Personalized Pemafibrate Dosing Regimens with OATP1B Inhibitor Co-administration Consideration

Publication ID: 24-11857540_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Personalized Pemafibrate Dosing Regimens with OATP1B Inhibitor Co-administration Consideration,” Published Technical Disclosure No. 24-11857540_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857540_0006_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,540.

Summary of the Inventive Concept

The present invention provides an innovative approach to optimize pemafibrate dosing regimens by integrating OATP1B inhibitor co-administration status, ensuring safer and more efficient treatment of dyslipidemia.

Background and Problem Solved

The original pemafibrate dosing regimens patent (Patent Literature 1) has limitations in addressing the impact of OATP1B inhibitors on pemafibrate pharmacokinetics, leading to potential adverse effects and suboptimal treatment outcomes. The present invention addresses this limitation by incorporating OATP1B inhibitor co-administration status into the dosing regimen optimization process.

Detailed Description of the Inventive Concept

The inventive concept comprises a system and method for optimizing pemafibrate dosing regimens, which takes into account the patient's original daily dose and OATP1B inhibitor co-administration status. The system utilizes a dosing calculator module, a database of OATP1B inhibitors, and a patient data input module to determine an adjusted daily dose of pemafibrate. The method involves identifying the patient's OATP1B inhibitor co-administration status and adjusting the pemafibrate dosing regimen accordingly, using a pharmacokinetic model to minimize the risk of adverse effects.

Novelty and Inventive Step

The new claims introduce the novel concept of integrating OATP1B inhibitor co-administration status into pemafibrate dosing regimen optimization, which is not disclosed in the original patent. This inventive step provides a more personalized and efficient approach to treating dyslipidemia, distinguishing the present invention from the prior art.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include different types of OATP1B inhibitors, various pharmacokinetic models, and diverse patient data input modules. Additionally, the system and method could be adapted for use with other medications affected by OATP1B inhibitors, expanding the scope of the inventive concept.

Potential Commercial Applications and Market

The present invention has significant commercial potential in the pharmaceutical industry, particularly in the treatment of dyslipidemia. The innovative approach to pemafibrate dosing regimen optimization could lead to improved treatment outcomes, reduced adverse effects, and enhanced patient safety, ultimately increasing market share and revenue for pharmaceutical companies.

Field of Art

Pharmaceutical dosing optimization, specifically clinical pharmacology focusing on drug metabolism, pharmacokinetics, and personalized medicine approaches for lipid-modifying therapies

Person of Ordinary Skill (PHOSITA) Profile

A clinical pharmacologist or pharmaceutical researcher with expertise in drug dosing strategies, pharmacogenomics, drug-drug interactions, and quantitative pharmacokinetic modeling, holding an advanced degree with 3-5 years of specialized experience in lipid-modifying therapeutics

Obviousness Rationale

A PHOSITA would recognize that integrating OATP1B inhibitor co-administration status into pemafibrate dosing represents a predictable extension of existing dosing optimization strategies, leveraging known pharmacokinetic principles to personalize drug therapy and mitigate potential adverse interactions through systematic dose adjustment based on well-understood metabolic pathways.

Obvious Combinations & Variations

Source Patent Element
Original pemafibrate dosing method with 0.4 mg daily dose
PTD Variation
Dynamic dose adjustment based on OATP1B inhibitor co-administration status
Obviousness Reasoning
Predictable application of known pharmacokinetic dose modulation techniques to optimize drug safety and efficacy, utilizing standard pharmacological principles of drug metabolism interaction management
Source Patent Element
Base dosing reduction methodology from original patent
PTD Variation
Algorithmic dosing calculator module for personalized dose determination
Obviousness Reasoning
Routine computational implementation of existing dosing reduction strategies using standard software engineering techniques for medical decision support systems
Source Patent Element
Original patent's focus on dyslipidemia treatment
PTD Variation
Expanded pharmacokinetic model incorporating OATP1B inhibitor interactions
Obviousness Reasoning
Logical extension of existing therapeutic approach by systematically addressing known drug interaction mechanisms through quantitative pharmacological modeling
Source Patent Element
Base pemafibrate dosing protocol
PTD Variation
Patient-specific data-driven dosing optimization system
Obviousness Reasoning
Conventional application of personalized medicine principles to existing pharmaceutical dosing methodology, representing an expected evolutionary step in clinical pharmacotherapy
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857540 and the principles of pharmaceutical dosing optimization, the claimed variations in personalized pemafibrate dosing represent obvious modifications to the existing art that would be readily apparent to a person having ordinary skill in clinical pharmacology, thereby rendering potential derivative claims anticipated and non-patentable under standard obviousness analysis.

Original Patent Information

Patent NumberUS 11,857,540
TitlePemafibrate dosing regimens
Assignee(s)KOWA COMPANY, LTD.