Patent Law Practice Center

Patent: Medication Selection and Dosing Based on Individual Genetic Makeup

One of the most important but unresolved problems in therapy with potent and often toxic drugs has been inability to describe, understand, and quantify the relationships and variability between drug doses, concentrations in blood, and the interplay between therapeutic and toxic drug effects. Defining drug action and inter-patient variability has been, for the most part, limited to simplistic descriptions of average maximum and minimum drug dosages. Until recently, this has not permitted true individualization of therapy for each patient.

Although significant inter-individual variability has been known to exists in the response to most medications, medication selection has historically used empiric data rather than individualized. This is despite the fact that the FDA is increasingly recognizing the importance of the genetic contribution to the individual variation in response to therapy. Nevertheless, the main reason that physicians have not incorporated genetic and non-heritable host factors into treatment plans is the lack of applicable, easy to use algorithms that translate the patient’s characteristics into clinical recommendations.

Cincinnati Children’s Hospital Medical Center (CCHMC) recently received U.S. Patent No. 8,589,175, titled Optimization and individualization of medication selection and dosing, which may change the way individual variability based on genetic make-up is utilized in order to both select and prescribe certain medicines.  The CCHMC patent specifically covers methods for optimizing dosing regimens for medications utilizing population models, genotype, and clinical information to treat patients with neuropsychiatric and other disorders.  Assurex Health is the exclusive worldwide licensee of the technology covered under the CCHMC patent and has developed pharmacogenomic tests for psychiatric, ADHD, and pain medications.

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