Wednesday, November 5, 2014

Personalized Medicine Update

Personalized medicine uses an individual patient’s variations with respect to one or more biomarkers or combination of biomarkers to determine which is the most appropriate pharmaceutical or medical intervention.   Such biomarkers can be genetic variations or other variations.  In Mayo Collaborative Services v. Prometheus Laboratories (Mayo v. Prometheus) the “biomarker” was the level of the metabolite in a patient who had been given a thiopurine drug, and the Supreme Court held that a patent that taught how to adjust the drug dosage after measuring the metabolite was invalid as an attempt to patent a natural phenomenon.  After one of Myriad Genetics’ patent claims related to gene sequences used in its genetic test for breast cancer risk was similarly invalidated as a natural phenomenon or product of nature, the biotech and diagnostic industries were understandably concerned.  Personalized medicine is clearly a vitally important area for future healthcare and the extent to which the difficulty of obtaining intellectual property protection for pharmacogenomic testing or other personalized medicine assays could delay or undermine progress in the area is a question of great importance.  The North Carolina Journal of Law and Technology recently devoted a symposium to the question of the significance of the decision in the Myriad case and Chris Holman’s contribution to that symposium, in which he considers the potential impact of Mayo and Myriad on personalized medicine is particularly worth reading.

By happenstance, I came across a reference to Holman’s article just after reading that the Centers for Medicare and Medicaid Services (CMS) had approved coverage in North Carolina for a multi-gene assay used to determine the appropriate pharmacotherapy for older persons with severe depression who had failed to respond to an initial anti-depressant drug.  The  CMS coverage determination for the MolDX: GeneSight® Assay for Refractory Depression is an important step forward in the acceptance and use of pharmacogenomics and includes a summary of the supporting clinical data that is extremely interesting.

I will try to keep readers of this blog informed of further developments in the critical area of personalized medicine.  The value is clear, the science is accelerating, and the policy issues are challenging, so stay tuned.

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