In mid-January, the U.S. Patent & Trademark Office (USPTO) is expected to announce dates and places for hearings on confirming genetic diagnostic tests. USPTO faces a June 16 deadline for submitting to Congress a study on “effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.” Advocates for such testing say the current system based on patent eligibility drives up costs, limits patient options, reduces innovation, and harms medical practice. Developers of diagnostics, however, say patent eligibility provides the financial incentives that allow them to recoup the costs of developing the tests. Where does the truth lie?

Poll Question:
Do you believe the U.S. can develop a system to protect innovator diagnostic firms but also safeguard those offering confirming tests against patent infringement?




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