The exclusions in PERA are so narrow that they’re meaningless – it expressly allows patenting isolated or enriched genes or natural material

PERA would impose effectively no limits on the patenting of genes and other natural materials and natural phenomena. While PERA contains exclusions from patentable subject matter for human genes and natural materials, PERA also contains substantial exceptions to those exclusions such that the “exclusions” of genes and other natural materials are so narrow as to be almost meaningless. Specifically, the bill excludes from patentability both “an unmodified human gene, as that gene exists in the human body,” and “an unmodified natural material, as that material exists in nature.” However, the bill expressly states that any gene or natural material that has either been “isolated, purified, enriched, or otherwise altered by human activity,” or “otherwise employed in a useful invention or discovery” ( where useful is defined in PERA to mean anything that has a specific and practical utility) is not “unmodified” and therefore would be eligible for patenting. Such a claim allowed under PERA would permit the privatization of newly observed biomarkers as detection of the presence or absence of a biomarker routinely involves the isolation, purification, or enrichment of a fragment of a genetic sequence embodying the natural variant that is the biomarker. Moreover, the last exception to these exclusions is telling because even if the natural material is completely unmodified and is existing exactly as it is found in nature it would still be patentable under PERA in the context of any alleged practical use for it. People do not seek to patent things as they exist in situ naturally, but instead seek to claim natural materials in the ways that humans may try to exploit them. PERA could permit patenting of natural materials that would prevent people from engaging in research on or engaging in any practical use of such natural material.