Detailed Analysis of the Scope and Claims of United States Patent 5,744,501
Introduction
United States Patent 5,744,501, titled "Sertraline hydrochloride for the treatment of premenstrual dysphoric disorder," is a significant patent in the pharmaceutical industry, particularly in the treatment of anxiety-related and hormonal disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent, issued to Pfizer Inc., pertains to the use of sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI), for the treatment of premenstrual dysphoric disorder (PMDD) and other related conditions. Sertraline hydrochloride, known by its brand name Zoloft, is chemically defined as (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride[4].
Claims and Scope
The patent includes several claims that define the scope of the invention:
Independent Claims
- The primary claim focuses on the method of treating PMDD using sertraline hydrochloride. This claim specifies the dosage and administration regimen for effective treatment[4].
Dependent Claims
- Dependent claims elaborate on the method by specifying different aspects such as the duration of treatment, dosage adjustments, and combinations with other therapeutic agents[4].
Patent Scope Metrics
To understand the scope of this patent, we can use metrics such as independent claim length and independent claim count, as suggested in research on patent scope[3].
- Independent Claim Length: The length of the independent claims can indicate the breadth of the invention. In this case, the claims are relatively specific, focusing on the method of treatment rather than broad therapeutic uses.
- Independent Claim Count: The number of independent claims is limited, indicating a focused scope on the treatment of PMDD.
Examination Process and Patent Quality
The examination process for this patent would have involved a thorough review to ensure the claims were clear, novel, and non-obvious. Research indicates that the examination process tends to narrow the scope of patent claims, ensuring that the granted patents have a higher probability of validity and a shorter examination process[3].
Maintenance and Expiration
Patents in the United States require maintenance fees to be paid at 3.5, 7.5, and 11.5 years after the grant date to remain in force. Failure to pay these fees results in the patent expiring[2].
Government Interest and Funding
The Bayh-Dole Act allows universities and other federal grant recipients to patent inventions created under federal funding. However, this patent does not appear to have been developed under such funding, as there is no indication of government-interest statements or public-sector patents associated with it[1].
Industry Impact and Market Dominance
The approval and patenting of sertraline hydrochloride for PMDD significantly impacted the pharmaceutical market. It provided a targeted treatment option for a specific condition, contributing to Pfizer's market dominance in the SSRI segment.
Litigation and Licensing
Patents like 5,744,501 can be subject to litigation and licensing agreements. The clarity and specificity of the claims can influence licensing costs and the likelihood of litigation. In this case, the focused scope of the patent likely reduced the risk of broad litigation challenges[3].
Forward Citations and Novelty
Forward citations, which are citations by later patents, can indicate the novelty and impact of a patent. While specific forward citation data for this patent is not provided here, the fact that sertraline hydrochloride has become a standard treatment for PMDD suggests significant influence in the field.
Broader Patent Landscape
The broader patent landscape for SSRIs and treatments for PMDD includes numerous patents covering different aspects such as formulations, dosages, and combinations with other drugs. This landscape is highly competitive, with multiple pharmaceutical companies holding patents in this area.
Key Takeaways
- Specific Scope: The patent has a specific scope focused on the treatment of PMDD using sertraline hydrochloride.
- Maintenance Requirements: Regular maintenance fees are necessary to keep the patent in force.
- Industry Impact: The patent significantly contributed to Pfizer's market presence in the SSRI segment.
- Litigation and Licensing: The clarity of claims reduces the risk of litigation and influences licensing agreements.
- Novelty and Influence: The patent's impact is evident from its widespread use and recognition in treating PMDD.
Frequently Asked Questions (FAQs)
Q: What is the primary claim of United States Patent 5,744,501?
A: The primary claim is for the method of treating premenstrual dysphoric disorder (PMDD) using sertraline hydrochloride.
Q: How does the Bayh-Dole Act relate to this patent?
A: The Bayh-Dole Act does not apply to this patent as it was not developed under federal funding.
Q: What are the maintenance requirements for this patent?
A: Maintenance fees must be paid at 3.5, 7.5, and 11.5 years after the grant date to keep the patent in force.
Q: How does the scope of this patent compare to other patents in the field?
A: The scope is relatively specific, focusing on the treatment of PMDD, which is different from broader patents covering various therapeutic uses.
Q: What is the significance of forward citations for this patent?
A: Forward citations indicate the patent's influence and novelty, though specific data is not provided here.
Sources:
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research.
- Patent and Trademark Office Notices - United States Patent and Trademark Office.
- Patent Claims and Patent Scope - Social Science Research Network.
- Processes for the preparation of sertraline hydrochloride - Google Patents.
