United States Patent 8,143,212: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,143,212, titled "Dalbavancin Compositions for Treatment of Bacterial Infections," is a significant patent in the pharmaceutical sector, particularly in the area of antibiotic treatments. This patent, assigned to Allergan (formerly Actavis, and initially to Vicuron Pharmaceuticals, Inc.), is crucial for understanding the intellectual property landscape surrounding dalbavancin, a glycopeptide antibiotic used to treat bacterial infections.
Inventors and Assignees
The patent was invented by Martin Stogniew, Luigi Colombo, and Romeo Ciabatti, and it was assigned to Vicuron Pharmaceuticals, Inc., which has since been acquired by Allergan, now part of AbbVie Inc.[4].
Patent Details
Filing and Grant Dates
The patent application was filed on June 2, 2009, and the patent was granted on March 27, 2012[4].
Patent Claims
The patent includes multiple claims that cover various aspects of dalbavancin compositions and their use in treating bacterial infections. Here are some key claims:
- Composition Claims: These claims cover the specific formulations of dalbavancin, including the active ingredient, excipients, and the method of preparation[4].
- Method Claims: These claims pertain to the methods of treating bacterial infections using dalbavancin compositions. This includes the dosage, administration route, and treatment regimens[4].
Scope of Protection
The scope of protection for this patent is broad, covering not only the specific chemical composition of dalbavancin but also its therapeutic applications. Here are some key aspects:
- Chemical Composition: The patent protects the specific chemical structure of dalbavancin and its derivatives, ensuring that any similar compounds would infringe on this patent[4].
- Therapeutic Use: The patent covers the use of dalbavancin for treating bacterial infections, including skin and skin structure infections, and other infections caused by Gram-positive bacteria[4].
Patent Landscape
Related Patents and Exclusivities
Dalbavancin is protected by multiple patents, including US 8,143,212. Here is an overview of the patent landscape:
- Active and Expired Patents: As of the current date, one patent related to dalbavancin is active, while three others have expired. The active patent ensures exclusivity for the drug until its estimated generic launch date in May 2028[2].
- Patent Term Extensions: The patent term for dalbavancin has been extended due to regulatory review periods, which is common for pharmaceutical patents to compensate for the time spent in regulatory approval processes[2].
Generic Competition
The Hatch-Waxman Act plays a crucial role in the generic competition landscape for drugs like dalbavancin. Here are some key points:
- Paragraph IV Certification: Generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with a Paragraph IV certification, challenging the validity or non-infringement of the listed patents. The first filer can gain a 180-day exclusivity period to market the generic version[1].
- Generic Launch Date: The estimated generic launch date for dalbavancin is May 23, 2028, based on the current patent and exclusivity landscape[2].
Claim Coverage and Scope Concepts
To analyze the patent claims effectively, it is essential to use tools like Claim Coverage Matrices and Claim Charts:
- Claim Coverage Matrix: This tool helps in categorizing patents by claims and scope concepts, making it easier to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
- Claim Charts: These charts are generated using software like ClaimScape® and help in reviewing patent coverage with technical experts. They facilitate the identification of areas where claim coverage is lacking and highlight future design opportunities[3].
Impact on Pharmaceutical Industry
The patent landscape for dalbavancin has significant implications for the pharmaceutical industry:
- Innovation Incentives: Patents like US 8,143,212 provide incentives for brand-name firms to innovate while facilitating the eventual marketing of generic pharmaceuticals. This balance is crucial for driving innovation and reducing healthcare costs[1].
- Market Dynamics: The exclusivity period granted by patents affects market dynamics, allowing brand-name drugs to capture a significant market share before generic competition enters. For example, as of 2016, generics accounted for 89% of prescriptions but only 26% of total medicine spending, while brand drugs were 11% of prescriptions but responsible for 74% of drug spending[1].
Key Takeaways
- Patent Scope and Claims: US 8,143,212 protects the chemical composition and therapeutic use of dalbavancin, ensuring broad protection for the drug.
- Patent Landscape: The patent landscape includes multiple related patents, with one active patent extending exclusivity until May 2028.
- Generic Competition: Generic manufacturers can challenge the patent through Paragraph IV certification, with the first filer gaining a 180-day exclusivity period.
- Claim Analysis Tools: Tools like Claim Coverage Matrices and Claim Charts are essential for analyzing patent claims and identifying gaps or opportunities.
- Industry Impact: The patent landscape influences innovation, market dynamics, and healthcare costs, highlighting the importance of balancing brand-name and generic drug markets.
FAQs
What is the main subject of United States Patent 8,143,212?
The main subject of United States Patent 8,143,212 is dalbavancin compositions for the treatment of bacterial infections.
Who are the inventors of this patent?
The inventors of this patent are Martin Stogniew, Luigi Colombo, and Romeo Ciabatti.
What is the current status of the patents related to dalbavancin?
As of the current date, one patent related to dalbavancin is active, while three others have expired.
When is the estimated generic launch date for dalbavancin?
The estimated generic launch date for dalbavancin is May 23, 2028.
How do generic manufacturers challenge the patent for dalbavancin?
Generic manufacturers can challenge the patent by filing an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, which challenges the validity or non-infringement of the listed patents.
Sources
- Seyfarth Shaw LLP, "The BioLoquitur Bulletin: Drugs Available in 2018 For Generic Competition" [PDF].
- Pharsight - GreyB, "Dalvance patent expiration".
- Schwegman Lundberg & Woessner, "Patent Analytics".
- United States Patent and Trademark Office, "United States Patent 8,143,212 B2".
