United States Patent 8,513,223: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,513,223, titled "Substituted tetracycline compounds for treatment of inflammatory skin disorders," is a significant patent in the field of pharmaceuticals, particularly for the treatment of skin conditions such as acne and rosacea. This patent, issued on August 20, 2013, is assigned to Paratek Pharmaceuticals, Inc.
Inventors and Assignees
The patent was invented by a team of researchers including Assefa Haregewein, Beena Bhatia, Michael P. Draper, Laura Honeyman, Oak Kim, and Dennis P. Molnar. It is assigned to Paratek Pharmaceuticals, Inc., a company known for its innovative approaches in developing antibiotics and other pharmaceuticals[2].
Patent Scope
The patent covers novel substituted tetracycline compounds and their methods of use for treating various inflammatory skin disorders. These compounds are designed to be more effective and have fewer side effects compared to traditional tetracycline antibiotics.
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Chemical Structure: The patent describes specific chemical structures of the substituted tetracycline compounds, including variations such as alkyl, alkynyl, alkenyl, and other functional groups[1][2].
- Therapeutic Uses: The claims specify the use of these compounds for treating inflammatory skin disorders, including acne, rosacea, and other conditions characterized by inflammation[1][2].
- Methods of Treatment: The patent outlines methods for administering these compounds, including topical and systemic applications[1][2].
Patent Claims Analysis
The claims in this patent are detailed and specific, ensuring that the invention is well-defined and distinguishable from prior art.
Independent Claims
The independent claims are crucial as they define the broadest scope of the invention. For example, Claim 1 might describe a general formula for the substituted tetracycline compounds, while subsequent claims narrow down to specific embodiments or methods of use[1].
Dependent Claims
Dependent claims further specify the invention by adding additional limitations or features to the independent claims. These claims help in protecting specific aspects of the invention and can be used to defend against infringement[1].
Patent Landscape
The patent landscape surrounding US 8,513,223 is complex and involves several related patents and applications.
Related Patents
- Patent 8,318,706: This patent, also assigned to Paratek Pharmaceuticals, Inc., covers novel substituted tetracycline compounds for treating bacterial infections and neoplasms. It has a broader scope but overlaps in some areas with US 8,513,223[2].
- Patent 9,255,068: This patent describes crystalline salts of specific tetracycline compounds and their use in treating inflammatory skin disorders and bacterial infections. It provides additional formulations that enhance stability and efficacy[2].
- Patent 9,481,639: This patent is another iteration of the substituted tetracycline compounds for treating skin disorders, further refining the methods and compositions described in US 8,513,223[2].
Patent Expiration Dates
The patent is set to expire on December 7, 2029. This expiration date is significant as it marks the end of the exclusive rights granted to Paratek Pharmaceuticals, Inc., allowing for potential generic versions of the drug to enter the market[2].
Generic Availability
As of the current date, there is no generic version of the drug approved in the United States. The lack of a generic version is due to the patent protection and the absence of a therapeutically equivalent version[2].
Therapeutic Impact
The substituted tetracycline compounds covered by this patent have shown promise in treating inflammatory skin disorders with reduced side effects compared to traditional antibiotics.
Acne and Rosacea
These compounds are particularly effective in treating acne and rosacea, conditions that affect millions of people worldwide. The therapeutic effect is attributed to their anti-inflammatory and antibacterial properties[1][2].
Regulatory and Legal Aspects
The patent is subject to various regulatory and legal considerations.
Patent Quality and Scope
The scope of the patent claims is a critical aspect of patent quality. Metrics such as independent claim length and independent claim count are used to assess the breadth and clarity of the claims. Narrower claims are generally associated with a higher probability of grant and shorter examination processes[3].
Litigation and Licensing
The patent's validity and scope can be challenged through litigation or post-grant administrative reviews. The clarity and breadth of the claims are crucial in defending against such challenges and in negotiating licensing agreements[3].
Conclusion
United States Patent 8,513,223 is a significant contribution to the field of pharmaceuticals, particularly in the treatment of inflammatory skin disorders. The patent's scope, claims, and expiration date are critical factors in understanding its impact and the potential for future developments.
Key Takeaways
- Novel Compounds: The patent covers novel substituted tetracycline compounds.
- Therapeutic Uses: These compounds are used for treating inflammatory skin disorders like acne and rosacea.
- Patent Expiration: The patent expires on December 7, 2029.
- Generic Availability: No generic version is currently approved.
- Regulatory Considerations: The patent's scope and clarity are crucial for regulatory and legal purposes.
FAQs
1. What is the main focus of United States Patent 8,513,223?
The main focus is on novel substituted tetracycline compounds for treating inflammatory skin disorders.
2. Who are the inventors of this patent?
The inventors include Assefa Haregewein, Beena Bhatia, Michael P. Draper, Laura Honeyman, Oak Kim, and Dennis P. Molnar.
3. What is the expiration date of this patent?
The patent expires on December 7, 2029.
4. Are there any generic versions of the drug approved?
No, there are currently no therapeutically equivalent generic versions approved in the United States.
5. What other patents are related to this one?
Related patents include US 8,318,706, US 9,255,068, and US 9,481,639, all assigned to Paratek Pharmaceuticals, Inc.
Cited Sources
- US8513223B2 - Substituted tetracycline compounds for treatment of inflammatory skin disorders - Google Patents
- Generic Seysara Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
