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- CAP Provides Critical Feedback on Patent-Reform
The CAP has outlined how gene patenting needs to have patent-eligibility, and that no single company or group should have sole jurisdiction on gene patenting. In a September 3 letter to the US Patent and Trade Office (USPTO), the CAP explained its position in three areas asked by the USPTO on gene patenting: Observations and Experiences in Gene Patenting, Precision Medicine, and Diagnostic Methods. Citing patient safety concerns, the CAP has long opposed gene patenting.
As genomic medicine evolves, it will become a cornerstone of medical diagnostics, requiring specialized medical knowledge in test selection, interpretation, and integration of test results with patients' medical history. The CAP sent a letter to the USPTO detailing how the patenting of genes and other laws of nature, natural phenomena, products of nature, and abstract ideas would negatively impact the practice of medicine and patient care.
“Patents over genes and gene sequences pose a serious threat to patient care, medical advancement, and medical education,” the CAP stated in the letter. “Allowing commercial entities to patent genes will impede the provision of genetic-based clinical testing and patient care through exclusive license agreements, excessive licensing fees, and restrictive licensing conditions.”
The CAP further discussed how a single entity should not have diagnostic ownership of specific diseases or serve as gatekeepers for therapeutic treatments. “If gene sequences and other natural phenomena can be considered intellectual property, a company with monopoly rights over the related disease can significantly hinder critical research,” the CAP emphasized.
The CAP also reinforced that "patent reform must maintain the judicially created exceptions to patent-eligibility as restricted by the Mayo, Myriad, and Alice decisions.” In addition, patent reform should not ignore the patenting of human genes and naturally occurring associations between genes and disease, as it would create barriers to patients’ access to lifesaving genetic/genomic tests.
The CAP understands how pathologists have a vested interest in ensuring that patent reform does not restrict the ability of physicians to provide quality diagnostic services to patients.