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Confusion over the patenting of laboratory diagnostics in wake of recent court decisions has curtailed enthusiasm for private investment in these technologies. A scientific session at the 71st AACC Annual Scientific Meeting & Clinical Lab Expo, Intellectual Property and Landmark Patent Lawsuits: The Role of U.S. Patents for Clinical Laboratory Diagnostic Tests (34103), will address the reasoning behind these decisions and what it takes these days to patent a molecular diagnostic test.

The current environment is extremely unsettled, according to session co-presenter Jonathan Loeb, a partner with Dechert LLP in Palo Alto, California. “On the one hand, recent court decisions have considerably restricted what is patentable in the diagnostics area.” A good example of this is the Supreme Court’s ruling in Mayo v. Prometheus that a natural correlation between biomarker and the therapeutic efficacy of a drug is a natural law and therefore can’t be patented. At the same time, “judges of the Federal Circuit Court of Appeals have expressly asked the Supreme Court to clarify, and potentially modify, its restrictive rulings on diagnostic testing,” Loeb said.

Congress has also been considering legislation that would significantly change the governing law. “Thus, action by either the Supreme Court or Congress has the potential for restoring the patentability of many diagnostic technologies,” Loeb said.

The session will explain why the courts have intervened to change U.S. law about patentable subject matter. As someone who’s served as an expert witness on patent lawsuits over the past few years, session moderator Alan Wu, PhD realizes how essential patent eligibility is for startup in vitro diagnostics companies to succeed. “Understanding intellectual property helps explain to clinical lab directors why some technologies are not available to them, e.g., cardiac troponin T versus cardiac troponin I,” Wu, a professor of laboratory medicine at the University of California, San Francisco, told CLN Stat.

Loeb will discuss what is patentable and enforceable against competitors today, summarizing patenting diagnostic methods and systems, and methods of treatment based on personalized medicine technologies. Robert Cook-Deegan, a professor at Arizona State University’s School for the Future of Innovation in Society, will offer insights on the court decisions that have impacted molecular diagnostics. Cook-Deegan “is someone close to the BRCA1 patent cases,” Wu said.

This scientific session at the 71st AACC Annual Scientific Meeting & Clinical Lab Expo will take place August 7 from 10:30 a.m. to noon and is worth 1.5 ACCENT credit hours.