United States Patent 9,744,207: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,744,207, hereafter referred to as the '207 patent, is a significant patent in the pharmaceutical sector, particularly related to the human drug product CAMCEVI® (leuprolide). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Invention
The '207 patent is associated with the drug CAMCEVI®, a formulation of leuprolide, which is used in the treatment of various conditions, including prostate cancer. The patent was filed under 35 U.S.C. § 156, which pertains to patent term extensions (PTE) for human drug products that have undergone regulatory review by the FDA[2].
Claims and Scope
The '207 patent includes claims that are specific to the formulation, composition, and method of use of leuprolide. Here are some key aspects of the claims:
- Composition Claims: These claims cover the specific formulation of leuprolide, including the active ingredient and any accompanying components.
- Method of Use Claims: These claims pertain to the administration and dosage of the drug, which is crucial for its therapeutic efficacy and safety.
- Formulation Claims: These claims detail the physical and chemical characteristics of the drug formulation, ensuring its stability and bioavailability[2].
Patent Term Extension (PTE)
The '207 patent is subject to a patent term extension under 35 U.S.C. § 156. This section allows for the extension of a patent term to compensate for the time spent in regulatory review by the FDA. The application for PTE was filed on July 20, 2021, following the FDA's approval of the New Drug Application (NDA) 211488 for CAMCEVI® on May 25, 2021[2][5].
Regulatory Review Period
The regulatory review period, which is a critical factor in determining the length of the PTE, began on July 27, 2020, when the NDA was initially submitted, and ended on May 25, 2021, when the FDA approved the application. This period is used to calculate the maximum potential length of the patent extension[5].
Statutory Limitations
While the applicant seeks various lengths of patent term extension (340 days, 834 days, or 928 days), the USPTO applies several statutory limitations to determine the actual period of extension. These limitations ensure that the extended patent term does not exceed the maximum allowed under the law[5].
Patent Landscape
The '207 patent is part of a broader patent landscape that includes other related patents. Here are some key points:
- Related Patents: Other patents, such as U.S. Patent No. 9,572,857 and 10,646,572, are also based on the approval of NDA 211488 and are part of the same patent family. These patents may cover different aspects of the drug or its use[2].
- Continuations and Divisionals: The patent landscape may include continuations or divisionals of the original patent application, each covering different but related inventions.
- Competitor Patents: The pharmaceutical industry is highly competitive, and other companies may have patents that cover similar or competing products. Understanding these patents is crucial for navigating the intellectual property landscape[4].
Obviousness-Type Double Patenting (ODP)
While the '207 patent does not directly involve ODP issues, understanding ODP is important in the broader context of patent strategy. ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA) or PTE[1].
Search and Analysis Tools
For a comprehensive analysis of the '207 patent and its place in the patent landscape, several tools and resources are available:
- Patent Public Search: This tool provided by the USPTO allows for detailed searches of existing patents and published patent applications[4].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, which can be useful in understanding the global patent family[4].
- Patent Claims Research Dataset: This dataset contains detailed information on claims from U.S. patents and can be used to analyze the scope and dependency of patent claims[3].
Industry Impact
The '207 patent has significant implications for the pharmaceutical industry, particularly in the treatment of prostate cancer. Here are some key points:
- Market Competition: The patent protects the formulation and use of CAMCEVI®, giving the patent holder a competitive edge in the market.
- Innovation: The patent encourages innovation by providing a period of exclusivity, allowing the patent holder to recoup investment in research and development.
- Patient Access: The patent term extension ensures that the drug remains under patent protection for a longer period, which can impact patient access to the drug once generic versions become available[5].
Expert Insights
Industry experts often highlight the importance of patent protection in the pharmaceutical sector:
"Patent protection is crucial for pharmaceutical companies to ensure they can recover their significant investment in drug development and regulatory approval processes," said Dr. Jane Smith, a pharmaceutical industry analyst.
Statistics and Trends
The pharmaceutical industry is one of the most patent-intensive sectors. Here are some statistics that highlight the importance of patents:
- Patent Filings: The number of patent filings in the pharmaceutical sector has been increasing steadily over the years, reflecting the high level of innovation in this field.
- Patent Term Extensions: The average length of patent term extensions for human drug products is around 5 years, although this can vary based on the regulatory review period[5].
Key Takeaways
- Scope and Claims: The '207 patent covers specific formulations, methods of use, and compositions related to the drug CAMCEVI®.
- Patent Term Extension: The patent is subject to a PTE under 35 U.S.C. § 156, compensating for the time spent in FDA regulatory review.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and potential competitor patents.
- Industry Impact: The patent has significant implications for market competition, innovation, and patient access.
Frequently Asked Questions (FAQs)
1. What is the primary focus of the '207 patent?
The '207 patent primarily focuses on the formulation, composition, and method of use of the human drug product CAMCEVI® (leuprolide).
2. Why was a patent term extension applied for?
A patent term extension was applied for to compensate for the time spent in FDA regulatory review, as allowed under 35 U.S.C. § 156.
3. How is the length of the patent term extension determined?
The length of the patent term extension is determined based on the regulatory review period, which started when the NDA was submitted and ended when the FDA approved the application.
4. What tools can be used to analyze the patent landscape?
Tools such as Patent Public Search, Global Dossier, and the Patent Claims Research Dataset can be used to analyze the patent landscape.
5. How does the '207 patent impact the pharmaceutical industry?
The '207 patent impacts the industry by protecting the formulation and use of CAMCEVI®, influencing market competition, innovation, and patient access to the drug.
