United States Patent 5,703,017: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,703,017 is a significant patent that has undergone various legal and regulatory processes, including applications for patent term extensions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 5,703,017. While the specific title of the patent is not provided in the sources, it is part of a series of patents related to pharmaceutical or biomedical innovations, as indicated by the context of regulatory review periods and patent term extensions[1].
Inventors and Assignees
The inventors and assignees of the patent are crucial for understanding the ownership and development history. However, the sources provided do not specify the names of the inventors or assignees. Typically, this information can be found in the patent document itself or through a search on the USPTO database[4].
Scope of the Patent
Technical Field
The technical field of U.S. Patent 5,703,017 is likely related to pharmaceuticals or biomedical products, given the regulatory review periods mentioned. This field often involves complex chemical compounds, biological processes, or medical devices.
Claims
The claims of a patent define the scope of the invention and are critical for determining what is protected. For U.S. Patent 5,703,017, the specific claims are not detailed in the provided sources. However, claims typically include descriptions of the invention, its components, and how it operates. To understand the claims fully, one would need to review the patent document directly[4].
Regulatory Review Period
FDA Approval and NDA Process
The patent has undergone a regulatory review process, which is a common requirement for pharmaceutical and biomedical patents. The regulatory review period includes the IND (Investigational New Drug) phase and the NDA (New Drug Application) phase. For U.S. Patent 5,703,017, the NDA phase and subsequent approval are key factors in determining the patent term extension[1].
Patent Term Extension
The patent term extension is calculated based on the regulatory review period. For U.S. Patent 5,703,017, the applicant sought a patent term extension of 995 days, which is part of a broader application that includes other related patents (U.S. Patent Nos. 5,840,722 and 5,932,730)[5].
Patent Term Adjustment
Calculation of Extension
The patent term adjustment is calculated according to 35 U.S.C. §154(b) and 37 C.F.R. §1.775. This involves subtracting the time spent in regulatory review before the patent grant and any lack of due diligence from the total regulatory review period. For U.S. Patent 5,703,017, the net preliminary term extension was determined to be 225 days, although this specific patent sought a 995-day extension as part of a combined application[1].
Patent Landscape
Related Patents
U.S. Patent 5,703,017 is part of a family of patents that include U.S. Patent Nos. 5,840,722 and 5,932,730. These patents are related in terms of their regulatory review periods and the applications for patent term extensions. The applicant has to elect one of these applications to proceed to grant and withdraw the others during the co-pendency of these applications[1].
Industry Impact
Patents like U.S. Patent 5,703,017 play a significant role in the pharmaceutical and biomedical industries. They protect innovative products and processes, allowing companies to recoup their investment in research and development. The extension of patent terms can significantly impact the market by delaying generic competition and maintaining the exclusivity of the patented product.
Search and Analysis Tools
USPTO Resources
To analyze patents like U.S. Patent 5,703,017, several tools are available from the USPTO. The Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) provide comprehensive resources for searching and analyzing patent documents. These tools help in understanding the patent family, prior art, and the overall patent landscape[4].
Duty of Disclosure
Compliance with Regulations
Applicants seeking patent term extensions have a duty to disclose any information material to the determination of entitlement to the extension. This duty is defined in 37 C.F.R. §1.765 and ensures transparency and compliance with regulatory requirements[1].
Fees and Charges
Application Fees
The application for a patent term extension involves prescribed fees. For U.S. Patent 5,703,017, the applicant is required to pay a fee of $1,120.00, as set forth in 37 C.F.R. §1.200, along with any additional fees that may be required during the pendency of the application[1].
Key Takeaways
- Regulatory Review Period: The patent term extension is calculated based on the regulatory review period, including IND and NDA phases.
- Patent Term Adjustment: The adjustment involves subtracting time spent in regulatory review and any lack of due diligence from the total regulatory review period.
- Related Patents: U.S. Patent 5,703,017 is part of a family of related patents, and the applicant must elect one application to proceed to grant.
- Industry Impact: Patents in this field protect innovative products and processes, significantly impacting the pharmaceutical and biomedical industries.
- Search and Analysis Tools: USPTO resources such as Patent Public Search and Global Dossier are essential for analyzing patent documents.
FAQs
What is the significance of the regulatory review period in patent term extensions?
The regulatory review period, which includes the IND and NDA phases, is crucial for calculating the patent term extension. It determines the maximum potential length of the patent extension.
How is the patent term adjustment calculated?
The patent term adjustment is calculated by subtracting the time spent in regulatory review before the patent grant and any lack of due diligence from the total regulatory review period.
What other patents are related to U.S. Patent 5,703,017?
U.S. Patent 5,703,017 is related to U.S. Patent Nos. 5,840,722 and 5,932,730, as part of a combined application for patent term extensions.
Why is the duty of disclosure important in patent term extension applications?
The duty of disclosure ensures transparency and compliance with regulatory requirements, helping to determine the entitlement to the patent term extension.
What fees are associated with applying for a patent term extension?
The application involves a prescribed fee of $1,120.00, as set forth in 37 C.F.R. §1.200, along with any additional fees that may be required during the pendency of the application.
Sources
- IN THE UNITED STATES PATENT AND TRADEMARK OFFICE In re ... - U.S. Patent and Trademark Office.
- Determination of Regulatory Review Period for ... - Federal Register.
- Patent Claims Research Dataset - USPTO.
- Search for patents - USPTO.
- Federal Register/Vol. 74, No. 26/Tuesday, February 10 ... - GovInfo.