"Prometheus acknowledged that physicians can infringe the patent by merely thinking about the relationship between drug metabolite levels and patient response," asserted Dr. Schrijver. "It is encouraging that the Court recognized that the Prometheus patents neither promote the advancement of medical practice, nor benefit patient care".
"In Prometheus, the Court wisely recognized that overly broad patents can inhibit innovation," stated Jennifer Hunt, MD, MEd, the Organization's President-Elect. "Establishing a drug reference range is important, but standard work for laboratory physicians. Awarding monopolies over the medical use of natural, biological relationships stifles innovation in true diagnostic test methods and obstructs improvements for patient care."
AMP believes the Supreme Court's reasoning in Mayo v. Prometheus extends to patents that claim ownership over another type of natural phenomenon, the biological relationships between genetic variants and clinical disease. Such relationships are at the heart of personalized medicine. "Patients are increasingly being disadvantaged by gene correlation patents," stated Roger D. Klein, MD, JD, Chair of AMP's Professional Relations Committee. As an example, Dr. Klein cited a method patent relating to a variation in a gene known as FLT3 that is used to qualify some leukemia patients for bone marrow transplant.
Enforcement of the FLT3 patent by a private company has been forcing physicians and laboratories to split and geographically distribute irreplaceable bone marrow specimens. "Splitting samples creates an additional risk of specimen loss and delays the receipt of patient results" stated Dr. Klein. "In addition, it interferes with the ability of pathologists to provide synoptic interpretations involving multiple tests, and prevents them from implementing cost saving algorithms that limit unnecessary testing. The Supreme Court's ruling is clearly a win both for our patients and for personalized healthcare."
Provided by Association for Molecular Pathology
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