United States Patent 7,208,516: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 7,208,516, titled "Methods of treating, managing or preventing psoriatic arthritis," is a significant patent in the pharmaceutical industry, particularly in the treatment of psoriatic arthritis. This patent is associated with the drug apremilast, which is marketed under the brand name Otezla.
Background
Psoriatic arthritis is a chronic inflammatory condition that affects the joints of people with psoriasis. The treatment of this condition has evolved significantly, and apremilast has been a key player in this advancement. The patent in question outlines specific methods for the administration of apremilast to treat, manage, or prevent psoriatic arthritis.
Patent Overview
Patent Number and Expiration
The United States Patent 7,208,516 was granted to Celgene Corporation and has an expiration date of March 19, 2023[2].
Inventors and Assignees
The patent was assigned to Celgene Corporation, which is now part of Bristol Myers Squibb after a merger. The inventors listed on the patent include researchers who contributed to the development of apremilast as a treatment for psoriatic arthritis.
Scope of the Patent
Claims
The patent includes multiple claims that cover various aspects of treating psoriatic arthritis with apremilast. These claims are broadly categorized into several types:
- Method Claims: These claims describe the methods of administering apremilast to patients suffering from psoriatic arthritis. This includes specific dosages, treatment regimens, and patient populations[1].
- Composition Claims: These claims cover the pharmaceutical compositions containing apremilast that are used in the treatment methods described in the patent[1].
Scope Concepts
The scope of the patent can be analyzed using scope concepts, which categorize the claims based on their overarching themes. For example, the claims can be grouped into those related to:
- Dosage Regimens: Claims that specify the dosage and frequency of apremilast administration.
- Patient Populations: Claims that define the patient groups for whom the treatment is intended.
- Pharmaceutical Compositions: Claims that describe the formulation and preparation of apremilast-containing medications[3].
Patent Landscape
Related Patents
The patent 7,208,516 is part of a larger portfolio of patents related to apremilast. Other relevant patents include:
- 7,427,638: Covers additional aspects of apremilast formulations and methods of use.
- 7,659,302: Relates to specific dosing regimens and patient populations.
- 7,893,101: Covers other pharmaceutical compositions and methods of administration[2].
Litigation and Settlements
The patent has been involved in several litigation cases, particularly in the context of generic drug approvals. For instance, in the case of Celgene Corp. v. Glenmark Pharms. Ltd., Glenmark was enjoined from making and selling its generic version of apremilast until the expiration of the patents-in-suit, which included the 7,208,516 patent[5].
Claim Coverage and Gaps
Claim Coverage Matrix
To understand the comprehensive coverage of the patent, a Claim Coverage Matrix can be used. This matrix categorizes the claims by their scope concepts, helping to identify which patents and claims are actively protecting the intellectual property. For example, the matrix might show that the 7,208,516 patent covers specific dosage regimens and patient populations, while other patents cover different aspects of apremilast use[3].
Identifying Gaps
Using tools like ClaimScape® software, companies can generate interactive claim charts to review patent coverage. These charts help in identifying gaps in the current claim coverage and highlight future design opportunities. For instance, if the 7,208,516 patent does not cover a particular formulation of apremilast, this gap can be identified and addressed through further patent filings or licensing agreements[3].
Impact on the Pharmaceutical Industry
Market Dominance
The patent 7,208,516 has played a crucial role in Celgene's market dominance in the treatment of psoriatic arthritis. By protecting the exclusive use of apremilast, Celgene has been able to maintain a significant market share until the patent's expiration.
Generic Competition
The expiration of the patent in 2023 has opened the door for generic competition. Companies like Glenmark Pharmaceuticals have been preparing to launch generic versions of apremilast, which is expected to increase competition and potentially reduce prices for patients[5].
Conclusion
The United States Patent 7,208,516 is a pivotal patent in the treatment of psoriatic arthritis, covering critical methods and compositions related to apremilast. Understanding the scope and claims of this patent, as well as its position within the broader patent landscape, is essential for pharmaceutical companies navigating the complex world of intellectual property.
Key Takeaways
- Patent Scope: The patent covers specific methods and compositions for treating psoriatic arthritis with apremilast.
- Related Patents: Part of a larger portfolio of patents related to apremilast.
- Litigation: Involved in several litigation cases related to generic drug approvals.
- Claim Coverage: Uses scope concepts to categorize claims and identify gaps in coverage.
- Market Impact: Significant in maintaining Celgene's market dominance until its expiration.
FAQs
Q: What is the primary focus of the United States Patent 7,208,516?
A: The primary focus is on methods of treating, managing, or preventing psoriatic arthritis using apremilast.
Q: Who is the assignee of the patent 7,208,516?
A: The patent is assigned to Celgene Corporation, now part of Bristol Myers Squibb.
Q: What is the expiration date of the patent 7,208,516?
A: The patent expired on March 19, 2023.
Q: How has the patent impacted the pharmaceutical industry?
A: It has maintained Celgene's market dominance in the treatment of psoriatic arthritis until its expiration and has been a subject of litigation involving generic drug approvals.
Q: What tools can be used to analyze the claim coverage of the patent?
A: Tools like Claim Coverage Matrix and ClaimScape® software can be used to categorize claims and identify gaps in coverage.
Sources
- Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy ... - Google Patents
- Apremilast Tablets - accessdata.fda.gov - FDA
- Patent Analytics | Intellectual Property Law - Schwegman
- Extended release pharmaceutical composition of apremilast - Google Patents
- ANDA Litigation Settlements | Robins Kaplan LLP Law Firm - Robins Kaplan LLP
