Detailed Analysis of the Scope and Claims of United States Patent 9,629,861
Introduction
United States Patent 9,629,861, titled "Compositions and methods for treating bacterial infections using ceftaroline," is a crucial patent in the pharmaceutical landscape, particularly for the drug Teflaro, which is owned by AbbVie Inc. This patent is one of the active patents protecting Teflaro, a cephalosporin antibiotic used to treat various bacterial infections.
Patent Overview
Patent Number and Title
- Patent Number: 9,629,861
- Patent Title: Compositions and methods for treating bacterial infections using ceftaroline[2][4][5].
Inventors and Assignees
- Inventors: Dirk Thye and George Talbot
- Assignees: Forest Laboratories Holding Limited, now part of AbbVie Inc.[4][5].
Issue Date
The patent was issued on April 25, 2017[4][5].
Patent Claims and Scope
Claim Structure
The patent includes a series of claims that define the scope of the invention. These claims are divided into independent and dependent claims.
- Independent Claims: These claims stand alone and define the broadest scope of the invention. They typically describe the core elements of the invention without referencing other claims.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations, narrowing the scope of the invention[3].
Specific Claims
The patent 9,629,861 focuses on compositions and methods for treating bacterial infections using ceftaroline fosamil. Here are some key aspects of the claims:
- Compositions: The patent claims cover specific formulations of ceftaroline fosamil, including its use in various dosage forms such as injectable solutions.
- Methods of Treatment: The claims also include methods for treating bacterial infections, specifying the types of infections and the dosing regimens[4][5].
Patent Expiration Date
The patent is set to expire on September 21, 2030. This date is critical as it marks when the exclusive rights granted by the patent will lapse, potentially allowing generic versions of Teflaro to enter the market[2][4][5].
Legal Activities and Maintenance
To maintain the patent's validity, various legal activities have been undertaken:
- Maintenance Fees: Payments of maintenance fees are essential to keep the patent in force. For example, a payment of the 4th-year maintenance fee for this patent was made on October 26, 2020[2][4].
- Litigation and Challenges: The patent has been subject to litigation and challenges. For instance, paragraph IV certifications have been filed by generic manufacturers, asserting that the patent is invalid, unenforceable, or will not be infringed by their products[4].
Impact on Generic Launch
The expiration of this patent, along with other related patents, will significantly impact the availability of generic versions of Teflaro. Currently, there are no therapeutically equivalent generic versions of Teflaro available in the United States. However, several generic applications have been filed, and these will likely be approved once the patent protection expires[5].
Patent Landscape
Related Patents
Teflaro is protected by a portfolio of patents, including:
- US8247400: Cephem compounds useful for the treatment of bacterial infections, expiring on February 10, 2031.
- US9629861: Compositions and methods for treating bacterial infections using ceftaroline, expiring on September 21, 2030.
- Expired Patents: Several other patents related to Teflaro have already expired, such as US6906055, US7419973, and US6417175[1][2][4].
Exclusivity and Market Rights
In addition to patent protection, Teflaro benefits from FDA-granted exclusivity periods, which can run concurrently with patent protection. These exclusivity periods can range from 180 days to seven years, depending on the circumstances[5].
Metrics for Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Conclusion
United States Patent 9,629,861 is a pivotal patent in the protection of Teflaro, ensuring AbbVie Inc.'s exclusive rights to the drug until its expiration in 2030. The patent's claims and scope are carefully defined to cover specific compositions and methods of treatment, and its maintenance and legal activities are crucial in maintaining its validity.
Key Takeaways
- Patent Number and Title: 9,629,861, "Compositions and methods for treating bacterial infections using ceftaroline."
- Inventors and Assignees: Dirk Thye, George Talbot, and Forest Laboratories Holding Limited.
- Issue Date: April 25, 2017.
- Expiration Date: September 21, 2030.
- Claims: Cover compositions and methods for treating bacterial infections using ceftaroline fosamil.
- Legal Activities: Include maintenance fee payments and litigation.
- Impact on Generic Launch: Expiration will allow generic versions of Teflaro to enter the market.
FAQs
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What is the main focus of United States Patent 9,629,861?
- The patent focuses on compositions and methods for treating bacterial infections using ceftaroline fosamil.
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Who are the inventors of this patent?
- The inventors are Dirk Thye and George Talbot.
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When is the patent set to expire?
- The patent is set to expire on September 21, 2030.
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What are the implications of this patent's expiration for generic versions of Teflaro?
- The expiration will allow generic versions of Teflaro to enter the market, as the exclusive rights granted by the patent will lapse.
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Are there any current generic versions of Teflaro available in the United States?
- No, there are currently no therapeutically equivalent generic versions of Teflaro available in the United States.
Sources
- Pharsight: Teflaro patent expiration.
- Pharsight: Drug Patents containing Ceftaroline Fosamil.
- Hoover Institution: Patent Claims and Patent Scope.
- FDA: Ceftaroline Fosamil for Injection.
- Drugs.com: Generic Teflaro Availability.
