Detailed Analysis of the Scope and Claims of United States Patent 6,258,795
Introduction
United States Patent 6,258,795, titled "Acylated uridine and cytidine and uses thereof," is a significant patent in the pharmaceutical sector, particularly in the treatment of hepatopathies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Issue Date
The patent was issued on July 10, 2001, to inventors Reid Warren von Borstel and Michael Kevin Bamat[4].
Patent Scope
The patent pertains to compositions comprising acyl derivatives of cytidine and uridine. These compounds are designed for the treatment of hepatopathies, which are diseases affecting the liver. The scope includes various formulations and methods of using these acylated nucleosides to improve liver function and health[4].
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Composition Claims: The patent claims compositions that contain acyl derivatives of cytidine and uridine. These compositions can be formulated in various ways, including pharmaceutical compositions suitable for treating hepatopathies[4].
- Method Claims: The patent also claims methods of treating hepatopathies using these acylated nucleosides. This includes specific dosages and administration routes[4].
- Specific Claims: Claims 10, 9, and 18 are particularly noteworthy as they are directed to "a composition or formulation which contains the active ingredient and reads on the composition or formulation approved for commercial marketing"[1].
Patent Claims and Scope Metrics
Research on patent scope often involves metrics such as independent claim length and independent claim count. These metrics can provide insights into 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, indicating that the claims in this patent may have undergone significant scrutiny to ensure their validity and specificity[3].
Regulatory Review and Patent Term Extension
The patent underwent a lengthy regulatory review process. The regulatory review period (RRP) spanned from May 4, 1992, to September 4, 2015, totaling 8,523 days. This period includes both the pre-grant and post-grant phases. The applicant sought a patent term extension under 35 U.S.C. § 156, which resulted in an extended expiration date of December 4, 2025[1].
Patent Term Extension Calculation
The extension was calculated based on the regulatory review period and the testing phase. The formula used was:
[ \text{Period of Extension} = \text{RRP} - \text{PGRRP} - \frac{1}{2}(\text{TP} - \text{PGTP}) ]
This calculation yielded an extension of 2,704 days, adding to the unextended expiration date of July 10, 2018, to result in an extended expiration date of December 4, 2025[1].
Related Patent Documents and Maintenance
The patent has been maintained through regular fee payments. Documents related to the patent, including receipts for maintenance fees, petitions to revive unintentionally delayed payments, and notices of payment acceptance, are part of the patent record[1].
Approved Product and Commercial Marketing
The patent claims the approved product XURIDEN (uridine triacetate), a human drug product reviewed by the FDA. The permission for commercial marketing was granted on September 4, 2015, after a comprehensive regulatory review process[5].
Broader Patent Landscape
The patent landscape for acylated nucleosides and their use in treating hepatopathies is complex. Patents in this area often face scrutiny regarding their scope and validity. The debates over patent quality, including concerns about overly broad patents and their impact on innovation, are relevant here. However, the specific claims and scope of this patent have been carefully defined and validated through the regulatory and patent examination processes[3].
Industry Impact
The approval and commercial marketing of XURIDEN have significant implications for the treatment of hepatopathies. This drug provides a new therapeutic option for patients, highlighting the importance of innovative pharmaceutical research and development.
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."
- Source: SSRN Paper on Patent Scope and Claims[3]
Key Takeaways
- Patent Scope: The patent covers compositions and methods involving acylated uridine and cytidine for treating hepatopathies.
- Claims: Specific claims include compositions, formulations, and methods of treatment.
- Regulatory Review: The patent underwent an extensive regulatory review process, resulting in a patent term extension.
- Approved Product: The patent claims the FDA-approved product XURIDEN (uridine triacetate).
- Industry Impact: The patent has significant implications for the treatment of hepatopathies and highlights the importance of pharmaceutical innovation.
FAQs
What is the main subject of United States Patent 6,258,795?
The main subject of the patent is compositions comprising acyl derivatives of cytidine and uridine, and their use in treating hepatopathies.
Who are the inventors of the patent?
The inventors are Reid Warren von Borstel and Michael Kevin Bamat.
What is the approved product claimed by the patent?
The approved product is XURIDEN (uridine triacetate), a human drug product reviewed by the FDA.
How was the patent term extension calculated?
The extension was calculated based on the regulatory review period and the testing phase, resulting in an extended expiration date of December 4, 2025.
What are the implications of this patent for the pharmaceutical industry?
The patent provides a new therapeutic option for treating hepatopathies, highlighting the importance of innovative pharmaceutical research and development.
What metrics are used to measure the scope of patent claims?
Metrics such as independent claim length and independent claim count are used to measure the scope and clarity of patent claims.
Sources
- FDA Application for Patent Term Extension: Patent No. 6,258,795 Application for Patent Term Extension[1].
- Regulations.gov Docket Details: Patent Term Application for XURIDEN, Patent No. 6,258,795[2].
- SSRN Paper on Patent Scope and Claims: Patent Claims and Patent Scope[3].
- Google Patents: US6258795B1 - Acylated uridine and cytidine and uses thereof[4].
- FDA U.S. FOOD & DRUG: Regulations.gov - Patent No. 6,258,795 filed by Wellstat Therapeutics Corporation[5].
