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
- RPX Corporation - IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...
