TheScientist | The debate over the patenting of technologies related to diagnostic and personalized medicine continues to swell with no resolution in sight. The Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. last December, but has not yet issued a decision. Just last month, the US Patent and Trademark Office held public hearings to gather information for the “study on genetic testing” that it will use to prepare a report for Congress on this issue. And, the Supreme Court is deciding whether to review the Federal Circuit decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the BRCAI/gene patenting case), although current speculation is that the Court may defer any action on this case until it issues its decision in Prometheus. While each of these proceedings raises different legal issues, they all relate to the ability to obtain or enforce patent rights on genes, tests, and methods used in personalized medicine.
Personalized medicine is the new frontier of healthcare. It offers the promise of treatments that are tailored to a patient’s individual situation, including the patient’s genetic makeup, the specific variation of the disease the patient suffers from, and the patient’s specific response to a given course of treatment. With personalized medicine, a patient can be given the most effective treatment, improving prognosis and saving considerable time and money on ineffective treatments. As noted on the US Food and Drug Administration’s Pharmacogentics webpage, “[p]harmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.”
The question being debated is whether these advances are most likely to flourish within the patent system or outside of it. Do patents promote investment in personalized medicine or stifle innovation by suppressing competition? Do patients benefit from patented therapies, or do they suffer without treatments because they are too expensive? The Founding Fathers established the patent system in the US Constitution as an incentive to “promote the Progress of Science and useful Arts,” but should a different paradigm apply to medical inventions?
Personalized medicine is the new frontier of healthcare. It offers the promise of treatments that are tailored to a patient’s individual situation, including the patient’s genetic makeup, the specific variation of the disease the patient suffers from, and the patient’s specific response to a given course of treatment. With personalized medicine, a patient can be given the most effective treatment, improving prognosis and saving considerable time and money on ineffective treatments. As noted on the US Food and Drug Administration’s Pharmacogentics webpage, “[p]harmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.”
The question being debated is whether these advances are most likely to flourish within the patent system or outside of it. Do patents promote investment in personalized medicine or stifle innovation by suppressing competition? Do patients benefit from patented therapies, or do they suffer without treatments because they are too expensive? The Founding Fathers established the patent system in the US Constitution as an incentive to “promote the Progress of Science and useful Arts,” but should a different paradigm apply to medical inventions?
