United States Patent 7,932,241: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,932,241, hereafter referred to as the '241 patent, is a significant intellectual property asset related to pharmaceutical products, specifically those comprising bisphosphonates. This patent has been a crucial factor in the protection and development of drugs like Zoledronic Acid. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '241 patent was granted for pharmaceutical products that include a container containing a bisphosphonate solution, with the internal surface of the container being treated to prevent interaction with the bisphosphonate[1][2][5].
Scope of the Patent
Product Description
The patent covers pharmaceutical products that contain bisphosphonates, such as Zoledronic Acid, which is commonly used in treatments for conditions like osteoporosis and bone metastases. The patent specifically addresses the formulation and packaging of these products to ensure stability and efficacy[1].
Container Treatment
A key aspect of the patent is the treatment of the container's internal surface to prevent adverse interactions between the container material and the bisphosphonate solution. This ensures the drug remains stable and effective throughout its shelf life[1].
Claims of the Patent
Main Claims
The '241 patent includes several claims that define the scope of protection:
- Claim 1: A pharmaceutical product comprising a container containing a bisphosphonate solution, where at least the internal surface of the container is treated to prevent interaction with the bisphosphonate.
- Subsequent Claims: These claims further specify the types of bisphosphonates, the treatment methods for the container, and other details related to the formulation and packaging[1].
Dependent Claims
Dependent claims build upon the main claims, providing additional specifics such as the types of materials used for the container, the methods of treating the container surface, and the concentrations of the bisphosphonate solution[1].
Patent Expiration and Protection
Expiration Date
The '241 patent is set to expire on August 5, 2028. This expiration date includes any extensions or exclusivities that may have been granted[2][5].
Patent Certifications
Generic manufacturers seeking to produce versions of drugs protected by this patent must submit specific certifications to the FDA. These include Paragraph IV certifications, which state that the generic product does not infringe on the patent or that the patent is invalid or unenforceable[5].
Patent Landscape
Related Patents
The '241 patent is part of a broader landscape of patents related to bisphosphonates and their formulations. Other patents, such as the '987 patent, cover different aspects like method of use patents, which do not claim the same indications as the '241 patent[5].
Generic Availability
With the patent nearing its expiration, generic versions of drugs like Reclast (Zoledronic Acid) are being approved. However, the commercial availability of these generics depends on various factors, including the resolution of any patent infringement disputes and the completion of regulatory approvals[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection and potential gaps, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where opportunities or gaps exist[3].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that help technical experts, engineers, and management review patent coverage. These charts are useful for determining whether a particular scope concept is applicable to a target product or method and for identifying areas where claim coverage is lacking[3].
Regulatory and Legal Considerations
FDA Approvals and Notifications
Generic manufacturers must comply with FDA regulations, including notifying the patent holder and submitting the necessary certifications. Failure to comply can result in legal actions and delays in approval[5].
Patent Infringement
The '241 patent has been the subject of Paragraph IV certifications, where generic manufacturers have argued that the patent is invalid, unenforceable, or not infringed by their products. These disputes are critical in determining the timeline for generic entry into the market[5].
Impact on the Pharmaceutical Industry
Market Competition
The expiration of the '241 patent will likely increase market competition for bisphosphonate-based drugs. Generic versions will offer more affordable alternatives, potentially altering market dynamics and pricing strategies for branded products[2].
Innovation and Development
The protection offered by the '241 patent has allowed for significant investment in research and development of bisphosphonate therapies. As the patent expires, companies may focus on developing new formulations or indications to maintain market share[1].
Key Takeaways
- The '241 patent protects pharmaceutical products containing bisphosphonates, with a focus on container treatment to ensure drug stability.
- The patent expires on August 5, 2028, and generic versions are being approved.
- Patent analytics tools are essential for understanding the scope of protection and identifying gaps.
- Regulatory compliance and legal considerations are critical for generic manufacturers.
- The expiration of the patent will increase market competition and may drive innovation in new formulations or indications.
FAQs
What is the main subject of the '241 patent?
The '241 patent covers pharmaceutical products containing bisphosphonates, specifically focusing on the treatment of the container's internal surface to prevent interaction with the bisphosphonate solution.
When does the '241 patent expire?
The '241 patent is set to expire on August 5, 2028.
What are the implications of the '241 patent expiration for generic manufacturers?
The expiration allows generic manufacturers to produce and market their versions of bisphosphonate-based drugs, provided they comply with FDA regulations and submit the necessary certifications.
How do patent analytics tools help in understanding the '241 patent?
Patent analytics tools, such as Claim Coverage Matrix and interactive claim charts, help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and determining the applicability of scope concepts to target products or methods.
What is the impact of the '241 patent expiration on the pharmaceutical industry?
The expiration will increase market competition, potentially leading to more affordable alternatives and driving innovation in new formulations or indications.
Sources
- US7932241B2 - Pharmaceutical products comprising bisphosphonates - Google Patents
- Generic Reclast Availability - Drugs.com
- Patent Analytics - SLWIP
- 203231Orig1s000 - accessdata.fda.gov
- ANDA 091363Orig1s000 - accessdata.fda.gov
