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The Wild, Wild West Of Laboratory Developed Tests, John Gilmore
The Wild, Wild West Of Laboratory Developed Tests, John Gilmore
Washington and Lee Law Review Online
Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label …
Decisionmaking In Patent Cases At The Federal Circuit, Jason Reinecke
Decisionmaking In Patent Cases At The Federal Circuit, Jason Reinecke
Washington and Lee Law Review
This Article provides the results of an empirical study assessing the impact of panel composition in patent cases at the Federal Circuit. The dataset includes 2675 three-judge panel-level final written decisions and Rule 36 summary affirmances issued by the Federal Circuit between January 1, 2014 and May 31, 2021. The study informs the longstanding debate concerning whether the Federal Circuit is succeeding as a court with nationwide jurisdiction in patent cases and provides insight into judicial decisionmaking more broadly. And several results show that many of the worst fears that commentators have about the Federal Circuit appear overstated or untrue. …