PERA causes a proliferation of patent thickets over biomarkers – that makes genetic diagnosis prohibitively expensive
Richard L. Blaylock, 2024 - partner with the law firm Pillsbury Winthrop Shaw Pittman LLP and have been a practicing intellectual property attorney since the mid-1990s. Statement Before the Subcommittee on Intellectual Property of the Committee on the Judiciary United States Senate Hearing on The Patent Eligibility Restoration Act – Restoring Clarity, Certainty, and Predictability to the U.S. Patent System, 1/24, https://www.judiciary.senate.gov/imo/media/doc/2024-01-23_-_testimony_-_blaylock.pdf //DH
PERA would slam the door shut on such innovation and also its clinical application in medicine. PERA would permit the privatization of natural phenomena in the form of knowledge of new biomarkers and their clinical relevance. Because the discernment of new (to us) biomarkers is highly distributed, patent filing on each new biomarker would proliferate with a very large and internationally dispersed group of patent applicants. Any one of those new patentees could stand in the way of a clinician’s effort to conduct an analysis of a patient’s genetic information because testing for a broad panel of possible variants would require permission from all of a large group of patentees, none of whom would be required to grant such permission.
From a policy perspective, we urge the subcommittee to think of natural phenomena such as biomarkers as pre-competitive information that is discovered and not invented and should be available to all. As noted above, this information is rapidly being developed now and privatization of such information is unnecessary to its discernment. Moreover, such privatization of natural phenomena biomarkers would impair patient self-knowledge about their own genetic make-up and critically an understanding of some of its implications.