No link – unmodified genes are still ineligible under PERA and isolated gene eligibility is a prerequisite to disease research
Mark Deem, 2024 – Operating Partner at Lightstone Ventures, a Menlo Park-based firm that invests in innovative biotech and medtech companies. Questions for the Record from Senator Alex Padilla Senate Judiciary Committee “The Patent Eligibility Restoration Act – Restoring Clarity, Certainty, and Predictability to the U.S. Patent System” 1/23, https://www.judiciary.senate.gov/imo/media/doc/2024-01-23_-_qfr_responses_-_deem.pdf //DH
It is important to acknowledge the point that many opponents of PERA have advanced – genes as part of the human body are not eligible and never were. PERA emphasizes that unmodified genes as they exist in the human body will remain ineligible. PERA is intended to override the Supreme Court’s decision in the Myriad Genetics case with respect to genes that have been isolated or otherwise modified by human effort. Stated differently, PERA will allow the eligibility of “genes that have been isolated, purified, enriched or otherwise altered by human activity,” provided they meet the other statutory tests for patentability. Isolating a gene to determine its specific function or the specific types of cell in which the gene expresses its particular protein often requires a lengthy study and extensive experimentation. Patents create incentives to invest time and capital in determining the correlation between a particular gene and a particular disease state, so eligibility is an essential prerequisite.