United States Patent 6,872,701: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,872,701, hereafter referred to as the '701 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent pertains to the drug telavancin, which is used to treat certain bacterial infections. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '701 patent was granted for the human drug telavancin, a bactericidal glycopeptide antibiotic used primarily for the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria[4].
Patent Scope
The scope of the '701 patent encompasses the composition, method of use, and manufacturing processes related to telavancin. Here are some key aspects:
Composition
The patent covers the chemical structure and formulation of telavancin, including its salts and hydrates. This ensures that any similar compounds or formulations would infringe on this patent[4].
Method of Use
The patent includes claims related to the therapeutic use of telavancin, specifying the conditions it is intended to treat and the dosages recommended. This protects the specific medical applications of the drug[4].
Manufacturing Processes
The patent also details the methods for synthesizing telavancin, which is crucial for maintaining exclusivity in production. Any entity seeking to manufacture a similar drug would need to avoid these patented processes[4].
Claims of the Patent
The '701 patent includes multiple claims that define the boundaries of the invention. Here are some types of claims typically found in such patents:
Independent Claims
These claims stand alone and define the core invention. For example, Claim 1 might describe the chemical structure of telavancin, while Claim 2 might outline the method of using telavancin to treat a specific infection[4].
Dependent Claims
These claims build upon the independent claims and provide additional details or limitations. For instance, a dependent claim might specify a particular dosage form or a specific bacterial infection treated by telavancin[4].
Patent Term and Extensions
The '701 patent had an original expiration date of June 5, 2021. However, the patent holder filed for patent term extensions (PTEs) under 35 U.S.C. ยง 156, which allows for the extension of the patent term to compensate for the time spent in regulatory review[4].
Regulatory Review Period
The regulatory review period for telavancin involved several stages, including the submission of the New Drug Application (NDA) and the subsequent approval by the FDA. The length of this period is crucial in determining the patent term extension[1].
Calculation of Patent Term Extension
The extension is calculated based on the regulatory review period, which includes the time from the submission of the NDA to the FDA approval. For the '701 patent, this period was significant, leading to a potential extension of the patent term[1].
Patent Landscape
The patent landscape surrounding the '701 patent is complex and involves multiple related patents.
Related Patents
Several other patents are associated with telavancin, including U.S. Patent Nos. 6,635,618 B2, 6,858,584 B2, 7,008,923 B2, and others. These patents cover various aspects of the drug, such as different formulations, methods of use, and manufacturing processes[4].
Patent Expiration Dates
Each of these patents has its own expiration date, which can impact the overall exclusivity period for telavancin. For example, some of these patents expired in 2021, while others extend into 2027[4].
Impact on the Pharmaceutical Industry
The '701 patent and its associated patents have significant implications for the pharmaceutical industry.
Exclusivity and Competition
The exclusivity provided by these patents allows the patent holder to maintain a monopoly on the market for telavancin, preventing generic competition until the patents expire[4].
Research and Development
The presence of these patents can influence research and development strategies for other pharmaceutical companies. They may need to develop alternative treatments or negotiate licensing agreements to avoid infringement[4].
Legal and Regulatory Considerations
The '701 patent is subject to various legal and regulatory considerations.
FDA Approval
The FDA approval process is a critical factor in determining the patent term extension. Any delays or changes in the regulatory process can impact the patent's expiration date[1].
Patent Term Extension Applications
The filing of PTE applications is a strategic move to extend the patent term. The outcome of these applications can significantly affect the patent's lifespan and the exclusivity period for the drug[4].
Conclusion
The United States Patent 6,872,701 is a pivotal intellectual property asset in the pharmaceutical sector, particularly for the drug telavancin. Understanding its scope, claims, and the broader patent landscape is essential for navigating the complex world of pharmaceutical patents.
Key Takeaways
- Patent Scope: Covers composition, method of use, and manufacturing processes related to telavancin.
- Claims: Includes independent and dependent claims defining the invention.
- Patent Term and Extensions: Original expiration date was June 5, 2021, with potential extensions based on regulatory review periods.
- Related Patents: Several other patents are associated with telavancin, each with its own expiration date.
- Impact on Industry: Maintains exclusivity, influences research and development, and is subject to legal and regulatory considerations.
FAQs
What is the primary use of the drug covered by the '701 patent?
The primary use of the drug covered by the '701 patent is the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria.
What is the significance of the patent term extension for the '701 patent?
The patent term extension compensates for the time spent in regulatory review, potentially extending the exclusivity period for the drug.
How does the '701 patent impact the pharmaceutical industry?
The '701 patent maintains exclusivity for the patent holder, preventing generic competition and influencing research and development strategies for other companies.
What are the key claims in the '701 patent?
The key claims include independent claims defining the chemical structure and therapeutic use of telavancin, and dependent claims providing additional details or limitations.
How does FDA approval affect the '701 patent?
FDA approval is crucial in determining the patent term extension, as it marks the end of the regulatory review period used to calculate the extension.
Sources
- Regulations.gov: "Statement as to the Length of Extension Claimed and How the Length Was Determined" - FDA-2010-E-0022-0002.
- Regulations.gov: "UNITED STATES PATENT AND TRADEMARK OFFICE" - FDA-2010-E-0024-0001.
- USPTO: "Patent Claims Research Dataset" - USPTO Economic Research.
- Theravance, Inc.: "THERAVANCE, INC. 901 GATEWAY BLVD. SOUTH SAN FRANCISCO, CA 94080" - Investor.inva.com.
