CAP ’13 – THE Pathologists’ Meeting – October 13 – 16, 2013™
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PM100  A Tale of Two Patents: The Legal Status of Patents on Laboratory Tests

Sunday, October 13
9:30–11:30 AM

Professionalism System Based Practice

The issue of medical ethics versus commercial ethics was the foundation of the recent Supreme Court decision in Mayo Collective Services v Prometheus Laboratories and may determine its decision in the pending case of Association for Molecular Pathology v Myriad Genetics. The Prometheus case called into question the patentability of a laboratory test for measuring thiopurine drug metabolites for evaluating the efficacy of those drugs in treating specific patients with certain autoimmune disorders. The Myriad Genetics case will address the validity of patents for isolated DNA containing the BRCA1 and BRCA2 gene sequences. This course will discuss the conceptual underpinnings of the United States patent laws, explain how these laws diverge from medical ethics, and explore their application in the area of laboratory medicine. These issues have inherent intellectual interest for pathologists and important economic consequences for laboratories. Attend this course and you will understand the issues that go into the analysis of determining whether various tests used in medical laboratories—and discoveries relating to the human genome—are, and should be, patentable.

You will learn to:

Jack R. Bierig, JD





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